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NCT Number: NCT06073223

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.

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Other

The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.

CQUPLE

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Effect of CQUPLE on patient treatment choice

    Time frame: baseline, pre-visit and post visit- up to 7 days

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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