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Active, Not Recruiting

NCT Number: NCT05870176

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Behavior Cardiovascular Diseases Neoplasms Physical Inactivity Sedentary Behavior

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01605, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

AIM 1 Inclusion Criteria for Aim 1a

  • Prior cancer diagnosis
  • 18 years of age and older
  • Speaks English

Exclusion criteria

for Aim 1a

  • No prior cancer diagnosis
  • Under 18 years of age
  • Prisoners
  • Does not speak English

AIM1B Survivor Inclusion Criteria for Aim 1b

  • Prior cancer diagnosis
  • 18 years of age and older
  • Speaks English

Survivor Exclusion Criteria for 1b

  • No prior cancer diagnosis
  • Under 18 years of age
  • Does not speak English
  • Prisoners
  • Participated in Aim 1a

Clinic Staff Inclusion Criteria for Aim 1b

  • Provide cancer care for patients at one of the four UMass cancer clinics,
  • Involved in survivorship care planning visits
  • Speaks English
  • 18 years of age and older

Clinic Staff Exclusion Criteria for 1b

  • Is not employed at one of the four UMass cancer clinics
  • Is not involved in survivorship care planning visits
  • Does not speak English
  • Prisoners
  • 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

  • Provide cancer care for patients at one of the four UMass cancer clinics
  • Involved in survivorship care visits
  • Speaks English
  • 18 years of age and older

Clinic Staff Exclusion Criteria for Aim 2

  • Is not employed at one of the four UMass cancer clinics
  • Is not involved in survivorship care visits
  • Does not speak English
  • Prisoners
  • Under 18 years of age

Survivor Inclusion Criteria for Aim 2

  • Cancer Patient at one of the four UMass cancer clinics
  • Has a survivorship care planning visit
  • Able to perform physical activity
  • Completes Physical Activity Readiness Questionnaire (PAR-Q) physical activity readiness questionnaire or has medical clearance to participate
  • Has a smartphone
  • Speaks English
  • 18 years of age and older

Survivor Exclusion Criteria for Aim 2:

  • Not a cancer patient at one of the four UMass cancer clinics
  • Does not have a survivorship care planning visit
  • Unable to perform physical activity or no medical clearance to participate
  • Does not speak English
  • Under 18 years of age
  • Does not have a smartphone
  • Prisoners
  • Is pregnant

AIM 3 Clinic Staff Inclusion Criteria for Aim 3

  • Are enrolled in ActivityChoice
  • ≥ 18 years of age
  • Provide written informed consent

Patient Inclusion Criteria for Aim 3

  • Are enrolled in ActivityChoice
  • Had a clinic visit with one of the enrolled clinic staff during the study period
  • ≥ 18 years of age
  • Speaks English
  • Provide written informed consent

Patient Exclusion Criteria for Aim 3

  • Not enrolled in ActivityChoice
  • Was not seen in the clinic by an enrolled clinic staff during the study period

UMass Cancer Clinic Administration Inclusion Criteria for Aim 3

  • Are ≥ 18 years of age
  • Are in positions of cancer center leadership
  • Provide written informed consent

UMass Cancer Clinic Administration Exclusion Criteria for Aim 3

  • Unable or unwilling to provide written informed consent
  • Not in positions of leadership within the UMass Medical Cancer Clinic Administration
  • <18 years of age.

External site stakeholders Inclusion Criteria for Aim 3

  • Are ≥18 years of age
  • Are in positions of cancer center leadership
  • Provide written informed consent.

External site stakeholders Exclusion Criteria for Aim 3

  • Unable or unwilling to provide written informed consent
  • Not in positions of leadership overseeing cancer survivorship
  • <18 years of age.

Treatment and study plan

Enhanced Referral

Behavioral

The enhanced referral uses an electronic referral and patient decision aid to provide choices to 3 different physical activity programs.

Standard Referral

Behavioral

The standard referral period will serve as the "usual care" comparator. Patients will receive a paper referral and Fitbit monitor.

Primary outcomes

  1. Proportion of patients referred as obtained by the electronic referral system and electronic health record

    Time frame: Baseline

    The number of patients referred/The number of eligible patients

Secondary outcomes

  1. Proportion of eligible clinicians enrolling in the the study

    Time frame: Baseline

    Number of enrolled clinicians/Number of eligible clinicians

  2. Clinic/Clinician fidelity of delivering patient decision aids

    Time frame: Baseline

    Clinic delivery of patient decision aids as reported by patients

  3. Patient Engagement

    Time frame: Examined at baseline, 3-, and 6-months

    Program enrollment (number referred/number enrolled);

  4. Patient Retention

    Time frame: 3- and 6-months

    Percent of enrolled patients completing follow-up surveys at 3- and 6-months

  5. Patient narrative decision aid acceptability and effectiveness (Enhanced Referral only)

    Time frame: Baseline following referrals

    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

  6. Patient Autonomous Regulation

    Time frame: Baseline, 3- and 6-months

    Behavioral Regulation for Exercise Questionnaire-2 (Minimum=0, Maximum=76; Higher scores indicates greater regulation/motivation)

  7. Patient Objective Physical Activity

    Time frame: Baseline, 3- and 6-months

    Change from baseline to 3- and 6-months in steps, light, moderate and vigorous physical activity measured via Fitbits.

  8. Patient Self-Report Physical Activity

    Time frame: Baseline, 3- and 6-months

    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.

  9. Patient Health-related Quality of Life

    Time frame: Baseline, 3- and 6-months

    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)

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 23, 2023
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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