רדאר קליני AI | ||
|---|---|---|
הניסוי הקליני NCT06980103 עבור סרטן בלוטת התריס הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyroid Cancer 408 פעילות גופנית
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT06980103 הוא מחקר מסוג התערבותי עבור סרטן בלוטת התריס, שנמצא כעת במצב מגייס. המחקר התחיל ב-6 באוגוסט 2025 ומתוכנן לכלול 408 משתתפים. המחקר מנוהל על ידי אוניברסיטת ג'ורג'טאון וצפוי להסתיים ב-31 ביולי 2029. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-8 בינואר 2026.
סיכום קצר
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...הצג עוד
תיאור מפורט
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...הצג עוד
כותרת רשמית
Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyroid Cancer: The Radiance Trial
מצבים רפואיים
סרטן בלוטת התריספרסומים
מאמרים מדעיים וניירות מחקר שפורסמו על ניסוי קליני זה:מזהי מחקר נוספים
מספר NCT
תחילת המחקר (בפועל)
2025-08-06
עדכון אחרון שפורסם
2026-01-08
סיום המחקר (מוערך)
2029-07-31
משתתפים (מתוכנן)
408
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
מגייס
מילות מפתח
Decision Aid
Radioactive Iodine Treatment
Thyroid Cancer
Intermediate Risk
Differentiated Thyroid Cancer
Intermediate risk DTC
Radioactive Iodine Treatment
Thyroid Cancer
Intermediate Risk
Differentiated Thyroid Cancer
Intermediate risk DTC
מטרה ראשית
אחר
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
יחיד
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
משווה פעילUsual Care Condition 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. | טיפול רגיל 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. |
ניסיDecision Aid 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; clarificat...הצג עוד | עזר החלטה 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. |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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. | 4 weeks |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6 months |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
- 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.
- 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)
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
אין נתוני קשר.
3 מיקומי המחקר ב-1 מדינות
District of Columbia
Lombardi Comprehensive Cancer Center, Washington D.C., District of Columbia, 20007, United States
Lourdes M Inbar-Albo, MD,MSc. Project Director, איש קשר, 202-687-3628, [email protected]
Jacqueline Jonklaas, MD, איש קשר, 202-687-3628, [email protected]
Jacqueline Jonklaas, MD, PhD, MPH, חוקר ראשי
Kristi D Graves, Ph.D., חוקר ראשי
מגייס
MedStar Washington Hospital Center, Washington D.C., District of Columbia, 20010, United States
Leila Shobab, MD, איש קשר, 202-877-0526, [email protected]
Leila Shobab, MD, Assistant Professor, חוקר משנה
מגייס
Virginia
Inova Health System, Falls Church, Virginia, 22031, United States
Samantha Diamond, MD, איש קשר, 703-776-3574, [email protected]
Samantha Diamond-Rossi, MD, חוקר משנה
מגייס