Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-29 @ 12:45 PM
Study NCT ID:
NCT06980103
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003661', 'term': 'Decision Support Techniques'}, {'id': 'C000614965', 'term': 'Iodine-131'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 408}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2032-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Informed choice about RAI treatment', 'timeFrame': '4 weeks', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Knowledge about RAI', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Knowledge about RAI', 'timeFrame': '1 week', 'description': "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."}, {'measure': 'Knowledge about RAI', 'timeFrame': '4 weeks', 'description': "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."}, {'measure': 'Knowledge about RAI', 'timeFrame': '6 months', 'description': "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."}, {'measure': 'Decisional Conflict', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Decisional Conflict', 'timeFrame': '1 week', 'description': "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."}, {'measure': 'Decisional Conflict', 'timeFrame': '4 weeks', 'description': "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."}, {'measure': 'Decisional Conflict', 'timeFrame': '6 months', 'description': "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."}, {'measure': 'Decisional Regret', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': 'Decisional Regret', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Satisfaction with Decision', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Informed choice about RAI treatment', 'timeFrame': '6 months', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Decision Aid', 'Radioactive Iodine Treatment', 'Thyroid Cancer', 'Intermediate Risk', 'Differentiated Thyroid Cancer', 'Intermediate risk DTC'], 'conditions': ['Thyroid Cancer']}, 'referencesModule': {'references': [{'pmid': '20157642', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18061368', 'type': 'BACKGROUND', 'citation': 'Kelly KM, Graves KD, Harper FW, Schmidt JE, Dickinson SL, Andrykowski MA. Assessing perceptions of cancer risk: does mode of assessment or numeracy matter? 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Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105."}, {'pmid': '22753906', 'type': 'BACKGROUND', 'citation': 'Sawka AM, Straus S, Rotstein L, Brierley JD, Tsang RW, Asa S, Segal P, Kelly C, Zahedi A, Freeman J, Solomon P, Anderson J, Thorpe KE, Gafni A, Rodin G, Goldstein DP. Randomized controlled trial of a computerized decision aid on adjuvant radioactive iodine treatment for patients with early-stage papillary thyroid cancer. J Clin Oncol. 2012 Aug 10;30(23):2906-11. doi: 10.1200/JCO.2011.41.2734. Epub 2012 Jul 2.'}, {'pmid': '12220754', 'type': 'BACKGROUND', 'citation': 'Michie S, Dormandy E, Marteau TM. The multi-dimensional measure of informed choice: a validation study. Patient Educ Couns. 2002 Sep;48(1):87-91. doi: 10.1016/s0738-3991(02)00089-7.'}], 'seeAlsoLinks': [{'url': 'https://www.cancer.org/cancer/thyroid-cancer/treating/radioactive-iodine.html', 'label': 'American Cancer Society. Radioactive Iodine (radioiodine) Therapy for Thyroid Cancer.'}, {'url': 'https://www.nccn.org/docs/default-source/patient-resources/nccn_distress_thermometer', 'label': 'NCCN Guidelines. NCCN Guidelines Version 1.2024 Distress Management'}]}, 'descriptionModule': {'briefSummary': '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.\n\nResearchers 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.', 'detailedDescription': "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.\n\nRationale 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.\n\nThe 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.\n\nDecisions 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.\n\nRAI 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.\n\nThis 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.\n\nStudy 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.\n\nThe 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).\n\nAlthough 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.\n\nParticipants 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 18 and older\n* Patients diagnosed with intermediate risk DTC \\< 6 months ago and who are making a decision about RAI treatment\n* 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.\n* Participants willingness to be contacted and remain available to complete study activities throughout the duration of the study.\n\nExclusion Criteria:\n\n* Diagnosis of low risk or high risk DTC\n* Prior history of RAI\n* Clinical contraindications that prevent consideration of RAI (e.g., pregnancy, lactation, neutropenia if considering high dose of RAI)"}, 'identificationModule': {'nctId': 'NCT06980103', 'briefTitle': 'Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyroid Cancer: The Radiance Trial', 'orgStudyIdInfo': {'id': '7775339'}, 'secondaryIdInfos': [{'id': '4UH3DE031248-03', 'link': 'https://reporter.nih.gov/quickSearch/4UH3DE031248-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Condition', 'description': '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.', 'interventionNames': ['Behavioral: Usual Care']}, {'type': 'EXPERIMENTAL', 'label': 'Decision Aid', 'description': '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.', 'interventionNames': ['Behavioral: Decision Aid']}], 'interventions': [{'name': 'Decision Aid', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Decision Aid']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'otherNames': ['American Cancer Society website on Radioactive Iodine (Radioiodine) Therapy'], 'description': '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.', 'armGroupLabels': ['Usual Care Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lourdes M Inbar-Albo, MD,MSc. Project Director', 'role': 'CONTACT', 'email': 'thyroidcancerstudy@georgetown.edu', 'phone': '202-687-3628'}, {'name': 'Jacqueline Jonklaas, MD', 'role': 'CONTACT', 'email': 'jonklaaj@georgetown.edu', 'phone': '202-687-3628'}, {'name': 'Jacqueline Jonklaas, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kristi D Graves, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lombardi Comprehensive Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leila Shobab, MD', 'role': 'CONTACT', 'email': 'Leila.Shobab@medstar.net', 'phone': '202-877-0526'}, {'name': 'Leila Shobab, MD, Assistant Professor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '22031', 'city': 'Falls Church', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samantha Diamond, MD', 'role': 'CONTACT', 'email': 'Samantha.Diamond-rossi@inova.org', 'phone': '\u202d703-776-3574\u202c'}, {'name': 'Samantha Diamond-Rossi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Inova Health System', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Dental and Craniofacial Research (NIDCR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}