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CHOICES: Understanding Clinical Trials as a Treatment Option

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00983866
First received: September 14, 2009
Last updated: May 6, 2014
Last verified: May 2014

September 14, 2009
May 6, 2014
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00983866 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Cancer
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2110
December 2015
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00983866
CN-04CSomk-02-B, R01CA114543
Yes
Kaiser Permanente
Kaiser Permanente
National Cancer Institute (NCI)
Principal Investigator: Carol P. Somkin, PhD Kaiser Permanente
Kaiser Permanente
May 2014

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