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

ABSTRACT: 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.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.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.Clinical Trials.gov Identifier: NCT01083550.

SUBMITTER: Sawka AM

PROVIDER: S-EPMC2917435 | biostudies-literature | 2010 Jul

REPOSITORIES: biostudies-literature

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

Sawka Anna M AM 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

Trials 20100726

<h4>Background</h4>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.<h4>Methods</h4>We report the protocol for a parallel, 2-arm, randomized trial comparing an intervention group expos ...[more]

PMID: 20659341

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Project description:BackgroundPatient decision aids (P-DAs) are used to inform patients about healthcare choices, but there is limited knowledge about their longer term effects, beyond the time period of decision-making.Methods/designWe developed a computerized P-DA that explains the choice of radioactive iodine (RAI) adjuvant treatment or no RAI, for patients with low risk papillary thyroid cancer after total thyroidectomy. The original protocol for a randomized controlled trial, comparing the use of the P-DA (with usual care) to usual care alone, has been published in Trials http://www.trialsjournal.com/content/11/1/81. We found that P-DA (with usual care) significantly improved patients' medical knowledge at the time of decision-making (primary outcome) compared to usual care alone (control). In this update, we present the protocol for an extended follow-up study (15 to 23 months post-randomization), including qualitative and quantitative methods. The patient outcomes evaluated using quantitative questionnaires include: the degree to which patients feel well-informed about their RAI treatment choice, decision satisfaction, decision regret, cancer-related worry, mood, and trust in the treating physician. The qualitative component explores the experiences of RAI treatment decision-making, treatment satisfaction, and trial participation in a representative subgroup of patients. Extended follow-up study results will be described for the entire study population, and data will be compared between the P-DA and control groups.Result and conclusionThis mixed methods extended follow-up study will provide data on long term outcomes, relating to the use of a computerized P-DA in decision-making about adjuvant RAI treatment in early stage papillary thyroid cancer.DiscussionOur results are intended to inform future research in this area, particularly relating to long term effects of the use of P-DAs in making healthcare choices.Trial registrationClinicaltrials.gov identifier NCT01083550, registered 24 February 2010 and last updated 5 January 2015.

Project description:It remains controversial whether papillary thyroid cancer (PTC) patients with low- to intermediate-risk disease should receive radioactive iodine (RAI) after total thyroidectomy (TT). We aim to identify those who might benefit from RAI treatment in PTC patients with cervical nodal metastasis after TT. Patients were divided into TT and TT+RAI groups from the Surveillance, Epidemiology, and End Results (SEER) database (2004-2018). Overall survival (OS) and cancer-specific survival (CSS) were compared, and propensity score matching (PSM) was performed between groups. A total of 15,179 patients were enrolled, including 3,387 (22.3%) who underwent TT and 11,792 (77.7%) who received TT+RAI. The following characteristics were more likely to present in the TT+RAI group: multifocality, capsular extension, T3, N1b, and more metastatic cervical lymph nodes. RAI was associated with better OS in low- to intermediate-risk PTC patients in the multivariate Cox regression model. The subgroup analysis showed that RAI predicted better OS in patients ≥55 years, American Joint Committee on Cancer (AJCC) stage II, and capsular extension with a hazard ratio (HR) (95% CI) of 0.57 (0.45-0.72), 0.57 (0.45-0.72), and 0.68 (0.51-0.91), respectively. However, RAI failed to improve the prognoses of patients with age <55 years, AJCC stage I, PTC ≤1 cm, and capsular invasion. In the PSM cohort with 3,385 paired patients, TT+RAI treatment predicted better OS compared with TT alone. In addition, TT+RAI predicted better OS in patients with metastatic cervical lymph nodes ≥2, multifocality, extracapsular extension, and American Thyroid Association (ATA) intermediate risk. In conclusion, RAI was associated with better OS in low- to intermediate-risk PTC patients with age ≥55 years, multifocality, extrathyroidal extension, and ATA intermediate risk. However, the survival benefit from RAI may be limited in patients with AJCC stage I, PTC ≤1 cm, unifocality, capsular invasion, and ATA low-risk diseases; these patients even showed pathological cervical lymph node metastasis.

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

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

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