Patient reported outcomes in high risk and advanced melanoma patients

Patient reported outcomes in high risk and advanced melanoma patients - PRO-MEL study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51119

Enrollment

300

Registered

2021-02-12

Start date

2021-04-30

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

Kwaliteit van leven Quality of life

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adults of 18 years and older; Melanoma patients indicated to receive treatment with immune checkpoint-inhibitors, according to the clinical guidelines; Written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Insufficient understanding of the Dutch or English language; Inclusion in experimental clinical trials

Design outcomes

Primary

Measure	Time frame
Primary outcome is to assess HRQoL. This will be assessed with The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).	—

Secondary

Measure	Time frame
Secondary outcomes are collected through different questionnaires: sociodemographic questions, the Functional Assessment of Cancer Therapy - Melanoma (FACT-M), the Hospital Anxiety and Depression Scale (HADS), the Cancer Worry Scale (CWS), the immunotherapy-specific questtionaire, 4 questions about sexual health (EORTC sexuality module), the work-ability index (WAI) questionnaire, the 5-level EuroQoL-5D (EQ-5D-5L) and patients' perceptions of received information (QLQ-INFO25).	—

Measure

Time frame

Secondary outcomes are collected through different questionnaires: sociodemographic questions, the Functional Assessment of Cancer Therapy - Melanoma (FACT-M), the Hospital Anxiety and Depression Scale (HADS), the Cancer Worry Scale (CWS), the immunotherapy-specific questtionaire, 4 questions about sexual health (EORTC sexuality module), the work-ability index (WAI) questionnaire, the 5-level EuroQoL-5D (EQ-5D-5L) and patients' perceptions of received information (QLQ-INFO25).

—

Countries

Netherlands

Outcome results