ASCO Statement Addresses Recommendations for Obesity Clinical Trials in Cancer Survivors


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As reported in the Journal of Clinical Oncology by Jennifer A. ­Ligibel, MD, of Dana-Farber Cancer Institute, and colleagues, ASCO has issued a statement providing recommendations for obesity clinical trials in cancer survivors.1 ASCO convened the Research Summit on Advancing Obesity Clinical Trials in Cancer Survivors in November 2014. The meeting involved stakeholders in the study of obesity and cancer, including obesity researchers, oncology providers, clinical trialists, patient advocates, governmental and private funding organizations, payers, and representatives from health systems.

As explained by the authors, the summit “sought to identify the knowledge gaps that clinical trials addressing energy balance factors in cancer survivors have not answered and to develop a roadmap for the design and implementation of studies with the potential to generate data that could lead to the evidence-based incorporation of weight management and physical activity programs into standard oncology practice.”

The statement presents key conclusions of the summit and provides recommendations for the development of a coordinated research agenda for obesity trials. The basic recommendations are summarized here.

Large prospective randomized intervention trials are needed to generate data on the impact of energy balance interventions on cancer outcomes. Recommendations for the components and structure of such trials include:

Research teams: Include multidisciplinary teams of researchers with expertise in oncology, clinical trials, behavioral science, weight management, nutrition, and physical activity.

Target patient populations: Focus on populations with the most evidence and largest groups of cancer survivors.

Study design: Ensure adequate power to detect biologically plausible effect size. Must take into account improvements in cancer prognosis. Must enroll patients with sufficient risk of recurrence.

Endpoints: Include cancer outcomes (including disease-free and overall survival), comorbidities, feasibility of implementation, economic endpoints, and intermediate biomarkers.

Concomitant dissemination, translational, and other research efforts are needed to provide evidence in areas including:

  • Long-term maintenance of behavioral change
  • Use of technology to facilitate referrals to energy balance intervention programs and support short- and longer-term behavioral change
  • Intervention approaches in special populations (eg, elderly, pediatric, minority, and rural populations and those with specific cancer types)
  • Translational science to define mechanisms through which energy balance factors affect cancer

Recommendations

Recommendations for the implementation of research initiatives include those in the following areas.

Study development: Foster transdisciplinary partnerships of investigators; bring stakeholders together through clinical trials planning meetings; guide new research to address critical gaps in knowledge through requests for applications targeting specific areas (eg, dissemination of lifestyle interventions, development of lifestyle interventions targeting unique populations); network with and foster career development of new and early-career investigators.

Funding: Develop mechanisms to bring together different sources of funding (eg, public and private sources) to support the cost of lifestyle interventions and other costs unique to this area of research; develop new funding partnerships between organizations; create standing funds across organizations for joint projects; jointly fund dream teams; develop collaborative relationships with nontraditional funding partners (eg, insurance companies, Centers for Medicare & Medicaid Services, large employers); develop collaborative projects with groups that study other patient populations with common risk factors (eg, cardiology or endocrinology groups).

Stakeholder engagement: Identify key stakeholders for both research and dissemination aspects of lifestyle interventions in cancer survivors and ensure that a broad range of perspectives are included in design and conduct of lifestyle intervention trials.

Engagement of providers: Provide education and training sessions at national oncology and primary care meetings and within oncology fellowship training; develop interventions that can be implemented in diverse clinic settings and tested through National Cancer Institute Community Oncology Research Program practices; integrate lifestyle elements into electronic medical records; provide training for oncology personnel in communication skills for dealing with sensitive topics like weight loss; incorporate lifestyle interventions into survivorship care plans.

Engagement of patients: Involve large advocacy organizations and a diverse group of individual advocates in lifestyle intervention studies; consider convenience, cost, time commitment, and flexibility in intervention design (with integration into routine care appointments and assessments, as possible); include quality-of-life and other patient-reported outcomes. ■

Disclosure: Dr. Ligibel reported no potential conflicts of interest. For full disclosures of the statement authors, visit jco.ascopubs.org.

Reference

1. Ligibel JA, Alfano CM, Hershman D, et al: Recommendations for obesity clinical trials in cancer survivors. J Clin Oncol. August 31, 2015 (early release online).

 


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About the Summit

The research summit was part of the ASCO Obesity Initiative, which sought to increase awareness of the links between obesity and cancer and to foster research in this area that evaluated the impact of weight loss and increased activity on cancer outcomes.

There have been hundreds of observational...


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