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CancerNCT05870176

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

A study testing Enhanced Referral and Standard Referral in people with Cancer and Cardiovascular Diseases, run by University of Massachusetts, Worcester at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 110 yearsHealthy volunteers can take part
What is being tested?
Enhanced Referral and Standard Referral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteUnited States
Study dates
11 Sep 2023to 1 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • No prior cancer diagnosis
  • Under 18 years of age
  • Prisoners
  • Does not speak English
  • AIM1B Survivor Inclusion Criteria for Aim 1b
  • Prior cancer diagnosis
Show all 83Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: ActivityChoice: A Clinic-delivered Implementation Program to Increase Physical Activity and Decrease Cardiovascular Disease Risk Amongst 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.

Being tested
Enhanced Referral, Standard Referral
Medical subject headings
Neoplasms, Cardiovascular Diseases, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced ReferralBehavioural

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

  • Standard ReferralBehavioural

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

Study groups in NCT05870176
Study groupRoleWhat they receive
Standard ReferralActive comparatorProvider education/training on referral process Patient education material on physical activity benefits Paper referral to LIVESTRONG at the YMCA Fitbit Activity Monitor
Receives: Behavioral: Standard Referral
Enhanced ReferralExperimentalProvider 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
Receives: Behavioral: Enhanced Referral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline

Secondary outcomes (9)

  1. Proportion of eligible clinicians enrolling in the the study

    Number of enrolled clinicians/Number of eligible clinicians

    Measured: Baseline

  2. Clinic/Clinician fidelity of delivering patient decision aids

    Clinic delivery of patient decision aids as reported by patients

    Measured: Baseline

  3. Patient Engagement

    Program enrollment (number referred/number enrolled);

    Measured: Examined at baseline, 3-, and 6-months

  4. Patient Retention

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

    Measured: 3- and 6-months

  5. 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

    Measured: Baseline following referrals

  6. Patient Autonomous Regulation

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

    Measured: Baseline, 3- and 6-months

  7. Patient Objective Physical Activity

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

    Measured: Baseline, 3- and 6-months

  8. 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.

    Measured: Baseline, 3- and 6-months

  9. 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)

    Measured: Baseline, 3- and 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2023
  2. Study start11 Sep 2023
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
Stepped-wedge sequential crossover design
Masking
None (open label)
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05870176
Sponsor's protocol ID
STUDY00000522
Other IDs
1K01HL163254
Status last verified
Aug 2026
First submitted
1 May 2023
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Referral and Standard Referral in people with Cancer and Cardiovascular Diseases, run by University of Massachusetts, Worcester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 83 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients referred as obtained by the electronic referral system and electronic health record (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05870176.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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