Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer: Protocol of a Multicenter...

Area of Science:

• Oncology
• Medical Decision Making
• Public Health

Background:

• Active surveillance (AS) is recommended for low-risk papillary thyroid microcarcinoma (PTMC), but implementing shared decision-making (SDM) remains challenging.
• Integrating patient values into clinical decisions is crucial for effective AS in PTMC management.
• Existing guidelines recommend AS, yet practical application requires enhanced patient involvement.

Purpose of the Study:

• To evaluate a newly developed PTMC-specific SDM model's impact on patient-reported outcomes (PROs) compared to usual care (UC).
• To assess the efficacy of structured counseling and decision aids in improving patient satisfaction and decision-making processes.
• To generate evidence for integrating SDM into routine PTMC management.

Main Methods:

• A multicenter, parallel-group, cluster-randomized controlled trial involving 310 patients with low-risk PTMC across seven Korean academic hospitals.
• Participants were assigned to either the SDM model group or the UC group via cluster randomization of clinicians.
• The SDM group received structured counseling with decision aids; the UC group received standard counseling.

Main Results:

• The primary outcome was the Decisional Conflict Scale score, with secondary outcomes including satisfaction, decision regret, anxiety, and quality of life.
• Data collection involved electronic Case Report Forms and PRO surveys at baseline, 1-4 weeks, and 6 months post-decision.
• The study aims to demonstrate improved PROs in the SDM group compared to the UC group.

Conclusions:

• The PTMC-specific SDM model has the potential to enhance patient-reported outcomes in low-risk PTMC management.
• Successful implementation of SDM can improve patient satisfaction and decision-making processes.
• This trial provides evidence for integrating SDM into routine care for patients with low-risk PTMC.