GET FIT Together: Testing a Socially Enhanced Exercise Program in Older Men With Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Socially enhanced supervised group exercise, Exercise Intervention, Unsupervised independent exercise.
- Who it may be relevant to
- Registry conditions: Prostate Carcinoma. Basic parameters: from 65 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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:
I. 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:
I. 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.
Interventions
- Behavioral Socially enhanced supervised group exercise
Participate in online 15 minute social time prior to participating in a one hour online supervised group exercise session - Behavioral Exercise Intervention
Participate in a one hour online supervised group exercise session - Behavioral Unsupervised independent exercise
Participate a one hour exercise session at home by following a written manual and video
Primary outcome measures
- Cancer loneliness [Time frame: Baseline, 3- and 6-months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- OHSU Knight Cancer Institute — Portland
Identifiers
NCT: NCT07504835 · STUDY00029324 · NCI-2025-09477 · STUDY00029324