Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments self-management group, symptom management group
Sponsor Yale University
Start date June 2014
End date April 2016
Trial size 109 participants
Trial identifier NCT02148575, 1307012400

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
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.
self-management group
(Active Comparator)
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.
symptom management group

Primary Outcomes

Measure
Knowledge of Care Options Test
time frame: 1 month
Knowledge of Care Options Test
time frame: 3 months
Knowledge of Care Options Test
time frame: baseline

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 21 years old.

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

Additional Information

Official title Integrating Palliative Care Into Self-Management of Breast Cancer
Principal investigator Dena Schulman-Green, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Yale University.