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Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads

Not Applicable
Active, not recruiting
Conditions
Neoplasms
Prostate Cancer
Exercise
Caregiver Burden
Interventions
Behavioral: Exercising together
Registration Number
NCT06018311
Lead Sponsor
University of Arizona
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Exercising TogetherExercising togetherDyads perform partnered exercise over 1 hour, 3 days per week in a supervised, group setting remotely for 3 months.
Primary Outcome Measures
NameTimeMethod
Feasibility measured by enrollment rate3 months

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

Implementation Success - composite measure of acceptability, appropriateness, and feasibility.3 months

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.

Acceptability measured by adherence to intervention3 months

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.

Appropriateness measured by retention rate3 months

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

Secondary Outcome Measures
NameTimeMethod
Objective Physical FunctionObjective Physical Function will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.

Measured by the Short Physical Performance Battery (SPPB) to determine ability to perform tasks of daily living independently. The SPPB includes 3 timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. The possible range of scores is 0-12.

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

Measured by the Relationship Quality Index (RQI), a six-item assessment of communication and satisfaction on a five-point likert scale.

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

Moderate to vigourous physical activity and sedentary time estimated using Rapid Assessment of Physical Activity (RAPA)

Health-Related Quality of Life (HR-QOL) for the survivorHR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.

Measured by the 39 item Functional Assessment of Cancer Therapy - Prostate (FACT-P), which includes subscales on physical, social, emotional, and functional well-being and an additional subscale specific to prostate cancer. Response items are five-point Likert scales, where higher scores indicate higher HR-QOL.physical, social, emotional, and functional well-being. FACT-G is 27 items while FACT-P is 39 items. FACT-P includes an additional subscale specific to prostate cancer. Response items are five-point likert scales, where higher scores indicate higher HR-QOL.

Health-Related Quality of Life (HR-QOL) for the caregiverHR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.

Measured by the 27 item Functional Assessment of Cancer Therapy - General (FACT-G), which includes subscales on physical, social, emotional, and functional well-being. FACT-G is 27 items while FACT-P is 39 items. Response items are five-point Likert scales, where higher scores indicate higher HR-QOL.

Trial Locations

Locations (1)

University of Arizona Cancer Center

🇺🇸

Tucson, Arizona, United States

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