CHOICES: Understanding Clinical Trials as a Treatment Option

Cancer Clinical Trial

— CHOICES  

Official title:

Increasing Participation in Cancer Clinical Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983866
• Other study ID #: CN-04CSomk-02-B
• Secondary ID: R01CA114543
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1376
• Est. completion date: December 2018
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients eligible for designated clinical trials who actually enroll in one of these trials		Up to three months after the index oncology visit
Secondary	Proportion of patients who leave the identification and recruitment process at each step.		Up to three months after the index oncology visit