Unspecified Adult Solid Tumor, Protocol SpecificNCT00276627
Computer Program in Improving Communication Between Doctors and Patients With Stage IV Cancer
A study testing communication lecture and lecture plus CD-ROM in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Duke University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- communication lecture and lecture plus CD-ROM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2003to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Cancer Institute
Durham, North Carolina, 27710
UPMC Cancer Center at UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Enhancing Patient-Oncologist Communication
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.
Read the 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.
- Being tested
- communication lecture, lecture plus CD-ROM
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
communication lectureBehavioural
lecture on communication skills with oncology patients
lecture plus CD-ROMBehavioural
Interactive CD-ROM about responding to patients' negative emotions. The CD-ROM included tailored feedback on the oncologists' own recorded conversations.
| Study group | Role | What they receive |
|---|---|---|
| communication lecture | Active comparator | Not described Receives: Behavioral: communication lecture |
| lecture plus CD-ROM | Experimental | Not described Receives: Behavioral: lecture plus CD-ROM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postintervention audio recordings and follow-up surveys
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startFeb 2003
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James A. Tulsky, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276627
- Sponsor's protocol ID
- Pro00010216
- Other IDs
- DUMC-4510-05-2RER, CDR0000452788
- Status last verified
- Feb 2014
- First submitted
- 12 Jan 2006
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22041948
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Patient-Oncologist Communication
- ClinicalTrials.gov ID
- NCT00276627
- Acronym / sponsor ID
- Pro00010216
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2003
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 13 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| communication lecture | Active comparator | Behavioral: communication lecture |
| lecture plus CD-ROM | Experimental | Behavioral: lecture plus CD-ROM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| communication lecturelecture on communication skills with oncology patients | Behavioural | communication lecture |
| lecture plus CD-ROMInteractive CD-ROM about responding to patients' negative emotions. The CD-ROM included tailored feedback on the oncologists' own recorded conversations. | Behavioural | lecture plus CD-ROM |
Primary outcome
Number of empathic statements and responses to patients' expressions of negative emotion
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
- Results publication: PubMed 22041948Tulsky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A. Tulsky, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing communication lecture and lecture plus CD-ROM in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of empathic statements and responses to patients' expressions of negative emotion (time frame: Postintervention audio recordings and follow-up surveys). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00276627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2014.