Overview

This trial is active, not recruiting.

Condition family caregivers
Treatments managing cancer care: a caregiver's guide, symptom management toolkit
Sponsor Yale University
Collaborator Icahn School of Medicine at Mount Sinai
Start date July 2014
End date October 2016
Trial size 35 participants
Trial identifier NCT02616107, 1407014318

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(Experimental)
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)
managing cancer care: a caregiver's guide MCC-CG
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]
(Active Comparator)
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)
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.

Primary Outcomes

Measure
Knowledge of Care Options (KOCO)
time frame: 3 months
Medical Communication Competence Scale (MCCS)
time frame: 3 months
Engagement in Cancer Self-Management Activities Scale (ECSMAS)
time frame: 3 months

Secondary Outcomes

Measure
Goals of Care Conversation
time frame: 3 months
Caregiver Burden Scale (CBS)
time frame: 3 months
Mishel Uncertainty in Illness Scale (MUIS)
time frame: 3 months
Caregiver Competence Scale
time frame: 3 months
Personal Gain Scale
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 110 years old.

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

Additional Information

Official title Improving Cancer Family Caregivers' Knowledge and Communication About Care Options
Principal investigator Dena J Schulman-Green, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Yale University.