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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age65+
SponsorOHSU Knight Cancer Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Socially enhanced supervised group exercise

    Behavioral

    Participate in online 15 minute social time prior to participating in a one hour online supervised group exercise session

  • Exercise Intervention

    Behavioral

    Participate in a one hour online supervised group exercise session

  • Unsupervised independent exercise

    Behavioral

    Participate a one hour exercise session at home by following a written manual and video

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Arm I (Socially enhanced supervised group exercise)Experimental treatment 1 intervention
Group B: Arm II (Supervised group exercise)Active comparator 1 intervention
Group C: Arm III (Unsupervised independent exercise)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

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.

Time frame
Baseline, 3- and 6-months
2

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.

Time frame
Baseline, 3- and 6-months
3

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.

Time frame
Baseline, 3- and 6-months
4

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.

Time frame
Baseline, 3- and 6-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OHSU Knight Cancer Institute

Lead sponsor

American Cancer Society, Inc.

Collaborator

Oregon Health and Science University

Collaborator