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A Randomized Control Trial That Teaches Oncology Clinical Trial Patients and Their Caregivers Problem Solving Skills.


N/A
18 Years
N/A
Open (Enrolling)
Both
Solid Tumor, Lymphoma

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Trial Information

A Randomized Control Trial That Teaches Oncology Clinical Trial Patients and Their Caregivers Problem Solving Skills.


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Principal Investigator

Michael Carducci, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Institutional Review Board

Study ID:

NCI CA 95260

NCT ID:

NCT00283257

Start Date:

February 2002

Completion Date:

June 2007

Related Keywords:

  • Solid Tumor
  • Lymphoma
  • Problem solving
  • psychosocial support
  • Lymphoma

Name

Location

UC Davis Cancer CenterSacramento, California  95817