CHOICES: Understanding Clinical Trials as a Treatment Option
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Increasing Participation in Cancer Clinical Trials|
- 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 ]
- 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 ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||July 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|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|
|United States, California|
|Kaiser Permanente Northern California|
|Oakland, California, United States, 94612|
|Principal Investigator:||Carol P. Somkin, PhD||Kaiser Permanente|