AzTrials
AzTrials

Metastatic CancerPhase 3NCT00244868

Computer-Based Survey and Communication Aid in Improving Physician-Patient Communication and Treatment Decision Making in Patients With Metastatic Cancer

A Phase 3 study testing counseling intervention and educational intervention in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Fox Chase Cancer Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: A computer-based survey and communication aid may help physicians and patients to communicate better and help make treatment decisions easier. PURPOSE: This phase III randomized clinical trial is studying how well giving a computer-based survey together with a communication aid works compared to a… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
counseling intervention and educational intervention
How many people
720 participants
Where
3 sitesUnited States
Study dates
Jul 2003to Apr 2007
Phase
Phase 3
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:

  • Documented metastatic malignancy
  • First visit with medical oncologist at study site

PATIENT CHARACTERISTICS:

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Able to read and speak English

PRIOR CONCURRENT THERAPY: Not specified

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • MBCCOP - Meharry Medical College - Nashville

    Nashville, Tennessee, 37208-3599

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

Other trials in United States

About this study

Official title: Facilitating Decision Making in Advanced Cancer Patients

RATIONALE: A computer-based survey and communication aid may help physicians and patients to communicate better and help make treatment decisions easier.

PURPOSE: This phase III randomized clinical trial is studying how well giving a computer-based survey together with a communication aid works compared to a computer-based survey alone in improving physician-patient communication and treatment decision making in patients with metastatic cancer.

Read the detailed description

OBJECTIVES:

  • Compare satisfaction with physician-patient communication and decisional conflict in patients with metastatic cancer undergoing a computer-based survey with vs without a communication aid.
  • Compare patient expectations regarding potential benefits and adverse reactions associated with treatment options in patients undergoing the computer-based survey and communication aid.
  • Compare the content of physician-patient consultations in patients undergoing the computer-based survey and communication aid.

OUTLINE: This is a randomized, controlled, multicenter study.

Patients are randomized to 1 of 3 study arms.

  • Arm I (generic computer-based survey): Patients complete a 45- to 60-minute generic computer-based survey that assesses demographics, familiarity and comfort with computers, treatment history, and affective elements.
  • Arm II (targeted computer-based survey and communication aid with physician summary report): Patients complete a 45- to 60-minute targeted computer-based survey assessing patient values, information needs, and distress. Patients then complete a targeted computer-based communication aid that addresses cognitive and affective components of cancer treatment education and provides communication skills training. After completion of the survey and communication aid, a summary report of the survey results is generated and provided to the patient's physician.
  • Arm III (targeted computer-based survey and communication aid): Patients complete a targeted computer-based survey and communication aid as in arm II. No summary report is provided to the physician.

After completion of a computer-based survey and communication aid, all patients undergo a consultation with their physician. A randomized subset of 25% of physician consultations* are audiotaped and later analyzed. Patients complete a 15-minute written survey after completion of the physician consultation and then at 3 months.

NOTE: *Patients are stratified according to study arm (I vs II vs III) and consulting physician gender for this randomization.

PROJECTED ACCRUAL: A total of 720 patients will be accrued for this study.

Being tested
counseling intervention, educational intervention
Keywords
unspecified adult solid tumor, protocol specific, metastatic cancer
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • counseling interventionOther

  • educational interventionOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Satisfaction with patient-physician communication by Medical Interview Satisfaction Survey and Face Valid Survey given immediately after the first consultation

  2. Assess decisional conflict by Decisional Conflict Scale immediately after the first consultation and at 3 months after study completion

  3. Expectations regarding potential benefits and adverse reactions associated with treatment options by Treatment Options Expectations Scale given immediately after the first consultation and at 3 months after study completion

  4. Assess content of consultation by applying a coding scheme to transcripts and design yes/no questions immediately after the first consultation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2005 (estimated)
  2. Study startJul 2003
  3. Primary completionApr 2007

Resources

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 3
Allocation
Randomised
Enrolment
720 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00244868
Sponsor's protocol ID
CDR0000442928
Other IDs
FCCC-03826, FCCC-NCI-FC03CC9, NU-119-385
Status last verified
Jan 2013
First submitted
25 Oct 2005
Last updated
29 Jan 2013
Results posted
No

Publications

  • Meropol NJ, Egleston BL, Buzaglo JS, Benson AB 3rd, Cegala DJ, Diefenbach MA, Fleisher L, Miller SM, Sulmasy DP, Weinfurt KP; CONNECT Study Research Group. Cancer patient preferences for quality and length of life. Cancer. 2008 Dec 15;113(12):3459-66. doi: 10.1002/cncr.23968.

    PubMed 18988231

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing counseling intervention and educational intervention in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Fox Chase Cancer Center at 3 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 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Satisfaction with patient-physician communication by Medical Interview Satisfaction Survey and Face Valid Survey given immediately after the first consultation. The study lists 4 primary outcomes in all. 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 NCT00244868, 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 29 Jan 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in