We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Simultaneous Care: Linking Palliation to Clinical Trials

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00283257
First Posted: January 27, 2006
Last Update Posted: June 27, 2017
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.
Information provided by (Responsible Party):
University of California, Davis
January 25, 2006
January 27, 2006
June 27, 2017
February 2002
December 2013   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00283257 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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: None (Open Label)
Primary Purpose: Other
  • Solid Tumor
  • Lymphoma
Behavioral: Patients and caregivers are taught problem solving skills
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
441
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00283257
200210794
NCI CA 95260
Not Provided
Not Provided
Not Provided
University of California, Davis
University of California, Davis
Not Provided
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
June 2017

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