Integrating Palliative Care Into Self-Management of Breast Cancer

Breast Cancer Clinical Trial

Official title:

Integrating Palliative Care Into Self-Management of Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148575
• Other study ID #: 1307012400
• Status: Completed
• Phase: N/A
• First received: May 21, 2014
• Last updated: April 25, 2017
• Start date: June 2014
• Est. completion date: January 2017

Study information

• Verified date: June 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: January 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Self-Management Group

• Symptom Management Group

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	Yale School of Nursing	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge of Care Options Test		1 month
Primary	Knowledge of Care Options Test		3 months
Primary	Knowledge of Care Options Test		baseline
Secondary	Control Preferences Scale		1 month
Secondary	Medical Communication Competence Scale		1 month
Secondary	Measurement of Transitions Scale		1 month
Secondary	Chronic Disease Self-Efficacy Scale		1 month
Secondary	Hospital Anxiety and Depression Scale		1 month
Secondary	Uncertainty in Illness Scale		1 month
Secondary	Health Care Utilization Form		3 months
Secondary	Goals of Care Conversations Form		1 month
Secondary	Control Preferences Scale		3 months
Secondary	Medical Communication Competence Scale		3 months
Secondary	Measurement of Transitions Scale		3 months
Secondary	Chronic Disease Self-Efficacy Scale		3 months
Secondary	Hospital Anxiety and Depression Scale		3 months
Secondary	Uncertainty in Illness Scale		3 months
Secondary	Goals of Care Conversations Form		3 months
Secondary	Control Preferences Scale		baseline
Secondary	Medical Communication Competence Scale		baseline
Secondary	Measurement of Transitions Scale		baseline
Secondary	Chronic Disease Self-Efficacy Scale		baseline
Secondary	Hospital Anxiety and Depression Scale		baseline
Secondary	Uncertainty in Illness Scale		baseline
Secondary	Goals of Care Conversations Form		baseline