NCT02836522已完成不适用
Validation of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 406
- 试验地点
- 4
- 主要终点
- degree of test-retest reliability in the ANCHOR HRSI
研究概览
简要总结
The purpose of this study is to finalize development of a questionnaire that measures health-related symptoms and concerns for persons diagnosed with, and either treated or monitored for, anal pre-cancer lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consented to the ANCHOR trial as per self-report and by providing a valid referral code on the information sheet provided by the referring site. Both men and women from the ANCHOR trial will be recruited to this study.
- •English fluent as we are only validating this measure in English at this time
- •At least one month post-treatment for anal HSIL as per self-report, or if the person is in the ANCHOR trial observation arm, then at least one month post- randomization.
- •Within two weeks post initial-treatment for anal HSIL on ANCHOR study or within two weeks post-randomization to ANCHOR study as per self-report.
- •ANCHOR participants who are randomized to the treatment arm must have completed initial treatment and are within two weeks of initial treatment completion.
- •ANCHOR participants who were treated initially with topical treatment are only eligible within two weeks after the last topical treatment application.
- •ANCHOR participants who were treated initially with both topical and ablation treatments are eligible within two weeks of completing both treatments.
- •ANCHOR participants who are randomized to the active monitoring arm are eligible if they are within two weeks of randomization
排除标准
- •Has a scheduled ANCHOR follow-up appointment in the next two weeks as per self report. The purpose of this exclusion criterion is to minimize the impact on a participant's responses to a post-test evaluation the potential occurrence of an interim diagnosis or treatment event, or anxiety related to an upcoming medical follow-up.
结局指标
主要结局
degree of test-retest reliability in the ANCHOR HRSI
时间窗: 7-10 days
measure from the initial assessment point to the 7-10 day follow-up.
次要结局
未报告次要终点
研究者
研究点 (4)
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