Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life

Study Overview
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Brief Summary
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The purpose of this study is to test an intervention to improve health promoting behaviors in family caregivers of patients receiving cancer therapy

Official Title
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C-PRIME: Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life

Conditions
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Stress, Quality of Life, Sleep Disturbance

Intervention / Treatment
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* Other: Remote health coaching to improve self-care behaviors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible family caregivers will be: An unpaid family member or friend who provides assistance and support with healthcare of a non-institutionalized patient receiving some form of treatment for stage III or IV colorectal cancer at Moffitt Cancer Center Age 18+ years English or Spanish speaking Able to complete questionnaires and engage in short discussions with coaches Able to identify a primary care medical provider Willing/able to use a mobile device provided by the study team or their own their device. Exclusion Criteria: Participants who do not meet the study inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-PRIME<br>Participants will wear an activity tracker for 8 weeks. During the 8 weeks of the study, participants will complete weekly survey questions about health and well-being and engage in weekly, 15-20 minute telephone/videoconference coaching sessions with a health coach. | Other: Remote health coaching to improve self-care behaviors<br>* Participants will be asked to wear an activity tracker, complete brief surveys, and participate in weekly health coaching sessions remotely for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Agree to Participate (Acceptability) | The study will be deemed acceptable if at least 50% of eligible family caregivers agree to participate | 12 Months | 
| Percentage of Participants Who Provide Data (Feasibility) | The study will be deemed feasible if at least 75% of family caregivers who participate provide data for at least 50% of study days | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self Care Behaviors - Primary Efficacy | Participant's self care behaviors will be measured using the Health-Promoting Lifestyle Profile-II. This is a 52-item questionnaire that assesses use of behaviors likely to promote a healthy lifestyle and indicate greater selfcare. Responses are categorized into an overall health-promoting lifestyle score as well as subscales assessing health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. | 8 Weeks | 
| Quality of Life -Secondary Efficacy | Participants' quality of life will be assessed using the EORT QLQ-C30, a 30-item measure that assesses quality of life in various domains of functioning and symptoms. | 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family Caregiver, Well-being