Clinical trial NCT03656276: The "ToPIC" Study = Tool to Improve Participation In Clinical Trials
Official title: The "ToPIC" Study = Tool to Improve Participation In Clinical Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Communication
Physician-Patient Relations
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-09-04
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UW Health Oncologists and their Patients

Brief summary: The purpose of this study is to pilot the "ToPIC" tool, a communication tool to facilitate clinical trial decision making conversations between oncologists and patients.

Detailed description: The ToPIC tool is a structured delivery of important treatment-related information. The oncologist remains entirely in charge of the information delivered (e.g. what are the treatment options, what are the potential benefits) and uses the ToPIC framework to organize the information and create a pen and paper diagram for the patient to assist in their processing and deliberation. The tool creates a forum for a clear presentation of options and facilitates a patient's ability to express their individual preferences.

Oncologists are the intervention population and will be trained in how to use the ToPIC communication tool. Volunteer oncologists will be randomly assigned to immediate training or wait list control. Oncologists who are randomly assigned to the intervention group will receive training, and once they have demonstrated competence with the tool, they will begin using the tool with their patients. Data collection for any patient whom they present treatment options which include a clinical trial will be included for the primary analysis related to recruitment for clinical trials. This collection will begin once the oncologist, regardless of their assigned group, has signed consent and been randomized.

Eligibility criteria: Inclusion Criteria:

* (Oncologists) - All UW Health oncologists who engage with patients about treatment decisions which involve therapeutic clinical trials. Eligible oncologists may work at UW Hospital and 1 South Park and include all medical, radiation and surgical oncologists. Participation by oncologists is completely voluntary.
* (Patients)

  * Any adults (over age 18)
  * Seen in any UW oncology clinic
  * Participated in a discussion with a participating oncologist about treatment options that included a therapeutic clinical trial.

Exclusion Criteria:

* (Oncologists) ToPIC Study PI
* (Patients) Non-English speaking patients. We exclude non-english speakers due to the unpredictable impacts of the translation/interpreter dynamic and the lack of a pen/paper diagram in the patient's native language. This would include deaf patients.

  * Blind patients (or someone who cannot see the pen/paper diagram)
  * Those who do not have capacity for decision making.
  * Those offered participation in non-therapeutic intent clinical trials. This would include Phase 1 clinical trials due to the non-therapeutic intent.

Primary outcomes:
measure: Number of patients that consent to a therapeutic trial.
timeFrame: may be up to 4 months following appointment with Oncologist
Secondary outcomes:
measure: Number of oncologists that can learn the ToPIC tool after 3 hours of training.
timeFrame: At completion of 3-hour training
measure: Number of patients that enroll in a therapeutic trial.
timeFrame: may be up to 6 months following consent
measure: Number of patients that agree to hear about therapeutic trial.
timeFrame: up to 18 months
Other outcomes:
measure: Qualitative interviews with patients and clinicians to assess the acceptability of ToPIC conversation.
timeFrame: Within 12 weeks following oncology appointment.
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Toby Campbell
role: PRINCIPAL_INVESTIGATOR
References: