Computer Program in Improving Communication Between Doctors and Patients With Stage IV Cancer
This study has been completed.
Sponsor:
Duke University
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00276627
First received: January 12, 2006
Last updated: April 9, 2013
Last verified: December 2012
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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
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: | April 9, 2013 |
| 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 May 16, 2013