Improving Communication With Patients With Breast Cancer

This study has been terminated.
(Preliminary findings did not support purpose.)
Sponsor:
Collaborator:
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
  Purpose

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.


Condition Intervention
Breast Cancer
Other: communication intervention

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Facilitating Caring Communication for People With Cancer: The Case of Breast Cancer

Resource links provided by NLM:


Further study details as provided by Northwestern University:

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

Enrollment: 30
Study Start Date: October 2005
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: communication intervention
    Patient Education Programs to include surveys, questionnaires, interviews, and videos.
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276822

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Gregory Makoul, PhD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00276822     History of Changes
Other Study ID Numbers: NU 05B4, P30CA060553, NU-05B4, NU-IRB-0608-011, STU00018976
Study First Received: January 12, 2006
Last Updated: June 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014