Clinical trial NCT05870176: ActivityChoice: Implementing Clinic-Based Physical Activity Program Choices for Cancer Survivors
Official title: ActivityChoice: A Clinic-delivered Implementation Program to Increase Physical Activity and Decrease Cardiovascular Disease Risk Amongst Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer
Cardiovascular Diseases
Physical Inactivity
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-05-23
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge sequential crossover design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: Proportion of patients referred as obtained by the electronic referral system and electronic health record
timeFrame: Baseline
Secondary outcomes:
measure: Proportion of eligible clinicians enrolling in the the study
timeFrame: Baseline
measure: Clinic/Clinician fidelity of delivering patient decision aids
timeFrame: Baseline
measure: Patient Engagement
timeFrame: Examined at baseline, 3-, and 6-months
measure: Patient Retention
timeFrame: 3- and 6-months
measure: Patient narrative decision aid acceptability and effectiveness (Enhanced Referral only)
timeFrame: Baseline following referrals
measure: Patient Autonomous Regulation
timeFrame: Baseline, 3- and 6-months
measure: Patient Objective Physical Activity
timeFrame: Baseline, 3- and 6-months
measure: Patient Self-Report Physical Activity
timeFrame: Baseline, 3- and 6-months
measure: Patient Health-related Quality of Life
timeFrame: Baseline, 3- and 6-months
Other outcomes:
measure: Clinician, Patient, Leadership, and External Partner Acceptability
timeFrame: At study completion, within 3 months of enrollment
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
Study officials:
affiliation: UMass Chan Medical School
name: Jamie M Faro, PhD
role: PRINCIPAL_INVESTIGATOR
References: