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

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ClinicalTrials.gov Identifier: NCT00983866
Recruitment Status : Active, not recruiting
First Posted : September 24, 2009
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kaiser Permanente

Brief 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.


Condition or disease Intervention/treatment Phase
Cancer Behavioral: Tailored Telephone Counseling Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Increasing Participation in Cancer Clinical Trials
Study Start Date : September 2009
Actual Primary Completion Date : December 2012
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Tailored Telephone Counseling 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.
No Intervention: Standard Trial Recruitment Procedures



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983866


Locations
United States, California
Kaiser Permanente Northern California
Oakland, California, United States, 94612
Sponsors and Collaborators
Kaiser Permanente
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lou Fehrenbacher, MD Kaiser Permanente

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00983866     History of Changes
Other Study ID Numbers: CN-04CSomk-02-B
R01CA114543 ( U.S. NIH Grant/Contract )
First Posted: September 24, 2009    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018