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Spots Global Cancer Trial Database for Improving Cancer Family Caregivers' Knowledge and Communication About Care Options

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Trial Identification

Brief Title: Improving Cancer Family Caregivers' Knowledge and Communication About Care Options

Official Title: Improving Cancer Family Caregivers' Knowledge and Communication About Care Options

Study ID: NCT02616107

Study Description

Brief Summary: The purpose of this two-year mixed methods study is to develop and test an intervention to improve cancer family caregivers' knowledge of care options (curative, palliative, and hospice care) and goals of care communication as part of a self-management (SM) training program. The two specific aims of this project are to: 1. Develop a psycho-educational intervention called Managing Cancer Care: A Caregiver's Guide (MCC-CG), for family caregivers of patients with breast cancer to increase knowledge of care options, goals of care communication, and other SM skills. 2. Evaluate the feasibility and preliminary efficacy of the MCC-CG in a pilot randomized controlled trial compared with an attention-control condition (symptom management education) on knowledge of care options, goals of care communication, and other key SM skills (engagement in SM, management of transitions and uncertainty, increasing self-efficacy, appropriate use of health care resources).

Detailed Description: The investigators will address and accomplish aim 1 by taking the following steps: 1. Conduct development focus groups with family caregivers of women with breast cancer. 2. Develop the MCC-CG intervention prototype. 3. Conduct feedback focus groups with family caregivers to evaluate the prototype. 4. Revise the MCC-CG. To address and accomplish aim 2, the investigators will do the following: 1. Conduct a pilot RCT to evaluate the feasibility of recruiting and retaining a sample of family caregivers. 2. Assess the initial efficacy of the MCC-CG to improve knowledge of care options, goals of care communication, and other SM skills. 3. Estimate power and determine the best measures for a large RCT testing the MCC-PT and MCC-CG together.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Smilow Cancer Hospital, New Haven, Connecticut, United States

Contact Details

Name: Dena J Schulman-Green, PhD

Affiliation: Yale School of Nursing

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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