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

Not Applicable

Completed

• Conditions: Quality of Life; Stress; Sleep Disturbance
• Interventions: Other: Remote health coaching to improve self-care behaviors

• Registration Number: NCT05379933
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-11
• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-13
• Study First Posted: 2022-05-18
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C-PRIME	Remote health coaching to improve self-care behaviors	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of Life -Secondary Efficacy	8 Weeks	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.
Self Care Behaviors - Primary Efficacy	8 Weeks	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.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States