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

NCT ID: NCT05870176

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2026-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Standard Referral

Intervention Type: BEHAVIORAL

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

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

Group Type: EXPERIMENTAL

Enhanced Referral

Intervention Type: BEHAVIORAL

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

Interventions

Enhanced Referral

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

Intervention Type: BEHAVIORAL

Standard Referral

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Prior cancer diagnosis

2. 18 years of age and older

3. Speaks English

1. Prior cancer diagnosis

2. 18 years of age and older

3. Speaks English

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

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

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

1. Are enrolled in ActivityChoice

2. ≥ 18 years of age

3. Provide written informed consent

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

1. Are ≥ 18 years of age

2. Are in positions of cancer center leadership

3. Provide written informed consent

1. Are ≥18 years of age

2. Are in positions of cancer center leadership

3. Provide written informed consent.

Exclusion Criteria

1. No prior cancer diagnosis

2. Under 18 years of age

3. Prisoners

4. Does not speak English

1. No prior cancer diagnosis

2. Under 18 years of age

3. Does not speak English

4. Prisoners

5. Participated in Aim 1a

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.

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

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

1. Not enrolled in ActivityChoice

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

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.

1. Unable or unwilling to provide written informed consent

2. Not in positions of leadership overseeing cancer survivorship

3. <18 years of age.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Jamie Faro

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jamie M Faro, PhD

Role: PRINCIPAL_INVESTIGATOR

UMass Chan Medical School

Locations

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

1K01HL163254

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000522

Identifier Type: -

Identifier Source: org_study_id