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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Behavioral exercise training (BET) to introduce behavioral skills for adopting an exercise program | Experimental | Single-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.
Feasibility of trial by assessing the recruitment rate
The number of participants that enroll
Measured: Day 1
Feasibility of trial by assessing the retention rate
The number of participants that complete greater than 80% of the planned assessments
Measured: 12 Weeks
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted9 Feb 2024
- Study start5 Feb 2024
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- NRG Oncology
- Responsible party
- Sponsor
- Investigators
- Alexander Lucas, PhD, Principal investigator, Virginia Commonwealth University
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Exercise TRaining for Medically Underserved Men Undergoing Androgen Deprivation Therapy for Prostate Cancer (BETR-PC)
- ClinicalTrials.gov ID
- NCT06250751
- Acronym / sponsor ID
- BETR-PC / MCC-23-20769
- Conditions
- Prostate Cancer
- Keywords
- Exercise, Prostate Cancer, Androgen Deprivation Therapy (ADT), Home Based Exercise Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- NRG Oncology
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To refine a remote behavioral exercise training intervention for testing in a larger randomized trial.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral exercise training (BET) to introduce behavioral skills for adopting an exercise program | Experimental | Behavioral: Behavioral Exercise Training (BET) interventionSingle-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. |
Who may qualify
- Ages
- 41 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Exercise Training (BET) interventionIntroduce 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. | Behavioural | Behavioral exercise training (BET) to introduce behavioral skills for adopting an exercise program |
Primary outcome
Feasibility of trial by assessing the recruitment rate
Time frame: Day 1
The number of participants that enroll
Feasibility of trial by assessing the retention rate
Time frame: 12 Weeks
The number of participants that complete greater than 80% of the planned assessments
Acceptability of the trial by assessing the retention rate
Time frame: 12 Weeks
Number of participants that adhere to and complete the intervention
18 secondary outcomes
Physical activity levels using accelerometry (ActivPAL, Actigraph)
Time frame: Baseline, 8 Weeks, and 12 Weeks
Physical activity levels using the Godin-Leisure Time Exercise Questionnaire (GLTEQ).
Time frame: Baseline, 8 Weeks, and 12 Weeks
Submaximal exercise capacity assessed with the 6-minute walk test.
Time frame: Baseline, 8 Weeks, and 12 Weeks
Physical function as assessed with the short physical performance battery (SPPB).
Time frame: Baseline, 8 Weeks, and 12 Weeks
Lower body strength assessed with a 30 seconds chair stand test.
Time frame: Baseline, 8 Weeks, and 12 Weeks
Upper body strength assessed with a grip strength dynamometer.
Time frame: Baseline, 8 Weeks, and 12 Weeks
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
Time frame: Baseline, 8 Weeks, and 12 Weeks
Social support for exercise scale to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns
Time frame: Baseline, 8 Weeks, and 12 Weeks
Walk Score to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns
Time frame: Baseline, 8 Weeks, and 12 Weeks
Assess health-related quality of life (HRQL) using the Functional Assessment of Cancer Therapy-Fatigue scale (FACIT-fatigue)
Time frame: Baseline, 8 Weeks, and 12 Weeks
Assess disease specific quality of life (HRQL) using the 42-item Functional Assessment of Cancer Treatment-Prostate (FACT-P)
Time frame: Baseline, 8 Weeks, and 12 Weeks
Assess health-related quality of life (HRQL) using the the MOS 36-item Short Form Health Survey (SF-36)
Time frame: Baseline, 8 Weeks, and 12 Weeks
Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Scale 4a
Time frame: Baseline, 8 Weeks, and 12 Weeks
Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Scale 4a
Time frame: Baseline, 8 Weeks, and 12 Weeks
Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Scale 4a
Time frame: Baseline, 8 Weeks, and 12 Weeks
Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Scale 4a
Time frame: Baseline, 8 Weeks, and 12 Weeks
Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Scale 4a
Time frame: Baseline, 8 Weeks, and 12 Weeks
Assess health-related quality of life (HRQL) using Social Determinants of Health
Time frame: Baseline, 8 Weeks, and 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Lucas, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
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.