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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05379933
Acronym
C-PRIME
Enrollment
33
Registered
2022-05-18
Start date
2022-05-11
Completion date
2022-11-15
Last updated
2023-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life, Sleep Disturbance, Stress

Keywords

Family Caregiver, Well-being

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

Interventions

OTHERRemote 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

Sponsors

H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Self Care Behaviors - Primary Efficacy8 WeeksParticipant'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 Efficacy8 WeeksParticipants' 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026