Hispanic Adapted and Culturally Relevant Exercising Together

NCT06018311 | Active Not Recruiting DMC

• 1 other identifier: STUDY00003138
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivors; Neoplasms; Prostate Cancer; Exercise; Caregiver Burden

Keywords

caregivers; Cancer survivorship; Hispanic Men's Health; Strength training; Pilot study

Outcome Measures

Primary Outcomes (4)

• Acceptability measured by adherence to intervention

  Acceptability will be measured by adherence to the intervention calculated as the total number of classes attended divided by the total possible schedule the patient could attend using descriptive statistics.

  3 months

• Appropriateness measured by retention rate

  Will be determined as the retention rate- calculated as the number of dyads completing the study versus consented using descriptive statistics.

  3 months

• Feasibility measured by enrollment rate

  Will be determined as the enrollment rate- the number of dyads enrolled out of those approached and eligible using descriptive statistics.

  3 months

• Implementation Success - composite measure of acceptability, appropriateness, and feasibility.

  Implementation success is a composite measure that will be measured by a single questionnaire that will determine the extent to which the intervention is considered acceptable, appropriate, and feasible. The single questionnaire will consist of 3 measures that will be summed into one final score, The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Responses from AIM, IAM, and FIM are summary scored with a possible range of 12-60; higher scores indicate greater acceptability, appropriateness, and feasibility.

  3 months

Secondary Outcomes (5)

• Physical activity

  Physical activity will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.

• Health-Related Quality of Life (HR-QOL) for the caregiver

  HR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.

• Health-Related Quality of Life (HR-QOL) for the survivor

  HR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.

• Relationship Health

  Relationship Health will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.

• Objective Physical Function

  Objective Physical Function will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.

Study Arms (1)

Exercising Together

EXPERIMENTAL

Dyads perform partnered exercise over 1 hour, 3 days per week in a supervised, group setting remotely for 3 months.

Behavioral: Exercising together

Interventions

Exercising together BEHAVIORAL

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.

Exercising Together

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Phase 1 was Prostate Cancer Specific; require male biological sex Phase 2 is not sex specific
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identifies as Hispanic
• Histologically confirmed prostate cancer diagnosis (self-report)
• Completed primary treatment at least 6 weeks prior at time of enrollment
• Has an identified caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them.
• \. Identifies as an individual (e.g., family member or friend) who provides unpaid care or support to a participating prostate cancer survivor.
• ≥18 years of age
• Understands (ability to read and speak) English or Spanish and able to provide informed consent
• Meets the American College of Sports Medicine pre-participation screening criteria for exercise
• Ability to ambulate (with or without assistive devices)
• Willing to attend study group exercise classes online, complete remote assessments, and answer online surveys
• Has access to a mobile device with camera and internet.
• Able to participate in classes at same time as other participating member.

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Neoplasms; Prostatic Neoplasms; Motor Activity; Caregiver Burden

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior; Stress, Psychological; Behavioral Symptoms

Study Officials

• Meghan B Skiba, PhD, MS, MPH, RDN

  University of Arizona College of Nursing Biobehavioral Health Science Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 30, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)