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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