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Adults with serious mental illness have high rates of obesity, with associated negative impacts on health-related quality of life. The present study utilized data from a randomized controlled trial (N = 276) to examine the effectiveness of in-person and online-delivered weight management interventions, compared to usual care, for improving health-related quality of life in this population. Participants completed quality of life assessments at baseline, 3 months, and 6 months. Mixed effects models examined group by time interactions. Compared to usual care, in-person MOVE was associated with improvements in loneliness (t = - 2.76, p = .006) and mental health related quality of life (t = 1.99, p = 0.048) at 6 months, and webMOVE was associated with improvements in weight-related self-esteem at 6 months (t = 2.23, p = .026) and mental health-related quality of life at 3 months (t = 2.17, p = 0.031) and 6 months (t = 2.38, p = .018). Web-based and in-person weight management led to improvements in health-related quality of life for adults with serious mental illness.ClinicalTrials.gov Identifier: NCT00983476.

OBJECTIVE: Mobile technologies, such as smartphones, can improve health services by delivering assessments and interventions that reach people in their daily lives. There is, however, disagreement regarding whether people with serious mental illness make meaningful use of mobile technology and whether interventions that rely on mobile technology should be tailored for this population. METHODS: At two clinics, 249 people with serious mental illness were interviewed regarding mobile phone use, and their cognitive functioning was assessed. RESULTS: Mobile phones were used by 86% of participants, including 60% who used a smartphone. Phones were used for messaging by 81%, Internet by 52%, e-mail by 46%, and applications by 45%. Individuals who were older, had a persistent psychotic disorder rather than bipolar disorder, received disability income, or had worse neurocognitive functioning were less likely to own a smartphone (χ2=52.7, p

ObjectiveMobile technologies, such as smartphones, can improve health services by delivering assessments and interventions that reach people in their daily lives. There is, however, disagreement regarding whether people with serious mental illness make meaningful use of mobile technology and whether interventions that rely on mobile technology should be tailored for this population.MethodsAt two clinics, 249 people with serious mental illness were interviewed regarding mobile phone use, and their cognitive functioning was assessed.ResultsMobile phones were used by 86% of participants, including 60% who used a smartphone. Phones were used for messaging by 81%, Internet by 52%, e-mail by 46%, and applications by 45%. Individuals who were older, had a persistent psychotic disorder rather than bipolar disorder, received disability income, or had worse neurocognitive functioning were less likely to own a smartphone (χ2=52.7, p

PurposeRegular physical activity is associated with reduced risk of recurrence and mortality in patients with nonmetastatic colorectal cancer. Its influence on patients with advanced/metastatic colorectal cancer (mCRC) has been largely unexplored.Patients and methodsWe conducted a prospective cohort study nested in Cancer and Leukemia Group B (Alliance)/SWOG 80405 (ClinicalTrials.gov identifier: NCT00265850), a National Cancer Institute-sponsored phase III trial of systemic therapy for mCRC. Within 1 month after therapy initiation, patients were invited to complete a validated questionnaire that reported average physical activity over the previous 2 months. On the basis of responses, we calculated metabolic equivalent task (MET) hours per week to quantify physical activity. The primary end point of the clinical trial and this companion study was overall survival (OS). Secondary end points included progression-free survival (PFS) and first grade 3 or greater treatment-related adverse events. To minimize confounding by poor and declining health, we excluded patients who experienced progression or died within 60 days of activity assessment and used Cox proportional hazards regression analysis to adjust for known prognostic factors, comorbidities, and weight loss.ResultsThe final cohort included 1,218 patients. Compared with patients engaged in less than 3 MET hours per week of physical activity, patients engaged in 18 or more MET hours per week experienced an adjusted hazard ratio for OS of 0.85 (95% CI, 0.71 to 1.02; PTrend = .06) and for PFS of 0.83 (95% CI, 0.70 to 0.99; PTrend = .01). Compared with patients engaging in less than 9 MET hours per week, patients engaging in 9 or more MET hours per week experienced an adjusted hazard ratio for grade 3 or greater treatment-related adverse events of 0.73 (95% CI, 0.62 to 0.86; PTrend < .001).ConclusionAmong patients with mCRC in Cancer and Leukemia Group B (Alliance)/SWOG 80405, association of physical activity with OS was not statistically significant. Greater physical activity was associated with longer PFS and lower adjusted risk for first grade 3 or greater treatment-related adverse events.

ObjectiveThis study examines barriers to participation and retention in 2 modalities (web-based and in-person) of a weight-management intervention tailored for individuals with serious mental illness (SMI).MethodUsing a mixed-methods approach, we explored the barriers veterans with SMI face when participating in a web-based (WebMOVE) or in-person (MOVE-SMI) version of the same SMI-adapted MOVE weight-management program. Participants in the randomized controlled trial (n = 277) were recruited from specialty mental health clinics at a Veterans Affairs medical center. Barriers were analyzed across treatment condition and program attendance (engagement) at baseline and follow-up using a generalized lineal model. Post hoc analyses assessed whether changes in the trajectory of barriers over time were associated with engagement. A subsample of participants (n = 48) from the WebMOVE and MOVE-SMI treatment conditions completed a qualitative interview, and 2 coders used open coding to analyze the data.ResultsAlthough barriers specific to treatment modality existed, most barriers cut across intervention modality, including financial hardship, lack of reliable housing and transportation, comorbid physical and mental health issues, and competing demands on personal time. Results of post hoc analyses found the association between engagement and emotional and motivational factors to be statistically significant.ConclusionsThis study is the 1st to identify barriers in a web-based intervention for SMI. Similar barriers persisted across treatment modalities. Known barriers, particularly socioeconomic barriers, should be addressed to improve engagement and retention of individuals in weight-management interventions adapted for SMI, irrespective of modality. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

ObjectiveMany adults with serious mental illness are sedentary and experience significant medical illness burden. This study examined the effectiveness of online weight management with peer coaching (WebMOVE) for increasing general physical activity among adults with serious mental illness.MethodsUsing quantitative and qualitative data from a randomized controlled trial (N=276), this study compared WebMOVE, in-person weight management for adults with serious mental illness (MOVE SMI), and usual care. Participants completed assessments of general physical activity (baseline, three months, and six months) and a qualitative assessment (six months). Mixed-effects models examined group × time interactions on general physical activity.ResultsThere were significant differences between MOVE SMI and usual care for total physical activity at three (t=3.06, p=.002) and six (t=3.12, p=.002) months, walking at six months (t=1.99, p=.048), and moderate (t=2.12, p=.035) and vigorous (t=2.34, p=.020) physical activity at six months. There was a significant difference between WebMOVE and usual care for total physical activity at six months (t=2.02, p=.044) and a trend for a group difference in walking at six months (t=1.78, p=.076). These findings reflected a decline in physical activity among participants in usual care and an increase in physical activity among participants in MOVE SMI or WebMOVE.ConclusionsIn-person weight management counseling increased total physical activity and led to initiation of moderate and vigorous physical activity among adults with serious mental illness. Computerized weight management counseling with peer support led to more gradual increases in total physical activity.

BackgroundEstimating prognosis on the basis of clinicopathologic factors can inform clinical practice and improve risk stratification for clinical trials. We constructed prognostic nomograms for one-year overall survival and six-month progression-free survival in metastatic colorectal carcinoma by using the ARCAD database.MethodsData from 22 674 patients in 26 randomized phase III clinical trials since 1997 were used to construct and validate Cox models, stratified by treatment arm within each study. Candidate variables included baseline age, sex, body mass index, performance status, colon vs rectal cancer, prior chemotherapy, number and location of metastatic sites, tumor mutation status (BRAF, KRAS), bilirubin, albumin, white blood cell count, hemoglobin, platelets, absolute neutrophil count, and derived neutrophil-to-lymphocyte ratio. Missing data (50% vs 50% vs

The anti-epidermal growth factor receptor (EGFR) monoclonal antibody cetuximab in combination with chemotherapy is a standard of care in the first-line treatment of RAS wild-type (wt) metastatic colorectal cancer (mCRC) and has demonstrated efficacy in later lines. Progressive disease (PD) occurs when tumours develop resistance to a therapy, although controversy remains about whether PD on a combination of chemotherapy and targeted agents implies resistance to both components. Here, we propose that some patients may gain additional clinical benefit from the reuse of cetuximab after having PD on regimens including cetuximab in an earlier treatment line. We conducted a non-systematic literature search in PubMed and reviewed published and ongoing clinical trials, focusing on later-line cetuximab reuse in patients with mCRC. Evidence from multiple studies suggests that cetuximab can be an efficacious and tolerable treatment when continued or when fit patients with mCRC are retreated with it after a break from anti-EGFR therapy. Furthermore, on the basis of available preclinical and clinical evidence, we propose that longitudinal monitoring of RAS status may identify patients suitable for such a strategy. Patients who experience progression on cetuximab plus chemotherapy but have maintained RAS wt tumour status may benefit from continuation of cetuximab with a chemotherapy backbone switch because they have probably developed resistance to the chemotherapeutic agents rather than the biologic component of the regimen. Conversely, patients whose disease progresses on cetuximab-based therapy due to drug-selected clonal expansion of RAS-mutant tumour cells may regain sensitivity to cetuximab following a defined break from anti-EGFR therapy. Looking to the future, we propose that RAS status determination at disease progression by liquid, needle or excisional biopsy may identify patients eligible for cetuximab continuation and rechallenge. With this approach, treatment benefit can be extended, adding to established continuum-of-care strategies in patients with mCRC.

Purpose After curative resection of gastric or gastroesophageal junction adenocarcinoma, Intergroup Trial 0116 (Phase III trial of postoperative adjuvant radiochemotherapy for high risk gastric and gastroesophageal junction adenocarcinoma: Demonstrated superior survival for patients who received postoperative chemoradiotherapy with bolus fluorouracil (FU) and leucovorin (LV) compared with surgery alone. CALGB 80101 (Alliance; Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma) assessed whether a postoperative chemoradiotherapy regimen that replaced FU plus LV with a potentially more active systemic therapy could further improve overall survival. Patients and Methods Between April 2002 and May 2009, 546 patients who had undergone a curative resection of stage IB through IV (M0) gastric or gastroesophageal junction adenocarcinoma were randomly assigned to receive either postoperative FU plus LV before and after combined FU and radiotherapy (FU plus LV arm) or postoperative epirubicin, cisplatin, and infusional FU (ECF) before and after combined FU and radiotherapy (ECF arm). Results With a median follow-up duration of 6.5 years, 5-year overall survival rates were 44% in the FU plus LV arm and 44% in the ECF arm ( Plogrank = .69; multivariable hazard ratio, 0.98; 95% CI, 0.78 to 1.24 comparing ECF with FU plus LV). Five-year disease-free survival rates were 39% in the FU plus LV arm and 37% in the ECF arm ( Plogrank = .94; multivariable hazard ratio, 0.96; 95% CI, 0.77 to 1.20). In post hoc analyses, the effect of treatment seemed to be similar across all examined patient subgroups. Conclusion After a curative resection of gastric or gastroesophageal junction adenocarcinoma, postoperative chemoradiotherapy using a multiagent regimen of ECF before and after radiotherapy does not improve survival compared with standard FU and LV before and after radiotherapy.

Purpose The objectives were to evaluate dosing schedules of labetuzumab govitecan, an antibody-drug conjugate targeting carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) for tumor delivery of 7-ethyl-10-hydroxycamptothecin (SN-38), in an expanded phase II trial of patients with relapsed or refractory metastatic colorectal cancer. Patients and Methods Eligible patients with at least one prior irinotecan-containing therapy received labetuzumab govitecan once weekly at 8 and 10 mg/kg, or two times per week at 4 and 6 mg/km on weeks 1 and 2 of 3-week repeated cycles. End points were safety, response, pharmacokinetics, and immunogenicity. Results Eighty-six patients who had undergone a median of five prior therapies (range, one to 13) were each enrolled into one of the four cohorts. On the basis of Response Evaluation Criteria in Solid Tumors 1.1, 38% of these patients had a tumor as well as plasma carcinoembryonic antigen reduction from baseline after labetuzumab govitecan treatment; one patient achieved a partial response with a sustained response spanning > 2 years, whereas 42 patients had stable disease as the best overall response. Median progression-free survival and overall survival were 3.6 and 6.9 months, respectively. The major toxicities (grade ≥ 3) among all cohorts were neutropenia (16%), leukopenia (11%), anemia (9%), and diarrhea (7%). The antibody-drug conjugate's mean half-life was 16.5 hours for the four cohorts. Anti-drug/anti-antibody antibodies were not detected. The two once-weekly dose schedules, showing comparable toxicity and efficacy, were chosen for further study. Conclusion Monotherapy with labetuzumab govitecan demonstrated a manageable safety profile and therapeutic activity in heavily pretreated patients with metastatic colorectal cancer, all with prior irinotecan therapy. Further studies of labetuzumab govitecan treatment alone or in combination with other therapies in earlier settings are indicated.

ImportanceCombining biologic monoclonal antibodies with chemotherapeutic cytotoxic drugs provides clinical benefit to patients with advanced or metastatic colorectal cancer, but the optimal choice of the initial biologic therapy in previously untreated patients is unknown.ObjectiveTo determine if the addition of cetuximab vs bevacizumab to the combination of leucovorin, fluorouracil, and oxaliplatin (mFOLFOX6) regimen or the combination of leucovorin, fluorouracil, and irinotecan (FOLFIRI) regimen is superior as first-line therapy in advanced or metastatic KRAS wild-type (wt) colorectal cancer.Design, setting, and participantsPatients (≥18 years) enrolled at community and academic centers throughout the National Clinical Trials Network in the United States and Canada (November 2005-March 2012) with previously untreated advanced or metastatic colorectal cancer whose tumors were KRAS wt chose to take either the mFOLFOX6 regimen or the FOLFIRI regimen as chemotherapy and were randomized to receive either cetuximab (n = 578) or bevacizumab (n = 559). The last date of follow-up was December 15, 2015.InterventionsCetuximab vs bevacizumab combined with either mFOLFOX6 or FOLFIRI chemotherapy regimen chosen by the treating physician and patient.Main outcomes and measuresThe primary end point was overall survival. Secondary objectives included progression-free survival and overall response rate, site-reported confirmed or unconfirmed complete or partial response.ResultsAmong 1137 patients (median age, 59 years; 440 [39%] women), 1074 (94%) of patients met eligibility criteria. As of December 15, 2015, median follow-up for 263 surviving patients was 47.4 months (range, 0-110.7 months), and 82% of patients (938 of 1137) experienced disease progression. The median overall survival was 30.0 months in the cetuximab-chemotherapy group and 29.0 months in the bevacizumab-chemotherapy group with a stratified hazard ratio (HR) of 0.88 (95% CI, 0.77-1.01; P = .08). The median progression-free survival was 10.5 months in the cetuximab-chemotherapy group and 10.6 months in the bevacizumab-chemotherapy group with a stratified HR of 0.95 (95% CI, 0.84-1.08; P = .45). Response rates were not significantly different, 59.6% vs 55.2% for cetuximab and bevacizumab, respectively (difference, 4.4%, 95% CI, 1.0%-9.0%, P = .13).Conclusions and relevanceAmong patients with KRAS wt untreated advanced or metastatic colorectal cancer, there was no significant difference in overall survival between the addition of cetuximab vs bevacizumab to chemotherapy as initial biologic treatment.Trial registrationclinicaltrials.gov identifier: NCT00265850.

BACKGROUND: People with serious mental illness have high rates of obesity and related medical problems, and die years prematurely, most commonly from cardiovascular disease. Specialized, in-person weight management interventions result in weight loss in efficacy trials with highly motivated patients. In usual care, patient enrollment and retention are low with these interventions, and effectiveness has been inconsistent. OBJECTIVE: To determine whether computerized provision of weight management with peer coaching is feasible to deliver, is acceptable to patients, and is more effective than in-person delivery or usual care. DESIGN: Mixed-methods randomized controlled trial. PARTICIPANTS: Two hundred seventy-six overweight patients with serious mental illness receiving care at a Veterans Administration medical center. INTERVENTIONS: Patients were randomized to 1) computerized weight management with peer coaching (WebMOVE), 2) in-person clinician-led weight services, or 3) usual care. Both active interventions offered the same educational content. MAIN MEASURES: Body mass index; and feasibility and acceptability of the intervention. KEY RESULTS: At 6 months, in obese patients (n = 200), there was a significant condition by visit effect (F = 4.02, p = 0.02). The WebMOVE group had an average estimated BMI change from baseline to 6 months of 34.9 ± 0.4 to 34.1 ± 0.4. This corresponds to 2.8 kg (6.2 lbs) weight loss (t = 3.2, p = 0.001). No significant change in BMI was seen with either in-person services (t = 0.10, p = 0.92), or usual care (t = -0.25, p = 0.80). The average percentage of modules completed in the WebMOVE group was 49% and in the in-person group was 41% (t = 1.4, p = 0.17). When non-obese patients were included in the analyses, there was a trend towards a condition by visit effect (F = 2.8, p = 0.06). WebMOVE was well received, while the acceptability of in-person services was mixed. CONCLUSIONS: Computerized weight management with peer support results in lower weight, and can have greater effectiveness than clinician-led in-person services. This intervention is well received, and could be feasible to disseminate.

BackgroundPeople with serious mental illness have high rates of obesity and related medical problems, and die years prematurely, most commonly from cardiovascular disease. Specialized, in-person weight management interventions result in weight loss in efficacy trials with highly motivated patients. In usual care, patient enrollment and retention are low with these interventions, and effectiveness has been inconsistent.ObjectiveTo determine whether computerized provision of weight management with peer coaching is feasible to deliver, is acceptable to patients, and is more effective than in-person delivery or usual care.DesignMixed-methods randomized controlled trial.ParticipantsTwo hundred seventy-six overweight patients with serious mental illness receiving care at a Veterans Administration medical center.InterventionsPatients were randomized to 1) computerized weight management with peer coaching (WebMOVE), 2) in-person clinician-led weight services, or 3) usual care. Both active interventions offered the same educational content.Main measuresBody mass index; and feasibility and acceptability of the intervention.Key resultsAt 6 months, in obese patients (n = 200), there was a significant condition by visit effect (F = 4.02, p = 0.02). The WebMOVE group had an average estimated BMI change from baseline to 6 months of 34.9 ± 0.4 to 34.1 ± 0.4. This corresponds to 2.8 kg (6.2 lbs) weight loss (t = 3.2, p = 0.001). No significant change in BMI was seen with either in-person services (t = 0.10, p = 0.92), or usual care (t = -0.25, p = 0.80). The average percentage of modules completed in the WebMOVE group was 49% and in the in-person group was 41% (t = 1.4, p = 0.17). When non-obese patients were included in the analyses, there was a trend towards a condition by visit effect (F = 2.8, p = 0.06). WebMOVE was well received, while the acceptability of in-person services was mixed.ConclusionsComputerized weight management with peer support results in lower weight, and can have greater effectiveness than clinician-led in-person services. This intervention is well received, and could be feasible to disseminate.

PurposeTumor levels of thymidylate synthase (TS), a target of 5-fluorouracil (5-FU)-based chemotherapy for colorectal cancer, have been studied as a predictive or prognostic biomarker with mixed results.Patients and methodsTumor TS levels were prospectively evaluated in two adjuvant therapy trials for patients with resected stage II or III colon cancer. TS expression was determined by standard immunohistochemistry and by automated quantitative analysis. Tumor mismatch repair deficiency (MMR-D) and BRAF c.1799T > A (p.V600E) mutation status were also examined. Relationships between tumor TS, MMR-D, and BRAF mutation status, overall survival (OS), and disease-free survival (DFS) were investigated in the subset of stage III patients.ResultsPatients whose tumors demonstrated high TS expression experienced better treatment outcomes, with DFS hazard ratio (HR) = 0.67, 95% confidence interval (CI) = 0.53, 0.84; and OS HR = 0.68, 95% CI = 0.53, 0.88, for high versus low TS expression, respectively. No significant interaction between TS expression and stage was observed (DFS: interaction HR = 0.94; OS: interaction HR = 0.94). Tumors with high TS expression were more likely to demonstrate MMR-D (22.2% vs. 12.8%; p =  .0003). Patients whose tumors demonstrated both high TS and MMR-D had a 7-year DFS of 77%, compared with 58% for those whose tumors had low TS and were non-MMR-D (log-rank p =  .0006). Tumor TS expression did not predict benefit of a particular therapeutic regimen.ConclusionThis large prospective analysis showed that high tumor TS levels were associated with improved DFS and OS following adjuvant therapy for colon cancer, although tumor TS expression did not predict benefit of 5-FU-based chemotherapy. The Oncologist 2017;22:107-114Implications for Practice: This study finds that measurement of tumor levels of thymidylate synthase is not helpful in assigning specific adjuvant treatment for colorectal cancer. It also highlights the importance of using prospective analyses within treatment clinical trials as the optimal method of determining biomarker utility.

INTRODUCTION: The American Joint Committee on Cancer (AJCC) staging system undergoes periodic revisions to maintain contemporary survival outcomes related to stage. Recently, the AJCC has developed a novel, systematic approach incorporating survival data to refine stage groupings. The objective of this study was to demonstrate data‐driven optimization of the version 9 AJCC staging system for anal cancer assessed through a defined validation approach. METHODS: The National Cancer Database was queried for patients diagnosed with anal cancer in 2012 through 2017. Kaplan–Meier methods analyzed 5‐year survival by individual clinical T category, N category, M category, and overall stage. Cox proportional hazards models validated overall survival of the revised TNM stage groupings. RESULTS: Overall, 24,328 cases of anal cancer were included. Evaluation of the 8th edition AJCC stage groups demonstrated a lack of hierarchical prognostic order. Survival at 5 years for stage I was 84.4%, 77.4% for stage IIA, and 63.7% for stage IIB; however, stage IIIA disease demonstrated a 73.0% survival, followed by 58.4% for stage IIIB, 59.9% for stage IIIC, and 22.5% for stage IV (p <.001). Thus, stage IIB was redefined as T1‐2N1M0, whereas Stage IIIA was redefined as T3N0‐1M0. Reevaluation of 5‐year survival based on data‐informed stage groupings now demonstrates hierarchical prognostic order and validated via Cox proportional hazards models. CONCLUSION: The 8th edition AJCC survival data demonstrated a lack of hierarchical prognostic order and informed revised stage groupings in the version 9 AJCC staging system for anal cancer. Thus, a validated data‐driven optimization approach can be implemented for staging revisions across all disease sites moving forward. Evaluation of the 8th edition American Joint Committee on Cancer staging system demonstrated a lack of hierarchical prognostic order for anal cancer. Thus, the version 9 American Joint Committee on Cancer staging system for anal cancer was revised through a validated and data‐driven approach and should similarly be applied across all disease sites moving forward. [ABSTRACT FROM AUTHOR]