Improving Communication With Patients With Breast Cancer

This study has been terminated.

(Preliminary findings did not support purpose.)

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Northwestern University

ClinicalTrials.gov Identifier:

NCT00276822

First received: January 12, 2006

Last updated: June 8, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 12, 2006

Last Updated Date

June 8, 2012

Start Date ^ICMJE

October 2005

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effect of Patient Education Programs on patient experience [ Time Frame: At baseline and at 2 month follow-up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00276822 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Improving Communication With Patients With Breast Cancer

Official Title ^ICMJE

Facilitating Caring Communication for People With Cancer: The Case of Breast Cancer

Brief Summary

RATIONALE: An education program based on patients' health communication needs may improve patients' overall healthcare experience and sense of control.

PURPOSE: This clinical trial is studying the health communication needs of patients with breast cancer to develop patient education programs.

Detailed Description

OBJECTIVES:

Determine patients' health communication needs during the first 6 months of care by interviewing patients with breast cancer (as well as their families, caregivers, and healthcare teams) and observing interactions between patients and oncologists throughout the trajectory of care from initial diagnosis through the initial treatment course.
Determine patients' health communication needs at the point of bone metastases by interviewing patients with breast cancer (as well as their families, caregivers, and healthcare teams) and observing interactions between patients and oncologists in the Hematology-Oncology Clinic.
Develop Patient Education Programs to help meet patients' health communication needs by conveying information about essential elements of cancer care in a clear and consistent manner, thus allowing clinicians to focus more attention on answering questions, engaging in counseling, and responding to emotional issues.
Create a Patient Education Program that models effective strategies for asking questions and expressing concerns and needs for symptom control (i.e., pain, anxiety, depression).
Develop Patient Narrative Videos, with women identified by their providers, to provide members of the healthcare team with a better understanding of the patient experience and issues that arise for patients outside the formal health care setting.
Conduct a pilot test to determine whether the Patient Education Programs affect patients' experience of care, sense of control, and perceptions of caring communication, as well as knowledge, satisfaction, anxiety, depression, pain, and self-reported health.
Determine patient and family response to Patient Narrative Videos and healthcare team response to Patient Narrative Videos and Patient Education Programs.

OUTLINE: This is a pilot, multicenter study.

A visit between the patient and his/her oncologist and healthcare team is videorecorded. Patients, family members, caregivers, and healthcare team members then undergo a 10-minute interview. Patients then undergo a 5-minute follow-up interview once every 2 weeks for 6 months. Some patients may participate in a one-time group discussion.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Other: communication intervention

Patient Education Programs to include surveys, questionnaires, interviews, and videos.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer

PATIENT CHARACTERISTICS:

Patients: 30 to 80 years of age
Family members: 20 to 80 years of age
Healthcare team members: 20 to 80 years of age
Must be conversant in English

PRIOR CONCURRENT THERAPY:

Not specified

Gender

Both

Ages

30 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00276822

Other Study ID Numbers ^ICMJE

NU 05B4, P30CA060553, NU-05B4, NU-IRB-0608-011, STU00018976

Has Data Monitoring Committee

Not Provided

Responsible Party

Northwestern University

Study Sponsor ^ICMJE

Northwestern University

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Gregory Makoul, PhD

Robert H. Lurie Cancer Center

Information Provided By

Northwestern University

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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