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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00283257
Enrollment
441
Registered
2006-01-27
Start date
2002-02-28
Completion date
2013-12-31
Last updated
2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Solid Tumor

Keywords

Problem solving, psychosocial support

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.

Interventions

BEHAVIORALPatients and caregivers are taught problem solving skills

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026