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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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