Improving Cancer Family Caregivers' Knowledge and Communication About Care Options

March 6, 2017 updated by: Dena-Schulman-Green, Yale University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Smilow Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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)
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 Names:
  • MCC-CG
ACTIVE_COMPARATOR: 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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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).
3 months
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).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goals of Care Conversation
Time Frame: 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.
3 months
Caregiver Burden Scale (CBS)
Time Frame: 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.
3 months
Mishel Uncertainty in Illness Scale (MUIS)
Time Frame: 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.
3 months
Caregiver Competence Scale
Time Frame: 3 months
Self-efficacy will be measured using a 4-point Likert scale, with four questions total.
3 months
Personal Gain Scale
Time Frame: 3 months
Self-efficacy will be measured using a 4-point Likert scale, with four questions total.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic/Clinical form
Time Frame: Baseline
Includes demographic data for caregivers and clinical data for the patient whom they provide care for.
Baseline
Health Care Utilization
Time Frame: 3 months after 3-month data collection time point
Data is abstracted from participants' medical records, including use of the emergency room, unscheduled hospital admissions, admission to ICU, use of chemotherapy and radiation in the last two weeks of life, and referral to hospice, among other indicators of disease burden as specified by the Center to Advance Palliative Care.
3 months after 3-month data collection time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Dena J Schulman-Green, PhD, Yale School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

November 9, 2016

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (ESTIMATE)

November 26, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1407014318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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