CHOICES: Understanding Clinical Trials as a Treatment Option

NCT00983866 | Completed DMC

• 2 other identifiers: CN-04CSomk-02-BR01CA114543
• Study Type: interventional
• Target: 1,376
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of patients who leave the identification and recruitment process at each step.

  Up to three months after the index oncology visit

Study Arms (2)

Tailored Telephone Counseling

EXPERIMENTAL

Behavioral: Tailored Telephone Counseling

Standard Trial Recruitment Procedures

NO INTERVENTION

Interventions

Tailored Telephone Counseling BEHAVIORAL

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.

Tailored Telephone Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are potentially eligible for one of the designated clinical trials on the basis of automated data from pathology reports and other databases

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Lou Fehrenbacher, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2009
• First Posted: September 24, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

US (1)