Text Size

CHOICES: Understanding Clinical Trials as a Treatment Option

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00983866
First received: September 14, 2009
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Cancer
 Behavioral: Tailored Telephone Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Increasing Participation in Cancer Clinical Trials

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2110
Study Start Date: September 2009
Estimated Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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: Carol P. Somkin, PhD Kaiser Permanente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00983866     History of Changes
Other Study ID Numbers: CN-04CSomk-02-B, R01CA114543
Study First Received: September 14, 2009
Last Updated: April 30, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013