Pragmatic Trial

Northwestern University At Chicago, Evanston IL

Investigators

Linked publications & trials

Abstract

Abstract - Pragmatic Clinical Trial Cancer risk behaviors, including smoking, physical inactivity, and obesity, are individually associated with reduced treatment response, side effects, heightened recurrence risk, decreased longevity, diminished quality of life, and increased treatment cost for many cancers. These behaviors are at least as prevalent among cancer patients and survivors as they are in healthy adults, but referral pathways to treat them are not routinely integrated into cancer care. By integrating cancer risk behavior assessment into the electronic health record system (EHR) and automating treatment referral, we plan to make telehealth-enabled treatment of health risk behaviors (a clinical service called health promotion) accessible to cancer providers and patients throughout the Center’s clinical practice network in a manner that is affordable, improves care quality, and is minimally disruptive to existing clinical workflow. Our success in implementing patient-reported outcomes assessments and EHR-supported smoking cessation, physical activity promotion, and obesity behavioral interventions uniquely position us to integrate these services across the entire Northwestern Medicine (NM) oncology care system using relatively few resources compared to in-person programs. We propose to build upon existing NCI-funded tobacco cessation and symptom monitoring programs that are fully integrated into cancer by: 1) adding brief screening for health risk behaviors, and 2) augmenting the existing smoking auto-referral system to include referral to a cancer-specific health promotion service that includes inactivity and obesity treatment. The Center will deploy a 2-arm pragmatic clinical trial comparing a 6-month facilitated telehealth intervention for obesity, physical inactivity, and tobacco use versus a 6-month self-guided intervention. Participants (n=1500) will be cancer survivors aged 18 or older who have completed curative intent cancer treatment and have at least one of the cancer risk factors. Treatment randomization will be stratified by sex and number of risk behaviors (1, 2 or 3). Facilitated intervention participants will receive 12 telehealth sessions (audio and/or video or phone per participant preference) every week for 6 months. Participants in the self-guided arm will receive written materials from the NCCN Guidelines about the three risk behaviors. They will also receive information about local treatment resources for health behavior change. Assessments at baseline, 3, 6, and 9 months will be done using REDCap. We will evaluate treatment reach and its effects on the risk behaviors, care access and quality, healthcare utilization, cost, patient-provider communication, and health outcomes. Findings from this rigorous pragmatic study will be broadly applicable to different clinical settings and patient populations and contribute substantially to the evidence-base for telehealth in cancer care, with potential to transform cancer care.