About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Socially enhanced supervised group exercise
BehavioralParticipate in online 15 minute social time prior to participating in a one hour online supervised group exercise session
Exercise Intervention
BehavioralParticipate in a one hour online supervised group exercise session
Unsupervised independent exercise
BehavioralParticipate a one hour exercise session at home by following a written manual and video
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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OHSU Knight Cancer Institute
Lead sponsor
American Cancer Society, Inc.
Collaborator
Oregon Health and Science University
Collaborator