This study will evaluate Health-Related Quality of Life (general and disease specific), socio-demographic data, anxiety, depression, fear for cancer recurrence, immunotherapy related discomforts, sexual health, social functioning (work ability),…
ID
Source
Brief title
Condition
- Other condition
- Skin neoplasms malignant and unspecified
Synonym
Health condition
Kwaliteit van Leven
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is Health Related Quality of Life will be assessed
with the he European Organization for Research and Treatment of Cancer Quality
of Life Questionnaire-core 30 (EORTC QLQ-C30).
Secondary outcome
The secondary outcome measurements will be gained from the use of the following
questionnaires: the Melanoma Subscale and Melanoma Surgery Subscale of the
Functional Assessment of Cancer Therapy * Melanoma (FACT-M), five questions
about sociodemographic data, the Hospital Anxiety and Depression Scale (HADS),
the Cancer Worry Scale (CWS), the immunotherapy-specific questionnaire, 4
questions about sexual health (EORTC sexuality module), social functioning
(work ability) will be assessed with the work-ability questionnaire, patients
will describe and value their experienced health (QUALY*s) with the 5-level
EuroQOL-5D (EQ-5D-5L), and cognitive functioning will be assessed with the
online Amsterdam Cognition Scan (ACS).
Background summary
The introduction of checkpoint inhibitors and targeted therapy has improved
clinical outcomes of stage III and IV melanoma patients substantially. These
treatments have led to long-term benefit or even cure for the patients, but
there is still insufficient data on the effects of these treatments on
health-related quality of life (HRQoL). Therefore, in this study we will
evaluate HRQoL and patients* cognitive functioning after active treatment.
Study objective
This study will evaluate Health-Related Quality of Life (general and disease
specific), socio-demographic data, anxiety, depression, fear for cancer
recurrence, immunotherapy related discomforts, sexual health, social
functioning (work ability), description and value of personal health (Quality
Adjusted Life Years; QUALY*s), and cognitive functioning in high-risk and
ad-vanced melanoma patients.
Study design
Patients with high-risk (resectable stage III) melanoma treated with adjuvant
immunotherapy or targeted therapy in combination with surgery or treated with
surgery only and patients with advanced (stage IV and unresectable stage III)
melanoma treated with immunotherapy (pembrolizumab, ipilimumab and/or
nivolumab) or targeted therapy (vemurafenib+cobimentinib,
dabrafenib+trametinib, encorafenib+binimetinib). The study will consist of
several databases:
1) A cohort of high-risk stage III patients that never received systemic
therapy, but were treated with surgery only in 2017-2019 (B16MEL cohort and
patients treated off-study at the AVL)
2) A cohort of patients treated with neoadjuvant immunotherapy (and adjuvant
immunotherapy or targeted therapy in case of non-response) (OpACIN-neo cohort,
PRADO extension cohort)
3) A cohort of unresectable stage III and IV melanoma patients treated with
nivolumab or nivolumab in combination with ipilimumab between 2017-2019.
4) A cohort of patients treated with adjuvant immunotherapy in 2019 (B16MEL
cohort and patients treated off-study at the AVL).
5) A cohort of unresectable stage III and IV melanoma patients treated with
BRAF+MEK inhibition between 2017-2019.
6) A cohort of patients treated with adjuvant BRAF+MEK in 2019 (B16MEL cohort
and patients treated off-study at the AVL).
Patient-reported outcome measurements in form of a questionnaire will be sent
to patients.
A neuropsychological screening will be performed online. Clinical data and
baseline quality of life data (if available) will be obtained from the medical
records.
Study burden and risks
Patients included in this study will have to fill in one questionnaire and
perform one test to determine cognitive functioning. Filling in this
questionnaire will take approximately 30 minutes. Performing the cognitive
functioning test can take up to 60 minutes and some of the questions might be
confronting, but there are no other risks associated with participation, nor
are there any additional benefits.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- At least 18 years of age
- Actively treated for melanoma by use of immunotherapy, targeted therapy,
surgery or a combination.
- Willing to fill in one questionnaire and perform one online cognition test.
Exclusion criteria
- Insufficient understanding of the Dutch or English language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75206.031.20 |