Improving Cancer Family Caregivers' Knowledge and Communication About Care Options

NCT02616107 | Completed

• 1 other identifier: 1407014318
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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. 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. 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).

Conditions

Family Caregivers

Keywords

Caregiver; Self-management; Care options; Goals of care; Breast cancer; Palliative care

Outcome Measures

Primary Outcomes (3)

• Knowledge of Care Options (KOCO)

  11-item questionnaire in true/false format to assess knowledge of curative, palliative, and hospice care.

  3 months

• Medical Communication Competence Scale (MCCS)

  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)

  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 Outcomes (5)

• Goals of Care Conversation

  3 months

• Caregiver Burden Scale (CBS)

  3 months

• Mishel Uncertainty in Illness Scale (MUIS)

  3 months

• Caregiver Competence Scale

  3 months

• Personal Gain Scale

  3 months

Other Outcomes (2)

• Demographic/Clinical form

  Baseline

• Health Care Utilization

  3 months after 3-month data collection time point

Study Arms (2)

Intervention

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)

Other: Managing Cancer Care: A Caregiver's Guide

Control

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)

Other: Symptom Management Toolkit

Interventions

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: 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 \[defining transitions, transition examples, helping yourself and patient to manage transitions; transitions worksheet\]

Also known as: MCC-CG

Intervention

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.

Control

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Smilow Cancer Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (8)

• McCorkle R, Ercolano E, Lazenby M, Schulman-Green D, Schilling LS, Lorig K, Wagner EH. Self-management: Enabling and empowering patients living with cancer as a chronic illness. CA Cancer J Clin. 2011 Jan-Feb;61(1):50-62. doi: 10.3322/caac.20093. Epub 2011 Jan 4.

  PMID: 21205833 BACKGROUND

• Schulman-Green D, Ercolano E, Jeon S, Dixon J. Validation of the knowledge of care options instrument to measure knowledge of curative, palliative, and hospice care. J Palliat Med. 2012 Oct;15(10):1091-9. doi: 10.1089/jpm.2011.0514. Epub 2012 Jun 13.

  PMID: 22694739 BACKGROUND

• Schulman-Green D, Jaser S, Martin F, Alonzo A, Grey M, McCorkle R, Redeker NS, Reynolds N, Whittemore R. Processes of self-management in chronic illness. J Nurs Scholarsh. 2012 Jun;44(2):136-44. doi: 10.1111/j.1547-5069.2012.01444.x. Epub 2012 May 2.

  PMID: 22551013 BACKGROUND

• Grey M, Schulman-Green D, Knafl K, Reynolds NR. A revised Self- and Family Management Framework. Nurs Outlook. 2015 Mar-Apr;63(2):162-70. doi: 10.1016/j.outlook.2014.10.003. Epub 2014 Oct 15.

  PMID: 25771190 BACKGROUND

• Schulman-Green D, Jeon S. Printed guide improves knowledge of curative, palliative, and hospice care among women with metastatic breast cancer. Support Care Cancer. 2013 Oct;21(10):2651-3. doi: 10.1007/s00520-013-1864-x. Epub 2013 Jun 1. No abstract available.

  PMID: 23729228 BACKGROUND

• Schulman-Green D, Jeon S. Managing Cancer Care: a psycho-educational intervention to improve knowledge of care options and breast cancer self-management. Psychooncology. 2017 Feb;26(2):173-181. doi: 10.1002/pon.4013. Epub 2015 Nov 4.

  PMID: 26537980 BACKGROUND

• Hinchey J, Goldberg J, Linsky S, Linsky R, Jeon S, Schulman-Green D. Knowledge of Cancer Stage among Women with Nonmetastatic Breast Cancer. J Palliat Med. 2016 Mar;19(3):314-7. doi: 10.1089/jpm.2015.0133. Epub 2016 Feb 8.

  PMID: 26855201 BACKGROUND

• Schulman-Green D, Linsky S, Blatt L, Jeuland J, Kapo J, Jeon S. Improving Breast Cancer Family Caregivers' Palliative Care Literacy: A Pilot Randomized Trial. J Fam Nurs. 2023 Feb;29(1):99-114. doi: 10.1177/10748407221099541. Epub 2022 Jun 7.

  PMID: 35670155 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dena J Schulman-Green, PhD

  Yale School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 26, 2015
• Study Start: July 1, 2014
• Primary Completion: November 9, 2016
• Study Completion: January 1, 2017
• Last Updated: March 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)