CQUPLE Intervention for Thyroid Cancer

Overseen By Katy Jensen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Disqualifiers: Previous thyroid cancer, Thyroid surgery, Parathyroid surgery, Non-English speaking, Deaf

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How is the CQUPLE treatment different from standard care for thyroid cancer?

The CQUPLE treatment is unique because it may offer an alternative for patients with aggressive thyroid cancer types that do not respond well to standard care, which typically involves surgery and radioactive iodine. This treatment could potentially include novel components or mechanisms not covered by existing therapies like tyrosine kinase inhibitors or other targeted treatments. ^{1 2 3 4 5}

Research Team

Susan Pitt, MD

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

This trial is for individuals aged 18-80 with low-risk papillary thyroid cancer. Eligible participants should have a tumor size of up to 4 cm, confined to the thyroid, no lymph node metastasis or distant spread based on imaging. They must be referred for surgical consultation and not have had previous thyroid/parathyroid surgery, nor be non-English speaking or deaf.

Inclusion Criteria

My thyroid cancer is low risk or highly suspected to be cancerous.

My thyroid cancer is small, within the thyroid, and hasn't spread.

I am between 18 and 80 years old.

Exclusion Criteria

I have had thyroid cancer or surgery on my thyroid or parathyroid.

I do not speak English.

I am deaf.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants are randomized to receive either the CQUPLE intervention or usual care. The intervention group receives a Chart of side-by-side, evidence-based information and a Question Prompt List.

Up to 7 days

1 visit (in-person)

Surgical Consult

Participants attend a surgical consult where their treatment choice is recorded.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for acceptability and feasibility of the intervention, including retention and recruitment rates.

Up to 7 days after surgery

Treatment Details

Interventions

• CQUPLE
• Usual Care

Trial Overview The study compares two approaches in treating low-risk thyroid cancer: 'CQUPLE' intervention versus usual care. CQUPLE involves specific information delivery before a surgeon visit while usual care does not provide extra information. Participants are randomly assigned to one of these groups and their treatment choices are recorded.

Participant Groups

Group I: CQUPLE Intervention Experimental Treatment 1 Intervention

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.

Group II: Usual Care Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Some patients with aggressive thyroid cancer do not respond well to standard treatments like surgery or radioactive iodine, highlighting the need for alternative therapies.

New treatments in development, such as tyrosine kinase inhibitors and other targeted therapies, show promise for managing aggressive forms of thyroid cancer that are resistant to conventional approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Aggressive Thyroid Cancer. Huang, J., Harris, EJ., Lorch, JH.[2021]

The 2015 NCCN Guidelines for Thyroid Carcinoma introduced significant updates for treating anaplastic thyroid carcinoma, including new recommendations for systemic therapy.

Docetaxel/doxorubicin regimens were added to the treatment options, while single-agent cisplatin was removed due to its ineffectiveness in advanced or metastatic cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaplastic Thyroid Carcinoma, Version 2.2015. Haddad, RI., Lydiatt, WM., Ball, DW., et al.[2022]

The study reviewed 48 cases of thyroid cancer over a five-year period, revealing that 70% of these were well-differentiated tumors, yet many patients experienced inadequate management, particularly those presenting as surgical emergencies who received only palliative care.

Only 42% of patients had fine-needle aspiration cytology before surgery, and 39% did not achieve adequate serum thyrotrophin suppression postoperatively, highlighting significant gaps in the standard of care that prompted the development of a new management protocol to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An audit of the management of thyroid cancer in a district general hospital. Vanderpump, MP., Alexander, L., Scarpello, JH., et al.[2019]

Differentiated thyroid carcinoma has a low incidence and generally good prognosis, leading to treatment protocols that rely on retrospective analyses rather than randomized controlled trials.

Current treatment guidelines in the Netherlands, established from a 1987 consensus, recommend near-total thyroidectomy and routine radioiodide therapy, which, while not proven to improve prognosis through trials, help standardize data collection for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The initial treatment of patients with differentiated thyroid carcinoma; consensus and controversies]. Smit, JW.[2007]

Surgery is the most common and effective treatment for recurrent well-differentiated thyroid cancer (WDTC), with reoperation yielding biochemical remission rates between 21% and 66%, although careful observation may be appropriate for some patients.

The management of recurrent WDTC should involve a multidisciplinary team, as treatment decisions are complex and the Thyroid Cancer Care Collaborative's clinical decision-making modules provide personalized recommendations based on individual patient data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of recurrent and persistent metastatic lymph nodes in well-differentiated thyroid cancer: a multifactorial decision-making guide for the Thyroid Cancer Care Collaborative. Urken, ML., Milas, M., Randolph, GW., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of Aggressive Thyroid Cancer. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Anaplastic Thyroid Carcinoma, Version 2.2015. [2022]

3. England pubmed.ncbi.nlm.nih.gov

An audit of the management of thyroid cancer in a district general hospital. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[The initial treatment of patients with differentiated thyroid carcinoma; consensus and controversies]. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Management of recurrent and persistent metastatic lymph nodes in well-differentiated thyroid cancer: a multifactorial decision-making guide for the Thyroid Cancer Care Collaborative. [2015]