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.
Is the CQUPLE treatment a promising treatment for thyroid cancer?The CQUPLE treatment could be promising for thyroid cancer, especially for aggressive types that don't respond well to usual care. Usual care often involves surgery and radioactive iodine, but some thyroid cancers need more advanced treatments. New treatments are being developed for these aggressive cancers, which might make CQUPLE a promising option.247912
What safety data exists for the CQUPLE intervention in thyroid cancer treatment?The provided research does not directly mention safety data for the CQUPLE intervention or its alternative names (Usual Care, Standard Care, Conventional Care) in thyroid cancer treatment. The studies focus on various treatment options and management strategies for thyroid cancer, including surgery, radioactive iodine, and chemotherapy, but do not specifically address safety data for the CQUPLE intervention.1581314
Do I have to stop taking my current medications for this trial?The trial information does not specify whether you need to stop taking your current medications.
What data supports the idea that CQUPLE Intervention for Thyroid Cancer is an effective treatment?The available research does not provide specific data on the effectiveness of the CQUPLE Intervention for Thyroid Cancer. Instead, it discusses the challenges and current practices in treating thyroid cancer, such as the use of radioiodine therapy and surgery. There is mention of new molecular targeted therapies being developed, but no direct comparison or data on CQUPLE's effectiveness is provided. Therefore, we cannot conclude its effectiveness based on the given information.3461011
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.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: CQUPLE InterventionExperimental Treatment1 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 ControlActive Control1 Intervention
The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.
Find a clinic near you
Research locations nearbySelect from list below to view details:
The University of Michigan Cancer CenterAnn Arbor, MI
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Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Current status of chemotherapy in the treatment of advanced carcinoma of the thyroid gland. [2004]An extensive review of the literature was undertaken to identify single agents and chemotherapeutic combinations active against advanced thyroid carcinoma. The two most intensively studied agents were Adriamycin and bleomycin, both of which appear to have definite activity against advanced disease. Studies of 25 other single agents and 17 drug combinations were also reviewed but most of the studies suffered from extremely poor patient accrual, thus precluding statistical analysis. Two cooperative group protocols are in progress which will hopefully accrue enough patients for meaningful interpretation. Physicians treating advanced thyroid carcinoma patients are urged to participate in these studies.
An audit of the management of thyroid cancer in a district general hospital. [2019]Thyroid cancer is the commonest endocrine malignancy yet it appeared to present infrequently to the endocrinologists at this large District General Hospital. The management of well-differentiated thyroid cancer remains controversial with a wide variation in clinical practice. The aim of this survey was to determine the characteristics of the patients diagnosed with thyroid cancer and whether any deficiencies existed in the management of subjects diagnosed with thyroid cancer over a five-year period using standards of care based upon long-term outcome data and recently published USA guidelines.
Current practice of radioiodine treatment in the management of differentiated thyroid cancer in Germany. [2019]This prospective, observational study of a cohort of thyroid cancer patients in Germany focusses on the "real-world" practice in the management of thyroid cancer patients. This report includes data from 2376 patients with primary differentiated thyroid carcinoma first diagnosed in the year 1996. The study reveals considerable differences in actual practice concerning surgery and radioiodine treatment. The results indicate that consensus is lacking with respect to the multimodality treatment approach for differentiated thyroid carcinoma. Our analysis represents the most current and comprehensive national assessment of presenting patient characteristics, diagnostic tests, treatment and complications for thyroid cancer.
[The initial treatment of patients with differentiated thyroid carcinoma; consensus and controversies]. [2007]Differentiated thyroid carcinoma has a low incidence and a relatively good prognosis. As a consequence, treatment protocols are largely based on retrospective analyses of heterogeneous patient groups, as no randomised controlled trials with residual disease and survival as outcome measures are available. In the Netherlands, guidelines for initial therapy are based on a 1987 international consensus meeting. These guidelines involve near-total thyroidectomy with a few exceptions and routine radioiodide ablative therapy in all cases. Recent publications still support the main measures as advised in this consensus. Although randomised trials have not proven that the consensus guidelines improve the prognosis in thyroid carcinoma, the guidelines provide a base for uniform data collection and thus scientific research. They also provide tools for health-practice quality surveys.
Treatment of advanced differentiated thyroid carcinoma with high activity radioiodine therapy. [2019]This was a retrospective study to assess the efficacy and morbidity of high activity I therapy in patients with advanced differentiated thyroid carcinoma.
New approaches in the management of radioiodine-refractory thyroid cancer: the molecular targeted therapy era. [2010]Although thyroid carcinoma usually has an excellent prognosis, the lack of therapeutic options is an issue for patients that develop metastases and are resistant to radioiodine therapy. The development of novel molecular targeted therapies and the characterization of several proteins that have a crucial role in the carcinogenesis process of differentiated thyroid cancer have created an opportunity to design new clinical trials for this setting. Moreover, the encouraging initial results of first clinical trials have accelerated the development of placebo-controlled phase III studies that will assess the role of these new agents in the management of differentiated thyroid cancer.
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]Well-differentiated thyroid cancer (WDTC) recurs in up to 30% of patients. Guidelines from the American Thyroid Association (ATA) and the National Comprehensive Cancer Network (NCCN) provide valuable parameters for the management of recurrent disease, but fail to guide the clinician as to the multitude of factors that should be taken into account. The Thyroid Cancer Care Collaborative (TCCC) is a web-based repository of a patient's clinical information. Ten clinical decision-making modules (CDMMs) process this information and display individualized treatment recommendations.
Optimal differentiated thyroid cancer management in the elderly. [2018]The incidence of differentiated thyroid cancer is increasing worldwide across all age groups. While most patients with differentiated thyroid cancer have a good prognosis, aggressive disease is more common in the elderly and disease-specific mortality is higher. Treatment options for differentiated thyroid cancer include surgery, levothyroxine, radioactive iodine, external beam radiotherapy and kinase inhibitors. Rational and evidence-based management is particularly important in older individuals because they may experience greater toxicities from the therapeutic options. We advocate an explicit risk-benefit analytic approach to thyroid cancer care that emphasises individual patient factors, likely disease biology and progression, and age-dependent treatment characteristics to ensure optimal treatment. In particular, this risk-benefit approach should seek to identify patients with aggressive disease, and, within a multidisciplinary setting, balance the likelihood of treatment success with the probability of treatment-related adverse effects.
Anaplastic Thyroid Carcinoma, Version 2.2015. [2022]This selection from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Thyroid Carcinoma focuses on anaplastic carcinoma because substantial changes were made to the systemic therapy recommendations for the 2015 update. Dosages and frequency of administration are now provided, docetaxel/doxorubicin regimens were added, and single-agent cisplatin was deleted because it is not recommended for patients with advanced or metastatic anaplastic thyroid cancer.
Differentiated Thyroid Cancer in Children: A UK Multicentre Review and Review of the Literature. [2020]To obtain an overview of the management and outcomes of children aged 18 years or younger diagnosed with differentiated thyroid carcinoma of follicular cell origin across the UK, by collecting and analysing data from the limited number of centres treating these patients. This multicentre data might provide a more realistic perspective than single-institution series.
Breast cancer prognosis is better in patients who develop subsequent metachronous thyroid cancer. [2020]Breast cancer (BC) and thyroid cancer (TC) are common malignancies among females. However, the connection between TC and BC is not well understood. To explore the relationship between these two cancers and to determine the effect of second metachronous TC on BC survival, we compared BC patients with or without second primary TC using data from the Surveillance, Epidemiology, and End Results (SEER) database. We extracted data from patients with only BC or TC and from BC patients with a second metachronous cancer from 2000-2014. Differences in the clinicopathological and treatment characteristics between BC patients with or without second metachronous TC were analyzed by chi-square tests. Multivariate analyses of BC survival were performed by using Cox regression models. Comparison of disease-specific survival (DSS) curves between these cohorts was performed with the log-rank (Mantel-Cox) test. Survival analyses were also performed using data from 1980-1994. Within this dataset, we found 1,262 BC cases in which a second metachronous TC (BC2TC) developed, accounting for 3.1% of all metachronous cancers following BC from 2000-2014. No significant differences were found in molecular markers. In addition, the mean age at BC diagnosis was younger in the BC2TC group than in the BC group (55.418 y vs 60.273 y). Half of the BC2TC patients developed TC in the first three years following BC diagnosis. Patients with BC2TC showed better DSS than those with BC alone from 2000-2014 (P
Treatment of Aggressive Thyroid Cancer. [2021]Although thyroid cancer generally has a good prognosis, there is a subset of patients for whom standard care (ie, treatment limited to surgery or surgery plus radioactive iodine) is either not appropriate because of the aggressive nature of their disease or not sufficient because of disease progression through standard treatment. Most of these tumors are in 3 groups: radioactive iodine-refractory differentiated thyroid carcinoma including poorly differentiated thyroid carcinoma anaplastic thyroid carcinoma, and progressive medullary thyroid carcinoma. Major classes of treatments in clinical development for these aggressive thyroid tumors include tyrosine kinase inhibitors, mammalian target of rapamycin inhibitors, and mitogen-activated protein kinase kinase inhibitors.
Combining data to perform population-based observational studies: know your sources. The case of thyroid cancer in Belgium. [2022]Large scale observational studies are crucial to study thyroid cancer incidence and management, known to vary in time and place. Combining cancer registry data with other data sources enables execution of population-based studies, provided data sources are accurate. The objective was to compare thyroid tumour and treatment information between the available data sources in Belgium.
Outcomes and Trends of Treatments in High-Risk Differentiated Thyroid Cancer. [2023]To analyze the variant-specific survival benefits and usage patterns of standardized treatment combinations of surgery (S), radioactive iodine ablation (RAI), and thyroid-stimulating hormone suppression therapy (THST) for high-risk differentiated thyroid cancer.