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About
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.
Full description
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
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):
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.
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Inclusion Criteria for patient participants:
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Inclusion criteria for the physician feedback component of this study:
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74 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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