跳至主要内容
临床试验/CTRI/2024/04/066464
CTRI/2024/04/066464招募中不适用

A feasibility study to develop a HRQoL module for metastatic and recurrent/ persistent anal cancer or to add metastatic anal cancer-specific items to the existing EORTC QLQ-ANL27

European Organisation for Research and Treatment of Cancer1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2024年5月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
55
试验地点
1
主要终点
1. Establish a preliminary item list of issues that are relevant to patients withmetastatic or recurrent/ persistent anal cancer.

研究概览

简要总结

We are running a study  looking at how cancer and its treatment can have an impact on your quality of life. The study involves a short interview whereby aspects of your life affected by cancer and its treatments will be explored.

Taking part involves reviewing a number of quality of life issues which have been identified as being important to patients with metastatic or recurrent/ persistent anal cancer in a previous phase of this study. You will be asked to take part in an interview to rate these issues according to whether you consider they are important and

relevant to yourself and other patients.

We are seeking to identify heath-related quality of life issues of most importance and relevance to patients with metastatic or recurrent/ persistent anal cancer treated with systemic therapies. This will help us to make a decision about whether there needs to be a specific Quality of Life questionnaire for patients with these

diagnoses or whether the current EORTC QLQ-ANL27 questionnaire for patients with anal cancer can be supplemented with additional items.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with a confirmed diagnosis of metastatic and/ or recurrent/persistent anal cancer managed by systemic treatment
  • Are aware of their diagnosis and treatment plan
  • Able to understand the language of the questioning
  • Aged 18 years or above
  • Receiving or having received treatment within the last 2 years
  • Patients who are willing and able to give fully informed consent to participate
  • No other diagnosed cancer.

排除标准

  • Poor command of the English language
  • Patients under the age of 18
  • Diagnosis with other cancers within the last 5 years
  • Patients taking part in a clinical trial for non-approved drugs.

结局指标

主要结局

1. Establish a preliminary item list of issues that are relevant to patients withmetastatic or recurrent/ persistent anal cancer.

时间窗: 1. Establish a preliminary item list of issues that are relevant to patients withmetastatic or recurrent/ persistent anal cancer. | 2. Establish which of the items on the preliminary item list are already represented in the EORTC item library, or existing EORTC quality of life modules.

2. Establish which of the items on the preliminary item list are already represented in the EORTC item library, or existing EORTC quality of life modules.

时间窗: 1. Establish a preliminary item list of issues that are relevant to patients withmetastatic or recurrent/ persistent anal cancer. | 2. Establish which of the items on the preliminary item list are already represented in the EORTC item library, or existing EORTC quality of life modules.

次要结局

未报告次要终点

研究者

发起方
European Organisation for Research and Treatment of Cancer
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Rahul Krishnatry

Tata Memorial Centre

研究点 (1)

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