Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer
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ClinicalTrials.gov Identifier: NCT01083550 |
Recruitment Status :
Completed
First Posted : March 9, 2010
Last Update Posted : November 29, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thyroid Cancer | Other: Decision aid exposure | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 74 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Decision Aid on Radioactive Iodine Treatment for Early Stage Papillary Thyroid Cancer (Randomized Controlled Trial) |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | November 2016 |
Actual Study Completion Date : | November 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: DA intervention
Decision aid exposure + usual care
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Other: Decision aid exposure
Exposure to a computerized decision aid on adjuvant radioactive iodine treatment decision-making. The exposure is during one visit. |
No Intervention: Control
Usual care
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- Knowledge about papillary thyroid cancer and radioactive iodine treatment [ Time Frame: Day 0 ]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).
- Decisional conflict (and subscale measures) [ Time Frame: Day 0 ]The decisional conflict 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).
- Decisional regret [ Time Frame: 6-12 months and 15-23 months ]Decisional regret will be assessed at least 6 months after the randomization, or later if the decision is not finalized at 6 months. The time frame should generally be about 6 - 12 months after the randomization visit. This outcome will also be evaluated at an extended follow-up study call at about 15-23 months
- Reasons for accepting or declining radioactive iodine treatment [ Time Frame: 6 - 12 months ]Rationale for accepting or declining radioactive iodine treatment will be assessed 6 months after the randomization visit as well as after the decision on radioactive iodine has been finalized (generally decision should have been finalized within 12 months).
- The final decision to accept or decline adjuvant radioactive iodine treatment [ Time Frame: 6-12 months ]The final decision to accept or decline adjuvant radioactive iodine treatment will be assessed 6 months after the randomization visit as well as after the decision on radioactive iodine has been finalized (generally decision should have been finalized within 12 months).
- Feeling informed about RAI treatment decision [ Time Frame: 15-23 months ]Questionnaire on feeling informed about a medical decision
- Feeling satisfied with RAI treatment decision [ Time Frame: 15-23 months ]Question on RAI decision satisfaction
- Cancer-related worry [ Time Frame: 15-23 months ]Assessment of Survivor Concerns questionnaire
- Trust in the treating physician [ Time Frame: 15-23 months ]Trust in Physician questionnaire
- Mood [ Time Frame: 15-23 months ]Depression and Anxiety Screen (PHQ-4) questionnaire
- Qualitative data [ Time Frame: 15-23 months ]In-depth interview, discussing RAI treatment decision-making, treatment satisfaction, and trial participation
- Cancer Impact [ Time Frame: 24 months or longer-post randomization ]Cancer Impact Questionnaire
- Information Needs [ Time Frame: 24 months or longer-post randomization ]Information Needs Questionnaire
- General Concerns [ Time Frame: 24 months or longer post-randomization ]General Concerns Questionnaire
- Cancer-related Worry [ Time Frame: 24 months or longer post-randomization ]Assessment of Survivor Concerns

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083550
Canada, Ontario | |
University Health Network | |
Toronto, Ontario, Canada, M5G 2C4 |
Principal Investigator: | Annie M Sawka, MD, PhD | University Health Network, Toronto | |
Study Director: | David P Goldstein, MD | University Health Network, Toronto |
Other Publications:
Responsible Party: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT01083550 |
Other Study ID Numbers: |
REB 09-0986-BE UHNREB 09-0986-BE ( Other Identifier: University Health Network Research Ethics Board Number ) |
First Posted: | March 9, 2010 Key Record Dates |
Last Update Posted: | November 29, 2016 |
Last Verified: | November 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No plan to share individual participant data |
thyroid carcinoma thyroid cancer therapeutic radioisotopes radioactive iodine |
Thyroid Neoplasms Thyroid Cancer, Papillary Thyroid Diseases Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Adenocarcinoma, Papillary Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |