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Trial Title:
ActivityChoice: Implementing Clinic-Based Physical Activity Program Choices for Cancer Survivors
NCT ID:
NCT05870176
Condition:
Cancer
Cardiovascular Diseases
Physical Inactivity
Conditions: Official terms:
Cardiovascular Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
Stepped-wedge sequential crossover design
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Enhanced Referral
Description:
The enhanced referral uses an electronic referral and patient decision aid to provide
choices to 3 different physical activity programs.
Arm group label:
Enhanced Referral
Intervention type:
Behavioral
Intervention name:
Standard Referral
Description:
The standard referral period will serve as the "usual care" comparator. Patients will
receive a paper referral and Fitbit monitor.
Arm group label:
Standard Referral
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
110 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Massachusetts Chan Medical School
Address:
City:
Worcester
Zip:
01605
Country:
United States
Start date:
September 11, 2023
Completion date:
November 1, 2026
Lead sponsor:
Agency:
University of Massachusetts, Worcester
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
National Heart, Lung, and Blood Institute (NHLBI)
Agency class:
NIH
Source:
University of Massachusetts, Worcester
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05870176
