Computer Program in Improving Communication Between Doctors and Patients With Stage IV Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00276627
First received: January 12, 2006
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

RATIONALE: A computer program and education materials may help improve the ability of doctors to communicate with patients.

PURPOSE: This randomized clinical trial is studying how well a computer program together with education materials works in improving communication between doctors and patients with stage IV cancer.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Behavioral: communication lecture
Behavioral: lecture plus CD-ROM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Enhancing Patient-Oncologist Communication

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Number of empathic statements and responses to patients' expressions of negative emotion [ Time Frame: Postintervention audio recordings and follow-up surveys ] [ Designated as safety issue: No ]
    Postintervention audio recordings were used to identify the number of empathic statements and responses to patients' expressions of negative emotion. Surveys evaluated patients' trust in their oncologists and perceptions of their oncologists' communication skills.


Enrollment: 800
Study Start Date: February 2003
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: communication lecture Behavioral: communication lecture
lecture on communication skills with oncology patients
Experimental: lecture plus CD-ROM Behavioral: lecture plus CD-ROM
Interactive CD-ROM about responding to patients' negative emotions. The CD-ROM included tailored feedback on the oncologists' own recorded conversations.

Detailed Description:

OBJECTIVES:

Primary

  • Determine the impact of a CD-ROM-based intervention in improving communication behaviors between oncologists and patients with stage IV cancer.
  • Compare the quality of audio-recorded conversations between oncologists and patients with advanced cancer with best practices described in the literature, with particular attention to communication behaviors that promote patient disclosure of concerns, use of emotion handling skills, recognition of empathic opportunities, and the conveying of prognostic information and compare.
  • Develop an intervention to improve oncologists' communication skills in these areas using an interactive CD-ROM based on the oncologists' own recorded discussions with patients.
  • Determine the feasibility of this intervention and, using a randomized, controlled design, measure its effectiveness for changing physician communication behaviors and relevant patient outcomes including reduced distress and increased satisfaction.

OUTLINE: This is a randomized, controlled, 3-part, multicenter study.

  • Part 1 (baseline): Patients undergo an audio-recorded outpatient encounter with their oncologist to see how oncologists elicit patients' concerns and respond to emotional content. Within 1 week later, patients undergo a 10-minute interview by telephone.
  • Part 2 (intervention): Oncologists are randomized to 1 of 2 arms.

    • Arm I (intervention): Oncologists receive a personalized, user-friendly CD-ROM that contains their coded conversations, packaged with related educational material to be used for 3 months.
    • Arm II (control): Oncologists do not receive a CD-ROM or any other educational material support.
  • Part 3 (post-intervention): Three months later, oncologists in both arms are reassessed by recording another 400 clinic visits between the same oncologists and a new group of patients to measure the intervention impact.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of advanced cancer (stage IV disease) AND meets all of the following criteria:

    • Referred by participating physician
    • Must speak English
    • Receiving primary oncology care at participating centers, defined as at least 2 visits to the clinic during the past year and a future scheduled appointment
    • Receiving treatment for any malignancy
    • Has access to a telephone

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  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: NCT00276627

Locations
United States, North Carolina
Duke Cancer Institute
Durham, North Carolina, United States, 27710
United States, Pennsylvania
UPMC Cancer Center at UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: James A. Tulsky, MD Duke University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00276627     History of Changes
Other Study ID Numbers: Pro00010216, DUMC-4510-05-2RER, CDR0000452788
Study First Received: January 12, 2006
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Duke University:
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on August 28, 2014