Improving Communication With Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00276822
• Other study ID #: NU 05B4
• Secondary ID: P30CA060553NU-05
• Status: Terminated
• Phase: N/A
• First received: January 12, 2006
• Last updated: June 8, 2012
• Start date: October 2005

Study information

• Verified date: June 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• communication intervention
Patient Education Programs to include surveys, questionnaires, interviews, and videos.

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Patient Education Programs on patient experience		At baseline and at 2 month follow-up	No