Prostate Carcinoma
Conditions
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.
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.
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
Sponsors
OHSU Knight Cancer Institute
American Cancer Society, Inc.
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
MALE
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer loneliness | Baseline, 3- and 6-months | 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
| Measure | Time frame | Description |
|---|---|---|
| General loneliness | Baseline, 3- and 6-months | 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 | Baseline, 3- and 6-months | 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 | Baseline, 3- and 6-months | 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 | Baseline, 3- and 6-months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKerri Winters-Stone
OHSU Knight Cancer Institute
Outcome results
None listed