Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer - a randomized controlled trial
Patients with early stage papillary thyroid carcinoma (PTC), are faced with the decision to either to accept or reject adjuvant radioactive iodine (RAI) treatment after thryroidectomy. This decision is often difficult because of conflicting reports of RAI treatment benefit and medical evidence uncertainty due to the lack of long-term randomized controlled trials.
Methods: We report the protocol for a parallel, 2-arm, randomized trial comparing an intervention group exposed to a computerized decision aid (DA) relative to a control group receiving usual care.
The DA explains the options of adjuvant radioactive iodine or no adjuvant radioactive iodine, as well as associated potential benefits, risks, and follow-up implications. Potentially eligible adult PTC patient participants will include: English-speaking individuals who have had recent thyroidectomy, and whose primary tumor was 1 to 4 cm in diameter, with no known metastases to lymph nodes or distant sites, with no other worrisome features, and who have not received RAI treatment for thyroid cancer.
We will measure the effect of the DA on the following patient outcomes: a) knowledge about PTC and RAI treatment, b) decisional conflict, c) decisional regret, d) client satisfaction with information received about RAI treatment, and e) the final decision to accept or reject adjuvant RAI treatment and rationale.DiscussionThis trial will provide evidence of feasibility and efficacy of the use of a computerized DA in explaining complex issues relating to decision making about adjuvant RAI treatment in early stage PTC.Trial registrationClinical Trials.gov Identifier: NCT01083550
Author: Anna SawkaSharon StrausJames BrierleyRichard TsangLorne RotsteinGary RodinAmiram GafniShereen EzzatLehana ThabaneKevin ThorpeDavid Goldstein
Credits/Source: Trials 2010, 11:81
Published on: 2010-07-26
Copyright by the authors listed above - made available via BioMedCentral (Open Access). Please
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(2) How is randomization to be accomplished?
(3)How many patients will be enrolled and what measure of statistical confidence will be used?
(2) How long will this study run, considering a long-term mortality rate of about 5%?