NCT00276627

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2003

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

3 years

First QC Date

January 12, 2006

Last Update Submit

February 5, 2014

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Number of empathic statements and responses to patients' expressions of negative emotion

    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.

    Postintervention audio recordings and follow-up surveys

Study Arms (2)

communication lecture

ACTIVE COMPARATOR
Behavioral: communication lecture

lecture plus CD-ROM

EXPERIMENTAL
Behavioral: lecture plus CD-ROM

Interventions

communication lectureBEHAVIORAL

lecture on communication skills with oncology patients

communication lecture
lecture plus CD-ROMBEHAVIORAL

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

lecture plus CD-ROM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

UPMC Cancer Center at UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • 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.

    PMID: 22041948RESULT

MeSH Terms

Interventions

CD-ROM

Intervention Hierarchy (Ancestors)

Compact DisksVideodisc RecordingOptical Storage DevicesAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • James A. Tulsky, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

February 1, 2003

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations

US(2)