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Simultaneous Care: Linking Palliation to Clinical Trials

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00283257
First received: January 25, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted

January 25, 2006
January 25, 2006
February 2002
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No Changes Posted
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Simultaneous Care: Linking Palliation to Clinical Trials
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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
  • Solid Tumor
  • Lymphoma
Behavioral: Patients and caregivers are taught problem solving skills
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
June 2007
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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.
Both
18 Years and older
No
Contact: Frederick J Meyers, M.D. 916 734-8596 fred.meyers@ucdmc.ucdavis.edu
Contact: Joan M Blais, MPA 916 734-2187 joan.blais@ucdmc.ucdavis.edu
United States
 
NCT00283257
NCI CA 95260, NCI CA 95260
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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
University of California, Davis
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP