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

NCT ID: NCT00276627

Last Updated: 2014-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2006-02-28

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

communication lecture

Group Type: ACTIVE_COMPARATOR

communication lecture

Intervention Type: BEHAVIORAL

lecture on communication skills with oncology patients

lecture plus CD-ROM

Group Type: EXPERIMENTAL

lecture plus CD-ROM

Intervention Type: BEHAVIORAL

Interactive CD-ROM about responding to patients' negative emotions. The CD-ROM included tailored feedback on the oncologists' own recorded conversations.

Interventions

communication lecture

lecture on communication skills with oncology patients

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James A. Tulsky, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Cancer Institute

Durham, North Carolina, United States

UPMC Cancer Center at UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22041948 (View on PubMed)

Other Identifiers

DUMC-4510-05-2RER

Identifier Type: -

Identifier Source: secondary_id

CDR0000452788

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00010216

Identifier Type: -

Identifier Source: org_study_id