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

University of Massachusetts, Worcester

Status: Invitation-only

Conditions: Physical Inactivity; Cardiovascular Diseases; Cancer

Treatments: Behavioral: Enhanced Referral; Behavioral: Standard Referral

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05870176

1K01HL163254 (U.S. NIH Grant/Contract)

STUDY00000522

Details and patient eligibility

About

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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Standard Referral

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Referral

Enhanced Referral

Experimental group

Description:

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

Treatment:

Behavioral: Enhanced Referral