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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercising Together | Experimental | Dyads perform partnered exercise over 1 hour, 3 days per week in a supervised, group setting remotely for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity | Moderate to vigourous physical activity and sedentary time estimated using Rapid Assessment of Physical Activity (RAPA) | 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 |
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Phase 1:
Inclusion Criteria (Survivor only):
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):
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
Phase 1 was Prostate Cancer Specific; require male biological sex Phase 2 is not sex specific
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| Name | Affiliation | Role |
|---|---|---|
| Meghan B Skiba, PhD, MS, MPH, RDN | University of Arizona College of Nursing Biobehavioral Health Science Division | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85719 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D011471 | Prostatic Neoplasms |
| D009043 | Motor Activity |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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|
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. |
| 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 | 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. | HR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months. |
| Relationship Health | Measured by the Relationship Quality Index (RQI), a six-item assessment of communication and satisfaction on a five-point likert scale. | Relationship Health will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months. |
| Objective Physical Function | 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. | Objective Physical Function will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months. |
| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |