Pragmatic Trial

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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, 2) augmenting the existing smoking auto-referral system to include referral to a cancer-specific health promotion service that includes inactivity and obesity treatment; and 3) refining the symptom monitoring dashboard to include smoking, physical inactivity, and obesity. The Center will deploy a 2-arm pragmatic clinical trial comparing a 12-month telehealth intervention for obesity, physical inactivity, and tobacco use versus an enhanced usual care control condition. Participants (n=3000) will be cancer survivors aged 18 or older who have at least one of the cancer risk factors. Treatment randomization will be stratified by primary risk behavior, study site (Northwestern Memorial Hospital vs other NM hospital), number of risk behaviors (1, 2 or 3), and cancer treatment (current treatment vs. not). Telehealth participants will receive 20 calls or videos in English or Spanish, per patient preference, according to the following schedule: weekly for 2 months, every other week for 4 months, monthly for 2 months, and every other month for the final 4 months. Participants in the control arm will receive a pamphlet with local/national resources to address their cancer risk behavior, which will be sent by either mail, email, or MyChart message depending on patient preference. Assessments will be conducted by assessors, blinded to treatment arm, at baseline, 3, 6, 9, and 12 months. We will evaluate treatment reach and its effects on the 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 diverse clinical settings and patient populations and contribute substantially to the evidence-base for telehealth in cancer care, with potential to transform cancer care.