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

Quality of Life Clinical Trial

— C-PRIME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05379933
• Other study ID #: MCC-21751
• Status: Completed
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: January 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Quality of Life
• Sleep Disturbance
• Stress

Intervention

Other:
• Remote health coaching to improve self-care behaviors
Participants will be asked to wear an activity tracker, complete brief surveys, and participate in weekly health coaching sessions remotely for 8 weeks

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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

External Links

•   Moffitt Cancer Center Clinical Trial Search