GET FIT Together: Testing a Socially Enhanced Exercise Program in Older Men With Prostate Cancer

NCT07504835 | Recruiting

• 2 other identifiers: STUDY00029324NCI-2025-09477
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3- and 6-months

Secondary Outcomes (4)

• General loneliness

  Baseline, 3- and 6-months

• Social isolation

  Baseline, 3- and 6-months

• Physical health

  Baseline, 3- and 6-months

• Mental health

  Baseline, 3- and 6-months

Study Arms (3)

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.

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.

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.

Behavioral: Unsupervised independent exercise

Interventions

Socially enhanced supervised group exercise BEHAVIORAL

Participate in online 15 minute social time prior to participating in a one hour online supervised group exercise session

Arm I (Socially enhanced supervised group exercise)

Unsupervised independent exercise BEHAVIORAL

Participate a one hour exercise session at home by following a written manual and video

Arm III (Unsupervised independent exercise)

Exercise Intervention BEHAVIORAL

Participate in a one hour online supervised group exercise session

Also known as: Supervised group exercise

Arm II (Supervised group exercise)

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• American Cancer Society, Inc.: collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kerri Winters-Stone

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To retain blinding of the research assistants who conduct the testing visits, the Project Director will send each participant an email that contains his random group assignment after baseline testing is complete.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months following final publication.
• Access Criteria: Access will be provided to investigators who provide a methodologically sound proposal and complete a data sharing agreement that includes commitments to: (1) using the data only for research purposes and not to identify any individual participant, (2) securing the data using appropriate computer technology, and (3) destroying or returning the data after analyses are completed. Proposals should be directed to wintersk@ohsu.edu. To gain access to data, data requestors will need to sign a data sharing agreement.

Locations

US (1)