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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00276627
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : February 6, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Brief Summary:

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 or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Behavioral: communication lecture Behavioral: lecture plus CD-ROM Not Applicable

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Enhancing Patient-Oncologist Communication
Study Start Date : February 2003
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Number of empathic statements and responses to patients' expressions of negative emotion [ Time Frame: Postintervention audio recordings and follow-up surveys ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00276627

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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
National Cancer Institute (NCI)
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Principal Investigator: James A. Tulsky, MD Duke University
Publications of Results:
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Responsible Party: Duke University Identifier: NCT00276627    
Other Study ID Numbers: Pro00010216
CDR0000452788 ( Other Identifier: NCI )
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014
Keywords provided by Duke University:
unspecified adult solid tumor, protocol specific