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



Status:Recruiting
Healthy:No
Age Range:19 - Any
Updated:9/5/2018
Start Date:March 10, 2017
End Date:July 2019
Contact:Cancer Connect
Email:cancerconnect@uwcarbone.wisc.edu
Phone:800-622-8922

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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.

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.

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.
We found this trial at
1
site
600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
Phone: 608-263-8606
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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mi
from
Madison, WI
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