NCT02616107

Improving Cancer Family Caregivers' Knowledge and Communication About Care Options

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Accepted

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.

Conditions

• Family Caregivers

Interventions

Type	Name	Description
OTHER	Managing Cancer Care: A Caregiver's Guide	MCC-CG is a set of 7 printed modules including information about caregiver-nominated SM topics, conversation starters to facilitate communication with patients and providers, and links to caregiver resources. The modules are as follows: 1. Becoming a Cancer Caregiver \[role, changes, challenges, adjusting, self-care\] 2. Basics of Cancer Caregiving \[physical, functional, emotional, social, \& spiritual support; treatment timeline worksheet\] 3. Caregiver's Role in Managing Patient Care \[who/what is involved; health care professionals worksheet\] 4. Managing Cancer Symptoms and Side Effects \[common symptoms/side effects; maintaining health; nutrition \& exercise; medication management worksheet\] 5. Care Options: \[information on curative, palliative and hospice care\] 6. Talking About Goals of Care \[information on goals of care conversations\] 7. Managing Transitions \[defining transitions, transition examples, helping yourself and patient to manage transitions; transitions worksheet\]
OTHER	Symptom Management Toolkit	Along with an overview of symptom management, the Toolkit provides concise information on commonly experienced symptoms, including fatigue, alopecia, cognitive dysfunction, nausea and vomiting, and sleep problems, among others. Each chapter uses a question-and-answer format to cover the topics of who is most likely to experience the symptom, when and why the symptom may occur, how the symptom can be managed, and when to call a provider. Drs. Schulman-Green and McCorkle have previously tested the Symptom Toolkit in an attention-control group.

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-11-09
• Completion: 2017-01-01
• First posted: 2015-11-26
• Last updated: 2017-03-07

Locations

1 site across 1 country: United States