Integrating Palliative Care Into Self-Management of Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), that is intended to improve patients' knowledge of palliative care and to facilitate its timely integration into self-management of their breast cancer. The MCC will be tested with patients with Stage I-IV breast cancer at baseline, one, and three months following enrollment. The intervention group will receive the MCC, and the attention-control group will receive a symptom management toolkit. Participants' family caregivers will also be enrolled to provide information on patients' self-management. Investigators hypothesize that users of MCC, as compared to attention-control participants, will demonstrate improved knowledge, feelings, and behaviors related to self-management of their cancer care. This innovative research can help to establish palliative care as a mainstay of self-management interventions that target serious illnesses.

Official Title
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Integrating Palliative Care Into Self-Management of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Self-Management Group
* Behavioral: Symptom Management Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over the age of 21 Stage I-IV breast cancer Live in the State of Connecticut Speak English Receiving any kind of treatment for breast cancer Prognosis of at least 6 months

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Management Group<br>Managing Cancer Care: A Personal Guide (MCC) is a set of magazine-format, printed modules that includes information about key self-management topics, worksheets, conversation starters, and targeted links to local and internet resources, among other features. | Behavioral: Self-Management Group<br> <br> |
| Active Comparator: Symptom Management Group<br>Participants in the Symptom Management Group will be given a symptom management toolkit that provides information on the most commonly experienced symptoms and side effects of cancer treatment, including fatigue, nausea, and sleep problems, among others. Each chapter includes information on when and why the symptom may occur, how the symptom can be managed, and when to call a provider. | Behavioral: Symptom Management Group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of Care Options Test |  | 1 month | 
| Knowledge of Care Options Test |  | 3 months | 
| Knowledge of Care Options Test |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control Preferences Scale |  | 1 month | 
| Medical Communication Competence Scale |  | 1 month | 
| Measurement of Transitions Scale |  | 1 month | 
| Chronic Disease Self-Efficacy Scale |  | 1 month | 
| Hospital Anxiety and Depression Scale |  | 1 month | 
| Uncertainty in Illness Scale |  | 1 month | 
| Health Care Utilization Form |  | 3 months | 
| Goals of Care Conversations Form |  | 1 month | 
| Control Preferences Scale |  | 3 months | 
| Medical Communication Competence Scale |  | 3 months | 
| Measurement of Transitions Scale |  | 3 months | 
| Chronic Disease Self-Efficacy Scale |  | 3 months | 
| Hospital Anxiety and Depression Scale |  | 3 months | 
| Uncertainty in Illness Scale |  | 3 months | 
| Goals of Care Conversations Form |  | 3 months | 
| Control Preferences Scale |  | baseline | 
| Medical Communication Competence Scale |  | baseline | 
| Measurement of Transitions Scale |  | baseline | 
| Chronic Disease Self-Efficacy Scale |  | baseline | 
| Hospital Anxiety and Depression Scale |  | baseline | 
| Uncertainty in Illness Scale |  | baseline | 
| Goals of Care Conversations Form |  | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care, Self-management, Breast Cancer