Clinical trial NCT06018311: Hispanic Adapted and Culturally Relevant Exercising Together
Official title: A Pilot Feasibility Study of a Culturally Adapted Partnered Strength Training Intervention for Hispanic Cancer Survivors and Their Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Prostate Cancer
Exercise
Caregiver Burden
Cancer Survivors
Keywords: caregivers
Cancer survivorship
Hispanic Men&#39;s Health
Strength training
Pilot study
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Phase 1:

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

Phase 2:

Inclusion Criteria (Survivor only):

1. Histologically confirmed cancer diagnosis (self-report)
2. Completed primary treatment at least 6 weeks prior at time of enrollment
3. Has an identified caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them.

Inclusion Criteria for Caregivers remains the same as Phase 1 Exclusion Criteria remain the same as Phase 1

Primary outcomes:
measure: Acceptability measured by adherence to intervention
timeFrame: 3 months
measure: Appropriateness measured by retention rate
timeFrame: 3 months
measure: Feasibility measured by enrollment rate
timeFrame: 3 months
measure: Implementation Success - composite measure of acceptability, appropriateness, and feasibility.
timeFrame: 3 months
Secondary outcomes:
measure: Physical activity
timeFrame: Physical activity will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
measure: Health-Related Quality of Life (HR-QOL) for the caregiver
timeFrame: HR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
measure: Health-Related Quality of Life (HR-QOL) for the survivor
timeFrame: HR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
measure: Relationship Health
timeFrame: Relationship Health will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
measure: Objective Physical Function
timeFrame: Objective Physical Function will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: University of Arizona College of Nursing Biobehavioral Health Science Division
name: Meghan B Skiba, PhD, MS, MPH, RDN
role: PRINCIPAL_INVESTIGATOR
References: