CHOICES: Understanding Clinical Trials as a Treatment Option (CHOICES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00983866
Recruitment Status : Active, not recruiting
First Posted : September 24, 2009
Last Update Posted : February 13, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kaiser Permanente

September 14, 2009
September 24, 2009
February 13, 2018
September 2009
December 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00983866 on Archive Site
Proportion of patients who leave the identification and recruitment process at each step. [ Time Frame: Up to three months after the index oncology visit ]
Same as current
Not Provided
Not Provided
CHOICES: Understanding Clinical Trials as a Treatment Option
Increasing Participation in Cancer Clinical Trials

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.

Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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.
  • Experimental: Tailored Telephone Counseling
    Intervention: Behavioral: Tailored Telephone Counseling
  • No Intervention: Standard Trial Recruitment Procedures
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
December 2018
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01CA114543 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Kaiser Permanente
Kaiser Permanente
National Cancer Institute (NCI)
Principal Investigator: Lou Fehrenbacher, MD Kaiser Permanente
Kaiser Permanente
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP