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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist people with low-risk thyroid cancer in making informed treatment decisions. It introduces the CQUPLE intervention, which provides a chart comparing all treatment options and a list of important questions for the surgeon. Participants will be divided into two groups: one will receive this new intervention, while the other will receive the usual care without additional information beyond the surgeon visit. This trial suits those newly diagnosed with low-risk thyroid cancer who are preparing for a surgical consultation. As an unphased trial, it offers participants the chance to contribute to innovative decision-making tools that could benefit future patients.

Will I have to stop taking my current medications?

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

What prior data suggests that the CQUPLE intervention is safe for patients with low-risk thyroid cancer?

In this study, researchers are testing the CQUPLE intervention. As a new approach, CQUPLE lacks specific safety data from studies, as it is not a drug or medical procedure. CQUPLE serves as a tool to help patients make informed decisions by offering clear information about treatment options and questions to ask their doctors.

This intervention emphasizes education and communication rather than medication or procedures, making it very low-risk. No reports of negative effects exist, as it does not involve drugs or physical treatments. Instead, it enhances patients' understanding and confidence in their choices.

In summary, CQUPLE is safe because it focuses on providing information and improving communication between patients and doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CQUPLE intervention for thyroid cancer because it offers a fresh approach to patient decision-making. Unlike standard treatments, which typically focus on surgery or active surveillance, CQUPLE combines a detailed chart comparing all treatment options with a list of critical questions for patients to ask their surgeons. This empowers patients with evidence-based information, fostering more informed and personalized treatment decisions. The novelty lies in enhancing communication between patients and healthcare providers, potentially improving patient satisfaction and treatment outcomes.

What evidence suggests that the CQUPLE intervention is effective for low-risk thyroid cancer?

Research has shown that the CQUPLE program, which participants in this trial may receive, is designed to help patients with low-risk thyroid cancer make better treatment decisions. This program includes a chart that compares treatment options side-by-side, based on evidence, and a list of important questions to ask the surgeon. Although specific data on CQUPLE's effectiveness is not yet available, similar tools have improved patient understanding and satisfaction with their decisions in other contexts. By helping patients understand their options and possible outcomes, CQUPLE aims to empower them to make choices that align with their personal values and health goals. This can lead to better patient involvement and, ultimately, more positive health outcomes. Meanwhile, the control group in this trial will receive usual care, which involves providing no disease or treatment-specific information outside the surgeon visit. ^{1 2 3 4 5}

Who Is on the Research Team?

Susan Pitt, MD

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

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.

My thyroid nodule is likely cancerous, under 4 cm, and hasn't spread beyond my thyroid.

Exclusion Criteria

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

I am deaf.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4898978/

The impact of marital status at diagnosis on cancer survival in ... These results showed that unmarried status, especially for widowhood, increased the risk of cancer mortality in DTC patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8683521/

Effects of marital status on survival of medullary thyroid cancer ... Extensive studies focused on marital status and cancers showed that married patients have significantly better survival compared to unmarried ...

3. researchgate.net researchgate.net/publication/316512409_Thyroid_cancer_has_a_small_impact_on_patient-partner_relationships_and_their_frequency_of_sexual_activity

Thyroid cancer has a small impact on patient-partner ... Some of the patients and their partners reported that the cancer diagnosis had reduced the frequency of sexual activity. However, compared with cancers of other ...

4. cambridge.org cambridge.org/core/journals/palliative-and-supportive-care/article/thyroid-cancer-has-a-small-impact-on-patientpartner-relationships-and-their-frequency-of-sexual-activity/DE9E348C873EB6044655F9B078DE945D

Thyroid cancer has a small impact on patient–partner ... A total of 20 patients (9.6%) and 22 partners (10.5%) reported having experienced both positive and negative changes. Observed negative ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820924001022

Survival Outcomes in Thyroid Cancer Patients with Co ... It has recently been reported that patients with BC and a history of TC have better survival than those with BC alone.