NCT03656276

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

August 28, 2018

Last Update Submit

February 7, 2020

Conditions

CommunicationPhysician-Patient Relations

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of oncologists that can learn the ToPIC tool after 3 hours of training.

    At completion of 3-hour training

  • Number of patients that enroll in a therapeutic trial.

    may be up to 6 months following consent

  • Number of patients that agree to hear about therapeutic trial.

    up to 18 months

Other Outcomes (1)

  • Qualitative interviews with patients and clinicians to assess the acceptability of ToPIC conversation.

    Within 12 weeks following oncology appointment.

Study Arms (2)

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)

Interventions

Tool to improve Participation In Clinical Trials (ToPIC)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.

Group B: Oncologists (training)

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

UW Health Oncologists and their Patients

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

Location

Related Links

MeSH Terms

Conditions

Communication

Interventions

Clinical Trials as Topic

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Clinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Toby Campbell

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2018

First Posted

September 4, 2018

Study Start

March 10, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

US(1)