NCT07504835

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial tests the impact of different levels of social support on the benefits of exercise in older men with prostate cancer. Prostate cancer survivors (PCS) experience fatigue, weakness, muscle loss, weight gain, sexual dysfunction, and pain that can contribute to worsening function and increased levels of anxiety and depressive symptoms. Men rarely access psychosocial support services for their mental health and may conceal their feelings from their spouse and family leading to feelings of isolation and cancer loneliness that are in turn linked to poor health outcomes, including fatigue, pain, sleep problems, anxiety and depressive symptoms, suicidal ideation and all-cause mortality. 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 PCS. A socially-enhanced supervised group exercise program may reduce feelings of cancer loneliness in PCS.

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: Patients are randomized to 1 of 3 arms. ARM I: Patients 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: Patients participate in online supervised group exercise training led by a certified exercise instructor over 60 minutes 3 times weekly over 6 months. ARM III: Patients participate in independent exercise training following written manual and/or video over 60 minutes 3 times weekly over 6 months. Patients attend two one-hour training sessions with an exercise trainer to learn functional training modified to their abilities and for home use, an exercise video to follow at home, and receive weekly check ins during month 1 and then monthly the following months with the exercise trainer on study.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
OTHER	Communication Intervention	Participate in pre-exercise social time
OTHER	Exercise Intervention	Participate in online supervised group exercise training
OTHER	Exercise Intervention	Participate in independent exercise training
OTHER	Physical Performance Testing	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
BEHAVIORAL	Training and Education	Attend training sessions with an exercise trainer

Timeline

• Start date: 2026-03-02
• Primary completion: 2028-09-30
• Completion: 2029-06-30
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States