Decision Aid for Thyroid Cancer

Overseen By Elizabeth G Grubbs, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cognitive impairment, Psychological impairment, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with medullary thyroid cancer make informed treatment decisions. It examines the effectiveness of a decision aid (Patient Decision Aid) in guiding patients and their caregivers on whether to start or stop new medications, join other clinical trials, or continue monitoring their cancer. Participants will use the decision aid and answer questions about their experience. Those who have medullary thyroid cancer or are caregivers of such patients and can speak, read, and write English are well-suited for the trial. As an unphased trial, this study offers participants the chance to contribute to research that may enhance decision-making tools for future patients.

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 prior data suggests that this decision aid is safe for patients with medullary thyroid cancer?

Research has shown that patient decision aids are safe and easy to use. These tools help individuals make informed healthcare choices without risk. One study found that decision aids were clear, fair, and useful for patients with thyroid cancer, facilitating discussions about treatment options with their doctors. No reports of negative effects have emerged from using these aids. Therefore, using a patient decision aid is considered safe for people with medullary thyroid cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid for Thyroid Cancer because it offers a new approach to patient care by empowering individuals to make informed decisions regarding their treatment. Unlike traditional methods, which often focus on medical procedures and medications, this decision aid emphasizes patient education and engagement through interactive tools and questionnaires. This approach could lead to more personalized and satisfactory treatment experiences for patients by helping them understand their options and potential outcomes better.

What evidence suggests that this decision aid is effective for supporting decision-making in medullary thyroid cancer?

Research has shown that tools called patient decision aids can greatly assist people with thyroid cancer. In this trial, participants will use a decision aid as part of the supportive care arm. These tools help patients better understand their treatment options and make clearer choices. One study found these aids easy to understand, fair, and useful for patients with differentiated thyroid cancer. They also improved patients' decision-making and their mental and social well-being over time. Overall, decision aids are designed to facilitate discussions between patients and doctors about preferences and to help choose the best care plan. ^{1 2 6 7 8}

Who Is on the Research Team?

Elizabeth G. Grubbs

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Patient Decision Aid

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.

How Is the Trial Designed?

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

Participants use decision aid and complete questionnaires.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A computerized decision aid (DA) significantly improved medical knowledge and reduced decisional conflict among 74 patients with early-stage papillary thyroid cancer (PTC) considering adjuvant radioactive iodine (RAI) treatment.

Despite the DA enhancing understanding, the actual choice to undergo adjuvant RAI treatment did not differ significantly between the DA group and the control group, indicating that while knowledge improved, it did not necessarily change treatment decisions.

NCBI (Pubmed)

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. Sawka, AM., Straus, S., Rotstein, L., et al.[2012]

The use of a patient decision aid (P-DA) significantly improved thyroid cancer patients' perceived knowledge about their treatment options and risks, with 95% of participants reporting feeling more informed after 15 to 23 months.

Despite the increased knowledge and confidence in decision-making, the P-DA did not lead to significant differences in decision satisfaction, regret, or cancer-related worry compared to usual care, indicating it is safe and beneficial without adverse psychological effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thyroid cancer patient perceptions of radioactive iodine treatment choice: Follow-up from a decision-aid randomized trial. Sawka, AM., Straus, S., Rodin, G., et al.[2018]

Patient decision aids (PtDAs) were developed for patients with differentiated thyroid cancer to assist in making informed decisions about surgery and the use of tyrosine kinase inhibitors, based on a structured process involving patient and physician feedback.

Testing showed that the PtDAs were well-received, with 90% of patients finding them readable and helpful for decision-making, indicating their potential effectiveness in enhancing patient engagement and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient decision aids for patients with differentiated thyroid carcinoma: development process and alpha and beta testing. Koot, A., Hermens, R., Ottevanger, P., et al.[2023]

The patient-directed decision aid (DA) for radioactive iodine treatment in early stage papillary thyroid carcinoma was found to be generally acceptable and user-friendly among various groups, including thyroid cancer survivors and lay individuals.

The DA significantly improved the medical knowledge of lay participants, demonstrating its effectiveness in helping patients understand complex treatment decisions, even amidst uncertainties in medical evidence.

NCBI (Pubmed)

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. Sawka, AM., Straus, S., Gafni, A., et al.[2019]

In a study involving 30 patients with low-risk thyroid cancer, 28 patients asked a total of 253 substantive questions during consultations, highlighting their focus on the extent of surgery, quality of life, and hormone supplementation.

Surgeons often provided indirect responses to patients' questions about surgery recommendations and quality of life, indicating a need for improved communication resources to enhance shared decision-making in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do patients want to know about surgery for low-risk thyroid cancer? A qualitative study. Underwood, HJ., Mott, NM., Saucke, MC., et al.[2023]

In a study involving 74 participants, those with a high preference for seeking information (monitoring style) were more likely to acquire detailed information from a computerized patient decision aid (P-DA), indicating that personal information preferences can influence how much patients engage with medical resources.

The study found a weak correlation between monitoring style and increased medical knowledge overall, suggesting that while seeking information may help in understanding treatment options, the relationship is not strong enough to guarantee improved knowledge in all cases.

NCBI (Pubmed)

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. Sawka, AM., Straus, S., Rodin, G., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10264809/

Patient decision aids for patients with differentiated thyroid ... Evidence-based PtDAs were created for patients with DTC for two different treatment decisions. Our final version was judged to be clear, balanced, and helpful ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03892993

Study Details | NCT03892993 | Patient Decision Aid in ... 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 ...

3. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2770969

Novel Decision Support Interventions for Low-risk Thyroid ... This quality improvement study examines a patient-oriented intervention to support decision-making about low-risk thyroid cancer treatment.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4832354/

Thyroid cancer patient perceptions of radioactive iodine ... In this follow‐up study, our aim was to explore the impact of our thyroid cancer P‐DA on patients' decision and psychosocial outcomes at longer term follow‐up ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399110004398

A usability study of a computerized decision aid to help ... We tested the usability of a patient-directed decision aid (DA), intended for patients with early stage papillary thyroid carcinoma (PTC) deciding to accept ...

6. ascopubs.org ascopubs.org/doi/10.1200/CCI.17.00148

What Is the Effectiveness of Patient Decision Aids for ... Patient decision aids improve the attributes of the choice made and decision-making process for patients who face cancer-related decisions.

7. e-epih.org e-epih.org/journal/view.php?doi=10.4178/epih/e2015018

Development and application of patient decision aids This article introduces the definition, usefulness, and developmental processes of PtDAs and suggests the urgent need for a Korean PtDA related ...

8. sciencedirect.com sciencedirect.com/org/science/article/pii/S2561326X21003255

Decision Making When Cancer Becomes Chronic: Needs ... Original Paper. Decision Making When Cancer Becomes Chronic: Needs Assessment for a Web-Based Medullary Thyroid Carcinoma Patient Decision Aid.