CHOICES: Understanding Clinical Trials as a Treatment Option

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Tailored Telephone Counseling

Group Type EXPERIMENTAL

Tailored Telephone Counseling

Intervention Type BEHAVIORAL

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.

Standard Trial Recruitment Procedures

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients who are potentially eligible for one of the designated clinical trials on the basis of automated data from pathology reports and other databases

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No