Skip to content

An international study to develop a questionnaire module to measure quality of life in melanoma patients

International validation study of the EORTC QLQ-MEL-38, a new melanoma quality of life questionnaire

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617000308392
Enrollment
89
Registered
2017-02-27
Start date
2016-04-22
Completion date
2019-03-28
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this study is to evaluate a new questionnaire, the EORTC QLQ-MEL-38, in comparison to two existing questionnaires assessing quality of life in participants with melanoma, to ensure that the questions accurately capture how a patient with melanoma feels when they are going through treatment and follow-up care, and how this affects mood, relationships, daily living activities, work life and the experience of being a patient in hospital. Who is it for? You may be eligible to enroll in this study if you are aged 18 or over and have been diagnosed with melanoma within the previous 5 years. Study details All participants enrolled in this study will be asked to complete a brief survey which includes personal information such as living circumstances, work status and information relating to their melanoma and treatment. They will then complete five paper-based questionnaires which ask questions about quality of life, one of which is the new questionnaire being evaluated. Participants will also be asked for feedback on the new questionnaire. This whole process should take about 40 minutes and can be completed during the time spent in the clinic. It is hoped that the findings from this study will lead to validation of the new questionnaire as an accurate quality of life assessment specific to patients with melanoma.

Interventions

The study aims to develop a questionnaire - the EORTC QLQ-MEL-38 - measuring the quality of life (QOL) for patients with melanoma. EORTC stands for the 'European Organisation for Research and Treatment of Cancer' and the melanoma questionnaire is being studied by the quality of life working group. The QLQ_C30 has been adapted for many specific cancer types. The objective of the study is to better understand and evaluate the experience of people diagnosed and treated for melanoma and its impact

The study aims to develop a questionnaire - the EORTC QLQ-MEL-38 - measuring the quality of life (QOL) for patients with melanoma. EORTC stands for the 'European Organisation for Research and Treatment of Cancer' and the melanoma questionnaire is being studied by the quality of life working group. The QLQ_C30 has been adapted for many specific cancer types. The objective of the study is to better understand and evaluate the experience of people diagnosed and treated for melanoma and its impact on their life. Patients with melanoma will be asked to complete a data collection pack containing some questionnaires whilst they are waiting to be seen at an outpatient appointment. A member of the research team will complete a form by asking the patient some socio-demographic information including: age, gender, initials, date of birth, indigenous status, country of birth, level of education attained, living circumstances and employment status..The study team member will then ask about the treatment and investigations for melanoma the patient has had and how long they have been attending the clinic. Patients are then asked to complete 2 standard questionnaires (EORTC QLQ-C30 and HADS), followed by a questionnaire that is the new research tool being tested. The EORTC QLQ-C30 questionnaire is a tool to asses the quality of life in patients with any form of cancer. It includes questions about the patient's rating of his/her physical and mental health. The Hospital Anxiety and Depression Scale (HADS).questionnaire is used to assess the levels of anxiety and depression that a patient may be experiencing. After completing the questionnaires, patients are asked to complete a survey asking what they thought of the questionnaires and if they required help in answering them. The entire process should take approximately 40 minutes. Patients may have any stage of melanoma which has been diagnosed in the past 5 years and they may be at any point in their treatment journey. Patients who complete the above data collection pack and who are in routine follow up care will be invited to re-take the same questionnaires a second time at 2 weeks from the first completion. This is to examine the reliability and validity of the melanoma questionnaire.

Sponsors

European Organisation for Research and Treatment of Cancer (EORTC)
Lead SponsorOther Collaborative groups

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Confirmed diagnosis of melanoma within the past 5 years 2. Aged 18 or over 3. Able to give written informed consent 4. Fluency in the language of the country where the study is being undertaken

Exclusion criteria

1. Participating in any other quality of life study 2. A psychiatric condition or major cognitive impairment that would hamper the completion of a self-reported quality of life questionnaire

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026