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CHOICES: Understanding Clinical Trials as a Treatment Option

NCT00983866 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1376

Last updated 2019-01-10

No results posted yet for this study

Summary

The goal of this study is to determine whether having a telephone discussion with a nurse educator about making treatment decisions and participating in a clinical trial increases trial participation.

The investigators hypothesize that the participants in the intervention group will be more likely to take part in a clinical trial than those in the usual care group.

Conditions

Interventions

BEHAVIORAL

Tailored Telephone Counseling

The intervention is comprised of a letter introducing patients to the idea of participating in a clinical trial as a possible treatment option, followed by a telephone call by a nurse educator who describes the clinical trials process and answers any questions patients may have. The nurse educators will use a tailored counseling protocol that will enable them to conduct an assessment of patients' understanding about and interest in clinical trials and tailor messages according to patient health literacy and language. The protocol will consist of both proactive and reactive counseling. The nurse educator will have a general list of topics to cover but will tailor the discussion and information provided to individual patients' questions and desire for particular types of information.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Lou Fehrenbacher, MD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00983866 on ClinicalTrials.gov