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. 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.
Interventions
OTHERCommunication Intervention
Participate in pre-exercise social time
OTHERExercise Intervention
Participate in online supervised group exercise training
OTHERPhysical Performance Testing
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
BEHAVIORALTraining and Education
Attend training sessions with an exercise trainer
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, we will have the Project Director 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. * Confirmed by self-report of date of birth on the Health History Questionnaire (HHQ). * Diagnosed with histologically confirmed prostate cancer. * Confirmed by self-report on the HHQ. If unknown, the participant's healthcare provider will be contacted. * Completed surgery, chemotherapy, radiation and/or systemic treatment for prostate cancer \> 3 months ago. * Confirmed by self-report on the HHQ. If unknown, the participant's healthcare provider will be contacted. * Experiencing cancer loneliness. * Confirmed by average score \> 1 on the Cancer Loneliness scale. * Able to ambulate independently; reliance on assistive devices other than a wheelchair is allowed. * Confirmed by self-report on the HHQ. * Willing to be randomized into any of the three study arms and attend 80% or more of planned exercise sessions. * Confirmed verbally with the participant and response documented in the participant tracking database. * Home internet sufficient for videoconferencing. * Confirmed by staff review of internet connectivity screening guide with the participants and outcome recorded in the participant tracking database.
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). * Confirmed verbally with the participant and response documented in the participant tracking database. * Contraindication to exercise. * Assessed by American College of Sports Medicine (ACSM) pre-exercise screening criteria or the professional opinion of the principal investigator, Dr. Kerri Winters-Stone. * Health or medical condition that affects movement or neurological disorder, or medication that contraindicates participation in live remote resistance exercise. * Confirmed by self-report or the professional opinion of the principal investigator, Dr. Kerri Winters-Stone. * Cognitive difficulties that preclude answering the survey questions, participating in the intervention, or giving informed consent. * Confirmed verbally with the participant and response documented in the participant tracking. * Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing informed consent in English. * Confirmed verbally with the participant and response documented in the participant tracking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer loneliness | At enrollment, 3- and 6-months | Will be 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 | At enrollment, 3- and 6-months | Will be 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 | At enrollment, 3- and 6-months | Will be 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 | At enrollment, 3- and 6-months | Will be 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 | At enrollment, 3- and 6-months | Will be 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