Simultaneous Care: Linking Palliation to Clinical Trials
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Solid Tumor Lymphoma |
Behavioral: Patients and caregivers are taught problem solving skills |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training |
| Official Title: | A Randomized Control Trial That Teaches Oncology Clinical Trial Patients and Their Caregivers Problem Solving Skills. |
| Estimated Enrollment: | 600 |
| Study Start Date: | February 2002 |
| Estimated Study Completion Date: | June 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| 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, California | |
| UC Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Frederick J Meyers, MD 916-734-8596 fred.meyers@ucdmc.ucdavis.edu | |
| Contact: Joan M Blais, MPA 916 734-2187 joan.blais@ucdmc.ucdavis.edu | |
| Principal Investigator: Frederick J Meyers, MD | |
| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00283257 History of Changes |
| Other Study ID Numbers: | NCI CA 95260, NCI CA 95260 |
| Study First Received: | January 25, 2006 |
| Last Updated: | January 25, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Davis:
|
Problem solving psychosocial support |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013