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Trial Title: Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads

NCT ID: NCT06018311

Condition: Neoplasms
Prostate Cancer
Exercise
Caregiver Burden

Conditions: Official terms:
Prostatic Neoplasms
Caregiver Burden

Conditions: Keywords:
caregivers
Cancer survivorship
Hispanic Men's Health
Strength training
Pilot study

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Exercising together
Description: The Exercising Together program is a partnered functional strength training program that encourages participating dyads to interact with one another, verbally and physically, during exercise sessions. In Exercising Together, the survivor and their caregiver will build skills to work as a team. We will incorporate skills that promote and reinforce communication, motivation, and support and use this to guide training of survivor-caregiver dyads to maximize their teamwork during each exercise session. Group sessions are delivered remotely through videoconferencing software and are supervised by two trained exercise instructors. Intervention and assessment is available in English or Spanish.
Arm group label: Exercising Together

Summary: The purpose of this study is to determine the feasibility and effects of an adapted Exercising Together, a partnered resistance training program, on the physical and mental health of prostate cancer survivors and their informal caregiver. The Exercising Together program is designed to promote teamwork during supervised group exercise classes delivered remotely through videoconferencing software. The intervention period will be 3-months with a 3-month follow-up.

Criteria for eligibility:
Criteria:
Inclusion Criteria (Survivor only): 1. Self-identifies as Hispanic 2. Histologically confirmed prostate cancer diagnosis (self-report) 3. Completed primary treatment at least 6 weeks prior at time of enrollment 4. Has an identified caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them. Inclusion Criteria (Caregivers): 1. Identifies as an individual (e.g., family member or friend) who provides unpaid care or support to a participating prostate cancer survivor. Inclusion Criteria (Survivors and Caregivers): 1. ≥18 years of age 2. Understands (ability to read and speak) English or Spanish and able to provide informed consent 3. Meets the American College of Sports Medicine pre-participation screening criteria for exercise 4. Ability to ambulate (with or without assistive devices) 5. Willing to attend study group exercise classes online, complete remote assessments, and answer online surveys 6. Has access to a mobile device with camera and internet. 7. Able to participate in classes at same time as other participating member. Exclusion Criteria: 1. Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent as determined by the professional opinion of the Principal Investigator 2. A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise or poses a significant safety concern/risk for the well-being of the participant (e.g., declared pregnancy, poorly controlled diabetes, recent cardiac event, neuromuscular disease, untreated orthostatic hypertension, recent surgery, acute hernia, acute rheumatoid arthritis, severe memory disorders, severe balance disorder, severe hearing or vision impairment) 3. Knowingly unable to attend >75% of the intervention classes due to conflict with the designated time of day, days of the week, and/or location for the exercise class which they initially enrolled 4. Incapable of providing informed consent, answering survey questions, participating in the intervention, and following directions during performance testing when English or Spanish language is used 5. Unable to be in the same location with participating member during remote exercise classes and performance testing and/or insufficient internet connectivity to support required videoconferencing software

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University of Arizona Cancer Center

Address:
City: Tucson
Zip: 85719
Country: United States

Start date: November 1, 2023

Completion date: March 28, 2025

Lead sponsor:
Agency: University of Arizona
Agency class: Other

Source: University of Arizona

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06018311

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