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Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer: update to study protocol with follow-up extension.

ABSTRACT: BACKGROUND:Patient 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/DESIGN:We 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 CONCLUSION:This 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. DISCUSSION:Our 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 REGISTRATION:Clinicaltrials.gov identifier NCT01083550, registered 24 February 2010 and last updated 5 January 2015.

SUBMITTER: Sawka AM

PROVIDER: S-EPMC4501089 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer: update to study protocol with follow-up extension.

Sawka Anna M AM Straus Sharon S Rodin Gary G Thorpe Kevin E KE Ezzat Shereen S Gafni Amiram A Goldstein David P DP

Trials 20150714

<h4>Background</h4>Patient 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.<h4>Methods/design</h4>We 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 us ...[more]

PMID: 26169592

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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.

Project description:ImportanceOne-third of patients with papillary thyroid cancer (PTC) develop persistent or recurrent disease after initial therapy. Most patients with persistent or recurrent disease undergo reoperation, but the role of treatment with radioactive iodine (RAI) after reoperation is unclear.ObjectiveTo determine whether receipt of RAI after reoperation for recurrent PTC is associated with improved outcomes.Design, setting, and participantsThis retrospective cohort study included electronic health record data from 102 patients who underwent neck reoperation for persistent or recurrent PTC at a tertiary referral center from April 2006 to January 2016; 50 patients received RAI after reoperation, and 52 did not receive RAI after reoperation. Data analysis was performed from September 1, 2017, to December 1, 2017.Main outcomes and measuresSuppressed thyroglobulin (Tg) levels were compared between patients who underwent reoperation and received RAI and patients who underwent reoperation without receipt of RAI at the following time points: before reoperation (Tg0), after reoperation (Tg1), and after RAI or a comparable time interval among patients whose cases were managed without RAI (Tg2). Outcomes were biochemical response and structural recurrence after reoperation.ResultsThe cohort comprised 102 patients who underwent neck reoperation for persistent or recurrent PTC (median age, 44 years [interquartile range, 33-54 years; SD, 14 years]; 67 [66%] female), 50 of whom received treatment with RAI after reoperation. Clinicopathologic characteristics of the patients at the time of the initial surgical procedure were similar between the reoperation with RAI group and the reoperation without RAI group with the exception of tumor (T) stage (T3 and T4, 28 of 50 [56%] vs 19 of 52 [37%]). Although median Tg levels were similar between the reoperation with RAI group and the reoperation without RAI group (Tg0, 3.3 ng/mL vs 2.4 ng/mL; Tg1, 0.6 ng/mL vs 0.2 ng/mL; and Tg2, 0.5 ng/mL vs 0.2 ng/mL; all differences were nonsignificant), the rate of excellent response at Tg1 was lower in the reoperation with RAI group (4 of 33 [12%] vs 24 of 51 [47%]; P = .007). Structural recurrence after reoperation occurred in 18 of 50 patients (36%) in the reoperation with RAI group and 10 of 52 patients (19%) in the reoperation without RAI group. In multivariable analysis accounting for clinicopathologic characteristics and Tg0, receipt of RAI after reoperation was not associated with the rate of a second structural recurrence. In subset analyses limited to patients with incomplete response to reoperation and patients with T3 or T4 tumors, no association between receipt of RAI and the risk of a second recurrence was found.Conclusions and relevancePatients who received RAI after reoperation had outcomes similar to those in patients who underwent reoperation alone. RAI after reoperation was not associated with a significant clinical benefit in this limited series. Larger multicenter studies are required to determine whether receipt of RAI after reoperation improves outcomes among patients with recurrent PTC.

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Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer: update to study protocol with follow-up extension.

Publications

Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer: update to study protocol with follow-up extension.

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