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

NCT ID: NCT05379933

Last Updated: 2023-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2022-11-15

Brief Summary

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

Detailed Description

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Conditions

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Stress Quality of Life Sleep Disturbance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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C-PRIME

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.

Group Type EXPERIMENTAL

Remote health coaching to improve self-care behaviors

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Gonzalez, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38416143 (View on PubMed)

Other Identifiers

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MCC-21751

Identifier Type: -

Identifier Source: org_study_id

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