The Telehealth STELLAR Program for the Treatment of Cancer Risk Behaviors, Scalable Telehealth Cancer Care Study

Status: active

This phase III trial compares the effect of the telehealth STELLAR program to enhanced usual care for the treatment of cancer risk behaviors in cancer patients and survivors. 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 and automating treatment referral, telehealth-enabled treatment of health risk behaviors (a clinical service called health promotion) may become more accessible to cancer providers and patients in a manner that is affordable, improves care quality, and is minimally disruptive to existing clinical workflow. Information gained from this study may contribute to the evidence-base for telehealth in cancer care, with potential to transform cancer care.

Inclusion Criteria

FIELD TRIAL AND PRAGMATIC TRIAL: The subject population of both the initial field trial and the full pragmatic trial will be adults aged over 18 who meet at least one of the following criteria: 1) engage in < 150 min/week of physical activity, 2) have a body mass index (BMI) of >= 25, or 3) report daily smoking. If they engage in < 150 min/week of physical activity and or have a BMI of ≥ 25 they must wait until they are 3 months post curative intent treatment to enroll. Individuals who only report daily smoking will be able to begin once they have completed post curative intent treatment
FIELD TRIAL AND PRAGMATIC TRIAL: They must also have a history of cancer (all tumor types) and have completed treatment with curative intent
FIELD TRIAL AND PRAGMATIC TRIAL: Additionally, participants must have the ability to attend telehealth visits throughout the study in some way, whether via landline, cell phone, smartphone, tablet, laptop, or desktop computer, as well as a smartphone to access the study app
FIELD TRIAL AND PRAGMATIC TRIAL: Any participants who screen positively on the Physical Activity Readiness Questionnaire will require physician approval before participating in the program
FIELD TRIAL: For field trial participation, participants will be required to have an iPhone operating system (iOS) or Android device to access the study app
PILOT 1 PATIENT SURVEY: The subject population for the patients in pilot 1 survey will be adults over 18 who have a history of cancer (all tumor types) and have completed curative intent treatment
PILOT 1 PATIENT SEMI-STRUCTURED INTERVIEW: For the pilot 1 patient semi-structured interview, the inclusion criteria will be the same as for the main intervention
PILOT 1 PROVIDER SEMI-STRUCTURED INTERVIEW: The subject population for the provider semi-structured interview that is part of pilot 1 will include clinicians at Northwestern Medicine over 18 years old

Exclusion Criteria

FIELD TRIAL AND PRAGMATIC TRIAL: Participants will be excluded from the field and pragmatic trial study if they have a limited level of oral and written English or Spanish, are cognitively impaired adults, or prisoners
FIELD TRIAL AND PRAGMATIC TRIAL: Participants will be excluded for: (1) absolute contraindications to exercise (i.e., acute myocardial infarction, complete heart block, acute congestive heart failure, unstable angina, uncontrolled hypertension), metastatic disease or planned elective surgery; or (2) pregnant or plans to become pregnant
FIELD TRIAL AND PRAGMATIC TRIAL: Individuals whose treatment includes engaging in the physical activity or weight loss interventions must pass pre-physical activity participation screening or obtain medical clearance
FIELD TRIAL AND PRAGMATIC TRIAL: Participants will also be excluded if they engage in < 150 min/week of physical activity and or have a BMI of ≥ 25 and are not 3 months post curative intent treatment
PILOT 1: Participants will be excluded from pilot 1 if they have a limited level of oral or written English or Spanish, are cognitively impaired adults, or are prisoners

PRIMARY OBJECTIVES:

I. Combine existing effective treatments for three major cancer behavioral risk factors (smoking, physical inactivity, obesity) into a comprehensive, unified telehealth treatment protocol that can be offered to adult cancer survivors identified as having these behavioral risks by an electronic health record (EHR)-supported population screening and management system.

IIa. Evaluate the reach of the risk behavior screening system by assessing the number of cancer survivors exposed to screening via the Enterprise Data Warehouse (EDW) and the proportion and representativeness of those who enroll in the study and are randomized;

IIb. Evaluate the reach of the STELLAR intervention by assessing the proportion and representativeness (in terms of disease characteristics, socioeconomic status, telehealth readiness, race/ethnicity, and insurance status) of those randomized to active intervention who attend at least one treatment session.

III. Evaluate the effects of the STELLAR telehealth risk behavior treatment program relative to enhanced usual care (information provision) on cancer risk behaviors, healthcare utilization, cost, and health outcomes (symptoms and quality of life) in a 2-arm parallel group pragmatic trial.

OUTLINE:

PILOT 1: Patients complete a survey and providers as well as a subset of patients also complete an interview about the telehealth approach in managing cancer risk behaviors for intervention development and refinement on study.

FIELD TRIAL: Patients are randomized to 1 of 2 arms.

ARM I: Patients in the facilitated group interact with up to three different cancer risk behavior modules and track their cancer risk behaviors on the STELLAR smartphone app with or without wireless scale daily over 2 weeks. Patients also complete health promotion sessions with a health promotionist via telehealth for 2-4 sessions over 2 weeks.

ARM II: Patients in the self-guided group receive enhanced usual care with a pamphlet containing National Comprehensive Cancer Network (NCCN) guideline material about cancer risk behaviors as well as information on local, regional or national behavioral treatment resources to address their cancer risk behavior on study.

After completion of study randomization, patients are followed-up at 2 weeks.

PRAGMATIC TRIAL: Patients are randomized to 1 of 2 arms.

ARM I: Patients in the facilitated group interact with up to three different cancer risk behavior modules and track their cancer risk behaviors on the STELLAR smartphone app with or without Fitbit and/or wireless scale daily over 9 months. Patients receive feedback and progress notifications via the app and text messages. Patients also complete health promotion sessions with a health promotionist via telehealth every other week for 6 months and if interested can be referred to a tobacco cessation program.

ARM II: Patients in the self-guided group receive enhanced usual care with a pamphlet containing NCCN guideline material about cancer risk behaviors and information on local, regional or national behavioral treatment resources to address their cancer risk behavior on study.

After completion of study randomization, patients are followed-up at 3, 6, and 9 months.

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The Telehealth STELLAR Program for the Treatment of Cancer Risk Behaviors, Scalable Telehealth Cancer Care Study

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The Telehealth STELLAR Program for the Treatment of Cancer Risk Behaviors, Scalable Telehealth Cancer Care Study

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