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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 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. In patients with early stage PTC, does the administration of a computerized decision aid, improve satisfaction with information received related to RAI decision making (compared to usual care), six months later, as well as after the decision is finalized (if not finalized at 6 months) (Client Satisfaction Questionnaire - Patient Information version, CSQI)?
5. What is the level of satisfaction of physicians and surgeons, whose patients have been exposed to a computerized decision aid explaining the options of RAI treatment and no RAI treatment in early stage papillary thyroid cancer? (Client Satisfaction Questionnaire - Physicians version, CSQMD) (descriptive analysis)
6. 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)
7. 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)
8. Do the respective monitoring or blunting scores on the Miller Behavioral Style Scale correlate with participant satisfaction six months later, as well as after the final decision on RAI treatment has been made (if not finalized at 6 months)? (Respective analyses planned for entire study population, as well as the treatment and control groups)
9. 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).
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.
Allocation: Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Decision aid exposure
University Health Network
University Health Network, Toronto
Published on BioPortfolio: 2014-07-23T21:09:53-0400
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