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临床试验/NCT06364579
NCT06364579招募中不适用

Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT).

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
QOL analysis

研究概览

简要总结

Radiochemotherapy is the standard treatment for neoplasms of the anal canal with excellent rates of local control and preservation of the anal sphincter. However, patients may experience a deterioration of quality of life related to sequelae of the treatment particularly at intestinal, anal sphincter and sexual level. Few studies to date have documented patient-reported outcomes (PROs) in this area. The aim of this observational study is to verify the quality of life (QOL) of the patients by means of self-completed questionnaires.

详细描述

In recent times, the focus on collecting patient-reported outcomes (PROs) has increased in healthcare. The Food and Drug Administration defines PROs as a -measurement of any aspect of a health status of the patient that comes directly from the patient-. These includes disease symptoms, functional aspects and quality of life (QOL). The collection of PROs, combined with physician-assessed toxicity, is constantly being incorporated into clinical practice and studies to provide a more holistic picture of the impact of treatment on patients and prove useful for planning future interventions. Although the use of PROs has now become the standard for measuring quality of life of patients there are still few studies on the self-reported long-term QOL of anal cancer patients and on disease or therapy related symptoms that affect QOL. Therefore, the EORTC (European Organisation for Research and Treatment of Cancer) has recently developed the specific Quality of Life Questionnaire for anal cancer (QLQ-AN27) module to explore typical symptoms of anal cancer and its therapy. In this study, the QLQ-AN27 questionnaire will be administered together with the EORTC Quality of Life 30 (QLQ 30) in patients with anal cancer who have undergone radio-chemotherapy. The questionnaire may be administered before treatment, after treatment and during follow-ups until completion of the fifth year. This is an observational study both retrospective and prospective.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

  • Eastern Cooperative Oncology Group (ECOG) 0-3
  • minimum 18 years old
  • squamous cell carcinoma of the anal canal
  • low burden of metastatic disease at diagnosis
  • indication for radiochemotherapy treatment
  • informed consent

排除标准

  • age under 18 years
  • Eastern Cooperative Oncology Group (ECOG) higher than 3
  • metastatic disease at diagnosis not amenable to radiochemotherapy treatment

结局指标

主要结局

QOL analysis

时间窗: 60 months from the last enrolled patient (january 2026)

Analysis of quality of life (QOL) by administration of PRO questionnaires to patients with cancer of the anus treated with IMRT radiochemotherapy.

次要结局

  • Acute toxicity(during treatment, end of treatment)
  • Loco-Regional Recurrence (LRR)(time 0, end of treatment, 6 month post treatment, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up)
  • Disease-Free Survival (DFS)(time 0, end of treatment, 6 month post treatment, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up)
  • Overall survival (OS)(time 0, end of treatment, 6 month post treatment, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up)
  • Colostomy Free Survival (CFS)(time 0, end of treatment, 6 month post treatment, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up)
  • Late toxicity(6 month post treatment ,1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manfrida Stefania

Radiation oncologist

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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