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Integrating Palliative Care Into Self-Management of Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Management Group
Symptom Management Group
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Palliative Care, Self-management, Breast Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Yale-New Haven Hospital
  • Yale School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-Management Group

Symptom Management Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Knowledge of Care Options Test
Knowledge of Care Options Test
Knowledge of Care Options Test

Secondary Outcome Measures

Control Preferences Scale
Medical Communication Competence Scale
Measurement of Transitions Scale
Chronic Disease Self-Efficacy Scale
Hospital Anxiety and Depression Scale
Uncertainty in Illness Scale
Health Care Utilization Form
Goals of Care Conversations Form
Control Preferences Scale
Medical Communication Competence Scale
Measurement of Transitions Scale
Chronic Disease Self-Efficacy Scale
Hospital Anxiety and Depression Scale
Uncertainty in Illness Scale
Goals of Care Conversations Form
Control Preferences Scale
Medical Communication Competence Scale
Measurement of Transitions Scale
Chronic Disease Self-Efficacy Scale
Hospital Anxiety and Depression Scale
Uncertainty in Illness Scale
Goals of Care Conversations Form

Full Information

First Posted
May 21, 2014
Last Updated
April 25, 2017
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02148575
Brief Title
Integrating Palliative Care Into Self-Management of Breast Cancer
Official Title
Integrating Palliative Care Into Self-Management of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Palliative Care, Self-management, Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-Management Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Symptom Management Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Management Group
Intervention Type
Behavioral
Intervention Name(s)
Symptom Management Group
Primary Outcome Measure Information:
Title
Knowledge of Care Options Test
Time Frame
1 month
Title
Knowledge of Care Options Test
Time Frame
3 months
Title
Knowledge of Care Options Test
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Control Preferences Scale
Time Frame
1 month
Title
Medical Communication Competence Scale
Time Frame
1 month
Title
Measurement of Transitions Scale
Time Frame
1 month
Title
Chronic Disease Self-Efficacy Scale
Time Frame
1 month
Title
Hospital Anxiety and Depression Scale
Time Frame
1 month
Title
Uncertainty in Illness Scale
Time Frame
1 month
Title
Health Care Utilization Form
Time Frame
3 months
Title
Goals of Care Conversations Form
Time Frame
1 month
Title
Control Preferences Scale
Time Frame
3 months
Title
Medical Communication Competence Scale
Time Frame
3 months
Title
Measurement of Transitions Scale
Time Frame
3 months
Title
Chronic Disease Self-Efficacy Scale
Time Frame
3 months
Title
Hospital Anxiety and Depression Scale
Time Frame
3 months
Title
Uncertainty in Illness Scale
Time Frame
3 months
Title
Goals of Care Conversations Form
Time Frame
3 months
Title
Control Preferences Scale
Time Frame
baseline
Title
Medical Communication Competence Scale
Time Frame
baseline
Title
Measurement of Transitions Scale
Time Frame
baseline
Title
Chronic Disease Self-Efficacy Scale
Time Frame
baseline
Title
Hospital Anxiety and Depression Scale
Time Frame
baseline
Title
Uncertainty in Illness Scale
Time Frame
baseline
Title
Goals of Care Conversations Form
Time Frame
baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dena Schulman-Green, PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale School of Nursing
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27107680
Citation
Schulman-Green D, Linsky S, Jeon S, Kapo J, Blatt L, Chagpar A. Integrating palliative care into self-management of breast cancer: Protocol for a pilot randomized controlled trial. Contemp Clin Trials. 2016 May;48:133-8. doi: 10.1016/j.cct.2016.04.009. Epub 2016 Apr 20.
Results Reference
derived

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Integrating Palliative Care Into Self-Management of Breast Cancer

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