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NCT Number: NCT07504835

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

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.

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

65 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Carolyn Guidarelli, MPH

CONTACT

[email protected]

503-346-0307

Kerri Winters-Stone

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Supervised group exercise

Unsupervised independent exercise

Behavioral

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

Primary outcomes

  1. Cancer loneliness

    Time frame: 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 outcomes

  1. General loneliness

    Time frame: 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.

  2. Social isolation

    Time frame: 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.

  3. Physical health

    Time frame: 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.

  4. Mental health

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • American Cancer Society, Inc.
  • Oregon Health and Science University

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 1, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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