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

Not Applicable

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Behavioral: communication lecture; Behavioral: lecture plus CD-ROM

• Registration Number: NCT00276627
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-05
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
communication lecture	communication lecture	-
lecture plus CD-ROM	lecture plus CD-ROM	-

Primary Outcome Measures

Name	Time	Method
Number of empathic statements and responses to patients' expressions of negative emotion	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.

Trial Locations

Locations (2)

UPMC Cancer Center at UPMC Presbyterian; 🇺🇸 Pittsburgh, Pennsylvania, United States

Duke Cancer Institute; 🇺🇸 Durham, North Carolina, United States