CommunicationNCT03656276
The "ToPIC" Study = Tool to Improve Participation In Clinical Trials
An observational study of Communication and Physician-Patient Relations, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Communication, Physician-Patient Relations
- What is being tested?
- Tool to improve Participation In Clinical Trials (ToPIC)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
Study population: UW Health Oncologists and their Patients
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
About this study
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.
Read the 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.
- Conditions
- Communication, Physician-Patient Relations
- Being tested
- Tool to improve Participation In Clinical Trials (ToPIC)
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tool to improve Participation In Clinical Trials (ToPIC)Behavioural
The Tool to improve Participation In Clinical Trials (ToPIC) is a communication tool to facilitate clinical trial decision making conversations between oncologists and patients.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Tool to improve Participation In Clinical Trials (ToPIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start10 Mar 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Toby Campbell, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656276
- Sponsor's protocol ID
- UW16060
- Other IDs
- 2016-1579, A534260, SMPH\MEDICINE\HEM-ONC, P30CA014520
- Status last verified
- Feb 2020
- First submitted
- 28 Aug 2018
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Campbell TC, Gedeon C, Qudah B, Jasicki M, Kwekkeboom KL, Zelenski A. Improving cancer clinical trial enrollment and patient understanding using TrialTalk, a structured communication method: a pilot randomized controlled trial. Support Care Cancer. 2026 Mar 24;34(4):359. doi: 10.1007/s00520-026-10505-4.
PubMed 41874721
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "ToPIC" Study = Tool to Improve Participation In Clinical Trials
- ClinicalTrials.gov ID
- NCT03656276
- Acronym / sponsor ID
- UW16060
- Conditions
- Communication, Physician-Patient Relations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) | – | Behavioral: Tool to improve Participation In Clinical Trials (ToPIC)Oncologists will receive immediate training on the Tool to improve Participation In Clinical Trials (ToPIC) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- UW Health Oncologists and their Patients
Key inclusion criteria (5 listed)
- (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)
Key exclusion criteria (5 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group B: Oncologists (training) |
Primary outcome
Number of patients that consent to a therapeutic trial.
Time frame: may be up to 4 months following appointment with Oncologist
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.
3 secondary outcomes
Number of oncologists that can learn the ToPIC tool after 3 hours of training.
Time frame: At completion of 3-hour training
Number of patients that enroll in a therapeutic trial.
Time frame: may be up to 6 months following consent
Number of patients that agree to hear about therapeutic trial.
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Derived from this study: PubMed 41874721Campbell TC, Gedeon C, Qudah B, Jasicki M, Kwekkeboom KL, Zelenski A. Improving cancer clinical trial enrollment and patient understanding using TrialTalk, a structured communication method: a pilot randomized controlled trial. Support Care Cancer. 2026 Mar 24;34(4):359. doi: 10.1007/s00520-026-10505-4.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toby Campbell principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Communication and Physician-Patient Relations, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that consent to a therapeutic trial. (time frame: may be up to 4 months following appointment with Oncologist). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03656276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.