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To evaluate changes in health-related and vision-related quality of life (VRQoL) among patients with noninfectious uveitis who were treated with antimetabolites.Secondary analysis of a randomized controlled trial.Patients with noninfectious uveitis from India, the United States, Australia, Saudi Arabia, and Mexico.From 2013 through 2017, 216 participants were randomized to receive 25 mg weekly oral methotrexate or 1.5 g twice daily oral mycophenolate mofetil. Median changes in quality of life (QoL) were measured using Wilcoxon signed-rank tests, and differences between treatment groups were measured using linear mixed models, adjusting for baseline QoL score, age, gender, and site. Among Indian patients, VRQoL scores from a general scale (the National Eye Institute Visual Function Questionnaire [NEI-VFQ]) and a culturally specific scale (the Indian Visual Function Questionnaire [IND-VFQ]) were compared using Pearson correlation tests.Vision-related QoL (NEI-VFQ and IND-VFQ) and health-related QoL (HRQoL; physical component score [PCS] and mental component score [MCS] of the Medical Outcomes Study 36-Item Short Form Survey [SF-36v2]) were measured at baseline, the primary end point (6 months or treatment failure before 6 months), and the secondary end point (12 months or treatment failure between 6 and 12 months).Among 193 participants who reached the primary end point, VRQoL increased from baseline by a median of 12.0 points (interquartile range [IQR], 1.0-26.1, NEI-VFQ scale), physical HRQoL increased by a median of 3.6 points (IQR, -1.4 to 14.9, PCS SF-36v2), and mental HRQoL increased by a median of 3.0 points (IQR, -3.7 to 11.9, MCS SF-36v2). These improvements in NEI-VFQ, SF-36v2 PCS, and SF-36v2 MCS scores all were significant (P0.01). The linear mixed models showed that QoL did not differ between treatment groups for each QoL assessment (NEI-VFQ, IND-VFQ, PCS SF-36v2, and MCS SF-36v2; P0.05 for all). The NEI-VFQ and IND-VFQ scores for Indian participants were correlated highly at baseline and the primary and secondary end points (correlation coefficients, 0.87, 0.80, and 0.90, respectively).Among patients treated with methotrexate or mycophenolate mofetil for uveitis, VRQoL and HRQoL improved significantly over the course of 1 year and did not differ by treatment allocation. These findings suggest that antimetabolites could improve overall patient well-being and daily functioning.

PURPOSE GOG-259 was a 3-arm randomized controlled trial of two web-based symptom management interventions for patients with recurrent ovarian cancer. Primary aims were to compare the efficacy of the nurse-guided (Nurse-WRITE) and self-directed (SD-WRITE) interventions to Enhanced Usual Care (EUC) in improving symptoms (burden and controllability) and quality of life (QOL). METHODS Patients with recurrent or persistent ovarian, fallopian, or primary peritoneal cancer with 3+ symptoms were eligible for the study. Participants completed baseline (BL) surveys (symptom burden and controllability and QOL) before random assignment. WRITE interventions lasted 8 weeks to develop symptom management plans for three target symptoms. All women received EUC: monthly online symptom assessment with provider reports; online resources; and every 2-week e-mails. Outcomes were evaluated at 8 and 12 weeks after BL. Repeated-measures modeling with linear contrasts evaluated group by time effects on symptom burden, controllability, and QOL, controlling for key covariates. RESULTS Participants (N = 497) reported mean age of 59.3 ± 9.2 years. At BL, 84% were receiving chemotherapy and reported a mean of 14.2 ± 4.9 concurrent symptoms, most commonly fatigue, constipation, and peripheral neuropathy. Symptom burden and QOL improved significantly over time ( P < .001) for all three groups. A group by time interaction ( P < .001) for symptom controllability was noted whereby both WRITE intervention groups had similar improvements from BL to 8 and 12 weeks, whereas EUC did not improve over time. CONCLUSION Both WRITE Intervention groups showed significantly greater improvements in symptom controllability from BL to 8 and BL to 12 weeks compared with EUC. There were no significant differences between Nurse-WRITE and SD-WRITE. SD-WRITE has potential as a scalable intervention for a future implementation study.

ObjectiveTo explore whether patient-reported lymphedema-related symptoms, as measured by the Gynecologic Cancer Lymphedema Questionnaire (GCLQ), are associated with a patient-reported diagnosis of lymphedema of the lower extremity (LLE) and limb volume change (LVC) in patients who have undergone radical surgery, including lymphadenectomy, for endometrial, cervical, or vulvar cancer on Gynecologic Oncology Group (GOG) study 244.MethodsPatients completed the baseline and at least one post-surgery GCLQ and LVC assessment. The 20-item GCLQ measures seven symptom clusters-aching, heaviness, infection-related, numbness, physical functioning, general swelling, and limb swelling. LLE was defined as a patient self-reported LLE diagnosis on the GCLQ. LVC was measured by volume calculations based on circumferential measurements. A linear mixed model was fitted for change in symptom cluster scores and GCLQ total score and adjusted for disease sites and assessment time.ResultsOf 987 eligible patients, 894 were evaluable (endometrial, 719; cervical, 136; vulvar, 39). Of these, 14% reported an LLE diagnosis (endometrial, 11%; cervical, 18%; vulvar, 38%). Significantly more patients diagnosed versus not diagnosed with LLE reported ≥4-point increase from baseline on the GCLQ total score (p10% was significantly associated with reported general swelling (p&nbsp

ObjectiveTo assess quality of life (QOL) in patients who developed lower-extremity lymphedema (LLE) after radical gynecologic cancer surgery on prospective clinical trial GOG 244.MethodsThe prospective, national, cooperative group trial GOG-0244 determined the incidence of LLE and risk factors for LLE development, as well as associated impacts on QOL, in newly diagnosed patients undergoing surgery for endometrial, cervical, or vulvar cancer from 6/4/2012-11/17/2014. Patient-reported outcome (PRO) measures of QOL (by the Functional Assessment of Cancer Therapy [FACT]), body image, sexual and vaginal function, limb function, and cancer distress were recorded at baseline (within 14days before surgery), and at 6, 12, 18, and 24months after surgery. Assessments of LLE symptoms and disability were completed at the time of lower limb volume measurement. A linear mixed model was applied to examine the association of PROs/QOL with a Gynecologic Cancer Lymphedema Questionnaire (GCLQ) total score incremental change ≥4 (indicative of increased LLE symptoms) from baseline, a formal diagnosis of LLE (per the GCLQ), and limb volume change (LVC) ≥10%.ResultsIn 768 evaluable patients, those with a GCLQ score change ≥4 from baseline had significantly worse QOL (p&nbsp

Objectives To review nursing science history within the Gynecology Oncology Group (GOG); to discuss challenges of nursing science in the cooperative group (CG) using a current nurse-led protocol (GOG-0259) as an exemplar; and to propose recommendations to advance nursing science in the CG setting. Data Sources Indexed citations and personal experience. Conclusion Benefits of CG research include opportunities for inter-disciplinary collaboration and ability to rapidly accrue large national samples. Challenges include limited resources to support non-treatment trials, a burdensome protocol approval process, and lack of experience with nursing/quality-of-life intervention studies. Formal GOG structures need to evolve to encourage nurse scientists to become active members; promote collaboration between experienced GOG advanced practice nurses and nurse scientists to identify nursing research priorities; and consider new funding sources to support pilot intervention studies. Implications for Nursing Practice Understanding the CG research process is critical for nurse scientists. A multi-disciplinary team of CG leaders can help investigators navigate a complex research environment and increase awareness of the value of nursing research.

Purpose/objectives To evaluate changes in body image and self-esteem in women with gynecologic malignancies who experience chemotherapy-induced alopecia and to examine the effectiveness of a videotape intervention on body image and self-esteem. Design A prospective, randomized study. Setting Subjects were accrued from 11 Gynecologic Oncology Group (GOG) member institutions participating in 14 GOG treatment protocols. Sample 136 women with chemotherapy-induced alopecia, a mean age of 57.7 years, and advanced disease at study entry. Methods Prior to the first course of chemotherapy, all subjects received standard counseling regarding hair loss. Body image and self-esteem scores were obtained prior to course 1 and 3 and after course 4 of chemotherapy. Prior to course 3, women with grade 2 alopecia were allocated randomly to the videotape intervention or no intervention. Main research variables Total body image and self-esteem as measured by the Body Cathexis/Self-Cathexis Scale (BCSCS). Findings A small but statistically significant change (p = 0.045) in body image was observed after chemotherapy-induced alopecia, with no change in self-esteem. The videotape did not produce a significant effect on body image score. Conclusions The study results support prior studies that have reported changes in body image as a result of chemotherapy-induced alopecia. The intervention employed (a videotape) was not effective. The BCSCS is a simple and quick measurement for use in future studies Implications for nursing Chemotherapy-induced alopecia has an adverse effect on body image. Novel interventions are needed to assist women in coping with this consequence of treatment.

Objective. The aim of this trial was to investigate the toxicity and efficacy of a 3-day topotecan administration schedule in combination with cyclophosphamide in the management of recurrent ovarian cancer. Methods. Patients with recurrent measurable ovarian cancer who had up to two prior chemotherapy regimens for the management of their disease participating in this phase II trial were to receive topotecan at a dose of 1.25 mg/m 2 /day × 3 days in combination with cyclophosphamide at 600 mg/m 2 on Day 1 every 21 days. Dose escalation and reductions were permitted. Results. A total of 36 patients (median age=65; range 37–84) were treated with this combination regimen. Seventeen were platinum-sensitive and 19 were platinum-resistant. A total of 169 cycles of chemotherapy was administered (median = 4; range 1–10). Major toxicity included grade 4 neutropenia (68.6%), neutropenic fever (7.1%), grade 3 thrombocytopenia (18.3%), and requirement for blood transfusion (19.5%). Dose escalation was possible in 3 (8.3%), and dose reduction was required in 14 (38.9%) patients. Overall response rate was 25 and 44.5% stable disease. Median progression-free interval and overall survival was 5.4 and 23.5 months, respectively, independent of platinum sensitivity. Conclusion. The 3-day topotecan schedule in combination with cyclophosphamide appears to have good activity in recurrent ovarian cancer regardless of platinum sensitivity. Neutropenia was the only severe toxicity and was less prevalent than other reported trials of topotecan. This tolerable regimen offers patients more convenience and appears to have moderate activity.

Purpose: To evaluate the efficacy of macular grid photocoagulation in preserving or improving central visual acuity in eyes with macular edema due to central vein occlusion (CVO) and best-corrected visual acuity of 20/50 or poorer. Methods: Patients with angiographically documented macular edema due to CVO were entered into a multicenter randomized controlled clinical trial supported by the National Eye Institute. Eligibility was determined based on both clinical examination findings and photographic documentation evaluated at a photograph reading center. Eyes were assigned randomly to macular grid photocoagulation (77 eyes) or no treatment (78 eyes). Patients were followed every 4 months for 3 years or until the end of the study. The outcome measure was visual acuity. Results: The study population consisted of 155 eyes in 155 patients. There was no difference between treated and untreated eyes in visual acuity at any point during the follow-up period. Initial median visual acuity was 20/160 in treated eyes and 20/ 125 in control eyes. Final median visual acuity was 20/200 in treated eyes and 20/160 in control eyes. However, treatment clearly reduced angiographic evidence of macular edema. Conclusion: The results of this study do not support a recommendation for macular grid photocoagulation for the population meeting the Central Vein Occlusion Study macular edema group eligibility criteria.

The number of HIV-infected women in the United States has continued to rise. Although risk-reducing behaviors such as condom use, partner selection, partner reduction, and safe sex practices have been identified, women continue to engage in high-risk activities. Nurses need to offer testing for HIV infection to all women. Education programs directed at the transmission and prevention of HIV infection also are needed. This article describes nursing strategies designed to incorporate primary, secondary, and tertiary prevention of HIV infection in women.The incidence of HIV infection in US women is rising, with a disproportionate number of cases in racial/ethnic minorities and urban women. This increasing trend will soon place AIDS as one of the top 5 causes of death for women aged 25-44. Horizontal transmission of HIV occurs through the exchange of blood, semen, and vaginal/cervical secretions. High-risk activities for women include sharing needles during iv drug use or engaging in sexual intercourse with a man who shares needles, is bisexual, was born in sub=Sahara Africa or in a Caribbean country, or is HIV infected. Women can prevent HIV infection by condom use, careful partner selection, reducing the number of sexual partners, refusing to share needles, and eliminating risky sexual behavior (such as anal intercourse). Nurses can reduce the spread of HIV infection in women by following 3 strategies. Primary strategies help women increase their level of perceived risk, allow nurses to identify and assess high-risk women through screening, and educate women about the transmission and prevention of HIV. Secondary prevention includes early detection and education to prevent further transmission of the disease. Counseling and partner notification are important aspects of this strategy. Tertiary prevention is early medical and psychiatric intervention to help the women manage and live with the disease. Nursing strategies should incorporate all 3 level of prevention.

Objective A phase II study was conducted to evaluate the anti-tumor activity and adverse effects of weekly docetaxel in patients with previously treated endometrial cancer. Methods Eligible patients were to have measurable disease with no more than one prior chemotherapy regimen. Docetaxel 36 mg/m 2 was administered intravenously over 1 h on days 1, 8 and 15. Cycles were repeated every 28 days until progression of disease or adverse effects prohibited further therapy. Results Twenty-seven patients were entered onto this study, of whom 26 were eligible and evaluable. All patients had received prior platinum with twenty (76.9%) having received prior treatment with paclitaxel. There were two (7.7%) partial responses, eight patients (30.8%) with stable disease, and fourteen patients (53.8%) with increasing disease. The most frequently reported adverse events were leucopenia, neutropenia, gastrointestinal, constitutional and peripheral neuropathy. Grade 3 and 4 adverse events were uncommon. Conclusions Docetaxel, at the dose and schedule tested, has modest activity in this patient population.

The incidence of CIN, VIN, and VAIN has increased dramatically in recent years due to a true increase in disease incidence as well as improved screening methods. Associated high-risk factors in the development of intraepithelial neoplasia are known, and effective treatment modalities are available. With the use of diagnostic techniques, patient education, and selection and utilization of appropriate therapies, intraepithelial neoplasia of the lower genital tract remains a disease that should not affect long-term morbidity, social status, or mortality of female patients.

PURPOSE A randomized trial was conducted to evaluate the impact of a telephone counseling intervention to improve patient adherence to colposcopic examination for suspected cervical intraepithelial neoplasia (CIN). METHODS Subjects were lower-income, minority women who missed a scheduled initial appointment for colposcopy at an urban medical clinic. Patients were randomly assigned to either a control condition (n = 42) or a telephone counseling condition (n = 48). The 15-minute, structured telephone counseling intervention protocol addressed educational, psychosocial, and practical barriers to colposcopy adherence. RESULTS The most common patient-reported barriers to colposcopy adherence included a lack of understanding of the purpose of colposcopy (50%), worry about or fear of cancer (25%), and forgetting (23%). Telephone counseling was found to be highly effective in addressing these barriers and improving adherence to diagnostic follow-up and treatment. Of patients in the control condition, 43% complied with a rescheduled colposcopy appointment, compared with 67% in the telephone counseling condition. Logistic regression analysis indicated that the effect of telephone counseling was independent of sociodemographic confounder variables (odds ratio = 2.6; P less than .003). Additionally, 74% of patients who received the initial telephone counseling adhered to recommended treatment, compared with 53% of patients in the control condition. CONCLUSION Brief, structured telephone contact may be a cost-effective mechanism for improving adherence to diagnostic follow-up and treatment for a variety of cancer screening tests.

Cervical cancer is still widely prevalent in the female population. This study explores the relationship of cervical cancer screening, positive versus negative Papanicolaou's test results, and psychologic status among lower-income minority women. All patients were interviewed 3 months after they had received initial test results. One hundred six women with normal Papanicolaou's test results were compared with 118 women who were referred for colposcopic examination for follow-up of positive test results. Women with positive Papanicolaou's-test results showed statistically significant elevations in worries about cancer and impairments in mood, daily activities, sexual interest, and sleep patterns. More fine-grained analyses revealed that the effects of positive results were most pronounced among those women who did not comply with colposcopy (n = 53). These findings suggest that lack of compliance with follow-up may maintain high levels of uncertainty about disease and may interfere with successful psychologic adaptation. Health education targeted to psychologically vulnerable individuals may reduce psychologic distress and enhance compliance.

15006 Background: The aim of this trial was to investigate the efficacy and toxicity of weekly combination of docetaxel (D) and gemcitabine (G) in the management of recurrent ovarian, peritoneal, or fallopian tube cancer. Methods: D (30 mg/m2) was given as a one-hour IV infusion followed by G (650 mg/m2) as a 30 minute IV infusion on Day 1, 8 & 15 of a 28-day cycle. Results: Thirty pts were enrolled. Mean age was 67.4 (range 47–85). Twelve (40%) pts had Platinum sensitive disease, and 18 (60%) had Platinum resistant disease. One hundred eighteen cycles were evaluable for toxicity. The mean number of cycles was 4 (range 1–7). Twenty-six (22%) of the cycles were incomplete due to toxicity (day # 15 not given in 25 of the incomplete cycles). Dose delay was observed in 4 (13.3%) pts, and a one-dose level reduction was required in 11 (36.7%) pts. Hematologic toxicity included grade 3 neutropenia in 13 (11%) cycles, grade 3 thrombocytopenia in 11 (9.3%) cycles. No grade 4 neutropenia, thrombocytopenia or neutropenic fever was encountered. Bone marrow support with erythropoiten (36.6% pts), and filgrastim (13.3% pts) were utilized. Blood transfusions were given in 10 (8.5%) cycles. Elevated LFT grade 1/2 was seen in 7 (23.3%) pts and 3 (10%) pts, respectively. Nonhematologic grade 3 toxicites occurred in 4 pts (including one seizure). Mean follow-up interval was 19.6 months (mos) (range 1–36.6). To date, 14 (46.6%) pts are alive with disease, and 16 (53.4%) have died of disease. The overall response rate was 32% (1 CR and 8 PR in 28 evaluable pts). Ten pts (33.3%) had SD and 5 had ID. Median progression-free interval (PFI) was 3.8 mos (95% CI: 1.65–5.97). Overall survival was 19.6 mos (95% CI: 14.23–24.96), and no significant differences in PFI and survival between the Platinum-sensitive and resistant pts (P = 0.5, P = 0.08, respectively). Conclusions: Weekly docetaxel plus gemcitabine is an active and tolerable regimen with minimal toxicity in this older population of pts (9 ≥ 80 years of age). No significant difference in response between Platinum sensitive and resistant pts was observed. Overall response rate appears to be better than single agent regimens currently available. Elimination of the third week of treatment may not affect efficacy and will be more acceptable to pts with less toxicity. No significant financial relationships to disclose.

5127 Background: The aim of this trial was to investigate the toxicity and efficacy of a 3-day topotecan (Hycamtin) administration schedule in combination with carboplatin in the management of plat...