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

Sponsor:

Collaborators:

Ontario Ministry of Health and Long Term Care

Canadian Institutes of Health Research (CIHR)

Information provided by (Responsible Party):

University Health Network, Toronto

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Thyroid Cancer	Other: Decision aid exposure	Phase 2 Phase 3

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Study Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Cancer Thyroid Diseases

Drug Information available for: Iodine Thyroid

Genetic and Rare Diseases Information Center resources: Papillary Thyroid Carcinoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: DA intervention Decision aid exposure + usual care	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

Outcome Measures

Primary Outcome Measures :

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).

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators

University Health Network, Toronto

Ontario Ministry of Health and Long Term Care

Canadian Institutes of Health Research (CIHR)

Investigators

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Principal Investigator:	Annie M Sawka, MD, PhD	University Health Network, Toronto
Study Director:	David P Goldstein, MD	University Health Network, Toronto

More Information

Publications of Results:

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.

Sawka 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.

Sawka 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.

Sawka 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.

Other Publications:

Sawka 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.

Sawka 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.

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Responsible Party:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT01083550 History of Changes
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

Keywords provided by University Health Network, Toronto:


thyroid carcinoma thyroid cancer therapeutic radioisotopes radioactive iodine

Additional relevant MeSH terms:

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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 Iodine Anti-Infective Agents, Local Anti-Infective Agents Trace Elements Micronutrients Nutrients Growth Substances Physiological Effects of Drugs

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