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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05870176
• Other study ID #: STUDY00000522
• Secondary ID: 1K01HL163254
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 11, 2023
• Est. completion date: November 1, 2026

Study information

• Verified date: October 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 114
• Est. completion date: November 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Diseases
• Physical Inactivity

Intervention

Behavioral:
• Enhanced Referral
The enhanced referral uses an electronic referral and patient decision aid to provide choices to 3 different physical activity programs.
• Standard Referral
The standard referral period will serve as the "usual care" comparator. Patients will receive a paper referral and Fitbit monitor.

Locations

Country	Name	City	State
United States	University of Massachusetts Chan Medical School	Worcester	Massachusetts

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Proportion of eligible clinicians enrolling in the the study	Number of enrolled clinicians/Number of eligible clinicians	Baseline
Secondary	Clinic/Clinician fidelity of delivering patient decision aids	Clinic delivery of patient decision aids as reported by patients	Baseline
Secondary	Patient Engagement	Program enrollment (number referred/number enrolled);	Examined at baseline, 3-, and 6-months
Secondary	Patient Retention	Percent of enrolled patients completing follow-up surveys at 3- and 6-months	3- and 6-months
Secondary	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
Secondary	Patient Autonomous Regulation	Behavioral Regulation for Exercise Questionnaire-2 (Minimum=0, Maximum=76; Higher scores indicates greater regulation/motivation)	Baseline, 3- and 6-months
Secondary	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
Secondary	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
Secondary	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