Pilot Study of an Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility of the CQUPLE intervention (burden of data collection on study team)
研究概览
简要总结
The study will include 50 patients newly diagnosed with low-risk thyroid cancer ranging from 18-80 years of age. After scheduling their surgeon visit, the investigators will enroll patients and measure their intended treatment choice, baseline awareness of the three treatment options, expected outcomes, self-efficacy, and activation. The participants will then be randomized 1:1 and deliver the CQUPLE intervention to the intervention group. The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit. The study team will repeat all measures prior to the surgical consult and after the surgical consult. The study team will record the patients' actual treatment choice after the consult.
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
- Single (Participant)
盲法说明
The control group will be blinded to the intervention and receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years
- •Low risk papillary thyroid cancer or highly suspicious for cancer
- •Low risk papillary thyroid cancer
- •cT1-2: Tumor size 4 cm or smaller and limited to the thyroid on ultrasound
- •cN0: No evidence of lymph node metastasis on ultrasound
- •cM0: No evidence of distant metastasis on imaging
- •Highly suspicious for cancer
- •Cytology meeting Bethesda V or Bethesday III or IV with molecular testing indicating a 70% risk of greater of thyroid cancer
- •Nodule size 4 cm and smaller
- •Limited to the thyroid on ultrasound
- •No evidence of suspicious lymph nodes
- •No evidence of thyroid cancer outside of the neck
- •Referred for surgical consultation.
排除标准
- •History of previous thyroid cancer or thyroid surgery and parathyroid surgery
- •Non-English speaking
- •Subject Selection (for Surgeons)
- •Surgeon Inclusion Criteria
- •Performs at least one thyroid surgery annually on adults
- •Credentialed at Michigan Medicine
- •Surgeon Exclusion Criteria
研究组 & 干预措施
CQUPLE Intervention
A novel intervention called CQUPLE (pronounced "couple"), which includes two interventions delivered together: (1) a Chart of side-by-side, evidence-based information comparing all three treatment options for low-risk thyroid cancer, including expected outcomes and (2) a Question Prompt List that contains key questions to consider asking the surgeon.
干预措施: CQUPLE (Other)
Usual Care Control
The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.
干预措施: Usual Care (Other)
结局指标
主要结局
Feasibility of the CQUPLE intervention (burden of data collection on study team)
时间窗: up to 7 days after surgery
To measure burden of data collection, the investigators will record the number of emails, texts, and phone calls needed for each participant to complete the measures.
Feasibility of the CQUPLE intervention (recruitment)
时间窗: up to 7 days after surgery
Recruitment rate will be defined as the number of patients who confirm eligibility during the screening process (they can be screened by phone or by questions in Qualtrics prior to consent) divided by the number who consent to participate.
Feasibility of the CQUPLE intervention (retention)
时间窗: up to 7 days after surgery
Retention will be defined as the number who complete the entire study (pre- and post-assessments) divided by the number consented.
Acceptability of the CQUPLE intervention to patients
时间窗: up to 14 days after visit
This 4-item quantitative instrument assesses participants' views on the acceptability of a novel intervention, such as CQUPLE. The response option are on a 5-point scale from 'completely disagree' to 'completely agree.' Scales are created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Interventional group only.
Acceptability of the CQUPLE intervention to providers
时间窗: at 6 months, and 2 years
This 15-question quantitative instrument measures physician acceptability of decision support interventions with respect to ease of use and approach. Response options are on a 5-point Likert scale from 1 to 5 ('strongly disagree' to 'strongly agree'). Responses are reported descriptively in terms of proportions responding positively or negatively on each criterion.
次要结局
- Effect of CQUPLE on patient treatment choice(baseline, pre-visit and post visit- up to 7 days)