Clinical trial NCT00276627: Computer Program in Improving Communication Between Doctors and Patients With Stage IV Cancer
Official title: Enhancing Patient-Oncologist Communication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-01-13
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Number of empathic statements and responses to patients' expressions of negative emotion
timeFrame: Postintervention audio recordings and follow-up surveys
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: Pittsburgh
country: United States
facility: UPMC Cancer Center at UPMC Presbyterian
state: Pennsylvania
Study officials:
affiliation: Duke University
name: James A. Tulsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.