Prostate CarcinomaNCT07504835
GET FIT Together: Testing a Socially Enhanced Exercise Program in Older Men With Prostate Cancer
A study testing Socially enhanced supervised group exercise, Exercise Intervention and Unsupervised independent exercise in people with Prostate Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This clinical trial tests the impact of different levels of social support on the benefits of exercise in older men with prostate cancer. This trial compares a socially-enhanced supervised group exercise program to a supervised group exercise program with no social enhancement, and an unsupervised home-based program… Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Socially enhanced supervised group exercise, Exercise Intervention and Unsupervised independent exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 30 Jun 2029
- 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 65 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years of age or older.
- Diagnosed with histologically confirmed prostate cancer.
- Completed surgery, chemotherapy, radiation and/or systemic treatment (other than ADT) for cancer > 3 months ago.
- Experiencing cancer loneliness.
- Able to ambulate independently; reliance on assistive devices other than a wheelchair is allowed.
- Willing to be randomized into any of the three study arms and attend 80% or more of planned exercise sessions.
- Home internet sufficient for videoconferencing.
Who cannot join
- Participating in regular group exercise and/or structured resistance training with other cancer survivors (> 1 exercise partner or groups of 3 or more).
- Health or medical condition that affects movement or neurological disorder, or medication that contraindicates participation in live remote resistance exercise.
- Cognitive difficulties that preclude answering the survey questions, participating in the intervention, or giving informed consent.
- Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing informed consent in English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Carolyn Guidarelli, MPH, 503-346-0307, borsch@ohsu.edu
Kerri Winters-Stone
About this study
This clinical trial tests the impact of different levels of social support on the benefits of exercise in older men with prostate cancer. This trial compares a socially-enhanced supervised group exercise program to a supervised group exercise program with no social enhancement, and an unsupervised home-based program on cancer loneliness, social isolation, mental and physical health in older prostate cancer survivors. All study arms exercise for 6 months and outcomes are measured at baseline, 3 and 6 months. The primary outcome is cancer loneliness with secondary outcomes of mental and physical health.
Read the detailed description
PRIMARY OBJECTIVE I. Determine the preliminary efficacy of socially-enhanced supervised group exercise on cancer loneliness and social isolation in older PCS.
SECONDARY OBJECTIVE:
- Examine potential mediators of the effect of socially-enhanced supervised group exercise on cancer loneliness (social support for exercise, cancer-related negative social expectations and self-efficacy).
TERTIARY OBJECTIVE:
- Determine the preliminary efficacy of socially-enhanced supervised group exercise on mental health (anxiety, depressive symptoms) and physical health (fatigue and physical function) in older PCS.
OUTLINE: PCS are randomized to 1 of 3 arms.
ARM I: PCS participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes with additional 15-minute pre-exercise social time 3 times weekly over 6 months.
ARM II: PCS participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes 3 times weekly over 6 months.
ARM III: PCS participate in independent exercise training following written manual and video over 60 minutes 3 times weekly over 6 months. Men have two individual training sessions with the trainer to learn the exercise program and then the trainer will check in monthly to adjust the program as necessary.
- Conditions
- Prostate Carcinoma
- Being tested
- Socially enhanced supervised group exercise, Exercise Intervention, Unsupervised independent exercise
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socially enhanced supervised group exerciseBehavioural
Participate in online 15 minute social time prior to participating in a one hour online supervised group exercise session
Exercise InterventionBehavioural
Also called Supervised group exercise
Participate in a one hour online supervised group exercise session
Unsupervised independent exerciseBehavioural
Participate a one hour exercise session at home by following a written manual and video
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Socially enhanced supervised group exercise) | Experimental | PCS participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes with additional 15-minute pre-exercise social time 3 times weekly over 6 months. Receives: Behavioral: Socially enhanced supervised group exercise |
| Arm II (Supervised group exercise) | Active comparator | PCS participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes 3 times weekly over 6 months. Receives: Behavioral: Exercise Intervention |
| Arm III (Unsupervised independent exercise) | Active comparator | PCS participate in independent exercise training following written manual and/or video over 60 minutes 3 times weekly over 6 months. Men have two one-hour training sessions with the trainer to learn the exercises and then the trainer will check in monthly. Receives: Behavioral: Unsupervised independent exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer loneliness
Assessed by the 7-item Cancer Loneliness scale measures cancer-related loneliness. Each items asks how often people experience a feeling of loneliness specific to having cancer, such as "how often do you feel others cannot provide the support your need to deal with your cancer?" on a Likert scale of 1 (never) to 5 (always). Responses are averaged and scores range from 1-7 with higher scores indicating greater feelings of cancer loneliness. The scale has excellent reliability and construct validity in adult cancer survivors.
Measured: Baseline, 3- and 6-months
Secondary outcomes (4)
General loneliness
Assessed by University of California, Los Angeles Loneliness scale, a well-established and accepted measure of one's subjective feelings of loneliness as well as feelings of social isolation. For the 20-item scale, participants rate each item on a scale from 1 (never) to 4 (often) where higher scores indicate higher levels of loneliness.
Measured: Baseline, 3- and 6-months
Social isolation
Assessed by Lubben Social Network scale, a valid and reliable 12-item questionnaire for older adults to assess the type, size, closeness, and frequency of contacts in a respondent's current social network. Higher scores indicate better social connectedness. This measure can categorize individuals based on social connectedness (socially isolated; moderately isolated; moderately integrated; and socially integrated) and can highlight those at risk for social isolation.
Measured: Baseline, 3- and 6-months
Physical health
Assessed by the Physical Performance Battery, an objective test of physical functioning and consists of 3 timed tests: 5 repeated chair stands, standing balance, and usual gait speed over 4 meters.
Measured: Baseline, 3- and 6-months
Mental health
Assessed by using Patient-Reported Outcomes Measurement Information System measures. Will use the 8-item measures for symptoms in the past 7 days. Global health is assessed with a 10-item measure that asks about physical, mental and social functioning.
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.
- First posted1 Apr 2026
- Study start15 Apr 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Oregon Health and Science University
- Responsible party
- Principal investigator, Kerri Winters, OHSU Knight Cancer Institute
- Investigators
- Kerri Winters-Stone, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504835
- Sponsor's protocol ID
- STUDY00029324
- Other IDs
- NCI-2025-09477, STUDY00029324
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual quantitative participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GET FIT Together: Testing a Socially Enhanced Exercise Program in Older Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT07504835
- Acronym / sponsor ID
- STUDY00029324
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Oregon Health and Science University
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 1 Apr 2026 (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.
This clinical trial tests the impact of different levels of social support on the benefits of exercise in older men with prostate cancer. This trial compares a socially-enhanced supervised group exercise program to a supervised group exercise program with no social enhancement, and an unsupervised home-based program on cancer loneliness, social isolation, mental and physical health in older prostate cancer survivors. All study arms exercise for 6 months and outcomes are measured at baseline, 3 and 6 months. The primary outcome is cancer loneliness with secondary outcomes of mental and physical health.
Detailed description
PRIMARY OBJECTIVE I. Determine the preliminary efficacy of socially-enhanced supervised group exercise on cancer loneliness and social isolation in older PCS.
SECONDARY OBJECTIVE:
- Examine potential mediators of the effect of socially-enhanced supervised group exercise on cancer loneliness (social support for exercise, cancer-related negative social expectations and self-efficacy).
TERTIARY OBJECTIVE:
- Determine the preliminary efficacy of socially-enhanced supervised group exercise on mental health (anxiety, depressive symptoms) and physical health (fatigue and physical function) in older PCS.
OUTLINE: PCS are randomized to 1 of 3 arms.
ARM I: PCS participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes with additional 15-minute pre-exercise social time 3 times weekly over 6 months.
ARM II: PCS participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes 3 times weekly over 6 months.
ARM III: PCS participate in independent exercise training following written manual and video over 60 minutes 3 times weekly over 6 months. Men have two individual training sessions with the trainer to learn the exercise program and then the trainer will check in monthly to adjust the program as necessary.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (Socially enhanced supervised group exercise) | Experimental | Behavioral: Socially enhanced supervised group exercisePCS participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes with additional 15-minute pre-exercise social time 3 times weekly over 6 months. |
| Arm II (Supervised group exercise) | Active comparator | Behavioral: Exercise InterventionPCS participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes 3 times weekly over 6 months. |
| Arm III (Unsupervised independent exercise) | Active comparator | Behavioral: Unsupervised independent exercisePCS participate in independent exercise training following written manual and/or video over 60 minutes 3 times weekly over 6 months. Men have two one-hour training sessions with the trainer to learn the exercises and then the trainer will check in monthly. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65 years of age or older.
- Diagnosed with histologically confirmed prostate cancer.
- Completed surgery, chemotherapy, radiation and/or systemic treatment (other than ADT) for cancer > 3 months ago.
- Experiencing cancer loneliness.
- Able to ambulate independently; reliance on assistive devices other than a wheelchair is allowed.
Key exclusion criteria (4 listed)
- Participating in regular group exercise and/or structured resistance training with other cancer survivors (> 1 exercise partner or groups of 3 or more).
- Health or medical condition that affects movement or neurological disorder, or medication that contraindicates participation in live remote resistance exercise.
- Cognitive difficulties that preclude answering the survey questions, participating in the intervention, or giving informed consent.
- Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing informed consent in English.
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 |
|---|---|---|
| Socially enhanced supervised group exerciseParticipate in online 15 minute social time prior to participating in a one hour online supervised group exercise session | Behavioural | Arm I (Socially enhanced supervised group exercise) |
| Exercise InterventionAlso: Supervised group exerciseParticipate in a one hour online supervised group exercise session | Behavioural | Arm II (Supervised group exercise) |
| Unsupervised independent exerciseParticipate a one hour exercise session at home by following a written manual and video | Behavioural | Arm III (Unsupervised independent exercise) |
Primary outcome
Cancer loneliness
Time frame: Baseline, 3- and 6-months
Assessed by the 7-item Cancer Loneliness scale measures cancer-related loneliness. Each items asks how often people experience a feeling of loneliness specific to having cancer, such as "how often do you feel others cannot provide the support your need to deal with your cancer?" on a Likert scale of 1 (never) to 5 (always). Responses are averaged and scores range from 1-7 with higher scores indicating greater feelings of cancer loneliness. The scale has excellent reliability and construct validity in adult cancer survivors.
4 secondary outcomes
General loneliness
Time frame: Baseline, 3- and 6-months
Social isolation
Time frame: Baseline, 3- and 6-months
Physical health
Time frame: Baseline, 3- and 6-months
Mental health
Time frame: Baseline, 3- and 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. All individual quantitative participant data collected during the trial, after deidentification.
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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.
Kerri Winters-Stone principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socially enhanced supervised group exercise, Exercise Intervention and Unsupervised independent exercise in people with Prostate Carcinoma, run by OHSU Knight Cancer Institute 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 May 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer loneliness (time frame: Baseline, 3- and 6-months). 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 6 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.