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Objectives: Patient-centered communication (PCC) occurs when clinicians respond to patients' needs, preferences, and concerns. While PCC is associated with better health-related quality of life in patients with cancer, patients with ovarian cancer have reported unmet communication needs. We used design thinking to develop an intervention to promote PCC in ovarian cancer care., Methods: Following the steps of design thinking, we empathized with stakeholders by reviewing the literature, then created stakeholder and journey maps to define the design challenge. To ideate solutions, we developed a challenge map. Finally, we developed wireframe prototypes and tested them with stakeholders., Results: Empathizing revealed that misaligned visit priorities precipitated suboptimal communication. Defining the design challenge and ideating solutions highlighted the need to normalize preference assessments, promote communication self-efficacy, and enhance visit efficiency. The Collaborative Agenda-Setting Intervention (CASI) elicits patients' needs and preferences and delivers communication guidance at the point of care. Stakeholders approved of the prototype., Conclusion: Design thinking provided a systematic approach to empathizing with stakeholders, identifying challenges, and innovating solutions., Practice Implications: To our knowledge, the CASI is the first intervention to set the visit agenda and support communication from within the electronic health record. Future research will assess its usability and acceptability., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Objective: To assess the role of self-efficacy as a mediator of the association between patient-centred communication (PCC) and health-related quality of life (HRQoL) in a sample of participants with ovarian cancer., Methods: English-speaking adults with ovarian cancer completed a cross-sectional survey. We assessed self-efficacy with the Self-Efficacy for Managing Chronic Disease scale, PCC with the Patient-Centred Communication in Cancer Care-36, and HRQoL with the Functional Assessment of Cancer Therapy-General. We used the PROCESS macro to calculate regression coefficients for the total effect of PCC on HRQoL and direct effect of PCC on HRQoL. We calculated a 95% CI for the indirect effect of PCC on HRQoL using 10 000 bootstrapped samples., Results: The total effect of PCC on HRQoL (9.47, 95% CI 6.21 to 12.74) was greater than the direct effect of PCC on HRQoL (3.47, 95% CI 0.73 to 6.21). The indirect effect of PCC on HRQoL was 6.00 (95% CI 3.56 to 8.95). Self-efficacy explained approximately 63.4% of the association between PCC and HRQoL., Conclusions: Self-efficacy partially mediated the association between PCC and HRQoL. Self-efficacy is a potential target for communication interventions that aim to improve HRQoL. Research to validate this finding in the setting of a randomised trial is warranted., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Poly(ADP-ribose) polymerase inhibitors (PARPi) have dramatically changed treatment for advanced ovarian cancer, but nearly half of patients experience significant fatigue. We conducted a two-site pilot randomized trial to evaluate the feasibility, acceptability, and preliminary efficacy of a brief, acceptance-based telehealth intervention (REVITALIZE) designed to reduce fatigue interference in patients on PARPi., Methods: From June 2021 to April 2022, 44 participants were randomized 1:1 to REVITALIZE (6 weekly one-on-one sessions+booster) or enhanced usual care. Feasibility was defined as: ≥50% approach-to-consent among potentially eligible patients and ≥70% completion of 12-week follow-up assessment; acceptance was <20% participants reporting burden and <20% study withdrawal. Fatigue, anxiety, depression, and quality of life were assessed at baseline, 4-, 8- and 12-weeks., Results: Among 44 participants (mean age = 62.5 years, 81.8% stage III/IV disease), the study was feasible (56.4% approach-to-consent ratio, 86.3% completion of 12-week assessment) and acceptable (0% reporting burden, 11.3% study withdrawal). At 12-week follow-up, REVITALIZE significantly reduced fatigue interference (Cohen's d = 0.94, p = .008) and fatigue severity (d = 0.54, p = .049), and improved fatigue levels (d = 0.62, p = .04) relative to enhanced usual care. REVITALIZE also showed promise for improved fatigue self-efficacy, fatigue catastrophizing, anxiety, depression, and quality of life (ds = 0.60-0.86, p ≥ .05). Compared with enhanced usual care, REVITALIZE participants had fewer PARPi dose reductions (6.7% vs. 19.0%), and dose delays (6.7% vs. 23.8%)., Conclusions: Among fatigued adults with ovarian cancer on PARPi, a brief, acceptance-based telehealth intervention was feasible, acceptable, and demonstrated preliminary efficacy in improving fatigue interference, severity, and levels. REVITALIZE is a novel, scalable telehealth intervention worthy of further investigation., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: Greater perceived patient-centered communication (PCC) is associated with better health-related quality of life (HRQoL) in patients with ovarian cancer. Quantitative measures of PCC and HRQoL do little to explain this association. We interviewed patients with high and low ratings of PCC to understand how it is associated with HRQoL., Methods: Explanatory sequential mixed methods study. Participants were English-speaking U.S. adults with ovarian cancer. We assessed PCC with the Patient-Centered Communication - Cancer (PCC-Ca)-36 (possible score range 1-5; higher scores represent greater patient-centeredness), and purposively sampled 14 participants with total scores in the top and bottom quartiles. Participants completed individual, semi-structured interviews about their communication experiences. Guided by the National Cancer Institute Framework for PCC in Cancer Care, we analyzed interview transcripts using directed content analysis. We integrated survey and interview findings in a joint display., Results: Among 176 survey respondents, PCC-Ca-36 total scores ranged from 1.7 to 5.0. Participants with scores in the top quartile (4.8-5.0) perceived clinicians as proactive and attentive to psychosocial concerns. Those with scores in the bottom quartile (1.7-3.5) described not feeling known as an individual and receiving limited support for self-management., Conclusions: The association between PCC and QoL may be partially explained by differences in perceived support for psychosocial concerns and self-management. PCC may facilitate receipt of proactive, personalized care., Competing Interests: Declaration of Competing Interest Authors RAP, NX, FH, AAW, BAG, MLU, JAT, MJH, and DLB have nothing to disclose., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Purpose: PARP inhibitor resistance may be overcome by combinatorial strategies with agents that disrupt homologous recombination repair (HRR). Multiple HRR pathway components are HSP90 clients, so that HSP90 inhibition leads to abrogation of HRR and sensitisation to PARP inhibition. We performed in vivo preclinical studies of the HSP90 inhibitor onalespib with olaparib and conducted a Phase 1 combination study., Patients and Methods: Tolerability and efficacy studies were performed in patient-derived xenograft(PDX) models of ovarian cancer. Clinical safety, tolerability, steady-state pharmacokinetics and preliminary efficacy of olaparib and onalespib were evaluated using a standard 3 + 3 dose-escalation design., Results: Olaparib/onalespib exhibited anti-tumour activity against BRCA1-mutated PDX models with acquired PARPi resistance and PDX models with RB-pathway alterations(CDKN2A loss and CCNE1 overexpression). Phase 1 evaluation revealed that dose levels up to olaparib 300 mg/onalespib 40 mg and olaparib 200 mg/onalespib 80 mg were safe without dose-limiting toxicities. Coadministration of olaparib and onalespib did not appear to affect the steady-state pharmacokinetics of either agent. There were no objective responses, but disease stabilisation ≥24 weeks was observed in 7/22 (32%) evaluable patients including patients with BRCA-mutated ovarian cancers and acquired PARPi resistance and patients with tumours harbouring RB-pathway alterations., Conclusions: Combining onalespib and olaparib was feasible and demonstrated preliminary evidence of anti-tumour activity., (© 2021. The Author(s), under exclusive licence to Springer Nature Limited.)

Objective: To describe perceptions of patient-centered communication (PCC); assess whether physician specialty, patient characteristics, or health system characteristics are associated with PCC; and identify associations between PCC, health-related quality of life (HRQoL), and symptom burden among individuals with ovarian cancer., Methods: Cross-sectional, descriptive survey of English-speaking adults with ovarian cancer. PCC, HRQoL, and ovarian cancer symptom burden were assessed with the PCC-Ca-36, the FACT-G, and the FOSI-18, respectively. PCC-Ca-36 scores were summarized using descriptive statistics. Predictors of PCC-Ca-36, FACT-G, and FOSI-18 scores were identified using multiple linear regression., Results: Participants (n = 176) had a mean age of 59.4 years (SD = 12.1). The majority (65.9%) had advanced-stage disease, while 42.0% were receiving treatment. The mean PCC-Ca-36 total score was 4.09 (SD = 0.78) out of a possible 5, indicating participants often perceived that clinicians engaged in PCC. Among the PCC functions, participants reported that clinicians least often enabled patient self-management (M = 3.65, SD = 0.99), responded to emotions (M = 3.84, SD = 1.04), and managed uncertainty (M = 3.91, SD = 0.93). In multivariable analyses, neither physician specialty nor patient and health system characteristics were significantly associated with overall PCC. Greater overall PCC predicted better overall HRQoL; better social/family, emotional, and functional well-being; and lower overall and physical symptom burden (all p ≤ 0.05)., Conclusion: Greater PCC is significantly associated with better HRQoL and lower symptom burden among individuals with ovarian cancer., Practice Implications: Promotion of PCC is a promising strategy to improve patient-reported outcomes in the ovarian cancer care setting., Competing Interests: Declaration of Competing Interest Authors RAP, NX, FH, AAW, BAG, MLU, JAT, MJH, and DLB have nothing to declare. The authors confirm that all patient/personal identifiers have been removed or disguised so the patient/person(s) described are not identifiable and cannot be identified through the details of the story., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Quality of life and patient reported outcome measures (PROMs) are important secondary endpoints and incorporated in most contemporary clinical trials. There have been deficiencies in their assessment and reporting in ovarian cancer clinical trials, particularly in trials of maintenance treatment where they are of particular importance. The Gynecologic Cancer InterGroup (GCIG) symptom benefit committee (SBC) recently convened a brainstorming meeting with representation from all collaborative groups to address questions of how to best incorporate PROMs into trials of maintenance therapies to support the primary endpoint which is usually progression free survival (PFS). These recommendations should harmonize the collection, analysis and reporting of PROM's across future GCIG trials., Methods: Through literature review, trials analysis and input from international experts, the SBC identified four relevant topics to address with respect to promoting the role of PROMs to support the PFS endpoint in clinical trials of maintenance treatment for OC., Results: The GCIG SBC unanimously accepted the importance of integrating PROM's in future maintenance trials and developed four guiding principles to be considered early in trial design. These include 1) adherence to SPIRIT-PRO guidelines, 2) harmonization of selection, collection and reporting of PROM's; 3) combining Health Related Quality of Life (HRQL) measures with clinical endpoints and 4) common approaches to dealing with incomplete HRQL data., Conclusions: Close attention to incorporating HRQL and PROM's is critical to interpret the results of ovarian cancer clinical trials of maintenance therapies. There should be a consistent approach to assessing and reporting patient centered benefits across all GCIG trials to enable cross trial comparisons which can be used to inform practice., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: Physical activity improves physical function, quality of life, and mental health, yet fewer than 80% of ovarian cancer survivors meet activity guidelines. This pilot intervention study aimed to increase physical activity in ovarian cancer survivors by leveraging principles of behavioral economics, gamification, and social support., Methods: This 24-week study (12-week intervention; 12-week follow-up) enrolled women with ovarian cancer after completion of first-line treatment with a self-selected "teammate." Participants used Fitbits to measure daily steps, select an increased step goal, and enroll in a collaborative game, including points and levels for achieving step goals. Primary outcomes were feasibility (defined a priori as ≥60% approach-to-consent ratio and ≥ 70% adherence to Fitbit), acceptability (≤20% of participants reporting burden or regret for participation) and preliminary efficacy (≥70% reporting increased motivation); exploratory outcomes included change in steps., Results: We recruited 24 participants (mean age = 63 years, range = 37-79 years) with a 94% approach-to-consent ratio. All participants completed the intervention with 94% tracker adherence. At 24-week follow-up, 1/24 (≤5%) of participants reported burden; 0/24 (0%) reported regret for study participation; and 22/24 (>90%) agreed/strongly agreed that "the study motivated me to increase activity levels." Participants' mean daily steps were 6210.7 (±3328.1) at baseline and increased to 7643 (± 3610.9) steps (p < 0.001) during the 12-week intervention., Conclusions: This pilot study demonstrated feasibility, acceptability, and preliminary efficacy, justifying a larger randomized clinical trial to test efficacy at increasing activity levels. Future studies should examine strategies for maintaining increased activity levels in survivors over time., (Copyright © 2021. Published by Elsevier Inc.)

Objective: Germline genetic testing is crucial to the care of ovarian cancer patients, and as part of the guideline-based care for ovarian cancer patient's adherence to this recommendation has been low. We sought to determine whether embedding a genetic counselor (GC) within a medical and gynecologic oncology clinic would increase testing rates and improve the timeliness of testing., Methods: Prospective cohort study of 358 ovarian cancer patients seen by medical and gynecologic oncologists between 2013 and 2015. Rates of referrals, completion of counseling, and genetic testing and timeliness of counseling were abstracted before and after a GC was embedded in the clinic in 2014. An additional year of data (2015) was collected to evaluate sustainability of the intervention., Results: Between 2013 and 2015, 88-92% of women were referred for genetic testing, but in 2013 only 66% completed counseling and 61% were tested. After a GC was embedded in the clinic in 2014, more than 80% of referred women completed counseling and germline genetic testing. Time to genetic counseling also decreased from a median of 107 to 40 days, irrespective of age and cancer family history (p < 0.01)., Conclusions: Embedding a GC into the workflow for ovarian cancer patients is an effective way of improving access to genetic counseling, testing rates, and the timeliness of testing., Competing Interests: Declaration of Competing Interest Dr. Judy E. Garber has the following COI: personal fees from Helix Genetics, Novartis Oncology, GTx, Aleta BioTherepeutics, H3 Biomedicine, Inc., Kronos Bio, American Society of Clinical Oncology (ASCO), James P. Wilmot Foundation, Inc., Diane Helis Henry Medical Research Foundation, and Adrienne Helis Melvin Medical Research Foundation, and other from Myriad Genetics, Astrazeneca, Ambry Genetics, Invitae Genetics, GV20 Therapeutics, American Association for Cancer Research, Breast Cancer Research Foundation, Konica Minolta, and Facing Our Risk of Cancer Empowered, outside the submitted work. Dr. Ursula Matulonis has the following COI: personal fees from Astrazeneca, Myriad Genetics, Clovis, Merck, Eli Lilly, Mersana, Geneos, Fuji Film, Cerulean, Immunogen, Novartis, and 2× Oncology, outside the submitted work. Ms. Kipnis reports personal fees from Invitae outside the submitted work. All other authors have nothing to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Purpose: The aim of this study was to estimate effects on life expectancy (LE) of imaging-based ovarian surveillance after detection of incidental postmenopausal ovarian cysts, under different assumptions of patient age, comorbidity level, and cancer risk and detection., Methods: A decision-analytic Markov model was developed to estimate LE benefits. Hypothetical cohorts of postmenopausal women with simple ovarian cysts were evaluated, with varied age (66-80 years) and comorbidity level (none, mild, moderate, severe). For each cohort, imaging "follow-up" (2 years) and "no-follow-up" strategies were compared. Consistent with current evidence, increased cancer risk in patients with cysts was not assumed; however, incident ovarian cancers could be detected during follow-up. To estimate theoretical maximal LE gains from follow-up, perfect ovarian cancer detection and treatment during follow-up were assumed. This and other key assumptions were varied in sensitivity analysis., Results: Projected LE gains from follow-up were limited. For 66-, 70-, 75-, and 80-year-old women with no comorbidities, LE gains were 5.1, 5.1, 4.5, and 3.7 days; with severe comorbidities, they were 3.5, 3.2, 2.7, and 2.1 days. With sensitivity of 50% for cancer detection, they were 3.7 days for 66-year-old women with no comorbidities and 1.3 days for 80-year-old women with severe comorbidities. When cancer risk for women with cysts was assumed to be elevated (1.1 times average risk), LE gains increased only modestly (5.6 and 2.3 days for analogous cohorts)., Conclusions: Even in the circumstance of perfect ovarian cancer detection and treatment, surveillance of postmenopausal women (≥66 years of age) with simple cysts affords limited benefits, particularly in women with advanced age and comorbidities., (Copyright © 2020 American College of Radiology. Published by Elsevier Inc. All rights reserved.)

Objective: Oral PARP inhibitors (PARPi) have dramatically changed the treatment landscape for patients with advanced ovarian cancer. However, a subset of patients discontinue PARPi due to treatment-related fatigue. The current study sought to explore patients' lived experiences with fatigue on PARPi., Methods: We conducted individual semi-structured interviews with N = 23 women receiving PARPi for advanced ovarian cancer who reported moderate to severe fatigue. Audiotaped interviews were transcribed and we used thematic analysis to code transcripts for emergent themes., Results: Four overarching themes emerged. First, participants described their fatigue as milder than what they experienced on intravenous chemotherapy, but noted it consistently limited their daily activities, including work, and interfered with participation in family and social events. Second, fatigue negatively impacted participants' sense of self and identity. Third, most wanted to continue treatment and believed discontinuing PARPi would lead to a cancer recurrence or death. Finally, many participants reported that their support networks were unaware of their ongoing cancer treatment or the resulting fatigue; a situation that may prove isolating and result in reduced social support., Conclusions: Our findings underscore patients' persistent experience of fatigue on PARPi, the impact of fatigue on multiple domains of functioning, and a lack of understanding of side effects resulting from oral maintenance treatments among patients' social networks. Our findings highlight the need for interventions to address treatment-related fatigue to limit the negative impacts of fatigue on ovarian cancer patients' well-being., Competing Interests: Declaration of Competing Interest The authors declare no conflicts of interest., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: Pegylated liposomal doxorubicin (PLD) in vitro may have immunomodulatory abilities and preclinical evidence suggests it synergizes with immune checkpoint blockade. We hypothesized that combining PLD and pembrolizumab would be active in patients with platinum-resistant ovarian cancer (PROC)., Methods: This was a single-arm, multi-center phase II trial. Eligible patients had PROC with ≤2 prior lines of cytotoxic therapy for recurrent or persistent disease. Twenty-six patients were enrolled and given pembrolizumab 200 mg intravenously (IV) every 3 weeks and PLD 40 mg/m 2 IV every 4 weeks. Patients were assessed radiographically every 8 weeks. The primary endpoint was clinical benefit rate (CBR), defined as complete response (CR) + partial response (PR) + stable disease (SD) ≥24 weeks. The study was powered to detect an improvement in CBR from 25% to 50%, with rejection of the null hypothesis if at least 10 patients achieved clinical benefit. T-cell inflamed gene expression profiles (GEP) and PD-L1 were assessed and correlated with clinical outcome., Results: Twenty-three patients were evaluable for best overall response. The study satisfied its primary endpoint, with 12 patients achieving clinical benefit for a CBR of 52.2% (95% CI 30.6-73.2%). There were 5 PRs (21.7%) and 1 CR (4.3%), for an overall response rate (ORR) of 26.1%. Six patients had SD lasting at least 24 weeks. Combination therapy was well tolerated without unexpected toxicities., Conclusions: The combination of pembrolizumab and PLD was manageable, without unexpected toxicities, and showed preliminary evidence of clinical benefit in the treatment of platinum resistant ovarian cancer. ORR and median PFS of combination therapy in this study was higher than historical comparisons of PLD alone or anti-PD-1/PD-L1 agents alone., Trial Registration: Clinicaltrials.gov identifier: NCT02865811., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Fatigue is a common and distressing symptom for patients with gynecologic cancers. Few studies have empirically examined whether it spontaneously resolves. This study was aimed at identifying longitudinal patterns of fatigue and predictors of clinically significant fatigue 1 year after treatment completion., Methods: This was a prospective cohort study of women with newly diagnosed ovarian (n = 81) or endometrial cancer (n = 181) that did not progress or recur within 1 year of treatment completion. Symptoms of fatigue, depression, and anxiety were assessed after surgery and 6 and 12 months after treatment completion with the Fatigue Assessment Scale and the Hospital Anxiety and Depression Scale. Patients' fatigue scores over time were classified (scores of 22-50, clinically significant; scores of 10-21, not clinically significant). Logistic regression models were fit to examine associations between fatigue and patient characteristics., Results: Among 262 participants, 48% reported clinically significant fatigue after surgery. One year later, 39% reported fatigue. There were 6 patterns over time: always low (37%), always high (25%), high then resolves (18%), new onset (10%), fluctuating (6%), and incidental (5%). Patients with fatigue after surgery were more likely to report fatigue at 12 months in comparison with others (odds ratio [OR], 6.08; 95% confidence interval [CI], 2.82-13.11; P < .001). Patients with depressive symptoms also had higher odds of fatigue (OR, 3.36; 95% CI, 1.08-10.65; P = .039), although only one-third of fatigued patients reported depressive symptoms., Conclusion: Nearly half of women with gynecologic cancers had clinically significant fatigue after surgery, whereas 44% and 39% had fatigue 6 months and 1 year later; this suggests that spontaneous regression of symptoms is relatively rare. Women who reported fatigue, depressive symptoms, or 2 or more medical comorbidities had higher odds of reporting fatigue 1 year later. Future studies should test scalable interventions to improve fatigue in women with gynecologic cancers., (© 2020 American Cancer Society.)

Although sexual dysfunction after ovarian cancer (OC) treatment is a common side effect, intervention for this issue remains largely unaddressed in the literature. To address this gap, we recently developed and tested a theory-driven psychosexual intervention that successfully improved sexual function in OC survivors. This study is a secondary analysis to determine whether the intervention effects were consistent with our theoretical model. We expected that improved self-efficacy, sexual knowledge and emotional distress would relate to improved sexual function, and that effects of sexual knowledge and self-efficacy on sexual function would be mediated by emotional distress. 46 OC survivors completed study measures prior to and two-months following the intervention. Results indicated that self-efficacy, sexual knowledge, and emotional distress improved significantly post-intervention. While self-efficacy and emotional distress were both directly associated with sexual function; contrary to expectation, change in knowledge was not. Results also demonstrated that the relationship between self-efficacy and sexual function was not mediated by emotional distress. Clinical implications underscore the importance of promoting self-efficacy and decreasing emotional distress in the context of sexual rehabilitation treatment for OC survivors. Next steps include refining the intervention based on these findings and testing in a larger, randomized trial of gynecological cancer survivors.

Background: Most women with advanced epithelial ovarian cancer develop recurrent disease, despite maximal surgical cytoreduction and adjuvant platinum-based chemotherapy. In observational studies, secondary cytoreductive surgery has been associated with improved survival; however its use is controversial, because there are concerns that the improved outcomes may reflect selection bias rather than the superiority of secondary surgery., Objective: To compare the overall survival of women with platinum-sensitive recurrent ovarian cancer treated at National Cancer Institute-designated cancer centers who receive secondary surgery vs chemotherapy., Study Design: This retrospective cohort study included women from 6 National Cancer Institute-designated cancer centers diagnosed with platinum-sensitive recurrent ovarian cancer between January 1, 2004, and December 31, 2011. The primary outcome was overall survival. Propensity score matching was used to compare similar women who received secondary surgery vs chemotherapy. Additional analyses examined how these findings may be influenced by the prevalence of unobserved confounders at the time of recurrence., Results: Among 626 women, 146 (23%) received secondary surgery and 480 (77%) received chemotherapy. In adjusted analyses, patients who received secondary surgery were younger (P = 0.001), had earlier-stage disease at diagnosis (P = 0.002), and had longer disease-free intervals (P < 0.001) compared with those receiving chemotherapy. In the propensity score-matched groups (n = 244 patients), the median overall survival was 54 months in patients who received secondary surgery and 33 months in those treated with chemotherapy (P < 0.001). Among patients who received secondary surgery, 102 (70%) achieved optimal secondary cytoreduction. There were no significant differences in complication rates between the 2 groups. In sensitivity analyses, the survival advantage associated with secondary surgery could be explained by the presence of more multifocal recurrences (if 4.3 times more common), ascites (if 2.7 times more common), or carcinomatosis (if 2.1 times more common) among patients who received chemotherapy instead of secondary surgery., Conclusion: Patients with platinum-sensitive recurrent ovarian cancer who received secondary surgery had favorable surgical characteristics and were likely to have minimal residual disease following secondary surgery. These patients had a superior median overall survival compared with patients who received chemotherapy, although unmeasured confounders may explain this observed difference., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Ovarian cancer is often diagnosed in advanced stages, when survival is poor. Treatment advances have been made, but are inconsistently implemented. Our purpose was to project the maximum life expectancy gains that could be achieved in women with stage IIIC epithelial ovarian cancer if the implementation of available chemotherapy regimens could be optimized., Methods: We used a microsimulation model to estimate life expectancy benefits associated with "optimized" implementation of four post-operative chemotherapy options: standard intravenous chemotherapy; intraperitoneal + intravenous chemotherapy; bevacizumab + intravenous chemotherapy; and hyperthermic intraperitoneal chemotherapy + intravenous chemotherapy. Optimized implementation was defined as follows. Patients triaged to primary cytoreductive surgery received intraperitoneal + intravenous chemotherapy if optimally or completely cytoreduced, and bevacizumab + intravenous chemotherapy if suboptimally cytoreduced. Patients triaged to neoadjuvant chemotherapy received hyperthermic intraperitoneal chemotherapy at interval cytoreductive surgery if optimally or completely cytoreduced, and standard IV chemotherapy if suboptimally cytoreduced. Life expectancy associated with optimized implementation was compared with that of current utilization practices, estimated using published literature and the National Cancer Database. Effects of model uncertainty were evaluated in sensitivity analyses., Results: Life expectancy associated with optimized implementation vs. current practice was 76.7 vs. 64.5 months (life expectancy gain = 12.2 months). Providing intraperitoneal + intravenous chemotherapy to all eligible patients was the largest driver of life expectancy gains, due to both the potential benefit conferred by intraperitoneal + intravenous chemotherapy and the proportion of eligible women who do not receive intraperitoneal + intravenous chemotherapy in current practice., Conclusion: Population-level life expectancy in stage IIIC epithelial ovarian cancer could be substantially improved through greater uptake of available chemotherapy regimens., Competing Interests: We have read the journal's policy and the authors of this manuscript have the following competing interests: JDW has served as a consultant for Tesaro and Clovis Oncology. PVP reports a grant from the Medical Imaging and Technology Alliance, outside the submitted work. These do not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: Neoadjuvant chemotherapy (NACT) may reduce perioperative morbidity in women undergoing primary treatment for ovarian cancer. We evaluated patterns of use and outcomes in a population-based cohort of elderly women with ovarian cancer (OC)., Methods: A cohort of patients ≥66 years old diagnosed between 2000 and 2013 with stage III-IV epithelial OC who received surgery and platinum/taxane chemotherapy for primary treatment was identified from the SEER-Medicare database. Propensity-score matching methods were used to examine differences in outcomes. Kaplan-Meier analysis was performed to compare overall survival (OS) in the matched cohort., Results: From 2000 to 2013, 22.5% of older women received NACT. The use of NACT increased over time from 16% in 2000 to 35.4% in 2013 (p < .0001). Among women who received PCS, the rate of ostomy creation was higher compared with NACT (23.3% vs. 10.8%, p < .0001). Infectious and other surgical complications were higher among those who had PCS, regardless of stage. Median OS of women III ovarian cancer who underwent PCS was longer compared with NACT (38.8 vs. 28 months, p ≤ .0001). There were no survival differences between NACT and PCS in women with stage IV disease (29.4 vs. 29.8 months, p = .61) or for women aged >80., Conclusion: Careful consideration should be given to older patients prior to undergoing PCS. Survival outcomes were similar for patients with stage IV disease, although NACT was associated with decreased perioperative morbidity compared with PCS. Among women with stage III disease, PCS was associated with improved overall survival, but higher rates of perioperative morbidity and acute care., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Sexual dysfunction is a distressing long-term effect after gynecological cancer and affects the majority of survivors for years after the completion of therapy. Despite its prevalence, treatment-related sexual dysfunction is underrecognized and undertreated for survivors. Thus, the aim of this study was to develop and test a brief psychoeducational intervention for managing sexual dysfunction for women who have undergone treatment for ovarian cancer (OC)., Methods: Forty-six OC survivors with documented, treatment-related sexual dysfunction received a single half-day group intervention that included sexual health education and rehabilitation training, relaxation and cognitive behavioral therapy skills to address sexual symptoms, and a single tailored booster telephone call 4 weeks after the group. Assessment measures were completed at the baseline (baseline 1), after an 8-week no-treatment run-in period (baseline 2), and then again 2 and 6 months after the intervention. The Female Sexual Function Index (FSFI) was used to assess sexual functioning, and the Brief Symptom Inventory 18 (BSI-18) was used to capture psychological distress., Results: Between baseline 1 and baseline 2, there were no significant changes in the study measures, and this indicated no natural improvement during the run-in period. In contrast, the total FSFI scores improved significantly from baseline 1 to the 2- (n = 45; P < .0005) and 6-month time points (n = 42; P < .05). The BSI-18 scores were also significantly improved at the 2- (P < .005) and 6-month time points (P < .01) in comparison with baseline 1., Conclusions: This brief behavioral intervention led to significant improvements in overall sexual functioning and psychological distress that were maintained at the 6-month follow-up. The results demonstrate the feasibility of this brief, low-intensity behavioral intervention and support the development of a larger randomized controlled trial. Cancer 2018;124:176-82. © 2017 American Cancer Society., (© 2017 American Cancer Society.)

Purpose In 2010, a randomized clinical trial demonstrated noninferior survival for patients with advanced ovarian cancer who were treated with neoadjuvant chemotherapy (NACT) compared with primary cytoreductive surgery (PCS). We examined the use and effectiveness of NACT in clinical practice. Patients and Methods A multi-institutional observational study of 1,538 women with stages IIIC to IV ovarian cancer who were treated at six National Cancer Institute-designated cancer centers. We examined NACT use in patients who were diagnosed between 2003 and 2012 (N = 1,538) and compared overall survival (OS), morbidity, and postoperative residual disease in a propensity-score matched sample of patients (N = 594). Results NACT use increased from 16% during 2003 to 2010 to 34% during 2011 to 2012 in stage IIIC disease ( P trend < .001), and from 41% to 62% in stage IV disease ( P trend < .001). Adoption of NACT varied by institution, from 8% to 30% for stage IIIC disease (P < .001) and from 27% to 61% ( P = .007) for stage IV disease during this time period. In the matched sample, NACT was associated with shorter OS in stage IIIC disease (median OS: 33 v 43 months; hazard ratio [HR], 1.40; 95% CI, 1.11 to 1.77) compared with PCS, but not stage IV disease (median OS: 31 v 36 months; HR, 1.16; 95% CI, 0.89 to 1.52). Patients with stages IIIC and IV disease who received NACT were less likely to have ≥ 1 cm postoperative residual disease, an intensive care unit admission, or a rehospitalization (all P ≤ .04) compared with those who received PCS treatment. However, among women with stage IIIC disease who achieved microscopic or ≤ 1 cm postoperative residual disease, NACT was associated with decreased OS (HR, 1.49; 95% CI, 1.01 to 2.18; P = .04). Conclusion Use of NACT increased significantly between 2003 and 2012. In this observational study, PCS was associated with increased survival in stage IIIC, but not stage IV disease. Future studies should prospectively consider the efficacy of NACT by extent of residual disease in unselected patients.

Importance: A 2009 randomized clinical trial demonstrated that using cancer antigen 125 (CA-125) tests for routine surveillance in ovarian cancer increases the use of chemotherapy and decreases patients' quality of life without improving survival, compared with clinical observation. The Society of Gynecologic Oncology guidelines categorize CA-125 testing as optional and discourage the use of radiographic imaging for routine surveillance. To date, few studies have examined the use of CA-125 tests in clinical practice., Objectives: To examine the use of CA-125 tests and computed tomographic (CT) scans in clinical practice before and after the 2009 randomized clinical trial and to estimate the economic effect of surveillance testing., Design, Setting, and Participants: A prospective cohort of 1241 women with ovarian cancer in clinical remission after completion of primary cytoreductive surgery and chemotherapy at 6 National Cancer Institute-designated cancer centers between January 1, 2004, and December 31, 2011, was followed up through December 31, 2012, to study the use of CA-125 tests and CT scans before and after 2009. Data analysis was conducted from April 9, 2014, to March 28, 2016., Main Outcomes and Measures: The use of CA-125 tests and CT scans before and after 2009. Secondary outcomes included the time from CA-125 markers doubling to retreatment among women who experienced a rise in CA-125 markers before and after 2009, and the costs associated with surveillance testing using 2015 Medicare reimbursement rates., Results: Among 1241 women (mean [SD] age 59 [12] years; 1112 white [89.6%]), the use of CA-125 testing and CT scans was similar during the study period. During 12 months of surveillance, the cumulative incidence of patients undergoing 3 or more CA-125 tests was 86% in 2004-2009 vs 91% in 2010-2012 (P = .95), and the cumulative incidence of patients undergoing more than 1 CT scan was 81% in 2004-2009 vs 78% in 2010-2012 (P = .50). Among women whose CA-125 markers doubled (n = 511), there was no significant difference in the time to retreatment with chemotherapy before and after 2009 (median, 2.8 vs 3.5 months; P = .40). During a 12-month period, there was a mean of 4.6 CA-125 tests and 1.7 CT scans performed per patient, resulting in a US population surveillance cost estimate of $1 999 029 per year for CA-125 tests alone and $16 194 647 per year with CT scans added., Conclusions and Relevance: CA-125 tests and CT scans are still routinely used for surveillance testing in patients with ovarian cancer, although their benefit has not been proven and their use may have significant implications for patients' quality of life as well as costs., Competing Interests: The following authors have confirmed that there are no potential conflicts of interest or disclosures to report pertaining to this submission: Katharine M. Esselen, Angel Cronin, Kristen Bixel, David E. Cohn, Michaela Cristea, Jennifer J. Griggs, Charles F. Levenback, Gina Mantia-Smaldone, Ursula A. Matulonis, Joyce C. Niland, Charlotte Sun, and Alexi A. Wright.

Purpose: To provide guidance to clinicians regarding the use of neoadjuvant chemotherapy and interval cytoreduction among women with stage IIIC or IV epithelial ovarian cancer., Methods: The Society of Gynecologic Oncology and the American Society of Clinical Oncology convened an Expert Panel and conducted a systematic review of the literature., Results: Four phase III clinical trials form the primary evidence base for the recommendations. The published studies suggest that for selected women with stage IIIC or IV epithelial ovarian cancer, neoadjuvant chemotherapy and interval cytoreduction are noninferior to primary cytoreduction and adjuvant chemotherapy with respect to overall and progression-free survival and are associated with less perioperative morbidity and mortality., Recommendations: All women with suspected stage IIIC or IV invasive epithelial ovarian cancer should be evaluated by a gynecologic oncologist prior to initiation of therapy. The primary clinical evaluation should include a CT of the abdomen and pelvis, and chest imaging (CT preferred). Women with a high perioperative risk profile or a low likelihood of achieving cytoreduction to < 1 cm of residual disease (ideally to no visible disease) should receive neoadjuvant chemotherapy. Women who are fit for primary cytoreductive surgery, and with potentially resectable disease, may receive either neoadjuvant chemotherapy or primary cytoreductive surgery. However, primary cytoreductive surgery is preferred if there is a high likelihood of achieving cytoreduction to < 1 cm (ideally to no visible disease) with acceptable morbidity. Before neoadjuvant chemotherapy is delivered, all patients should have confirmation of an invasive ovarian, fallopian tube, or peritoneal cancer. Additional information is available at www.asco.org/NACT-ovarian-guideline and www.asco.org/guidelineswiki., (© 2016 Society of Gynecologic Oncology and American Society of Clinical Oncology.)

Purpose: A 2006 randomized trial demonstrated a 16-month survival benefit with intraperitoneal and intravenous (IP/IV) chemotherapy administered to patients who had ovarian cancer, compared with IV chemotherapy alone, but more treatment-related toxicities. The objective of this study was to examine the use and effectiveness of IP/IV chemotherapy in clinical practice., Patients and Methods: Prospective cohort study of 823 women with stage III, optimally cytoreduced ovarian cancer diagnosed at six National Comprehensive Cancer Network institutions. We examined IP/IV chemotherapy use in all patients diagnosed between 2003 and 2012 (N = 823), and overall survival and treatment-related toxicities with Cox regression and logistic regression, respectively, in a propensity score-matched sample (n = 402) of patients diagnosed from 2006 to 2012, excluding trial participants, to minimize selection bias., Results: Use of IP/IV chemotherapy increased from 0% to 33% between 2003 and 2006, increased to 50% from 2007 to 2008, and plateaued thereafter. Between 2006 and 2012, adoption of IP/IV chemotherapy varied by institution from 4% to 67% (P < .001) and 43% of patients received modified IP/IV regimens at treatment initiation. In the propensity score-matched sample, IP/IV chemotherapy was associated with significantly improved overall survival (3-year overall survival, 81% v 71%; hazard ratio, 0.68; 95% CI, 0.47 to 0.99), compared with IV chemotherapy, but also more frequent alterations in chemotherapy delivery route (adjusted rates discontinuation or change, 20.4% v 10.0%; adjusted odds ratio, 2.83; 95% CI, 1.47 to 5.47)., Conclusion: Although the use of IP/IV chemotherapy increased significantly at National Comprehensive Cancer Network centers between 2003 and 2012, fewer than 50% of eligible patients received it. Increasing IP/IV chemotherapy use in clinical practice may be an important and underused strategy to improve ovarian cancer outcomes., Competing Interests: Authors' disclosures of potential conflicts of interest are found in the article online at www.jco.org. Author contributions are found at the end of this article., (© 2015 by American Society of Clinical Oncology.)

Objectives: To determine the degree of consensus regarding the probabilities of outcomes associated with IP/IV and IV chemotherapy., Methods: A survey was administered to an expert panel using the Delphi method. Ten ovarian cancer experts were asked to estimate outcomes for patients receiving IP/IV or IV chemotherapy. The clinical estimates were: 1) probability of completing six cycles of chemotherapy, 2) probability of surviving five years, 3) median survival, and 4) probability of ER/hospital visits during treatment. Estimates for two patients, one with a low comorbidity index (patient 1) and the other with a moderate index (patient 2), were included. The survey was administered in three rounds, and panelists could revise their subsequent responses based on review of the anonymous opinions of their peers., Results: The ranges were smaller for IV compared with IP/IV therapy. Ranges decreased with each round. Consensus converged around outcomes related to IP/IV chemotherapy for: 1) completion of 6 cycles of therapy (type 1 patient, 62%, type 2 patient, 43%); 2) percentage of patients surviving 5 years (type 1 patient, 66%, type 2 patient, 47%); and 3) median survival (type 1 patient, 83 months, type 2 patient, 58 months). The group required three rounds to achieve consensus on the probabilities of ER/hospital visits (type 1 patient, 24%, type 2 patient, 35%)., Conclusions: Initial estimates of survival and adverse events associated with IP/IV chemotherapy differ among experts. The Delphi process works to build consensus and may be a pragmatic tool to inform patients of their expected outcomes., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Purpose: To date, few studies have examined end-of-life care for patients with ovarian cancer. One study documented increased hospice use among older patients with ovarian cancer from 2000 to 2005. We sought to determine whether increased hospice use was associated with less-intensive end-of-life medical care., Patients and Methods: We identified 6,956 individuals age ≥ 66 years living in SEER areas who were enrolled in fee-for-service Medicare, diagnosed with epithelial ovarian cancer between 1997 and 2007, and died as a result of ovarian cancer by December 2007. We examined changes in medical care during patients' last month of life over time., Results: Between 1997 and 2007, hospice use increased significantly, and terminal hospitalizations decreased (both P < .001). However, during this time, we also observed statistically significant increases in intensive care unit admissions, hospitalizations, repeated emergency department visits, and health care transitions (all P ≤ .01). In addition, the proportion of patients referred to hospice from inpatient settings rose over time (P = .001). Inpatients referred to hospice were more likely to enroll in hospice within 3 days of death than outpatients (adjusted odds ratio, 1.36; 95% CI, 1.12 to 1.66)., Conclusion: Older women with ovarian cancer were more likely to receive hospice services near death and less likely to die in a hospital in 2007 compared with earlier years. Despite this, use of hospital-based services increased over time, and patients underwent more transitions among health care settings near death, suggesting that the increasing use of hospice did not offset intensive end-of-life care., (© 2014 by American Society of Clinical Oncology.)

Introduction: Peritoneal carcinomatosis (PC) afflicts women with advanced gynecologic cancers. Patients with PC often require ostomies, gastric tubes, or catheters to palliate symptoms, yet patients and caregivers report feeling unprepared to manage these devices. The purpose of this study was to develop and field test the Building Out Lifelines for Safety, Trust, Empowerment, and Renewal (BOLSTER) intervention to support patients and their caregivers after hospitalization for PC. Materials and Methods: We adapted components of the Standard Nursing Intervention Protocol with stakeholders and topical experts. We developed educational content; built a smartphone application to assess patients' symptoms; and assessed preliminary feasibility and acceptability in two single-arm prepilot studies. Eligible participants were English-speaking adults hospitalized for gynecologic cancer-associated PC and their caregivers. Feasibility criteria were a ≥50% consent-to-approach ratio and ≥80% outcome measure completion. The acceptability criterion was ≥70% of participants recommending BOLSTER. Results: During the first prepilot, BOLSTER was a 10-week intervention. While 7/8 (87.5%) approached patients consented, we experienced high attrition to hospice. Less than half of patients (3/7) and caregivers (3/7) completed outcome measures. For the second prepilot, BOLSTER was a four-week intervention. All (7/7) approached patients consented. Two withdrew before participating in any study activity because they were "too overwhelmed." We excluded data from one caregiver who completed baseline measures with the patient's assistance. All remaining patients (5/5) and caregivers (4/4) completed outcome measures and recommended BOLSTER. Conclusion: BOLSTER is a technology-enhanced, nurse-led intervention that is feasible and acceptable to patients with gynecologic cancer-associated PC and their caregivers. [ABSTRACT FROM AUTHOR]