A Randomized Controlled Trial Evaluating Educational Resources for Patients With Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- TC-MAX
研究概览
简要总结
Through a pilot randomized controlled trial (RCT), we aim to test the feasibility and preliminary impact of two online educational resources among adult patients with thyroid cancer. Each online program can be accessed on the patient's personal device, and will be provided to the patient following a diagnosis of thyroid cancer but before meeting with their surgeon to discuss treatment options. The goal of the resource is to educate patients on the various treatment options for thyroid cancer prior to surgical consultation, so that clinic visit time can be better utilized to discuss patient questions and priorities, and support shared decision making. Clinical (TC-MAX; thyroid cancer related anxiety) and behavioral outcomes (decisional conflict, shared-decision making, treatment decision) will be assessed via online surveys 1-day and 14-days post-visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Newly diagnosed with either:
- •≤2cm Bethesda 6 thyroid nodule (papillary thyroid carcinoma) (T1N0)
- •≤2cm Bethesda 5 thyroid nodule
- •≤2cm Bethesda 3-4 thyroid nodule with molecular testing that confers >75% risk of malignancy
- •Able to understand and complete questionnaires independently in English
- •Access to an internet-enabled device for online surveys and intervention access
排除标准
- •Cognitive impairment or other condition that, in the opinion of the investigators, would interfere with protocol participation
- •Has nodule >2cm in size, or with non-papillary thyroid carcinoma histology
- •High-grade or poorly differentiated papillary thyroid carcinoma (PTC) variants
- •Central or lateral neck lymphadenopathy suspicious for PTC
- •Unfavorable nodule location, to be determined by the surgeon (e.g. Near dorsal surface (by recurrent laryngeal nerve); adjacent to trachea (risk of cartilage invasion)
- •Recurrent thyroid cancer case
研究组 & 干预措施
Education Control
Participants randomized to the education control arm will be sent a link to access the 2-page American Cancer Society (ACS) handout: "After a Thyroid Cancer Diagnosis." The handout can take between 5-15 minutes to read through. Completion of the ACS handout prior to the clinic visit will be monitored and confirmed by study staff.
干预措施: ACS "After a Thyroid Cancer Diagnosis" Flyer (Other)
THRIVE
Participants randomized to the THRIVE arm will be sent a link to access the THRIVE portal up to 3 weeks prior to their clinic visit. The THRIVE modules can take between 20-35 minutes to complete. Completion of the THRIVE modules prior to the clinic visit will be monitored and confirmed by study staff. Upon completing the program, a report summarizing the conversation and questions/comments brought up by the patient will be shared with their physician prior to the clinic visit.
干预措施: THRIVE (Behavioral)
结局指标
主要结局
TC-MAX
时间窗: Baseline, 1-day post clinic visit, 14-days post clinic visit
Thyroid cancer-related anxiety as measured by the 18-item TC-MAX questionnaire created by Dr. Allen Ho at Cedars-Sinai. It is a psychometric scale assessing thyroid cancer-related anxiety across three different subscales (Collective Anxiety, Ultrasound Anxiety, and Fear of Recurrence/Progression). Scale range is between 0-100, with higher scores indicating greater anxiety. Means and standard deviations will be used to describe the scores.
次要结局
- Decisional Conflict Scale(1-day post clinic visit)
- Shared Decision Making(1-day post clinic visit)
研究者
Allen Ho
Physician
Cedars-Sinai Medical Center