Clinical trial NCT02616107: Improving Cancer Family Caregivers' Knowledge and Communication About Care Options
Official title: Improving Cancer Family Caregivers' Knowledge and Communication About Care Options
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Caregivers
Keywords: Caregiver
Self-management
Care options
Goals of care
Breast cancer
Palliative care
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2015-11-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge of Care Options (KOCO)
timeFrame: 3 months
measure: Medical Communication Competence Scale (MCCS)
timeFrame: 3 months
measure: Engagement in Cancer Self-Management Activities Scale (ECSMAS)
timeFrame: 3 months
Secondary outcomes:
measure: Goals of Care Conversation
timeFrame: 3 months
measure: Caregiver Burden Scale (CBS)
timeFrame: 3 months
measure: Mishel Uncertainty in Illness Scale (MUIS)
timeFrame: 3 months
measure: Caregiver Competence Scale
timeFrame: 3 months
measure: Personal Gain Scale
timeFrame: 3 months
Other outcomes:
measure: Demographic/Clinical form
timeFrame: Baseline
measure: Health Care Utilization
timeFrame: 3 months after 3-month data collection time point
Locations:
city: New Haven
country: United States
facility: Smilow Cancer Hospital
state: Connecticut
Study officials:
affiliation: Yale School of Nursing
name: Dena J Schulman-Green, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. Epub 2012 Jun 13.
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. Epub 2012 May 2.
citation: 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.
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. Epub 2013 Jun 1. No abstract available.
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. Epub 2015 Nov 4.
citation: 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.