Skip to main content
OpenTrials
Completed

NCT Number: NCT02616107

Improving Cancer Family Caregivers' Knowledge and Communication About Care Options

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Family Caregivers Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Smilow Cancer Hospital

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Managing Cancer Care: A Caregiver's Guide

Other

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:

  • Becoming a Cancer Caregiver [role, changes, challenges, adjusting, self-care]
  • Basics of Cancer Caregiving [physical, functional, emotional, social, & spiritual support; treatment timeline worksheet]
  • Caregiver's Role in Managing Patient Care [who/what is involved; health care professionals worksheet]
  • Managing Cancer Symptoms and Side Effects [common symptoms/side effects; maintaining health; nutrition & exercise; medication management worksheet]
  • Care Options: [information on curative, palliative and hospice care]
  • Talking About Goals of Care [information on goals of care conversations]
  • Managing Transitions [defining transitions, transition examples, helping yourself and patient to manage transitions; transitions worksheet]

Other names: MCC-CG

Symptom Management Toolkit

Other

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.

Primary outcomes

  1. 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.

  2. 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. 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

  1. 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.

  2. 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. 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.

  4. Caregiver Competence Scale

    Time frame: 3 months

    Self-efficacy will be measured using a 4-point Likert scale, with four questions total.

  5. Personal Gain Scale

    Time frame: 3 months

    Self-efficacy will be measured using a 4-point Likert scale, with four questions total.

Other outcomes

  1. Demographic/Clinical form

    Time frame: Baseline

    Includes demographic data for caregivers and clinical data for the patient whom they provide care for.

  2. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Nov 26, 2015
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.