Thyroid CancerNCT06980103
Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyroid Cancer
A study testing Decision Aid in people with Thyroid Cancer, run by Georgetown University at 3 sites in United States.
Trial summary
The goal of this study is to learn if a decision aid (DA) website helps people with thyroid cancer make informed decisions about radioactive iodine (RAI) treatment. The main questions it aims to answer are: - Does the decision aid help participants understand the risks and benefits of RAI treatment? - Does it help… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Aug 2025to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and older
- Patients diagnosed with intermediate risk DTC < 6 months ago and who are making a decision about RAI treatment
- Ability to understand the information conveyed in the informed consent form, pose questions and process answers (e.g., no cognitive impairment per direct consultation with the patient's physician), and, finally, provided informed consent to participate.
- Participants willingness to be contacted and remain available to complete study activities throughout the duration of the study.
Who cannot join
- Diagnosis of low risk or high risk DTC
- Prior history of RAI
- Clinical contraindications that prevent consideration of RAI (e.g., pregnancy, lactation, neutropenia if considering high dose of RAI)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Inova Health System
Falls Church, Virginia, 22031
Samantha Diamond, MD, 703-776-3574, Samantha.Diamond-rossi@inova.org
Samantha Diamond-Rossi, MD
- Recruiting
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Lourdes M Inbar-Albo, MD,MSc. Project Director, 202-687-3628, thyroidcancerstudy@georgetown.edu
Jacqueline Jonklaas, MD, 202-687-3628, jonklaaj@georgetown.edu
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Leila Shobab, MD, 202-877-0526, Leila.Shobab@medstar.net
Leila Shobab, MD, Assistant Professor
About this study
Official title: Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyroid Cancer: The Radiance Trial
The goal of this study is to learn if a decision aid (DA) website helps people with thyroid cancer make informed decisions about radioactive iodine (RAI) treatment. The main questions it aims to answer are: - Does the decision aid help participants understand the risks and benefits of RAI treatment? - Does it help participants make choices that reflect what matters most to them? - How does the decision aid compare to usual care in supporting patients through this decision? Participants who have been recently diagnosed with intermediate-risk differentiated thyroid cancer (DTC) will be randomly assigned to one of two groups. One group will receive a special decision aid website. This site includes detailed information about RAI, short videos, drop-down menus with extra details, exercises to help clarify values, and tools to help patients prepare questions for their doctor. The other group will receive the American Cancer Society (ACS) website. This site gives basic information about RAI but does not include interactive tools and is not specific to intermediate-risk thyroid cancer. Follow up surveys will be sent to the participants periodically, first at the start of the study, and again at 1 week, 4 weeks, and 6 months later.
Researchers will compare how the two groups differ in making informed decisions. The decision aid is meant to support, not replace, a conversation with the medical team. Doctor recommendations remain an important part of treatment decisions.
Read the detailed description
Background Information Differentiated thyroid cancer (DTC) presents with a spectrum of disease severity, which is associated with varying recurrence rates. Radioactive iodine (RAI) treatment is often considered for moderate to high recurrence risk cases. Patients with low-risk DTC typically have very low recurrence rates, and RAI is generally not used. In contrast, patients with high-risk DTC commonly receive RAI due to a substantial risk of recurrence. The intermediate-risk group experiences uncertainty regarding the potential benefit of RAI in reducing recurrence risk. This study is designed to evaluate the effect of a decision aid (DA) on the decision-making process among patients with intermediate-risk DTC.
Rationale In 2020, an estimated 860,000 individuals in the United States were living as thyroid cancer survivors, with approximately 55% classified as having low-risk disease. Use of RAI in patients with high-risk DTC has been associated with extended survival and reduced recurrence. Among patients with intermediate-risk DTC, 15-year survival rates remain high at 85% to 93%. However, the benefits of RAI in this population may apply only to certain subgroups, such as older individuals or those with larger tumors.
The study intervention consists of a web-based decision aid called RAI Decisions. Eligible patients are randomized to either the DA arm or a usual care (UC) arm. The UC arm receives standard educational material from the American Cancer Society (ACS) website.
Decisions regarding RAI in intermediate-risk DTC are more complex due to several factors: variability in disease severity, limited data on risk and benefit, and differences among physicians and institutions in treatment recommendations and communication practices. Additional factors influencing decision-making may include age, comorbidities, and fertility considerations. Current clinical practice guidelines recommend consideration of RAI in this group, rendering the decision one of personal preference. These guidelines have contributed to a shift away from over treatment of DTC.
RAI usage within the intermediate-risk category is often influenced by disease severity markers (e.g., number of lymph nodes involved, thyroglobulin levels), physician specialty and perceptions, geographic proximity to care, and institutional practices such as multidisciplinary tumor board discussions. Standard of care currently ranges from minimal patient engagement to robust shared decision-making. The decision aid used in this study does not intend to direct or alter clinical decisions regarding RAI use. Instead, it is designed to support informed, value-based decisions through balanced educational content. The decision aid clearly states that it does not provide medical advice and that treatment decisions should be made in consultation with the patient's clinical team.
This research addresses a documented gap in informational support for patients with intermediate-risk DTC making decisions about RAI. The web-based DA seeks to promote informed choice through evidence-based content, interactive tools, and guidance for communicating with healthcare providers. Previous research suggests that patients who understand the trade-offs of treatment options are more likely to make decisions consistent with their values and experience less regret.
Study Design This is a multi-site randomized controlled trial (RCT) conducted at three hospital systems in the Washington, DC metropolitan area. A total of 713 newly diagnosed intermediate-risk DTC patients will be screened to enroll and randomize 408 participants, specifically 204 in the DA arm and 204 in the UC arm. Participants will be assessed at four timepoints: baseline, 1 week, 4 weeks, and 6 months post-randomization. Retention of 85%, calculated as 346 participants, at 6 months is expected.
The primary outcome is informed choice, assessed at 4 weeks. Secondary outcomes include knowledge, decisional conflict, regret, and treatment satisfaction, assessed at 4 weeks and 6 months. Additional analyses will examine whether self-efficacy and satisfaction with physician communication mediate the DA's effect. Exploratory outcomes include quality of life (QOL), treatment choice, and intermediate indicators of cancer recurrence (e.g., serum thyroglobulin levels, lymph node characteristics via ultrasound, and clinician concerns noted during routine care).
Although treatment decisions will be recorded, the DA is not designed to encourage or discourage RAI use. Instead, the focus is on whether patients make informed decisions aligned with their personal values. Because intermediate-risk DTC is generally an indolent condition, the trial will assess surrogate markers of recurrence risk rather than long-term clinical outcomes.
Participants will complete study assessments via phone or online, according to their preference. Assessors will be blinded to randomization status. Satisfaction with the assigned website (DA or UC) will be measured at the end of each follow-up survey. It is hypothesized that the DA will increase rates of informed choice compared to UC among patients with intermediate-risk DTC.
- Conditions
- Thyroid Cancer
- Being tested
- Decision Aid, Usual Care
- Keywords
- Decision Aid, Radioactive Iodine Treatment, Thyroid Cancer, Intermediate Risk, Differentiated Thyroid Cancer, Intermediate risk DTC
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidBehavioural
The study intervention is a web-based decision aid (DA) developed by the study team. The Radioactive Iodine Decisions decision aid is designed as an educational tool to help patients have information about Radioactive Iodine and encourage them to talk with their medical team about this treatment decision.
Usual CareBehavioural
Also called American Cancer Society website on Radioactive Iodine (Radioiodine) Therapy
Patients randomized in the Usual Care Condition arm will receive a link for the American Cancer Society website on Radioactive Iodine (Radioiodine) Therapy for Thyroid Cancer as our comparison.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Condition | Active comparator | Patients randomized in the Usual Care Condition arm will receive a link for the American Cancer Society website on Radioactive Iodine (Radioiodine) Therapy for Thyroid Cancer as our comparison. Receives: Behavioral: Usual Care |
| Decision Aid | Experimental | Patients randomized in the RAI Decision website arm will receive information about intermediate risk DTC; treatment options for intermediate risk DTC following thyroidectomy; clarification of the decision to be made (to have RAI therapy or not); risks and benefits of each treatment option, including potential side effects related to salivary gland damage, lacrimal and nasal symptoms, delay in childbearing; clarification of values and preferences around treatment options; structured guidance around communication with the healthcare team and information to support decision-making about RAI. Receives: Behavioral: Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Informed choice about RAI treatment
The primary outcome is informed choice measured with the Multi-Dimensional Measure of Informed Choice (MMIC). The scores for informed choice include two components: knowledge categorized as high/low based on the mid-point in the range of scores on the knowledge measure (minimum score of 0 and maximum score of 10; higher scores indicate greater knowledge) and values (attitudes) that are categorized as positive or negative based on the mid-point on the attitude items (minimum score of 4; maximum score of 28; higher scores more greater alignment of the RAI treatment decision with personal values. Informed choice is characterized as informed or uninformed. An informed choice means a decision based on high knowledge and values (attitudes) that align with the patient's preferences and final treatment decision. An uninformed choice occurs when a patient has low knowledge or makes a decision that doesn't match their personal values and attitudes.
Measured: 4 weeks
Secondary outcomes (12)
Knowledge about RAI
Knowledge about RAI is measured with an adapted version of a knowledge measure developed by Sawka and colleagues, using 10 items with true, false, or unsure response options. Scores range from a minimum of 0 to a maximum of 10. Knowledge refers to a patient's factual understanding of RAI treatment. Higher scores indicate higher knowledge.
Measured: Baseline
Knowledge about RAI
Knowledge about RAI is measured with an adapted version of a knowledge measure developed by Sawka and colleagues, using 10 items with true, false, or unsure response options. Scores range from a minimum of 0 to a maximum of 10. Knowledge refers to a patient's factual understanding of RAI treatment. Higher scores indicate higher knowledge.
Measured: 1 week
Knowledge about RAI
Knowledge about RAI is measured with an adapted version of a knowledge measure developed by Sawka and colleagues, using 10 items with true, false, or unsure response options. Scores range from a minimum of 0 to a maximum of 10. Knowledge refers to a patient's factual understanding of RAI treatment. Higher scores indicate higher knowledge.
Measured: 4 weeks
Knowledge about RAI
Knowledge about RAI is measured with an adapted version of a knowledge measure developed by Sawka and colleagues, using 10 items with true, false, or unsure response options. Scores range from a minimum of 0 to a maximum of 10. Knowledge refers to a patient's factual understanding of RAI treatment. Higher scores indicate higher knowledge.
Measured: 6 months
Decisional Conflict
Decisional Conflict is measured with the 4-item SURE scale, a short form of the Decisional Conflict Scale developed by O'Connor and colleagues. Response options are Yes or No; the minimum score is 0 and the maximum score is 4. Lower scores indicate higher levels of decisional conflict.
Measured: Baseline
Decisional Conflict
Decisional Conflict is measured with the 4-item SURE scale, a short form of the Decisional Conflict Scale developed by O'Connor and colleagues. Response options are Yes or No; the minimum score is 0 and the maximum score is 4. Lower scores indicate higher levels of decisional conflict.
Measured: 1 week
Decisional Conflict
Decisional Conflict is measured with the 4-item SURE scale, a short form of the Decisional Conflict Scale developed by O'Connor and colleagues. Response options are Yes or No; the minimum score is 0 and the maximum score is 4. Lower scores indicate higher levels of decisional conflict.
Measured: 4 weeks
Decisional Conflict
Decisional Conflict is measured with the 4-item SURE scale, a short form of the Decisional Conflict Scale developed by O'Connor and colleagues. Response options are Yes or No; the minimum score is 0 and the maximum score is 4. Lower scores indicate higher levels of decisional conflict.
Measured: 6 months
Decisional Regret
Decisional regret is assessed using the 5-item Decisional Regret Scale developed by Brehaut and colleagues. Responses are made on a 5-point Likert Scale from strongly agree to strongly disagree. Scores range from a minimum of 0 to a maximum of 100. Higher scores indicate higher decisional regret.
Measured: 4 weeks
Decisional Regret
Decisional regret is assessed using the 5-item Decisional Regret Scale developed by Brehaut and colleagues. Responses are made on a 5-point Likert Scale from strongly agree to strongly disagree. Scores range from a minimum of 0 to a maximum of 100. Higher scores indicate higher decisional regret.
Measured: 6 months
Satisfaction with Decision
Satisfaction with treatment decision about RAI treatment is assessed using the 6-item Satisfaction with Decision Scale by Wills and colleagues. Responses are made on a 5-point Likert scale from strongly disagree to strongly agree. Scores range from a minimum of 6 to a maximum of 30. Higher scores indicate higher satisfaction with treatment decision.
Measured: 6 months
Informed choice about RAI treatment
Informed choice is measured with the Multi-Dimensional Measure of Informed Choice (MMIC). The scores for informed choice include two components: knowledge categorized as high/low based on the mid-point in the range of scores on the knowledge measure (minimum score of 0 and maximum score of 10; higher scores indicate greater knowledge) and values (attitudes) that are categorized as positive or negative based on the mid-point on the attitude items (minimum score of 4; maximum score of 28; higher scores more greater alignment of the RAI treatment decision with personal values. Informed choice is characterized as informed or uninformed. An informed choice means a decision based on high knowledge and values (attitudes) that align with the patient's preferences and final treatment decision. An uninformed choice occurs when a patient has low knowledge or makes a decision that doesn't match their personal values and attitudes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start6 Aug 2025
- Primary completion28 Feb 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980103
- Sponsor's protocol ID
- 7775339
- Other IDs
- 4UH3DE031248-03
- Status last verified
- Jan 2026
- First submitted
- 8 Apr 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon completion of the study, de-identified data may be shared with other researchers for the purpose of scientific inquiry. We anticipate generating a de-identified dataset to post to a publicly accessible data repository such as Open Science Framework. Prior to posting, requests for access to the de-identified data will be evaluated by the principal investigators and study team to ensure compatibility with the study's objectives and participant confidentiality.
Publications
Mackinnon DP, Lockwood CM, Williams J. Confidence Limits for the Indirect Effect: Distribution of the Product and Resampling Methods. Multivariate Behav Res. 2004 Jan 1;39(1):99. doi: 10.1207/s15327906mbr3901_4.
PubMed 20157642Kelly KM, Graves KD, Harper FW, Schmidt JE, Dickinson SL, Andrykowski MA. Assessing perceptions of cancer risk: does mode of assessment or numeracy matter? Cancer Detect Prev. 2007;31(6):465-73. doi: 10.1016/j.cdp.2007.10.011.
PubMed 18061368Ehlers SL, Davis K, Bluethmann SM, Quintiliani LM, Kendall J, Ratwani RM, Diefenbach MA, Graves KD. Screening for psychosocial distress among patients with cancer: implications for clinical practice, healthcare policy, and dissemination to enhance cancer survivorship. Transl Behav Med. 2019 Mar 1;9(2):282-291. doi: 10.1093/tbm/iby123.
PubMed 30566662Podnos YD, Smith DD, Wagman LD, Ellenhorn JD. Survival in patients with papillary thyroid cancer is not affected by the use of radioactive isotope. J Surg Oncol. 2007 Jul 1;96(1):3-7. doi: 10.1002/jso.20656.
PubMed 17567872Podnos YD, Smith D, Wagman LD, Ellenhorn JD. Radioactive iodine offers survival improvement in patients with follicular carcinoma of the thyroid. Surgery. 2005 Dec;138(6):1072-6; discussion 1076-7. doi: 10.1016/j.surg.2005.09.021.
PubMed 16360393Ibrahimpasic T, Nixon IJ, Palmer FL, Whitcher MM, Tuttle RM, Shaha A, Patel SG, Shah JP, Ganly I. Undetectable thyroglobulin after total thyroidectomy in patients with low- and intermediate-risk papillary thyroid cancer--is there a need for radioactive iodine therapy? Surgery. 2012 Dec;152(6):1096-105. doi: 10.1016/j.surg.2012.08.034.
PubMed 23158181Ghaznavi SA, Ganly I, Shaha AR, English C, Wills J, Tuttle RM. Using the American Thyroid Association Risk-Stratification System to Refine and Individualize the American Joint Committee on Cancer Eighth Edition Disease-Specific Survival Estimates in Differentiated Thyroid Cancer. Thyroid. 2018 Oct;28(10):1293-1300. doi: 10.1089/thy.2018.0186. Epub 2018 Aug 2.
PubMed 29897011Ruel E, Thomas S, Dinan M, Perkins JM, Roman SA, Sosa JA. Adjuvant radioactive iodine therapy is associated with improved survival for patients with intermediate-risk papillary thyroid cancer. J Clin Endocrinol Metab. 2015 Apr;100(4):1529-36. doi: 10.1210/jc.2014-4332. Epub 2015 Feb 2.
PubMed 25642591Yang Z, Flores J, Katz S, Nathan CA, Mehta V. Comparison of Survival Outcomes Following Postsurgical Radioactive Iodine Versus External Beam Radiation in Stage IV Differentiated Thyroid Carcinoma. Thyroid. 2017 Jul;27(7):944-952. doi: 10.1089/thy.2016.0650. Epub 2017 May 17.
PubMed 28446057Chow SM, Law SC, Mendenhall WM, Au SK, Chan PT, Leung TW, Tong CC, Wong IS, Lau WH. Papillary thyroid carcinoma: prognostic factors and the role of radioiodine and external radiotherapy. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):784-95. doi: 10.1016/s0360-3016(01)02686-4.
PubMed 11849802Chow SM, Yau S, Kwan CK, Poon PC, Law SC. Local and regional control in patients with papillary thyroid carcinoma: specific indications of external radiotherapy and radioactive iodine according to T and N categories in AJCC 6th edition. Endocr Relat Cancer. 2006 Dec;13(4):1159-72. doi: 10.1677/erc.1.01320.
PubMed 17158761Jonklaas J, Sarlis NJ, Litofsky D, Ain KB, Bigos ST, Brierley JD, Cooper DS, Haugen BR, Ladenson PW, Magner J, Robbins J, Ross DS, Skarulis M, Maxon HR, Sherman SI. Outcomes of patients with differentiated thyroid carcinoma following initial therapy. Thyroid. 2006 Dec;16(12):1229-42. doi: 10.1089/thy.2006.16.1229.
PubMed 17199433Grani G, Zatelli MC, Alfo M, Montesano T, Torlontano M, Morelli S, Deandrea M, Antonelli A, Francese C, Ceresini G, Orlandi F, Maniglia CA, Bruno R, Monti S, Santaguida MG, Repaci A, Tallini G, Fugazzola L, Monzani F, Giubbini R, Rossetto R, Mian C, Crescenzi A, Tumino D, Pagano L, Pezzullo L, Lombardi CP, Arvat E, Petrone L, Castagna MG, Spiazzi G, Salvatore D, Meringolo D, Solaroli E, Monari F, Magri F, Triggiani V, Castello R, Piazza C, Rossi R, Ferraro Petrillo U, Filetti S, Durante C. Real-World Performance of the American Thyroid Association Risk Estimates in Predicting 1-Year Differentiated Thyroid Cancer Outcomes: A Prospective Multicenter Study of 2000 Patients. Thyroid. 2021 Feb;31(2):264-271. doi: 10.1089/thy.2020.0272. Epub 2020 Jul 1.
PubMed 32475305Tuttle RM, Haddad RI, Ball DW, Byrd D, Dickson P, Duh QY, Ehya H, Haymart M, Hoh C, Hunt JP, Iagaru A, Kandeel F, Kopp P, Lamonica DM, Lydiatt WM, McCaffrey J, Moley JF, Parks L, Raeburn CD, Ridge JA, Ringel MD, Scheri RP, Shah JP, Sherman SI, Sturgeon C, Waguespack SG, Wang TN, Wirth LJ, Hoffmann KG, Hughes M. Thyroid carcinoma, version 2.2014. J Natl Compr Canc Netw. 2014 Dec;12(12):1671-80; quiz 1680. doi: 10.6004/jnccn.2014.0169.
PubMed 25505208Carhill AA, Litofsky DR, Ross DS, Jonklaas J, Cooper DS, Brierley JD, Ladenson PW, Ain KB, Fein HG, Haugen BR, Magner J, Skarulis MC, Steward DL, Xing M, Maxon HR, Sherman SI. Long-Term Outcomes Following Therapy in Differentiated Thyroid Carcinoma: NTCTCS Registry Analysis 1987-2012. J Clin Endocrinol Metab. 2015 Sep;100(9):3270-9. doi: 10.1210/JC.2015-1346. Epub 2015 Jul 14.
PubMed 26171797
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyroid Cancer: The Radiance Trial
- ClinicalTrials.gov ID
- NCT06980103
- Acronym / sponsor ID
- 7775339
- Conditions
- Thyroid Cancer
- Keywords
- Decision Aid, Radioactive Iodine Treatment, Thyroid Cancer, Intermediate Risk, Differentiated Thyroid Cancer, Intermediate risk DTC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to learn if a decision aid (DA) website helps people with thyroid cancer make informed decisions about radioactive iodine (RAI) treatment. The main questions it aims to answer are: - Does the decision aid help participants understand the risks and benefits of RAI treatment? - Does it help participants make choices that reflect what matters most to them? - How does the decision aid compare to usual care in supporting patients through this decision? Participants who have been recently diagnosed with intermediate-risk differentiated thyroid cancer (DTC) will be randomly assigned to one of two groups. One group will receive a special decision aid website. This site includes detailed information about RAI, short videos, drop-down menus with extra details, exercises to help clarify values, and tools to help patients prepare questions for their doctor. The other group will receive the American Cancer Society (ACS) website. This site gives basic information about RAI but does not include interactive tools and is not specific to intermediate-risk thyroid cancer. Follow up surveys will be sent to the participants periodically, first at the start of the study, and again at 1 week, 4 weeks, and 6 months later.
Researchers will compare how the two groups differ in making informed decisions. The decision aid is meant to support, not replace, a conversation with the medical team. Doctor recommendations remain an important part of treatment decisions.
Detailed description
Background Information Differentiated thyroid cancer (DTC) presents with a spectrum of disease severity, which is associated with varying recurrence rates. Radioactive iodine (RAI) treatment is often considered for moderate to high recurrence risk cases. Patients with low-risk DTC typically have very low recurrence rates, and RAI is generally not used. In contrast, patients with high-risk DTC commonly receive RAI due to a substantial risk of recurrence. The intermediate-risk group experiences uncertainty regarding the potential benefit of RAI in reducing recurrence risk. This study is designed to evaluate the effect of a decision aid (DA) on the decision-making process among patients with intermediate-risk DTC.
Rationale In 2020, an estimated 860,000 individuals in the United States were living as thyroid cancer survivors, with approximately 55% classified as having low-risk disease. Use of RAI in patients with high-risk DTC has been associated with extended survival and reduced recurrence. Among patients with intermediate-risk DTC, 15-year survival rates remain high at 85% to 93%. However, the benefits of RAI in this population may apply only to certain subgroups, such as older individuals or those with larger tumors.
The study intervention consists of a web-based decision aid called RAI Decisions. Eligible patients are randomized to either the DA arm or a usual care (UC) arm. The UC arm receives standard educational material from the American Cancer Society (ACS) website.
Decisions regarding RAI in intermediate-risk DTC are more complex due to several factors: variability in disease severity, limited data on risk and benefit, and differences among physicians and institutions in treatment recommendations and communication practices. Additional factors influencing decision-making may include age, comorbidities, and fertility considerations. Current clinical practice guidelines recommend consideration of RAI in this group, rendering the decision one of personal preference. These guidelines have contributed to a shift away from over treatment of DTC.
RAI usage within the intermediate-risk category is often influenced by disease severity markers (e.g., number of lymph nodes involved, thyroglobulin levels), physician specialty and perceptions, geographic proximity to care, and institutional practices such as multidisciplinary tumor board discussions. Standard of care currently ranges from minimal patient engagement to robust shared decision-making. The decision aid used in this study does not intend to direct or alter clinical decisions regarding RAI use. Instead, it is designed to support informed, value-based decisions through balanced educational content. The decision aid clearly states that it does not provide medical advice and that treatment decisions should be made in consultation with the patient's clinical team.
This research addresses a documented gap in informational support for patients with intermediate-risk DTC making decisions about RAI. The web-based DA seeks to promote informed choice through evidence-based content, interactive tools, and guidance for communicating with healthcare providers. Previous research suggests that patients who understand the trade-offs of treatment options are more likely to make decisions consistent with their values and experience less regret.
Study Design This is a multi-site randomized controlled trial (RCT) conducted at three hospital systems in the Washington, DC metropolitan area. A total of 713 newly diagnosed intermediate-risk DTC patients will be screened to enroll and randomize 408 participants, specifically 204 in the DA arm and 204 in the UC arm. Participants will be assessed at four timepoints: baseline, 1 week, 4 weeks, and 6 months post-randomization. Retention of 85%, calculated as 346 participants, at 6 months is expected.
The primary outcome is informed choice, assessed at 4 weeks. Secondary outcomes include knowledge, decisional conflict, regret, and treatment satisfaction, assessed at 4 weeks and 6 months. Additional analyses will examine whether self-efficacy and satisfaction with physician communication mediate the DA's effect. Exploratory outcomes include quality of life (QOL), treatment choice, and intermediate indicators of cancer recurrence (e.g., serum thyroglobulin levels, lymph node characteristics via ultrasound, and clinician concerns noted during routine care).
Although treatment decisions will be recorded, the DA is not designed to encourage or discourage RAI use. Instead, the focus is on whether patients make informed decisions aligned with their personal values. Because intermediate-risk DTC is generally an indolent condition, the trial will assess surrogate markers of recurrence risk rather than long-term clinical outcomes.
Participants will complete study assessments via phone or online, according to their preference. Assessors will be blinded to randomization status. Satisfaction with the assigned website (DA or UC) will be measured at the end of each follow-up survey. It is hypothesized that the DA will increase rates of informed choice compared to UC among patients with intermediate-risk DTC.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Condition | Active comparator | Behavioral: Usual CarePatients randomized in the Usual Care Condition arm will receive a link for the American Cancer Society website on Radioactive Iodine (Radioiodine) Therapy for Thyroid Cancer as our comparison. |
| Decision Aid | Experimental | Behavioral: Decision AidPatients randomized in the RAI Decision website arm will receive information about intermediate risk DTC; treatment options for intermediate risk DTC following thyroidectomy; clarification of the decision to be made (to have RAI therapy or not); risks and benefits of each treatment option, including potential side effects related to salivary gland damage, lacrimal and nasal symptoms, delay in childbearing; clarification of values and preferences around treatment options; structured guidance around communication with the healthcare team and information to support decision-making about RAI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 and older
- Patients diagnosed with intermediate risk DTC < 6 months ago and who are making a decision about RAI treatment
- Ability to understand the information conveyed in the informed consent form, pose questions and process answers (e.g., no cognitive impairment per direct consultation with the patient's physician), and, finally, provided informed consent to participate.
- Participants willingness to be contacted and remain available to complete study activities throughout the duration of the study.
Key exclusion criteria (3 listed)
- Diagnosis of low risk or high risk DTC
- Prior history of RAI
- Clinical contraindications that prevent consideration of RAI (e.g., pregnancy, lactation, neutropenia if considering high dose of RAI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision AidThe study intervention is a web-based decision aid (DA) developed by the study team. The Radioactive Iodine Decisions decision aid is designed as an educational tool to help patients have information about Radioactive Iodine and encourage them to talk with their medical team about this treatment decision. | Behavioural | Decision Aid |
| Usual CareAlso: American Cancer Society website on Radioactive Iodine (Radioiodine) TherapyPatients randomized in the Usual Care Condition arm will receive a link for the American Cancer Society website on Radioactive Iodine (Radioiodine) Therapy for Thyroid Cancer as our comparison. | Behavioural | Usual Care Condition |
Primary outcome
Informed choice about RAI treatment
Time frame: 4 weeks
The primary outcome is informed choice measured with the Multi-Dimensional Measure of Informed Choice (MMIC). The scores for informed choice include two components: knowledge categorized as high/low based on the mid-point in the range of scores on the knowledge measure (minimum score of 0 and maximum score of 10; higher scores indicate greater knowledge) and values (attitudes) that are categorized as positive or negative based on the mid-point on the attitude items (minimum score of 4; maximum score of 28; higher scores more greater alignment of the RAI treatment decision with personal values. Informed choice is characterized as informed or uninformed. An informed choice means a decision based on high knowledge and values (attitudes) that align with the patient's preferences and final treatment decision. An uninformed choice occurs when a patient has low knowledge or makes a decision that doesn't match their personal values and attitudes.
12 secondary outcomes
Knowledge about RAI
Time frame: Baseline
Knowledge about RAI
Time frame: 1 week
Knowledge about RAI
Time frame: 4 weeks
Knowledge about RAI
Time frame: 6 months
Decisional Conflict
Time frame: Baseline
Decisional Conflict
Time frame: 1 week
Decisional Conflict
Time frame: 4 weeks
Decisional Conflict
Time frame: 6 months
Decisional Regret
Time frame: 4 weeks
Decisional Regret
Time frame: 6 months
Satisfaction with Decision
Time frame: 6 months
Informed choice about RAI treatment
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 20157642Mackinnon DP, Lockwood CM, Williams J. Confidence Limits for the Indirect Effect: Distribution of the Product and Resampling Methods. Multivariate Behav Res. 2004 Jan 1;39(1):99. doi: 10.1207/s15327906mbr3901_4.
- Background: PubMed 18061368Kelly KM, Graves KD, Harper FW, Schmidt JE, Dickinson SL, Andrykowski MA. Assessing perceptions of cancer risk: does mode of assessment or numeracy matter? Cancer Detect Prev. 2007;31(6):465-73. doi: 10.1016/j.cdp.2007.10.011.
- Background: PubMed 30566662Ehlers SL, Davis K, Bluethmann SM, Quintiliani LM, Kendall J, Ratwani RM, Diefenbach MA, Graves KD. Screening for psychosocial distress among patients with cancer: implications for clinical practice, healthcare policy, and dissemination to enhance cancer survivorship. Transl Behav Med. 2019 Mar 1;9(2):282-291. doi: 10.1093/tbm/iby123.
- Background: PubMed 17567872Podnos YD, Smith DD, Wagman LD, Ellenhorn JD. Survival in patients with papillary thyroid cancer is not affected by the use of radioactive isotope. J Surg Oncol. 2007 Jul 1;96(1):3-7. doi: 10.1002/jso.20656.
- Background: PubMed 16360393Podnos YD, Smith D, Wagman LD, Ellenhorn JD. Radioactive iodine offers survival improvement in patients with follicular carcinoma of the thyroid. Surgery. 2005 Dec;138(6):1072-6; discussion 1076-7. doi: 10.1016/j.surg.2005.09.021.
- Background: PubMed 23158181Ibrahimpasic T, Nixon IJ, Palmer FL, Whitcher MM, Tuttle RM, Shaha A, Patel SG, Shah JP, Ganly I. Undetectable thyroglobulin after total thyroidectomy in patients with low- and intermediate-risk papillary thyroid cancer--is there a need for radioactive iodine therapy? Surgery. 2012 Dec;152(6):1096-105. doi: 10.1016/j.surg.2012.08.034.
- Background: PubMed 29897011Ghaznavi SA, Ganly I, Shaha AR, English C, Wills J, Tuttle RM. Using the American Thyroid Association Risk-Stratification System to Refine and Individualize the American Joint Committee on Cancer Eighth Edition Disease-Specific Survival Estimates in Differentiated Thyroid Cancer. Thyroid. 2018 Oct;28(10):1293-1300. doi: 10.1089/thy.2018.0186. Epub 2018 Aug 2.
- Background: PubMed 25642591Ruel E, Thomas S, Dinan M, Perkins JM, Roman SA, Sosa JA. Adjuvant radioactive iodine therapy is associated with improved survival for patients with intermediate-risk papillary thyroid cancer. J Clin Endocrinol Metab. 2015 Apr;100(4):1529-36. doi: 10.1210/jc.2014-4332. Epub 2015 Feb 2.
- Background: PubMed 28446057Yang Z, Flores J, Katz S, Nathan CA, Mehta V. Comparison of Survival Outcomes Following Postsurgical Radioactive Iodine Versus External Beam Radiation in Stage IV Differentiated Thyroid Carcinoma. Thyroid. 2017 Jul;27(7):944-952. doi: 10.1089/thy.2016.0650. Epub 2017 May 17.
- Background: PubMed 11849802Chow SM, Law SC, Mendenhall WM, Au SK, Chan PT, Leung TW, Tong CC, Wong IS, Lau WH. Papillary thyroid carcinoma: prognostic factors and the role of radioiodine and external radiotherapy. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):784-95. doi: 10.1016/s0360-3016(01)02686-4.
- Background: PubMed 17158761Chow SM, Yau S, Kwan CK, Poon PC, Law SC. Local and regional control in patients with papillary thyroid carcinoma: specific indications of external radiotherapy and radioactive iodine according to T and N categories in AJCC 6th edition. Endocr Relat Cancer. 2006 Dec;13(4):1159-72. doi: 10.1677/erc.1.01320.
- Background: PubMed 17199433Jonklaas J, Sarlis NJ, Litofsky D, Ain KB, Bigos ST, Brierley JD, Cooper DS, Haugen BR, Ladenson PW, Magner J, Robbins J, Ross DS, Skarulis M, Maxon HR, Sherman SI. Outcomes of patients with differentiated thyroid carcinoma following initial therapy. Thyroid. 2006 Dec;16(12):1229-42. doi: 10.1089/thy.2006.16.1229.
- American Cancer Society. Radioactive Iodine (radioiodine) Therapy for Thyroid Cancer.Link provided by the sponsor.
- NCCN Guidelines. NCCN Guidelines Version 1.2024 Distress ManagementLink provided by the sponsor.
- Individual participant dataSharing planned: No. Upon completion of the study, de-identified data may be shared with other researchers for the purpose of scientific inquiry. We anticipate generating a de-identified dataset to post to a publicly accessible data repository such as Open Science Framework. Prior to posting, requests for access to the de-identified data will be evaluated by the principal investigators and study team to ensure compatibility with the study's objectives and participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lombardi Comprehensive Cancer Center
Washington D.C., United States
MedStar Washington Hospital Center
Washington D.C., United States
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid in people with Thyroid Cancer, run by Georgetown University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Informed choice about RAI treatment (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06980103, which also lists 48 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.