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临床试验/NCT03048435
NCT03048435已完成不适用

Feasibility and Acceptability of Measuring Cervical Cancer Specific Patient-Reported Outcomes in Clinical Practice

University Health Network, Toronto3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
3
主要终点
Percentage of EORTC QLQ CX24 questionnaire completed

研究概览

简要总结

Concurrent chemo-radiotherapy followed by intracavitary brachytherapy is standard of care for patients with locally advanced cervical cancer. Although curative, this treatment is challenging and leaves a significant proportion of women with severe toxicity, negatively impacting their quality of life. Although most recover over time, a proportion of women do not. Therefore, evaluation of quality of life becomes increasingly more important as cancer specific outcomes improve. One such method is through patient-reported outcomes (PROs), defined as "any report coming directly from the patient about a health condition and its treatment." This prospective multi-institutional study, involving the Princess Margaret (PM), Odette Regional Cancer Centre(ORCC) and Royal Victoria Regional Health Center (RVH), will assess to feasibility and acceptability of integrating a cervical cancer specific PRO measurement tool into clinical practice. Cervical cancer patients coming for follow-up appointments will be asked to complete the EORTC QLQ-CX24, a validated cervical cancer specific PRO questionnaire. At the end of the study period, Feedback Forms will be completed by participating patients and health care providers to obtain their perspectives regarding the feasibility and acceptability of incorporating the instrument into clinical practice. Future directions include designing an electronic platform and expanding its use in cervical cancer clinics provincially and nationally. The data collected should help identify disease-related symptoms, treatment-related toxicities, facilitate patient-physician communication, shared treatment planning and target intervention strategies.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (> 18 years) English speaking patients
  • Treated with curative intent with chemo-radiotherapy
  • Seen in routine clinic follow-up within 5 years post completion of treatment

排除标准

  • Patients at their anticipated last clinic visit prior to cancer center discharge
  • Patients unable to complete the EORTC QLQ CX-24 questionnaire due to inability to read or write.
  • Non-English speaking patients
  • Patients of the principal investigator. The rationale for this is that patients of the principal investigator who complete the Feedback form may be biased and this may be reflected in the results.
  • Oncologist Inclusion Criteria:
  • Oncologists who treat cervix cancer
  • Oncologists with at least one consenting patient enrolled in the study
  • Oncologist Exclusion Criteria:
  • Principal investigator listed on the protocol. The rationale for this is that oncologists who are also investigators on this study may have inherent bias in the study which may be reflected in the results of the Feedback form.

结局指标

主要结局

Percentage of EORTC QLQ CX24 questionnaire completed

时间窗: 9 months

Gather information on feasibility of administering questionnaire

Percentage of favorable scores (Agree or strongly agree) on Feedback Form

时间窗: 9 months

Gather information on acceptability of incorporating the questionnaire in routine follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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