Integrating Palliative Care Into Self-Management of Breast Cancer

April 25, 2017 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale-New Haven Hospital
      • West Haven, Connecticut, United States, 06516
        • Yale School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Self-Management Group
Active Comparator: 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.
Behavioral: Symptom Management Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knowledge of Care Options Test
Time Frame: 1 month
1 month
Knowledge of Care Options Test
Time Frame: 3 months
3 months
Knowledge of Care Options Test
Time Frame: baseline
baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Dena Schulman-Green, PhD, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimate)

May 28, 2014

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1307012400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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