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临床试验/NCT01083550
NCT01083550已完成2 期

Decision Aid on Radioactive Iodine Treatment for Early Stage Papillary Thyroid Cancer (Randomized Controlled Trial)

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
74
试验地点
2
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

  1. 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).
  2. 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)
  3. 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)?
  4. 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)
  5. 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)
  6. 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

入选标准

  • 未提供

排除标准

  • 未提供

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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