- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00283257
Simultaneous Care: Linking Palliation to Clinical Trials
June 26, 2017 updated by: University of California, Davis
A Randomized Control Trial That Teaches Oncology Clinical Trial Patients and Their Caregivers Problem Solving Skills.
This is a multi-site randomized control trial taking place at six cancer centers.
UC Davis is the lead site.
Additional performance sites include the City of Hope Medical Center, Fred Hutchinson Cancer Center at the Univ. of Washington, USC Norris Cancer Center, UCSD Cancer Center, and Johns Hopkins Cancer Center.
Clinical trial patients and their caregivers who are randomized to the intervention arm of the study are scheduled for three educational sessions.
The sessions focus on teaching problem solving skills based on the COPE problem solving model.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The project introduces and evaluates the effects of a Simultaneous Care Education Intervention, using the COPE model (Creativity, Optimism, Planning and Expert Information) developed by D'Zurilla and Nezu, as one of its key components for cancer patients in Phase I, II and III clinical trials.
The SCEI team will use the COPE problem solving educational model to instruct patients on how to problem solve and manage challenges associated not only with the investigational therapy, but also the psychosocial issues that arise from cancer diagnosis, disease progression, treatment, and disease or treatment related symptoms.
The educational intervention also sets up a system for regularly contacting the patient and caregiver in order to reinforce what is taught.
Patients and caregivers randomized to the intervention arm will receive three education sessions.
Patients and designated caregiver will be asked to complete the set of measurement tools approximately every 30 days while enrolled in the study.
Study Type
Interventional
Enrollment (Actual)
441
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Sacramento, California, United States, 95817
- UC Davis Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- English speaking, must have caregiver who is willing to participate, must be entering a phase 1-3 oncology clinical trial. Must be able to complete first educational session on or before treatment start date. Solid tumor or lymphoma only.
Exclusion Criteria:
- Non-English speaking, no caregiver available, unable to complete first educational session on or before treatment start date.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Betty Ferrell, Ph.D, City of Hope Medical Center
- Principal Investigator: Anthony Back, M.D., Fred Hutchinson Cancer Center, Univ. of Washington
- Principal Investigator: Heinz Josef Lenz, M.D., USC Norris Cancer Center
- Principal Investigator: Joanne Mortimer, M.D., University of California, San Diego
- Study Chair: Frederick J Meyers, MD, University of California, Davis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2002
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
January 25, 2006
First Submitted That Met QC Criteria
January 25, 2006
First Posted (Estimate)
January 27, 2006
Study Record Updates
Last Update Posted (Actual)
June 27, 2017
Last Update Submitted That Met QC Criteria
June 26, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 200210794
- NCI CA 95260
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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