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

NCT05379933 | Completed

• 1 other identifier: MCC-21751
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Stress; Quality of Life; Sleep Disturbance

Keywords

Family Caregiver; Well-being

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Self Care Behaviors - Primary Efficacy

  8 Weeks

• Quality of Life -Secondary Efficacy

  8 Weeks

Study Arms (1)

C-PRIME

EXPERIMENTAL

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.

Other: Remote health coaching to improve self-care behaviors

Interventions

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

C-PRIME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Gudenkauf LM, Li X, Hoogland AI, Oswald LB, Lmanirad I, Permuth JB, Small BJ, Jim HSL, Rodriguez Y, Bryant CA, Zambrano KN, Walters KO, Reblin M, Gonzalez BD. Feasibility and acceptability of C-PRIME: A health promotion intervention for family caregivers of patients with colorectal cancer. Support Care Cancer. 2024 Feb 28;32(3):198. doi: 10.1007/s00520-024-08395-5.

  PMID: 38416143 DERIVED

Related Links

• Moffitt Cancer Center Clinical Trial Search

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Brian Gonzalez, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 18, 2022
• Study Start: May 11, 2022
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)