Improving Cancer Family Caregivers' Knowledge and Communication About Care Options

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

A family member of an individual with any stage of breast cancer receiving curative, palliative, or hospice care
Aged 18+
English speaking
Live in Connecticut
The patient for whom the participant is a caregiver has a six-month prognosis

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Control	Symptom Management Toolkit	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)

Primary Outcome Measures

Name	Time	Method
Knowledge of Care Options (KOCO)	3 months	11-item questionnaire in true/false format to assess knowledge of curative, palliative, and hospice care.
Medical Communication Competence Scale (MCCS)	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)	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 Outcome Measures

Name	Time	Method
Caregiver Competence Scale	3 months	Self-efficacy will be measured using a 4-point Likert scale, with four questions total.
Goals of Care Conversation	3 months	This form documents frequency, perceived quality, and content of goals of care conversations with patients and providers, as well as capturing any transitions experienced.
Caregiver Burden Scale (CBS)	3 months	This 22-item scale was developed to assess the experience of burden among caregivers, specifically addressing the dimensions of personal strain and role strain. Each item is presented with five response options ranging from 0-4 indicating "never", "rarely", "sometimes", "frequently", and "nearly always" sequentially.
Mishel Uncertainty in Illness Scale (MUIS)	3 months	Uncertainty will be measured using the 32-item MUIS, which was developed to measure the uncertainty adults perceive regarding symptoms, diagnosis, relationships, and planning for the future. Each item on the MUIS represents uncertainty in terms of a 5-point Likert-type format ranging from 1 (strongly disagree) to 5 (strongly agree). All items adjusted to reflect views of the caregiver.
Personal Gain Scale	3 months	Self-efficacy will be measured using a 4-point Likert scale, with four questions total.

Locations (1): Smilow Cancer Hospital
🇺🇸
New Haven, Connecticut, United States