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Prostate CancerBETR-PCNCT06250751

Behavioral Exercise TRaining for Men Undergoing Androgen Depr Therapy for Prostate Ca

A study testing Behavioral Exercise Training (BET) intervention in people with Prostate Cancer, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To refine a remote behavioral exercise training intervention for testing in a larger randomized trial. Read more about this study

Who is it for?
Ages 41 to 85 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Behavioral Exercise Training (BET) intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
5 Feb 2024to 6 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

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 41 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be eligible men, transwomen or non-binary individuals must meet the following criteria:
  • Be diagnosed with stage II/III/IV prostate cancer
  • Be currently undergoing treatment with ADT (intermittent or prolonged)
  • Have completed local curative-intent treatment, including prostatectomy or definitive radiation
  • Be >40 years of age if non-Hispanic Black or rural dwelling; Otherwise >60 years of age up to 85
  • Be willing to give an informed consent and sign a HIPAA authorization form
Show all 11Show fewer
  • Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation
  • Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview
  • Be without any serious medical condition that precludes safe participation in an exercise program
  • Speak English.
  • Meet protocol definition of medically underserved: which is consider medically underserved patients to be a) older men (>75 years), b) men who live in rural zip code areas, or c) men who identify as being non-Hispanic Black. They may also be at the intersectionality of these groups (i.e., older Black men living in a rural zip code area).

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: Behavioral Exercise TRaining for Medically Underserved Men Undergoing Androgen Deprivation Therapy for Prostate Cancer (BETR-PC)

To refine a remote behavioral exercise training intervention for testing in a larger randomized trial.

Read the detailed description

Determine feasibility of recruiting a sample of medically underserved prostate cancer patients undergoing treatment with Androgen Deprivation Therapy (ADT) to a remotely delivered (i.e., home-based) exercise intervention and determine the interventions acceptability.

Conditions
Prostate Cancer
Being tested
Behavioral Exercise Training (BET) intervention
Keywords
Exercise, Prostate Cancer, Androgen Deprivation Therapy (ADT), Home Based Exercise Intervention
Medical subject headings
Prostatic Neoplasms, Motor Activity

What participants receive

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

  • Behavioral Exercise Training (BET) interventionBehavioural

    Introduce and refine concept of exercise and cardiovascular health by initiating walking or cycling and provide behavioral counseling sessions to foster support for adoption and maintenance of exercise, and to troubleshoot barriers. During the first two weeks, the study team will meet with participants twice per week (virtually) to introduce the intervention, familiarize men with the exercise program, exercise logs, resistance bands for strength training. Contact will drop to once per week during weeks 3-8 (total=10 contacts in weeks 1-8). Behavioral counseling will be delivered by the PI or the study coordinator for 30-40 minutes prior to 20-30 mins of an individual or group-based strength training class.

Study groups in NCT06250751
Study groupRoleWhat they receive
Behavioral exercise training (BET) to introduce behavioral skills for adopting an exercise programExperimentalSingle-arm, ORBIT-prospective, multicenter, nonblinded clinical trial, feasibility pilot. The BET intervention will be delivered and refined over 12 weeks. The protocol aim is to enroll men from the same representative groups of underserved men in groups of 5-10, to foster social support and group cohesion.
Receives: Behavioral: Behavioral Exercise Training (BET) intervention

What is being measured

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

  1. Feasibility of trial by assessing the recruitment rate

    The number of participants that enroll

    Measured: Day 1

  2. Feasibility of trial by assessing the retention rate

    The number of participants that complete greater than 80% of the planned assessments

    Measured: 12 Weeks

  3. Acceptability of the trial by assessing the retention rate

    Number of participants that adhere to and complete the intervention

    Measured: 12 Weeks

Secondary outcomes (18)
  1. Physical activity levels using accelerometry (ActivPAL, Actigraph)

    An ActivPAL is a small, previously validated thigh-worn device that continuously measures physical activity, sitting time or movement. An Actigraph is a small wrist worn device that continuously measures physical activity intensity (i.e., exercise intensity), sleep time or movement.

    Measured: Baseline, 8 Weeks, and 12 Weeks

  2. Physical activity levels using the Godin-Leisure Time Exercise Questionnaire (GLTEQ).

    The average of the scores for participants using the GLTEQ is a 3-item measure used to classify participant's activity levels per week. The Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). The Godin scale score = 24 units or more=active, 14-23 units= moderately active, and less than 14 unites = insufficiently active/ sedentary.

    Measured: Baseline, 8 Weeks, and 12 Weeks

  3. Submaximal exercise capacity assessed with the 6-minute walk test.

    Measuring changes in a 6 minute walk distance. The participant has a goal to walk as fast, but safely, as possible without running for a period of 6 minutes.

    Measured: Baseline, 8 Weeks, and 12 Weeks

  4. Physical function as assessed with the short physical performance battery (SPPB).

    Short Physical Performance Battery (Short Physical Performance Battery (SPPB) is a battery of 3 tests (standing balance, gait speed and char stands) that are combined to assess overall physical function. Each test is scored on a scale of 1-4 with 4 being reflective of good function and 0 of poor function. Overall scores of 10 or less are reflective of mobility limitations.

    Measured: Baseline, 8 Weeks, and 12 Weeks

  5. Lower body strength assessed with a 30 seconds chair stand test.

    Participants will be first asked to stand from a sitting position without using their arms. If they can perform the task, they will then be asked to stand up and sit down as many times as possible in a 30 second period. The greater the number of chair stands the better the lower body strength.

    Measured: Baseline, 8 Weeks, and 12 Weeks

  6. Upper body strength assessed with a grip strength dynamometer.

    Grip strength will be assessed using an isometric handgrip dynamometer while the participant is seated with the head facing straight ahead. The elbow should be bent at a 90-degree angle and the wrist should be at the mid-prone position. The participant should exert maximally and quickly (about 1 second) and two trials should be made alternately with each hand, with at least 30 seconds between trials for the same hand (recorded in kilograms).

    Measured: Baseline, 8 Weeks, and 12 Weeks

  7. Self-efficacy for exercise using the exercise self-efficacy scale (EXSE) to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns

    The Exercise Self-Efficacy Scale assesses an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40+ minutes per session in the future. For each item, participants indicate their confidence to execute the behavior on a 100-point percentage scale comprised of 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). Total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.

    Measured: Baseline, 8 Weeks, and 12 Weeks

  8. Social support for exercise scale to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns

    Assessment of the level of support individuals making health-behavior changes (exercise) felt they were receiving from family and friends.

    Family Participation: sum items 11 - 16 and 20 - 23 Family Rewards and Punishment (an optional scale): sum items 17 - 19 Friend Participation: sum items 11 - 16 and 20 - 23

    Higher scores reflect more support.

    Measured: Baseline, 8 Weeks, and 12 Weeks

  9. Walk Score to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns

    Walk Score measures the walkability of any address using a patented system. For each address, Walk Score analyzes hundreds of walking routes to nearby amenities. Points are awarded based on the distance to amenities in each category. Amenities within a 5 minute walk (.25 miles) are given maximum points.

    90-100 is a good walk score 70-89 is very walkable 50-69 is somewhat walkable 0-49 is car dependent

    Measured: Baseline, 8 Weeks, and 12 Weeks

  10. Assess health-related quality of life (HRQL) using the Functional Assessment of Cancer Therapy-Fatigue scale (FACIT-fatigue)

    The FACIT-fatigue scale is a 13-item scale that has been widely used in many studies to assess cancer related fatigue

    Scores range from 0-52 with higher scores indicating better quality of life.

    Measured: Baseline, 8 Weeks, and 12 Weeks

  11. Assess disease specific quality of life (HRQL) using the 42-item Functional Assessment of Cancer Treatment-Prostate (FACT-P)

    The FACT-P measure is composed of the FACT-General which assesses four primary HRQOL domains: physical well-being , functional well-being, social well-being, and emotional well-being and an additional component for prostate specific concerns.

    Scores range from 0-156 with higher scores reflecting better quality of life

    Measured: Baseline, 8 Weeks, and 12 Weeks

  12. Assess health-related quality of life (HRQL) using the the MOS 36-item Short Form Health Survey (SF-36)

    The SF-36 is perhaps the most widely used measure of health status and includes domains of vitality and physical function.

    The SF-36 has 8 subdomains (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health). Each scale item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively with 100 higher quality of life.

    Measured: Baseline, 8 Weeks, and 12 Weeks

  13. Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Scale 4a

    PROMIS - Fatigue is a validated self-report measure of fatigue among patients diagnosed with cancer and higher scores indicate a lower level of fatigue. All scores are on a T-score distribution with a mean of 50 and standard deviation of 10.

    Measured: Baseline, 8 Weeks, and 12 Weeks

  14. Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Scale 4a

    PROMIS - Physical function is a validated self-report measure of physical function among patients diagnosed with cancer and higher scores indicate better functioning. All scores are on a T-score distribution with a mean of 50 and standard deviation of 10.

    Measured: Baseline, 8 Weeks, and 12 Weeks

  15. Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Scale 4a

    PROMIS - Anxiety is a validated self-report measure of physical function among patients diagnosed with cancer and higher scores indicate better functioning. All scores are on a T-score distribution with a mean of 50 and standard deviation of 10.

    Measured: Baseline, 8 Weeks, and 12 Weeks

  16. Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Scale 4a

    PROMIS - Depression is a validated self-report measure of physical function among patients diagnosed with cancer and higher scores indicate better functioning. All scores are on a T-score distribution with a mean of 50 and standard deviation of 10.

    Measured: Baseline, 8 Weeks, and 12 Weeks

  17. Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Scale 4a

    PROMIS - Sleep disturbance is a validated self-report measure of physical function among patients diagnosed with cancer and higher scores indicate better functioning. All scores are on a T-score distribution with a mean of 50 and standard deviation of 10.

    Measured: Baseline, 8 Weeks, and 12 Weeks

  18. Assess health-related quality of life (HRQL) using Social Determinants of Health

    Social Determinants of Health (SDOH) questionnaire is a self-administered questionnaire used to examine education and income variables in relation to cardiovascular risk. The questionnaire is administered at the baseline visit. We will also ask about difficult paying for basics and experience of racial discrimination at 3- and 6-month follow up visits.

    Measured: Baseline, 8 Weeks, and 12 Weeks

Timeline

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

  1. First posted9 Feb 2024
  2. Study start5 Feb 2024
  3. Primary completion6 Oct 2025
  4. Study completion6 Oct 2025

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06250751
Sponsor's protocol ID
MCC-23-20769
Other IDs
HM20028651
Acronym
BETR-PC
Status last verified
Oct 2025
First submitted
30 Jan 2024
Last updated
31 Oct 2025
Results posted
No
Data monitoring committee
Yes
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 Behavioral Exercise Training (BET) intervention in people with Prostate Cancer, run by Virginia Commonwealth University 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 11 inclusion and 0 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: finished, as of the sponsor's last update on 31 Oct 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Feasibility of trial by assessing the recruitment rate (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Oct 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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