Decision Aid for Thyroid Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Elizabeth G. Grubbs

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cognitive impairment, Psychological impairment, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial develops and studies how well a patient decision aid works in supporting decision-making about when to start or stop new drugs, join clinical trials, or continue active cancer monitoring for patients with medullary thyroid cancer and their caregivers. Developing a patient decision aid may help patients with medullary thyroid cancer make well-informed decisions about their cancer care and be able to discuss their preferences with their doctors.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Patient Decision Aid for thyroid cancer?

Research shows that using a computerized patient decision aid helps patients with early-stage papillary thyroid cancer improve their medical knowledge and reduce uncertainty when deciding on radioactive iodine treatment. ^{1 2 3 4 5}

Is the Patient Decision Aid safe for use in humans?

The research does not provide specific safety data for the Patient Decision Aid itself, as it is a tool to help patients make informed decisions about their treatment options, rather than a medical treatment or drug. ^{1 2 3 4 5}

How does the decision aid treatment for thyroid cancer differ from other treatments?

The decision aid treatment for thyroid cancer is unique because it helps patients make informed choices about their treatment options, such as the extent of surgery or the use of tyrosine kinase inhibitors (TKIs) for advanced tumors, by providing structured information and facilitating shared decision-making with healthcare providers. ^{1 2 3 4 6}

Eligibility Criteria

This trial is for adults with medullary thyroid cancer and their caregivers. Participants must be able to communicate in English, and pregnant patients can join. It's also open to healthcare providers treating this condition. People with cognitive or psychological impairments are not eligible.

Inclusion Criteria

Pregnant patients are included

Able to speak, read, and write English

I am dealing with medullary thyroid carcinoma, either personally or as a caregiver.

Exclusion Criteria

You have been diagnosed with severe mental illness, depression, or anxiety.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Decision Aid Development

Participants use the decision aid and complete questionnaires to assess decision-making needs and refine the decision aid design

Up to 1 year

Follow-up

Participants are monitored for the acceptability and usability of the decision aid in a real-world environment

Up to 1 year post decision aid

Treatment Details

Interventions

• Patient Decision Aid (Behavioural Intervention)

Trial Overview The study is testing a decision aid designed to help patients and caregivers make informed choices about starting or stopping medications, joining clinical trials, or continuing with active monitoring of medullary thyroid cancer.

Participant Groups

Group I: Supportive care (decision aid) Experimental Treatment 2 Interventions

Participants use decision aid and complete questionnaires.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

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

Thyroid cancer patient perceptions of radioactive iodine treatment choice: Follow-up from a decision-aid randomized trial. [2018] Patient decision aids (P-DAs) inform medical decision making, but longer term effects are unknown. This article describes extended follow-up from a thyroid cancer treatment P-DA trial.

2. Ireland pubmed.ncbi.nlm.nih.gov

A usability study of a computerized decision aid to help patients with, early stage papillary thyroid carcinoma in, decision-making on adjuvant radioactive iodine treatment. [2019] We tested the usability of a patient-directed decision aid (DA), intended for patients with early stage papillary thyroid carcinoma (PTC) deciding to accept or reject adjuvant radioactive iodine (RAI) treatment. This decision is complicated by uncertainty of the medical evidence relating to potential treatment benefits.

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

Randomized controlled trial of a computerized decision aid on adjuvant radioactive iodine treatment for patients with early-stage papillary thyroid cancer. [2012] Decision-making on adjuvant radioactive iodine (RAI) treatment for early-stage papillary thyroid cancer (PTC) is complex because of uncertainties in medical evidence. Using a parallel, two-arm, randomized, controlled trial design, we examined the impact of a patient-directed computerized decision aid (DA) on the medical knowledge and decisional conflict in patients with early-stage PTC considering the choice of being treated with adjuvant RAI or not. The DA describes the rationale, possible risks and benefits, and the medical evidence uncertainty relating to the choice.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Patient decision aids for patients with differentiated thyroid carcinoma: development process and alpha and beta testing. [2023] Patient decision aids (PtDAs) are structured clinical tools that facilitate shared decision-making. Two important treatment decisions for patients with differentiated thyroid cancer (DTC), which could benefit from PtDAs, are as follows (1): the extent of surgery decision in patients with low-risk DTC and (2) the decision to start or delay starting the treatment with tyrosine kinase inhibitors (TKIs) in patients with advanced tumors.

5. England pubmed.ncbi.nlm.nih.gov

Exploring the relationship between patients' information preference style and knowledge acquisition process in a computerized patient decision aid randomized controlled trial. [2019] We have shown in a randomized controlled trial that a computerized patient decision aid (P-DA) improves medical knowledge and reduces decisional conflict, in early stage papillary thyroid cancer patients considering adjuvant radioactive iodine treatment. Our objectives were to examine the relationship between participants' baseline information preference style and the following: 1) quantity of detailed information obtained within the P-DA, and 2) medical knowledge.

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

What do patients want to know about surgery for low-risk thyroid cancer? A qualitative study. [2023] Shared decision-making about treatment for low-risk thyroid cancer requires patients and surgeons to work together to select treatment that best balances risks and expected outcomes with patient preferences and values. To participate, patients must be activated and ask questions. We aimed to characterize what topics patients prioritize during treatment decision-making.