Improving Cancer Family Caregivers' Knowledge and Communication About Care Options
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Knowledge of Care Options (KOCO)
Study Overview
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:
- 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.
- 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:
- Conduct development focus groups with family caregivers of women with breast cancer.
- Develop the MCC-CG intervention prototype.
- Conduct feedback focus groups with family caregivers to evaluate the prototype.
- Revise the MCC-CG.
To address and accomplish aim 2, the investigators will do the following:
- Conduct a pilot RCT to evaluate the feasibility of recruiting and retaining a sample of family caregivers.
- Assess the initial efficacy of the MCC-CG to improve knowledge of care options, goals of care communication, and other SM skills.
- Estimate power and determine the best measures for a large RCT testing the MCC-PT and MCC-CG together.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 110 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •A family member of an individual with any stage of breast cancer receiving curative, palliative, or hospice care
- •English speaking
- •Live in Connecticut
- •The patient for whom the participant is a caregiver has a six-month prognosis
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention
Family caregivers of breast cancer patients who consent to participate in the study have a 50/50 chance of being randomized to the intervention group and will receive the booklet, Managing Cancer Care: A Caregiver's Guide (MCC-CG) (N=18)
Intervention: Managing Cancer Care: A Caregiver's Guide (Other)
Control
Family caregivers of breast cancer patients who consent to participate in the study have a 50/50 chance of being randomized to the control group and will receive the Symptom Management Toolkit (N=17)
Intervention: Symptom Management Toolkit (Other)
Outcomes
Primary Outcomes
Knowledge of Care Options (KOCO)
Time Frame: 3 months
11-item questionnaire in true/false format to assess knowledge of curative, palliative, and hospice care.
Medical Communication Competence Scale (MCCS)
Time Frame: 3 months
Adjusted to reflect views of the family caregiver, the MCCS will assess participants' communication skills, including information seeking, providing, and verifying, and socio-emotional communication will be measured using the MCCS. Each item on the MCCS is presented with a Likert scale ranging from 7 (strongly agree) to 1 (strongly disagree).
Engagement in Cancer Self-Management Activities Scale (ECSMAS)
Time Frame: 3 months
The 33-item ECSMAS was developed to measure cancer patients' self-reported self-management. The ECSMAS is organized around three conceptual domains derived from a metasynthesis of process of self-management in chronic illness: focus on illness needs, activating resources, and living with chronic illness. Items are adjusted to reflect views of the family caregiver, and an additional item has been added to the ECSMAS to assess caregivers' ability to manage transitions as a self-management skill (34 items total).
Secondary Outcomes
- Caregiver Competence Scale(3 months)
- Goals of Care Conversation(3 months)
- Caregiver Burden Scale (CBS)(3 months)
- Mishel Uncertainty in Illness Scale (MUIS)(3 months)
- Personal Gain Scale(3 months)
Investigators
Dena-Schulman-Green
Research Scientist
Yale University