ActivityChoice: Implementing Clinic-Based Physical Activity Program Choices for Cancer Survivors

NCT05870176 | Enrolling By Invitation

• 2 other identifiers: STUDY000005221K01HL163254
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease, the number one leading cause of death in the United States, is highly prevalent in cancer survivors. Physical activity can reduce risk, and referrals to programs addressing survivors' choices are highly recommended from providers in cancer survivorship, though rarely implemented. The study team proposes to develop ActivityChoice, a clinic-based implementation program, using patient narrative decision aids to support choices to a group in-person, group virtual, or self-monitored digital health physical activity program.

Conditions

Cancer; Cardiovascular Diseases; Physical Inactivity

Outcome Measures

Primary Outcomes (1)

• Proportion of patients referred as obtained by the electronic referral system and electronic health record

  The number of patients referred/The number of eligible patients

  Baseline

Secondary Outcomes (9)

• Proportion of eligible clinicians enrolling in the the study

  Baseline

• Clinic/Clinician fidelity of delivering patient decision aids

  Baseline

• Patient Engagement

  Examined at baseline, 3-, and 6-months

• Patient Retention

  3- and 6-months

• Patient narrative decision aid acceptability and effectiveness (Enhanced Referral only)

  Baseline following referrals

Study Arms (2)

Standard Referral

ACTIVE COMPARATOR

Provider education/training on referral process Patient education material on physical activity benefits Paper referral to LIVESTRONG at the YMCA Fitbit Activity Monitor

Behavioral: Standard Referral

Enhanced Referral

EXPERIMENTAL

Provider education/training on referral process Patient education material on physical activity benefits Patient decision aid on physical activity program choices Electronic referral to program of patient's choice Fitbit Activity Monitor

Behavioral: Enhanced Referral

Interventions

Enhanced Referral BEHAVIORAL

The enhanced referral uses an electronic referral and patient decision aid to provide choices to 3 different physical activity programs.

Enhanced Referral

Standard Referral BEHAVIORAL

The standard referral period will serve as the "usual care" comparator. Patients will receive a paper referral and Fitbit monitor.

Standard Referral

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior cancer diagnosis
• years of age and older
• Speaks English

You may not qualify if:

• No prior cancer diagnosis
• Under 18 years of age
• Prisoners
• Does not speak English
• Prior cancer diagnosis
• years of age and older
• Speaks English
• No prior cancer diagnosis
• Under 18 years of age
• Does not speak English
• Prisoners
• Participated in Aim 1a
• Provide cancer care for patients at one of the four UMass cancer clinics,
• Involved in survivorship care planning visits
• Speaks English

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Neoplasms; Cardiovascular Diseases; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jamie M Faro, PhD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Stepped-wedge sequential crossover design

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 23, 2023
• Study Start: September 11, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)