ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of Anxiety at 6 months
研究概览
简要总结
This is a pilot study to compare two ways of managing newly identified thyroid nodules that are likely to be cancerous based on ultrasound result and which under usual care would undergo immediate biopsy.
The main goals of this pilot study are 1) compare anxiety at 6 months in each treatment arm using the validated instrument Anxiety-CA, 2) measure thyroid quality of life in each treatment arm
Participants will be randomized to one of two groups:
- immediate biopsy (usual care)
- Active monitoring (serial ultrasound based monitoring and close clinical follow-up)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be ≥18 years of age.
- •Participants must be able and willing to provide informed consent or have a surrogate capable of providing same.
- •Participants must be absent of symptoms referable to the nodule: dysphagia or nodule physically visible and/or bothersome to patient.
- •Participants' thyroid nodule must have a TI-RADS rating of 4 or
- •Participants thyroid nodule must be ≤2 cm in largest diameter.
- •Participants must be being considered for biopsy.
- •Participants with a prior history of papillary thyroid cancer are eligible.
排除标准
- •Patients who fall into one of the following categories will NOT be eligible for this study:
- •Adults who are unable to provide informed consent.
- •Patients for whom biopsy is not a consideration.
- •Patients with a prior history of thyroid cancer other than papillary thyroid cancer.
- •Patients with a history of radiation to the neck.
- •Patients who are athyroidal (thyroid gland has been removed or patient has only lingual thyroid tissue).
- •Patients who have ultrasound evidence of one or more of the following:
- •Airway invasion of the nodule.
- •Nodule adjacency to/invading the recurrent nerve.
- •Extra-thyroidal invasion by the nodule.
- •Patients who have metastasis to cervical lymph nodes (confirmed by needle biopsy if ultrasound suspicious), distant metastases, if identified) testing not required, not usual care)
- •Patients who have already had a biopsy of the nodule being considered for inclusion in the study.
- •TRAIL Pilot Integrated QRI: Inclusion/Exclusion Criteria
- •Inclusion Criteria for Study Patient Participants:
- •Participants must meet the eligibility requirements above and will be or have been approached about enrolling in the pilot study.
- •Participants must be willing to allow audio recorder presence and / or willing to be interviewed by the QRI team.
- •Exclusion Criteria for Study Patient Participants:
- •Patients who are not willing to allow audio recorder presence and/or not willing to be interviewed by QRI team will be excluded from this study.
- •Inclusion Criteria for Study Staff Participants:
- •Staff must be willing to audio record their communications with patients about enrolling in the study.
- •Staff must be willing to participate in interviews with QRI team about their views of the study.
- •Exclusion Criteria for Study Staff Participants:
- •Staff members who are not willing to participate in audio taping of recruitment discussions and/or interviews with QRI team about their views of the study will be excluded.
结局指标
主要结局
Rate of Anxiety at 6 months
时间窗: 6 months after randomization
Rate of anxiety will be measured using Anxiety-CA instrument PROMIS-Anxiety Short form. Each question has five response options ranging in value from one to five. (1 = never experiencing a type of distressing emotion; 5 = always feeling that emotion). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For the adult PROMIS Anxiety 7a short form, a raw score of 10 converts to a T-score of 46.7 with a standard error (SE) of 2.6.
次要结局
- Clinical outcomes: needle biopsy cytology results (if done),(6 months after randomization.)
- Clinical outcomes: pathology at surgery (if surgery performed),(6 months after randomization.)
- Representativeness of enrolled participants compared to eligible participants(6 months after randomization.)
- Score on selected domains of the ThyPRO short form instrument(3 and 6 months post randomization)
- Study Procedure compliance(6 months after randomization)
- Clinical outcomes; Nodule size(Baseline and 6 months after randomization.)
研究者
Louise Davies
Staff Physician - Section of Otolaryngology Head & Neck Surgery
Dartmouth-Hitchcock Medical Center