Decision Aid on Radioactive Iodine Treatment for Early Stage Papillary Thyroid Cancer (Randomized Controlled Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Knowledge about papillary thyroid cancer and radioactive iodine treatment
研究概览
简要总结
In this study, we will test, using a randomized controlled trial design, whether the use of a computer-based decision aid (DA) may improve general knowledge and reduce personal decisional conflict in patients with early stage papillary thyroid cancer (PTC), when compared to usual care. Patients with early stage PTC will be required to have surgical pathologic criteria for which adjuvant RAI treatment may be considered optional.
详细描述
A. Primary research question
In patients with early stage papillary thyroid cancer, does the administration of a computerized decision aid improve the score on a test of knowledge about early stage PTC and adjuvant RAI treatment, when compared to usual care? (The knowledge score is a sum of positive responses from a total of 10 true/false questions in a self-administered questionnaire, to be administered at the study visit, Q2A).
B. Secondary research questions
- In patients with early stage PTC, does the administration of a computerized decision aid reduce overall decisional conflict (as well as the following respective subscales - informed subscale, uncertainty subscale, and effective decision subscale), when compared to usual care? (Decisional Conflict questionnaire, DCS).
- In patients with early stage PTC, does the administration of a computerized decision aid, improve reduce decisional regret relating to RAI decision making after the final decision has been made? (Decision Regret Questionnaire, DRQ)
- In patients with early stage PTC, does the administration of a computerized decision aid, reduce the number of participants receiving adjuvant radioactive iodine treatment (analysis for all participants, as well as those who are not already on a waiting list for radioactive iodine treatment at the time of recruitment, respectively)?
- Do the respective monitoring or blunting scores on the Miller Behavioral Style Scale (MBSS) correlate with the number of clicks for information performed by participants reviewing the decision aid? (subgroup analysis in the decision aid intervention group)
- Do the respective monitoring or blunting scores on the Miller Behavioral Style Scale (MBSS) correlate with the score on a test of knowledge about early stage PTC and adjuvant RAI treatment? (Respective analyses planned for entire study population, as well as the intervention and control groups)
- What are the main reasons why RAI treatment is selected or not selected (after the decision has been finalized), grouping descriptions according to exposure or non-exposure to a computerized decision aid? (See Follow-up questionnaire [administered by telephone], question 2, qualitative description, with reasons to be coded and quantified using mixed methods).
NOTE: In the original design of this study, we hoped to utilize a modified Client Satisfaction Questionnaire for assessment of satisfaction of patient participants and physicians as secondary trial outcomes. However, we are unable to utilize any modified Client Satisfaction Questionnaires in this study, because of lack of permission from the original developer of the Client Satisfaction Questionnaire-8, who has copyrighted and trademarked the questionnaire and prohibits such modifications. No modified client satisfaction questionnaire results have been analyzed in this study and will not be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •for patient participants:
- •Individuals with papillary thyroid carcinoma who have had complete resection of their thyroid at surgery (total or near-total thyroidectomy, or hemi- [subtotal] with completion thyroidectomy)on or after September 1, 2009
- •Age at time of first thyroid cancer surgery must be at least 18 years or older
- •The papillary thyroid cancer TNM pathologic stage must be pT1 or pT2, N0 (or Nx), M0 (or Mx) (TNM stage, AJCC VI) (ie. primary tumor size 1-4 cm, no known positive lymph nodes at the time of primary surgery, no extension of the tumor outside the thyroid, no venous or lymphatic invasion, and no known distant metastases at primary surgery, with no tall cell features, as per surgical pathology report)
- •Must be able to communicate in spoken and written English
- •Must be able to use a computer
- •Must be able to provide informed consent on one's own (without any need for translation)
排除标准
- •for patient participants:
- •Participants not meeting inclusion criteria
- •Concurrent diagnosis of medullary or anaplastic or poorly differentiated thyroid cancer or thyroid lymphoma
- •Prior radioactive treatment for thyroid cancer
- •Individuals who have been taken off their thyroid hormone for testing or treatment, will not be eligible for the study while off this medication.
- •Individuals who are unwilling for investigators to confirm their pathologic stage of disease through review of pathology report(s) will be ineligible for the study
- •Inclusion criteria for the physician feedback component of this study:
- •Physicians and surgeons caring for thyroid cancer patients, in active practice at University Health Network in Toronto, Ontario, Canada.
研究组 & 干预措施
DA intervention
Decision aid exposure + usual care
干预措施: Decision aid exposure (Other)
Control
Usual care
结局指标
主要结局
Knowledge about papillary thyroid cancer and radioactive iodine treatment
时间窗: Day 0
The knowledge questionnaire will be administered on the same day as the randomization visit (after the exposure to the decision aid for participants in the intervention group, or without exposure to the decision aid in the control group).
次要结局
- Decisional conflict (and subscale measures)(Day 0)
- Qualitative data(15-23 months)
- Decisional regret(6-12 months and 15-23 months)
- Feeling satisfied with RAI treatment decision(15-23 months)
- Cancer-related Worry(24 months or longer post-randomization)
- The final decision to accept or decline adjuvant radioactive iodine treatment(6-12 months)
- Feeling informed about RAI treatment decision(15-23 months)
- Trust in the treating physician(15-23 months)
- Mood(15-23 months)
- Cancer-related worry(15-23 months)
- Reasons for accepting or declining radioactive iodine treatment(6 - 12 months)
- Cancer Impact(24 months or longer-post randomization)
- Information Needs(24 months or longer-post randomization)
- General Concerns(24 months or longer post-randomization)