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Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads

Primary Purpose

Neoplasms, Prostate Cancer, Exercise

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercising together
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neoplasms focused on measuring caregivers, Cancer survivorship, Hispanic Men's Health, Strength training, Pilot study

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (Survivor only): 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. 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): ≥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. Exclusion Criteria: 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

Sites / Locations

  • University of Arizona Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercising Together

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2023
Last Updated
September 28, 2023
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT06018311
Brief Title
Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads
Official Title
A Pilot Feasibility Study of a Culturally Adapated Partnered Strength Training Intervention for Hispanic Prostate Cancer Survivors and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Prostate Cancer, Exercise, Caregiver Burden
Keywords
caregivers, Cancer survivorship, Hispanic Men's Health, Strength training, Pilot study

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercising Together
Arm Type
Experimental
Arm Description
Dyads perform partnered exercise over 1 hour, 3 days per week in a supervised, group setting remotely for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Exercising together
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability measured by adherence to intervention
Description
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
Title
Appropriateness measured by retention rate
Description
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
Title
Feasibility measured by enrollment rate
Description
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
Title
Implementation Success - composite measure of acceptability, appropriateness, and feasibility.
Description
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
3 months
Secondary Outcome Measure Information:
Title
Physical activity
Description
Moderate to vigourous physical activity and sedentary time estimated using Rapid Assessment of Physical Activity (RAPA)
Time Frame
Physical activity will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Title
Health-Related Quality of Life (HR-QOL) for the caregiver
Description
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.
Time Frame
HR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Title
Health-Related Quality of Life (HR-QOL) for the survivor
Description
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
HR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Title
Relationship Health
Description
Measured by the Relationship Quality Index (RQI), a six-item assessment of communication and satisfaction on a five-point likert scale.
Time Frame
Relationship Health will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Title
Objective Physical Function
Description
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.
Time Frame
Objective Physical Function will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (Survivor only): 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. 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): ≥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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel E Jarrett, MPH
Phone
520-626-0375
Email
UACC-IIT@uacc.arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marjorie Barrera
Phone
520-626-6154
Email
marjoriebarrera1@arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghan B Skiba, PhD, MS, MPH, RDN
Organizational Affiliation
University of Arizona College of Nursing Biobehavioral Health Science Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan B Skiba, PhD, MS, MPH, RDN
Phone
520-621-9036
Email
mbskiba@arizona.edu
First Name & Middle Initial & Last Name & Degree
Marjorie Barrera
Phone
520-626-6154
Email
marjoriebarrera1@arizona.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads

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