Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer
Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer
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.
A. Primary research question

 In patients with early stage papillary thyroid cancer, does the administration of a
 computerized decision aid improve the score on a test of knowledge about early stage PTC and
 adjuvant RAI treatment, when compared to usual care? (The knowledge score is a sum of
 positive responses from a total of 10 true/false questions in a self-administered
 questionnaire, to be administered at the study visit, Q2A).

 B. Secondary research questions

 1. In patients with early stage PTC, does the administration of a computerized decision aid
 reduce overall decisional conflict (as well as the following respective subscales -
 informed subscale, uncertainty subscale, and effective decision subscale), when compared
 to usual care? (Decisional Conflict questionnaire, DCS).

 2. In patients with early stage PTC, does the administration of a computerized decision
 aid, improve reduce decisional regret relating to RAI decision making after the final
 decision has been made? (Decision Regret Questionnaire, DRQ)

 3. In patients with early stage PTC, does the administration of a computerized decision
 aid, reduce the number of participants receiving adjuvant radioactive iodine treatment
 (analysis for all participants, as well as those who are not already on a waiting list
 for radioactive iodine treatment at the time of recruitment, respectively)?

 4. Do the respective monitoring or blunting scores on the Miller Behavioral Style Scale
 (MBSS) correlate with the number of clicks for information performed by participants
 reviewing the decision aid? (subgroup analysis in the decision aid intervention group)

 5. Do the respective monitoring or blunting scores on the Miller Behavioral Style Scale
 (MBSS) correlate with the score on a test of knowledge about early stage PTC and
 adjuvant RAI treatment? (Respective analyses planned for entire study population, as
 well as the intervention and control groups)

 6. What are the main reasons why RAI treatment is selected or not selected (after the
 decision has been finalized), grouping descriptions according to exposure or
 non-exposure to a computerized decision aid? (See Follow-up questionnaire [administered
 by telephone], question 2, qualitative description, with reasons to be coded and
 quantified using mixed methods).

 NOTE: In the original design of this study, we hoped to utilize a modified Client
 Satisfaction Questionnaire for assessment of satisfaction of patient participants and
 physicians as secondary trial outcomes. However, we are unable to utilize any modified Client
 Satisfaction Questionnaires in this study, because of lack of permission from the original
 developer of the Client Satisfaction Questionnaire-8, who has copyrighted and trademarked the
 questionnaire and prohibits such modifications. No modified client satisfaction questionnaire
 results have been analyzed in this study and will not be analyzed.

 Study design The project design will be a single-centre randomized controlled trial conducted
 at University Health Network. The participants will be randomized to a) the decision aid
 group (in addition to usual care [counseling by his or her physician, called usual care]) or
 b) usual care. The DA will be available only to participants during the study (not the public
 or treating physicians). The decision aid testing will be performed at the Toronto General
 Hospital.

 15-23 Month Extended Follow-up Study: After initiation of the primary study above, we were
 subsequently awarded funding to contact the enrolled study participants about 15 and 23
 months post-randomization to inquire for permission to participate in an extended follow-up
 study. The extended follow-up study was approved by the University Health Network Research
 Ethics Board. Participants from the original randomized controlled trial (above) are
 contacted by telephone for consent to participate in the extended follow-up study, which is
 considered exploratory (secondary).

 The extended follow-up study includes a quantitative questionnaire telephone interview
 component and a qualitative component. For the quantitative questionnaire component, a single
 telephone interview is performed updating demographics, thyroid cancer outcomes/treatments
 (with confirmatory medical record review and administering quantitative questionnaires
 verbally. A participants consenting to the extended follow-up study are also offered the
 opportunity to participate in an in-depth qualitative study, involving a one-on in-person
 interview (which is audio-recorded, transcribed, and analyzed using qualitative methods). A
 representative subgroup of about 15-30 participants are invited in the qualitative interview
 and sampling continued until saturation of themes is achieved.

 The following exploratory questions are to be addressed in the quantitative component of the
 extended follow-up study (about 15-23 months post-randomization):

 1. To what degree do participants in the study (decision aid and control groups) perceive
 themselves to be respectively informed and satisfied with the original radioactive
 iodine treatment decision? The results in respective study arms are compared.

 2. To what degree do participants in the study (decision aid and control groups) perceive
 themselves to regret their original radioactive iodine treatment decision? The results
 in respective study arms are compared.

 3. To what degree do participants in the study (decision aid and control groups) perceive
 current cancer-related worry (Assessment of Survivor Concerns Questionnaires)? The
 results in respective study arms are compared.

 4. To what degree do participants in the study (decision aid and control groups) perceive
 trust in their treating physician (Trust in Physician Scale)? The results in respective
 study arms are compared.

 5. How do participants in the study (decision aid and control groups) perceive their mood
 (PHQ-4 questionnaire)? The results in respective study arms are compared.

 The qualitative subgroup study includes semi-structured questions on the experiences of
 radioactive iodine treatment decision-making, overall thyroid cancer treatment satisfaction,
 and study participation.

 Exploratory Telephone Survey Study - 24 months or longer after randomization:

 After initiation of the primary study above, we were subsequently awarded pilot study funding
 to contact the study participants on one occasion, two or more years post-randomization to
 inquire for permission to participate in an exploratory telephone survey study, intended to
 guide future research directions, and generate data for possible use in sample size
 calculations for potential future studies. The 24 month or longer post-randomization
 exploratory telephone survey study was approved by the University Health Network Research
 Ethics Board. Participants from the original randomized controlled trial (above) are
 contacted by telephone for consent to participate in the study, which is considered
 exploratory (secondary) and is thus, hypothesis-generating.

 The telephone survey exploratory study (2 or more years post-randomization) consists of
 quantitative telephone questionnaires. A single telephone interview is performed updating
 demographics, thyroid cancer outcomes/treatments (with confirmatory medical record review and
 administering quantitative questionnaires verbally.

 The following exploratory questions are to be addressed in the exploratory 24 month (or
 longer) post-randomization study. For all of the analyses below, descriptive data will be
 described for the entire study population, and if sample size permits, subgroup analyses
 according to decision aid status, radioactive iodine status, and age (<45 years at time of
 original surgery or 45 years or older at time of original surgery), and recurrence status,
 will be considered.

 1. To describe the Cancer Impact in consenting participants, 2 or more years
 post-randomization. For participants in whom a negative financial impact of cancer is
 reported, an additional question is posed requesting explanation of this impact.

 2. To describe the Information Needs of consenting participants, 2 or more years
 post-randomization.

 3. To describe the General Concerns of consenting participants, 2 or more years
 post-randomization.

 4. To describe cancer-related worry (Assessment of Survivor Concerns Questionnaires) two or
 more years following randomization.
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.