Thyroid CancerNCT06073223
Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
A study testing CQUPLE in people with Thyroid Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
The study will include 50 patients newly diagnosed with low-risk thyroid cancer ranging from 18-80 years of age. After scheduling their surgeon visit, the investigators will enroll patients and measure their intended treatment choice, baseline awareness of the three treatment options, expected outcomes, self-efficacy… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- CQUPLE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to 20 Dec 2025
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years
- Low risk papillary thyroid cancer or highly suspicious for cancer
- Low risk papillary thyroid cancer
- cT1-2: Tumor size 4 cm or smaller and limited to the thyroid on ultrasound
- cN0: No evidence of lymph node metastasis on ultrasound
- cM0: No evidence of distant metastasis on imaging
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- Highly suspicious for cancer
- Cytology meeting Bethesda V or Bethesday III or IV with molecular testing indicating a 70% risk of greater of thyroid cancer
- Nodule size 4 cm and smaller
- Limited to the thyroid on ultrasound
- No evidence of suspicious lymph nodes
- No evidence of thyroid cancer outside of the neck
- Referred for surgical consultation.
Who cannot join
- History of previous thyroid cancer or thyroid surgery and parathyroid surgery
- Non-English speaking
- Deaf
- Subject Selection (for Surgeons)
- Surgeon Inclusion Criteria
- Performs at least one thyroid surgery annually on adults
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- Credentialed at Michigan Medicine
- Surgeon Exclusion Criteria
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Pilot Study of an Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
The study will include 50 patients newly diagnosed with low-risk thyroid cancer ranging from 18-80 years of age. After scheduling their surgeon visit, the investigators will enroll patients and measure their intended treatment choice, baseline awareness of the three treatment options, expected outcomes, self-efficacy, and activation. The participants will then be randomized 1:1 and deliver the CQUPLE intervention to the intervention group. The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit. The study team will repeat all measures prior to the surgical consult and after the surgical consult. The study team will record the patients' actual treatment choice after the consult.
- Conditions
- Thyroid Cancer
- Being tested
- Usual Care, CQUPLE
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.
CQUPLEOther
Our research team developed a novel intervention called CQUPLE (pronounced "couple"), which includes two interventions delivered together: (1) a Chart of side-by-side, evidence-based information comparing all three treatment options for low-risk thyroid cancer, including expected outcomes and (2) a Question Prompt List that contains key questions to consider asking the surgeon. The intervention is grounded in social cognitive theory and aims to increase patient awareness of treatment options and their outcomes, patient activation, and self-efficacy for decision making.
| Study group | Role | What they receive |
|---|---|---|
| CQUPLE Intervention | Experimental | A novel intervention called CQUPLE (pronounced "couple"), which includes two interventions delivered together: (1) a Chart of side-by-side, evidence-based information comparing all three treatment options for low-risk thyroid cancer, including expected outcomes and (2) a Question Prompt List that contains key questions to consider asking the surgeon. Receives: Other: CQUPLE |
| Usual Care Control | Active comparator | The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the CQUPLE intervention to patients
This 4-item quantitative instrument assesses participants' views on the acceptability of a novel intervention, such as CQUPLE. The response option are on a 5-point scale from 'completely disagree' to 'completely agree.' Scales are created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Interventional group only.
Measured: up to 14 days after visit
Acceptability of the CQUPLE intervention to providers
This 15-question quantitative instrument measures physician acceptability of decision support interventions with respect to ease of use and approach. Response options are on a 5-point Likert scale from 1 to 5 ('strongly disagree' to 'strongly agree'). Responses are reported descriptively in terms of proportions responding positively or negatively on each criterion.
Measured: at 6 months, and 2 years
Feasibility of the CQUPLE intervention (recruitment)
Recruitment rate will be defined as the number of patients who confirm eligibility during the screening process (they can be screened by phone or by questions in Qualtrics prior to consent) divided by the number who consent to participate.
Measured: up to 7 days after surgery
Feasibility of the CQUPLE intervention (retention)
Retention will be defined as the number who complete the entire study (pre- and post-assessments) divided by the number consented.
Measured: up to 7 days after surgery
Feasibility of the CQUPLE intervention (burden of data collection on study team)
To measure burden of data collection, the investigators will record the number of emails, texts, and phone calls needed for each participant to complete the measures.
Measured: up to 7 days after surgery
Secondary outcomes (1)
Effect of CQUPLE on patient treatment choice
The investigators will assess patient's intended treatment choice at baseline and pre-visit. The investigators will assess actual treatment choice post-visit. The investigators will ask: "Knowing what you know now, which treatment option would/did you choose for yourself?" Answers will include: removal of the entire thyroid, removal of half of the thyroid, surveillance with ultrasound.
Measured: baseline, pre-visit and post visit- up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start18 Sep 2023
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan Pitt, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073223
- Sponsor's protocol ID
- UMCC 2023.009
- Other IDs
- HUM00218043, R03CA283105
- Status last verified
- Feb 2026
- First submitted
- 26 Sep 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will make de-identified data available on a by request basis and will require a DUA
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06073223
- Acronym / sponsor ID
- UMCC 2023.009
- Conditions
- Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 10 Oct 2023 (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 study will include 50 patients newly diagnosed with low-risk thyroid cancer ranging from 18-80 years of age. After scheduling their surgeon visit, the investigators will enroll patients and measure their intended treatment choice, baseline awareness of the three treatment options, expected outcomes, self-efficacy, and activation. The participants will then be randomized 1:1 and deliver the CQUPLE intervention to the intervention group. The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit. The study team will repeat all measures prior to the surgical consult and after the surgical consult. The study team will record the patients' actual treatment choice after the consult.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CQUPLE Intervention | Experimental | Other: CQUPLEA novel intervention called CQUPLE (pronounced "couple"), which includes two interventions delivered together: (1) a Chart of side-by-side, evidence-based information comparing all three treatment options for low-risk thyroid cancer, including expected outcomes and (2) a Question Prompt List that contains key questions to consider asking the surgeon. |
| Usual Care Control | Active comparator | Other: Usual CareThe control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 to 80 years
- Low risk papillary thyroid cancer or highly suspicious for cancer
- Referred for surgical consultation.
Key exclusion criteria (9 listed)
- History of previous thyroid cancer or thyroid surgery and parathyroid surgery
- Non-English speaking
- Deaf
- Subject Selection (for Surgeons)
- Surgeon Inclusion Criteria
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 |
|---|---|---|
| Usual CareThe control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit. | Other | Usual Care Control |
| CQUPLEOur research team developed a novel intervention called CQUPLE (pronounced "couple"), which includes two interventions delivered together: (1) a Chart of side-by-side, evidence-based information comparing all three treatment options for low-risk thyroid cancer, including expected outcomes and (2) a Question Prompt List that contains key questions to consider asking the surgeon. The intervention is grounded in social cognitive theory and aims to increase patient awareness of treatment options and their outcomes, patient activation, and self-efficacy for decision making. | Other | CQUPLE Intervention |
Primary outcome
Acceptability of the CQUPLE intervention to patients
Time frame: up to 14 days after visit
This 4-item quantitative instrument assesses participants' views on the acceptability of a novel intervention, such as CQUPLE. The response option are on a 5-point scale from 'completely disagree' to 'completely agree.' Scales are created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Interventional group only.
Acceptability of the CQUPLE intervention to providers
Time frame: at 6 months, and 2 years
This 15-question quantitative instrument measures physician acceptability of decision support interventions with respect to ease of use and approach. Response options are on a 5-point Likert scale from 1 to 5 ('strongly disagree' to 'strongly agree'). Responses are reported descriptively in terms of proportions responding positively or negatively on each criterion.
Feasibility of the CQUPLE intervention (recruitment)
Time frame: up to 7 days after surgery
Recruitment rate will be defined as the number of patients who confirm eligibility during the screening process (they can be screened by phone or by questions in Qualtrics prior to consent) divided by the number who consent to participate.
Feasibility of the CQUPLE intervention (retention)
Time frame: up to 7 days after surgery
Retention will be defined as the number who complete the entire study (pre- and post-assessments) divided by the number consented.
Feasibility of the CQUPLE intervention (burden of data collection on study team)
Time frame: up to 7 days after surgery
To measure burden of data collection, the investigators will record the number of emails, texts, and phone calls needed for each participant to complete the measures.
1 secondary outcome
Effect of CQUPLE on patient treatment choice
Time frame: baseline, pre-visit and post visit- up to 7 days
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 17 Feb 2026.
- Individual participant dataSharing planned: Yes. The investigators will make de-identified data available on a by request basis and will require a DUA
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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.
Susan Pitt principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CQUPLE in people with Thyroid Cancer, run by University of Michigan Rogel Cancer Center 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 13 inclusion and 9 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 17 Feb 2026. 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?
Acceptability of the CQUPLE intervention to patients (time frame: up to 14 days after visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.