Abstract
BackgroundPatients 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.MethodsWe 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
Highlights
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
In a recent focus group study conducted in Canada [12], thyroid cancer survivors reported receiving conflicting recommendations on adjuvant post-surgical RAI treatment from healthcare providers and insufficient information on rationale, risks, and uncertainties relating to this treatment
Decision aids are instruments used to inform patients about available treatment options which have been found to generally improve general patient knowledge, to result in more realistic patient treatment expectations, to increase active patient participation in decision making, and to reduce indecisiveness, when compared to usual care; (decision aid) (DA)’s may be computerized or paper-based or a combination of both [13]. Our aim in this randomized controlled trial, is to evaluate, in individuals with early stage PTC who have had thyroidectomy, the effect of a computer-based DA on the following 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 the rationale for this decision
Summary
Design In order to evaluate this DA, we propose to conduct a single-centre, patient-level randomized controlled trial, comparing exposure to the DA (with usual care) to a control group of usual care. Invitation for feedback from treating physicians In the months before study completion, we will mail out a self-administered written satisfaction survey (modified from general questionnaire on client satisfaction [20]) to thyroid physicians and surgeons in active practice at the University Health Network (where the majority of patient participants are expected to be recruited). This survey will invite physicians’ feedback on their experience with patients who may have been exposed to the DA intervention in the trial. Sharing our findings with a Canadian thyroid cancer support group (Canadian Thyroid Cancer Canada, formerly known as Thry’vors), and sharing links to the DA website if the group is interested
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