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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Tailored Telephone Counseling

• Study Type: Interventional
• Enrollment (Actual): 1376
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Northern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who leave the identification and recruitment process at each step.	Up to three months after the index oncology visit

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lou Fehrenbacher, MD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: September 14, 2009
• First Submitted That Met QC Criteria: September 23, 2009
• First Posted (Estimate): September 24, 2009

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CN-04CSomk-02-B; R01CA114543 (U.S. NIH Grant/Contract)