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

ActivityChoice: A Clinic-delivered Implementation Program to Increase Physical Activity and Decrease Cardiovascular Disease Risk Amongst Cancer Survivors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Cancer; Physical Inactivity
• Intervention / Treatment: Behavioral: Standard Referral; Behavioral: Enhanced Referral

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts Chan Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

AIM 1 Inclusion Criteria for Aim 1a

1. Prior cancer diagnosis
2. 18 years of age and older
3. Speaks English

Exclusion Criteria for Aim 1a

1. No prior cancer diagnosis
2. Under 18 years of age
3. Prisoners
4. Does not speak English

AIM1B Survivor Inclusion Criteria for Aim 1b

1. Prior cancer diagnosis
2. 18 years of age and older
3. Speaks English

Survivor Exclusion Criteria for 1b

1. No prior cancer diagnosis
2. Under 18 years of age
3. Does not speak English
4. Prisoners
5. Participated in Aim 1a

Clinic Staff Inclusion Criteria for Aim 1b

1. Provide cancer care for patients at one of the four UMass cancer clinics,
2. Involved in survivorship care planning visits
3. Speaks English
4. 18 years of age and older

Clinic Staff Exclusion Criteria for 1b

1. Is not employed at one of the four UMass cancer clinics
2. Is not involved in survivorship care planning visits
3. Does not speak English
4. Prisoners
5. Under 18 years of age

Pregnant Women Pregnant women may be included in this study as an incidental population.

AIM 2 Clinic Staff Inclusion Criteria for Aim 2

1. Provide cancer care for patients at one of the four UMass cancer clinics
2. Involved in survivorship care visits
3. Speaks English
4. 18 years of age and older

Clinic Staff Exclusion Criteria for Aim 2

1. Is not employed at one of the four UMass cancer clinics
2. Is not involved in survivorship care visits
3. Does not speak English
4. Prisoners
5. Under 18 years of age

Survivor Inclusion Criteria for Aim 2

1. Cancer Patient at one of the four UMass cancer clinics
2. Has a survivorship care planning visit
3. Able to perform physical activity
4. Completes Physical Activity Readiness Questionnaire (PAR-Q) physical activity readiness questionnaire or has medical clearance to participate
5. Has a smartphone
6. Speaks English
7. 18 years of age and older

Survivor Exclusion Criteria for Aim 2:

1. Not a cancer patient at one of the four UMass cancer clinics
2. Does not have a survivorship care planning visit
3. Unable to perform physical activity or no medical clearance to participate
4. Does not speak English
5. Under 18 years of age
6. Does not have a smartphone
7. Prisoners
8. Is pregnant

AIM 3 Clinic Staff Inclusion Criteria for Aim 3

1. Are enrolled in ActivityChoice
2. ≥ 18 years of age
3. Provide written informed consent

Patient Inclusion Criteria for Aim 3

1. Are enrolled in ActivityChoice
2. Had a clinic visit with one of the enrolled clinic staff during the study period
3. ≥ 18 years of age
4. Speaks English
5. Provide written informed consent

Patient Exclusion Criteria for Aim 3

1. Not enrolled in ActivityChoice
2. Was not seen in the clinic by an enrolled clinic staff during the study period

UMass Cancer Clinic Administration Inclusion Criteria for Aim 3

1. Are ≥ 18 years of age
2. Are in positions of cancer center leadership
3. Provide written informed consent

UMass Cancer Clinic Administration Exclusion Criteria for Aim 3

1. Unable or unwilling to provide written informed consent
2. Not in positions of leadership within the UMass Medical Cancer Clinic Administration
3. <18 years of age.

External site stakeholders Inclusion Criteria for Aim 3

1. Are ≥18 years of age
2. Are in positions of cancer center leadership
3. Provide written informed consent.

External site stakeholders Exclusion Criteria for Aim 3

1. Unable or unwilling to provide written informed consent
2. Not in positions of leadership overseeing cancer survivorship
3. <18 years of age.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Referral; 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; The standard referral period will serve as the "usual care" comparator. Patients will receive a paper referral and Fitbit monitor.
Experimental: Enhanced Referral; 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; The enhanced referral uses an electronic referral and patient decision aid to provide choices to 3 different physical activity programs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of eligible clinicians enrolling in the the study	Number of enrolled clinicians/Number of eligible clinicians	Baseline
Clinic/Clinician fidelity of delivering patient decision aids	Clinic delivery of patient decision aids as reported by patients	Baseline
Patient Engagement	Program enrollment (number referred/number enrolled);	Examined at baseline, 3-, and 6-months
Patient Retention	Percent of enrolled patients completing follow-up surveys at 3- and 6-months	3- and 6-months
Patient narrative decision aid acceptability and effectiveness (Enhanced Referral only)	Acceptability of decision aid using the Ottawa Decision Aid Centre 10-item acceptability of decision aids (Minimum score=0, Maximum score=100; Higher score indicates higher decisional conflict and uncertainty	Baseline following referrals
Patient Autonomous Regulation	Behavioral Regulation for Exercise Questionnaire-2 (Minimum=0, Maximum=76; Higher scores indicates greater regulation/motivation)	Baseline, 3- and 6-months
Patient Objective Physical Activity	Change from baseline to 3- and 6-months in steps, light, moderate and vigorous physical activity measured via Fitbits.	Baseline, 3- and 6-months
Patient Self-Report Physical Activity	Change from baseline to 3- and 6-months in light, moderate and vigorous physical activity survey-measured (Godin leisure time questionnaire) physical activity. The questionnaire is a 4-item self-administered questionnaire with the first three questions seeking information on the number of times one engages in mild, moderate and strenuous leisure-time physical activity bouts of at least 15 min duration in a typical week. Scores can range from 0 to 98, with the higher score meaning a greater level of activity for that week.	Baseline, 3- and 6-months
Patient Health-related Quality of Life	Functional Assessment of Cancer Therapy-General (FACT-G): Physical, social, emotional and functional well-being (Minimum=0, Maximum=127; Higher score means a higher quality of life)	Baseline, 3- and 6-months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician, Patient, Leadership, and External Partner Acceptability	Semi-structured interviews using interview guides with enrolled clinicians, referred survivors, clinic leadership, and external partners	At study completion, within 3 months of enrollment

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Jamie M Faro, PhD, UMass Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Neoplasms; Cardiovascular Diseases; Sedentary Behavior
• Other Study ID Numbers: STUDY00000522; 1K01HL163254 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No