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}

Research Team

Elizabeth G. Grubbs

Principal Investigator

M.D. Anderson Cancer Center

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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

Patient decision aids for patients with differentiated thyroid carcinoma: development process and alpha and beta testing. [2023]

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]

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]