Integrating Palliative Care Into Self-Management of Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Symptom Management Group; Behavioral: Self-Management Group

• Registration Number: NCT02148575
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-28
• Study Start: 2014-06
• Primary Completion: 2016-04
• Status Verified: 2016-06
• Study Completion: 2017-01
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Symptom Management Group	Symptom Management Group	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.
Self-Management Group	Self-Management Group	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.

Primary Outcome Measures

Name	Time	Method
Knowledge of Care Options Test	baseline

Secondary Outcome Measures

Name	Time	Method
Measurement of Transitions Scale	baseline
Health Care Utilization Form	3 months
Control Preferences Scale	baseline
Medical Communication Competence 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

Trial Locations

Locations (2)

Yale School of Nursing; 🇺🇸 West Haven, Connecticut, United States

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States