NCT00283257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
441

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

11.8 years

First QC Date

January 25, 2006

Last Update Submit

June 26, 2017

Conditions

Solid TumorLymphoma

Keywords

Problem solvingpsychosocial support

Interventions

Patients and caregivers are taught problem solving skillsBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Non-English speaking, no caregiver available, unable to complete first educational session on or before treatment start date.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Frederick J Meyers, MD

    University of California, Davis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 27, 2006

Study Start

February 1, 2002

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 27, 2017

Record last verified: 2017-06

Locations

US(1)