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Simultaneous Care: Linking Palliation to Clinical Trials

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00283257
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : June 27, 2017
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Lymphoma Behavioral: Patients and caregivers are taught problem solving skills Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 441 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized Control Trial That Teaches Oncology Clinical Trial Patients and Their Caregivers Problem Solving Skills.
Actual Study Start Date : February 2002
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00283257

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United States, California
UC Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
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Principal Investigator: Michael Carducci, M.D. Johns Hopkins University
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
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Responsible Party: University of California, Davis Identifier: NCT00283257    
Other Study ID Numbers: 200210794
NCI CA 95260
First Posted: January 27, 2006    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Keywords provided by University of California, Davis:
Problem solving
psychosocial support