Skip to main content
OpenTrials
Completed

NCT Number: NCT05379933

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stress Mental Disorders Nervous System Diseases Parasomnias Quality of Life Sleep Disturbance Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote health coaching to improve self-care behaviors

Other

Participants will be asked to wear an activity tracker, complete brief surveys, and participate in weekly health coaching sessions remotely for 8 weeks

Primary outcomes

  1. Percentage of Participants Who Agree to Participate (Acceptability)

    Time frame: 12 Months

    The study will be deemed acceptable if at least 50% of eligible family caregivers agree to participate

  2. Percentage of Participants Who Provide Data (Feasibility)

    Time frame: 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

Secondary outcomes

  1. Self Care Behaviors - Primary Efficacy

    Time frame: 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.

  2. Quality of Life -Secondary Efficacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Acronym: C-PRIME

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 18, 2022
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.