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OpenTrials
Completed

NCT Number: NCT00983866

CHOICES: Understanding Clinical Trials as a Treatment Option

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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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Patients who meet specific exclusion criteria for designated clinical trials

Treatment and study plan

Tailored Telephone Counseling

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.

Primary outcomes

  1. Proportion of patients eligible for designated clinical trials who actually enroll in one of these trials

    Time frame: Up to three months after the index oncology visit

Secondary outcomes

  1. Proportion of patients who leave the identification and recruitment process at each step.

    Time frame: Up to three months after the index oncology visit

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Increasing Participation in Cancer Clinical Trials

Acronym: CHOICES

Important dates

Study start
2009
Primary completion
2012
Study completion
2018
First posted
Sep 24, 2009
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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