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

January 12, 2006
February 5, 2014
February 2003
February 2006   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00276627 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Computer Program in Improving Communication Between Doctors and Patients With Stage IV Cancer
Enhancing Patient-Oncologist Communication

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Unspecified Adult Solid Tumor, Protocol Specific
  • Behavioral: communication lecture
    lecture on communication skills with oncology patients
  • 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.
  • Active Comparator: communication lecture
    Intervention: Behavioral: communication lecture
  • Experimental: lecture plus CD-ROM
    Intervention: Behavioral: lecture plus CD-ROM
Tulsky JA, Arnold RM, Alexander SC, Olsen MK, Jeffreys AS, Rodriguez KL, Skinner CS, Farrell D, Abernethy AP, Pollak KI. Enhancing communication between oncologists and patients with a computer-based training program: a randomized trial. Ann Intern Med. 2011 Nov 1;155(9):593-601. doi: 10.7326/0003-4819-155-9-201111010-00007.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
February 2006
February 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00276627
Pro00010216, DUMC-4510-05-2RER, CDR0000452788
No
Duke University
Duke University
National Cancer Institute (NCI)
Principal Investigator: James A. Tulsky, MD Duke University School of Medicine
Duke University
February 2014

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