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Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer--a randomized controlled trial.
Trials 2010; 11:81T

Abstract

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.

DISCUSSION

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.

TRIAL REGISTRATION

Clinical Trials.gov Identifier: NCT01083550.

Authors+Show Affiliations

Division of Endocrinology, Department of Medicine, University Health Network and University of Toronto, Toronto, Ontario, Canada. sawkaam@yahoo.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20659341

Citation

Sawka, Anna M., et al. "Decision Aid On Radioactive Iodine Treatment for Early Stage Papillary Thyroid Cancer--a Randomized Controlled Trial." Trials, vol. 11, 2010, p. 81.
Sawka AM, Straus S, Brierley JD, et al. Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer--a randomized controlled trial. Trials. 2010;11:81.
Sawka, A. M., Straus, S., Brierley, J. D., Tsang, R. W., Rotstein, L., Rodin, G., ... Goldstein, D. P. (2010). Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer--a randomized controlled trial. Trials, 11, p. 81. doi:10.1186/1745-6215-11-81.
Sawka AM, et al. Decision Aid On Radioactive Iodine Treatment for Early Stage Papillary Thyroid Cancer--a Randomized Controlled Trial. Trials. 2010 Jul 26;11:81. PubMed PMID: 20659341.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer--a randomized controlled trial. AU - Sawka,Anna M, AU - Straus,Sharon, AU - Brierley,James D, AU - Tsang,Richard W, AU - Rotstein,Lorne, AU - Rodin,Gary, AU - Gafni,Amiram, AU - Ezzat,Shereen, AU - Thabane,Lehana, AU - Thorpe,Kevin E, AU - Goldstein,David P, Y1 - 2010/07/26/ PY - 2010/04/23/received PY - 2010/07/26/accepted PY - 2010/7/28/entrez PY - 2010/7/28/pubmed PY - 2010/9/30/medline SP - 81 EP - 81 JF - Trials JO - Trials VL - 11 N2 - 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. DISCUSSION: 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. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT01083550. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/20659341/Decision_aid_on_radioactive_iodine_treatment_for_early_stage_papillary_thyroid_cancer__a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-11-81 DB - PRIME DP - Unbound Medicine ER -