search
Back to results

Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life (C-PRIME)

Primary Purpose

Stress, Quality of Life, Sleep Disturbance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote health coaching to improve self-care behaviors
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress focused on measuring Family Caregiver, Well-being

Eligibility Criteria

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

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

Sites / Locations

  • Moffitt Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C-PRIME

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 13, 2022
Last Updated
January 19, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT05379933
Brief Title
Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life
Acronym
C-PRIME
Official Title
C-PRIME: Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Quality of Life, Sleep Disturbance
Keywords
Family Caregiver, Well-being

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C-PRIME
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Remote health coaching to improve self-care behaviors
Intervention Description
Participants will be asked to wear an activity tracker, complete brief surveys, and participate in weekly health coaching sessions remotely for 8 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants Who Agree to Participate (Acceptability)
Description
The study will be deemed acceptable if at least 50% of eligible family caregivers agree to participate
Time Frame
12 Months
Title
Percentage of Participants Who Provide Data (Feasibility)
Description
The study will be deemed feasible if at least 75% of family caregivers who participate provide data for at least 50% of study days
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Self Care Behaviors - Primary Efficacy
Description
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.
Time Frame
8 Weeks
Title
Quality of Life -Secondary Efficacy
Description
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.
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Gonzalez, PhD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://moffitt.org/clinicaltrialssearch?DiseaseSite=&q=21751
Description
Moffitt Cancer Center Clinical Trial Search

Learn more about this trial

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

We'll reach out to this number within 24 hrs