Clinical trial · Interventional
Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer
Decision Aid on Radioactive Iodine Treatment for Early Stage Papillary Thyroid Cancer (Randomized Controlled Trial)
NCT01083550CI-TRIAL-00024936completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, we will test, using a randomized controlled trial design, whether the use of a computer-based decision aid (DA) may improve general knowledge and reduce personal decisional conflict in patients with early stage papillary thyroid cancer (PTC), when compared to usual care. Patients with early stage PTC will be required to have surgical pathologic criteria for which adjuvant RAI treatment may be considered optional.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision aid exposure | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DA intervention
- description
- Decision aid exposure + usual care
- interventionNames
- Other: Decision aid exposure
- type
- NO_INTERVENTION
- label
- Control
- description
- Usual care
Primary outcomes (1)
- measure
- Knowledge about papillary thyroid cancer and radioactive iodine treatment
- timeFrame
- Day 0
- description
- The knowledge questionnaire will be administered on the same day as the randomization visit (after the exposure to the decision aid for participants in the intervention group, or without exposure to the decision aid in the control group).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for patient participants: * Individuals with papillary thyroid carcinoma who have had complete resection of their thyroid at surgery (total or near-total thyroidectomy, or hemi- \[subtotal\] with completion thyroidectomy)on or after September 1, 2009 * Age at time of first thyroid cancer surgery must be at least 18 years or older * The papillary thyroid cancer TNM pathologic stage must be pT1 or pT2, N0 (or Nx), M0 (or Mx) (TNM stage, AJCC VI) (ie. primary tumor size 1-4 cm, no known positive lymph nodes at the time of primary surgery, no extension of the tumor outside the thyroid, no venous or lymphatic invasion, and no known distant metastases at primary surgery, with no tall cell features, as per surgical pathology report) * Must be able to communicate in spoken and written English * Must be able to use a computer * Must be able to provide informed consent on one's own (without any need for translation) Exclusion criteria for patient participants: * Participants not meeting inclusion criteria * Concurrent diagnosis of medullary or anaplastic or poorly differentiated thyroid cancer or thyroid lymphoma * Prior radioactive treatment for thyroid cancer * Individuals who have been taken off their thyroid hormone for testing or treatment, will not be eligible for the study while off this medication. * Individuals who are unwilling for investigators to confirm their pathologic stage of disease through review of pathology report(s) will be ineligible for the study Inclusion criteria for the physician feedback component of this study: \- Physicians and surgeons caring for thyroid cancer patients, in active practice at University Health Network in Toronto, Ontario, Canada.
References
Publications (6)
- BACKGROUNDSawka AM, Straus S, Brierley JD, Tsang RW, Rotstein L, Rodin G, Gafni A, Ezzat S, Thabane L, Thorpe KE, Goldstein DP. Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer--a randomized controlled trial. Trials. 2010 Jul 26;11:81. doi: 10.1186/1745-6215-11-81. PMID 20659341
- BACKGROUNDSawka AM, Straus S, Rodin G, Thorpe KE, Ezzat S, Gafni A, Goldstein DP. Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer: update to study protocol with follow-up extension. Trials. 2015 Jul 14;16:302. doi: 10.1186/s13063-015-0819-6. PMID 26169592
- RESULTSawka 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 22753906
- RESULTSawka AM, Rilkoff H, Tsang RW, Brierley JD, Rotstein L, Ezzat S, Asa SL, Segal P, Kelly C, Zahedi A, Gafni A, Goldstein DP. The rationale of patients with early-stage papillary thyroid cancer for accepting or rejecting radioactive iodine remnant ablation. Thyroid. 2013 Feb;23(2):246-7. doi: 10.1089/thy.2012.0422. No abstract available. PMID 23009127
- RESULTSawka AM, Straus S, Rodin G, Heus L, Brierley JD, Tsang RW, Rotstein L, Ezzat S, Segal P, Gafni A, Thorpe KE, Goldstein DP. Thyroid cancer patient perceptions of radioactive iodine treatment choice: Follow-up from a decision-aid randomized trial. Cancer. 2015 Oct 15;121(20):3717-26. doi: 10.1002/cncr.29548. Epub 2015 Jul 20. PMID 26195199
- RESULTSawka AM, Straus S, Rodin G, Tsang RW, Brierley JD, Rotstein L, Segal P, Gafni A, Ezzat S, Goldstein DP. Exploring the relationship between patients' information preference style and knowledge acquisition process in a computerized patient decision aid randomized controlled trial. BMC Med Inform Decis Mak. 2015 Jun 19;15:48. doi: 10.1186/s12911-015-0168-0.