Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer--a randomized controlled trial.
BACKGROUND
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.


CONCLUSIONS
This 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.


BACKGROUND
Clinical Trials.gov Identifier: NCT01083550.
Sawka
Anna M
AM
Division of Endocrinology, Department of Medicine, University Health Network and University of Toronto, Toronto, Ontario, Canada. sawkaam@yahoo.com
Straus
Sharon
S
Brierley
James D
JD
Tsang
Richard W
RW
Rotstein
Lorne
L
Rodin
Gary
G
Gafni
Amiram
A
Ezzat
Shereen
S
Thabane
Lehana
L
Thorpe
Kevin E
KE
Goldstein
David P
DP
D000328:Adult; D002291:Carcinoma, Papillary / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy; D003657:Decision Making; D005500:Follow-Up Studies; D006801:Humans; D007457:Iodine Radioisotopes / Q000627:therapeutic use*; D009367:Neoplasm Staging; D018714:Radiotherapy, Adjuvant / Q000379:methods*; D013964:Thyroid Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D013965:Thyroidectomy
D007457:Iodine Radioisotopes