Improving Cancer Family Caregivers' Knowledge and Communication About Care Options

Family Caregivers Clinical Trial

Official title:

Improving Cancer Family Caregivers' Knowledge and Communication About Care Options

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616107
• Other study ID #: 1407014318
• Status: Completed
• Phase: N/A
• First received: November 18, 2015
• Last updated: March 6, 2017
• Start date: July 2014
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2017
• Est. primary completion date: November 9, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

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

Related Conditions & MeSH terms

• Family Caregivers

Intervention

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: 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]
• 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.

Locations

Country	Name	City	State
United States	Smilow Cancer Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

Hinchey, J., Goldberg, J. Linsky, S. Linsky, R., Jeon, S., Schulman-Green, D. Knowledge of cancer stage among women with non-metastatic breast cancer. Journal of Palliative Medicine. [e-pub ahead of print]

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic/Clinical form	Includes demographic data for caregivers and clinical data for the patient whom they provide care for.	Baseline
Other	Health Care Utilization	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
Primary	Knowledge of Care Options (KOCO)	11-item questionnaire in true/false format to assess knowledge of curative, palliative, and hospice care.	3 months
Primary	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
Primary	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	Goals of Care Conversation	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
Secondary	Caregiver Burden Scale (CBS)	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
Secondary	Mishel Uncertainty in Illness Scale (MUIS)	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
Secondary	Caregiver Competence Scale	Self-efficacy will be measured using a 4-point Likert scale, with four questions total.	3 months
Secondary	Personal Gain Scale	Self-efficacy will be measured using a 4-point Likert scale, with four questions total.	3 months