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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-10

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Communication Physician-Patient Relations

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A: Oncologists (wait list control)

Oncologists will be wait-listed for training on the Tool to improve Participation In Clinical Trials (ToPIC)

No interventions assigned to this group

Group B: Oncologists (training)

Oncologists will receive immediate training on the Tool to improve Participation In Clinical Trials (ToPIC)

Tool to improve Participation In Clinical Trials (ToPIC)

Intervention Type BEHAVIORAL

The Tool to improve Participation In Clinical Trials (ToPIC) is a communication tool to facilitate clinical trial decision making conversations between oncologists and patients.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No