GET FIT Together: Testing a Socially Enhanced Exercise Program in Older Men With Prostate Cancer
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.
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.
Arms & interventions
- BehavioralSocially enhanced supervised group exercise
Participate in online 15 minute social time prior to participating in a one hour online supervised group exercise session
- BehavioralExercise Intervention
Participate in a one hour online supervised group exercise session
- BehavioralUnsupervised independent exercise
Participate a one hour exercise session at home by following a written manual and video
Outcome measures
Primary
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.
Time frame: Baseline, 3- and 6-months
Secondary
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
Study locations (1)
OHSU Knight Cancer Institute
Portland, Oregon, 97239