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

• Sponsor: University of Massachusetts, Worcester (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05870176
• Collaborator: National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 114
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 42.1
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer; Cardiovascular Diseases; Physical Inactivity	Behavioral: Enhanced Referral; Behavioral: Standard Referral	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Stepped-wedge sequential crossover designStepped-wedge sequential crossover design
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: ActivityChoice: A Clinic-delivered Implementation Program to Increase Physical Activity and Decrease Cardiovascular Disease Risk Amongst Cancer Survivors
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2026
• Anticipated Study Completion Date: Nov 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Proportion of patients referred as obtained by the electronic referral system and electronic health record [Baseline]

   The number of patients referred/The number of eligible patients

Secondary Outcome Measures

1. Proportion of eligible clinicians enrolling in the the study [Baseline]

   Number of enrolled clinicians/Number of eligible clinicians

2. Clinic/Clinician fidelity of delivering patient decision aids [Baseline]

   Clinic delivery of patient decision aids as reported by patients

3. Patient Engagement [Examined at baseline, 3-, and 6-months]

   Program enrollment (number referred/number enrolled);

4. Patient Retention [3- and 6-months]

   Percent of enrolled patients completing follow-up surveys at 3- and 6-months

5. Patient narrative decision aid acceptability and effectiveness (Enhanced Referral only) [Baseline following referrals]

   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

6. Patient Autonomous Regulation [Baseline, 3- and 6-months]

   Behavioral Regulation for Exercise Questionnaire-2 (Minimum=0, Maximum=76; Higher scores indicates greater regulation/motivation)

7. Patient Objective Physical Activity [Baseline, 3- and 6-months]

   Change from baseline to 3- and 6-months in steps, light, moderate and vigorous physical activity measured via Fitbits.

8. Patient Self-Report Physical Activity [Baseline, 3- and 6-months]

   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.

9. Patient Health-related Quality of Life [Baseline, 3- and 6-months]

   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)

Other Outcome Measures

1. Clinician, Patient, Leadership, and External Partner Acceptability [At study completion, within 3 months of enrollment]

   Semi-structured interviews using interview guides with enrolled clinicians, referred survivors, clinic leadership, and external partners

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 110 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Massachusetts Chan Medical School	Worcester	Massachusetts	United States	01605

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Jamie M Faro, PhD, UMass Chan Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jamie Faro, Assistant Professor, University of Massachusetts, Worcester
• ClinicalTrials.gov Identifier: NCT05870176
• Other Study ID Numbers: STUDY00000522; 1K01HL163254
• First Posted: May 23, 2023
• Last Update Posted: May 23, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of May 23, 2023