Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title:

Pilot Study of an Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073223
• Other study ID #: UMCC 2023.009
• Secondary ID: HUM00218043R03CA
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: April 2025

Study information

• Verified date: December 2023
• Source: University of Michigan Rogel Cancer Center
• Contact: Katy Jensen
• Phone: 734-764-5424
• Email: gensurgadmin-choiceresearchteam[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Other:
• Usual Care
The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.
• CQUPLE
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.

Locations

Country	Name	City	State
United States	The University of Michigan Cancer Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	day after clinic visit
Primary	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.	at time of surgery
Primary	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.	up to 7 days after surgery
Primary	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.	up to 7 days after surgery
Primary	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.	up to 7 days after surgery
Secondary	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.	baseline, pre-visit and post visit- up to 7 days