The "ToPIC" Study = Tool to Improve Participation In Clinical Trials

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.

Study Overview

• Status: Completed
• Conditions: Communication; Physician-Patient Relations
• Intervention / Treatment: Behavioral: Tool to improve Participation In Clinical Trials (ToPIC)

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.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

UW Health Oncologists and their Patients

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A: Oncologists (wait list control); Oncologists will be wait-listed for training on the Tool to improve Participation In Clinical Trials (ToPIC)
Group B: Oncologists (training); Oncologists will receive immediate training on the Tool to improve Participation In Clinical Trials (ToPIC)	Behavioral: Tool to improve Participation In Clinical Trials (ToPIC); The Tool to improve Participation In Clinical Trials (ToPIC) is a communication tool to facilitate clinical trial decision making conversations between oncologists and patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients that consent to a therapeutic trial.	Number of patients that consent to a therapeutic trial in the wait-list control vs. the trained oncologist groups. Per protocol, there is no timeframe within which patients need to consent. Due to the nature of oncology care, some patients are presented with the trial months before they are eligible, and the team follows up to see if they choose to consent if/when they are eligible.	may be up to 4 months following appointment with Oncologist

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of oncologists that can learn the ToPIC tool after 3 hours of training.	Oncologists will demonstrate their post-training competence with a standardized patient-actor encounter. Competency is assessed by a 4-person panel using a 20-point scoring system. A consensus score of 14 or above indicates competency.	At completion of 3-hour training
Number of patients that enroll in a therapeutic trial.	Number of patients that enroll in a therapeutic trial in the wait-list control vs. the trained oncologist groups. Per protocol, there is no timeframe within which patients need to enroll. Enrollment in the trial may be prolonged due to extensive screening requirements.	may be up to 6 months following consent
Number of patients that agree to hear about therapeutic trial.	Number of patients that agree to hear about therapeutic trial in the wait-list control vs. the trained oncologist groups. Physicians will be on study for up to 18 months once they are trained (ToPIC trained group) or enrolled (waitlist control group). The number of patients who agree to hear about the trial will be collected during the 18 month period.	up to 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative interviews with patients and clinicians to assess the acceptability of ToPIC conversation.	Interviews to better understand the factors that clinicians and patients consider when making treatment decisions about clinical trials and their impression of the decision making discussion.	Within 12 weeks following oncology appointment.

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Toby Campbell, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: UW16060; P30CA014520 (U.S. NIH Grant/Contract); A534260 (Other Identifier: UW Madison); SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison); 2016-1579 (Other Identifier: Health Science Institutional Review Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No