Improving Cancer Family Caregivers' Knowledge and Communication About Care Options
NCT ID: NCT02616107
Last Updated: 2017-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2014-07-31
2017-01-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention
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 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 \[defining transitions, transition examples, helping yourself and patient to manage transitions; transitions worksheet\]
Control
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.
Interventions
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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:
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 \[defining transitions, transition examples, helping yourself and patient to manage transitions; transitions worksheet\]
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 18+
* English speaking
* Live in Connecticut
* The patient for whom the participant is a caregiver has a six-month prognosis
18 Years
110 Years
ALL
Yes
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Yale University
OTHER
Responsible Party
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Dena-Schulman-Green
Research Scientist
Principal Investigators
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Dena J Schulman-Green, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale School of Nursing
Locations
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Smilow Cancer Hospital
New Haven, Connecticut, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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1407014318
Identifier Type: -
Identifier Source: org_study_id
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