Clinical trial NCT06073223: Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
Official title: Pilot Study of an Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-10-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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, 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.


Eligibility criteria: Inclusion Criteria:

* 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
  * 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.

Exclusion Criteria:

* 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
* Credentialed at Michigan Medicine

Surgeon Exclusion Criteria

* None

Primary outcomes:
measure: Acceptability of the CQUPLE intervention to patients
timeFrame: day after clinic visit
measure: Acceptability of the CQUPLE intervention to providers
timeFrame: at time of surgery
measure: Feasibility of the CQUPLE intervention (recruitment)
timeFrame: up to 7 days after surgery
measure: Feasibility of the CQUPLE intervention (retention)
timeFrame: up to 7 days after surgery
measure: Feasibility of the CQUPLE intervention (burden of data collection on study team)
timeFrame: up to 7 days after surgery
Secondary outcomes:
measure: Effect of CQUPLE on patient treatment choice
timeFrame: baseline, pre-visit and post visit- up to 7 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Susan Pitt
role: PRINCIPAL_INVESTIGATOR
References: