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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- 1. Establish a preliminary item list of issues that are relevant to patients withmetastatic or recurrent/ persistent anal cancer.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1. Establish a preliminary item list of issues that are relevant to patients withmetastatic or recurrent/ persistent anal cancer.
Time Frame: 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.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Rahul Krishnatry
Tata Memorial Centre