University of Arizona Cancer Center
Tucson, Arizona, 85719, United States
NCT Number: NCT06018311
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.
This study is active but is not currently recruiting participants.
18 year–99 year
All sexes
Interventional
Not applicable
Tucson, Arizona, 85719, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Phase 1:
Inclusion criteria
(Survivor only):
Inclusion criteria
(Caregivers):
Inclusion criteria
(Survivors and Caregivers):
Exclusion criteria
Phase 2:
Inclusion criteria
(Survivor only):
Inclusion criteria
for Caregivers remains the same as Phase 1 Exclusion Criteria remain the same as Phase 1
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.
Time frame: 3 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.
Time frame: 3 months
Will be determined as the retention rate- calculated as the number of dyads completing the study versus consented using descriptive statistics.
Time frame: 3 months
Will be determined as the enrollment rate- the number of dyads enrolled out of those approached and eligible using descriptive statistics.
Time frame: 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.
Time frame: Physical 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)
Time frame: HR-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. Response items are five-point Likert scales, where higher scores indicate higher HR-QOL.
Time frame: HR-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.
Time frame: Relationship 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.
Time frame: Objective 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.
University of Arizona
Other
A Pilot Feasibility Study of a Culturally Adapted Partnered Strength Training Intervention for Hispanic Cancer Survivors and Their Caregivers
Acronym: HACER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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