Cancer
Conditions
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.
Interventions
BEHAVIORALTailored 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.
Sponsors
National Cancer Institute (NCI)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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 |
Countries
United States
Outcome results
None listed