Overview

This trial is active, not recruiting.

Condition cancer
Treatment tailored telephone counseling
Sponsor Kaiser Permanente
Collaborator National Cancer Institute (NCI)
Start date September 2009
End date December 2012
Trial size 2110 participants
Trial identifier NCT00983866, CN-04CSomk-02-B, R01CA114543

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
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)

Primary Outcomes

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

Secondary Outcomes

Measure
Proportion of patients who leave the identification and recruitment process at each step.
time frame: Up to three months after the index oncology visit

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Increasing Participation in Cancer Clinical Trials
Principal investigator Carol P. Somkin, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Kaiser Permanente.