Papillary Thyroid Carcinoma, Thyroid Cancer
Conditions
Keywords
Active surveillance, Shared decision making
Brief summary
This study is a multicenter cluster-randomized controlled trial conducted in Korea. A parallel, two-group cluster-randomized design will be used to test whether the Shared decision-making Group (SDM; intervention) is different from the Standard Care Group (SC; control).
Detailed description
The primary objective of this clinical trial is to evaluate whether the group provided with a decision support tool for treatment planning (Intervention; SDM group) demonstrates improved satisfaction with the decision-making process compared to the group receiving standard care (Control; SC group) among patients diagnosed with low-risk thyroid cancer who need to determine their treatment plan. The data are collected from patients who are diagnosed with low-risk PTC and Twenty doctors with various experience of AS will participate in the study.
Interventions
OTHERSDM protocol
Card news and Videos related to general knowledge and treatment of low-risk thyroid cancer
Sponsors
Seoul National University Hospital
Seoul National University Bundang Hospital
SMG-SNU Boramae Medical Center
Nowon Eulji Medical Center
Hanyang University
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older with a thyroid nodule of 1.0 cm or less confirmed as Bethesda category V (suspicious for PTC) or VI (PTC) based on cytopathological examination, or Bethesda category III (atypia of undetermined significance) with a confirmed BRAF V600E mutation. * Patients with no evidence of distant metastasis, cervical lymph node metastasis, recurrent laryngeal nerve invasion, or tracheal invasion. Additionally, no evidence of extrathyroidal extension (ETE) should be present, and the tumor must not belong to high-risk subtypes of PTC (e.g., diffuse sclerosing, columnar cell, or solid subtype).
Exclusion criteria
* Patients who cannot undergo regular follow-up or are expected to have difficulties with follow-up. * Patients with indeterminate or benign findings on thyroid biopsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision Conflict Scale: DCS | at enrollment | which assesses an individual's perception and understanding of decision-making by 16 items. The scale is 5-point Likert scale from 0 (Strongly Agree) to 4 (Strongly Disagree), and scores are calculated through a) summed, b) divided by 16, and c) multiplied by 25, and range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision Making Questionnaire (SDM-Q-9) | at enrollment, and 6month, 12month after enrollment | a nine-item questionnaire assessing the quality of SDM from both patient and clinician perspectives. Scale ranges from 1(completely disagree) to 6(completely agree). Higher scores are indicative of more SDM. |
| Patients' Perceived involvement of Care Scale (PICS) | at enrollment, and 6month, 12month after enrollment | a 13-item questionnaire evaluating patient engagement in primary care \[12\]. It measures Clinician's information provision, patient's proactive information-seeking, and patient participation in treatment decisions (5-point Likert scale; 1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate lower clinician control and greater patient involvement in decision-making. |
| Decision Regret Scale: DRS | at 6month, 12month after enrollment | measures distress and remorse after making a healthcare decision. Scale ranges from 1 (Strongly agree) to 5(Strongly Disagree). The final score, the items are summed and averaged. ranging from 0 (no regret) to 100 (high regret). |
| Comparison of Quality of Life between the shared decision group and standard care group | at enrollment, and 6month, 12month after enrollment | The Quality of Life - Thyroid (QOL-Thyroid) questionnaire was 30 items. These are assigned to four scales, each reflecting an aspect of QoL. Physical well-being is measured with two items and 13 questions, psychological well-being with 13 items and 22 questions, social concerns with eight items and 14 questions, and spiritual well-being with seven items and questions. Response options range from '0 = worst outcome' to '10 = best outcome' on an ordinal 11-point scale. |
| Hospital Anxiety and Depression | at enrollment, and 6month, 12month after enrollment | a 14-item tool (7 for anxiety, 7 for depression), developed to measure hospital patients' levels of anxiety and depression. Each item is rated on a 0-3 scale, with total scores ranging from 0 to 21 per subscale. A cutoff score of 8 or higher indicates clinically significant symptoms, based on Korean validation studies. |
| multifocal approach to sharing in shared decision making(Mappin'SDM) | at enrollment, and 6month, 12month after enrollment | that incorporates physician, patient, and observer perspectives during medical consultations. a 15-item tool adapted from the 12-item OPTION scale to evaluate observed patient involvement in decision-making \[13\]. Each item consists of behavioral and outcome components (a total of 30 items), rated by patients, clinicians, and observers (through real-time or via video review). Scale ranges from 0(not at all) to 5(absolutely true). High scores indicate high quality of decision-making communication across patient engagement. |
Contacts
Primary ContactEun Kyung Lee
Outcome results
None listed