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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Behavioral: Socially enhanced supervised group exercise; Behavioral: Exercise Intervention; Behavioral: Unsupervised independent exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • OHSU Knight Cancer Institute
      • Principal Investigator: Kerri Winters-Stone
      • Contact: Carolyn Guidarelli, MPH; Phone Number: 503-346-0307; Email: borsch@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (Socially enhanced supervised group exercise); 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; Participate in online 15 minute social time prior to participating in a one hour online supervised group exercise session
Active Comparator: Arm II (Supervised group exercise); 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; Participate in a one hour online supervised group exercise session; Other Names: Supervised group exercise
Active Comparator: Arm III (Unsupervised independent exercise); 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; Participate a one hour exercise session at home by following a written manual and video

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline, 3- and 6-months

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University; American Cancer Society, Inc.
• Investigators: Principal Investigator: Kerri Winters-Stone, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Socioeconomic Factors; Population Characteristics; Diagnostic Techniques, Respiratory System; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Respiratory Function Tests; Ergometry; Educational Status; Exercise Test
• Other Study ID Numbers: STUDY00029324 (Other Identifier: OHSU Knight Cancer Institute); NCI-2025-09477 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual quantitative participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Beginning 3 months following final publication.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No