Clinical trial NCT00283257: Simultaneous Care: Linking Palliation to Clinical Trials
Official title: A Randomized Control Trial That Teaches Oncology Clinical Trial Patients and Their Caregivers Problem Solving Skills.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Tumor
Lymphoma
Keywords: Problem solving
psychosocial support
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2006-01-27
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Cancer Center
state: California
Study officials:
affiliation: Johns Hopkins University
name: Michael Carducci, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: City of Hope Medical Center
name: Betty Ferrell, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutchinson Cancer Center, Univ. of Washington
name: Anthony Back, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: USC Norris Cancer Center
name: Heinz Josef Lenz, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Joanne Mortimer, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Frederick J Meyers, MD
role: STUDY_CHAIR
References: