Computer Program in Improving Communication Between Doctors and Patients With Stage IV Cancer
|ClinicalTrials.gov Identifier: NCT00276627|
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : February 6, 2014
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||800 participants|
|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|
|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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276627
|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|
|Principal Investigator:||James A. Tulsky, MD||Duke University|