Melanoma
Conditions
Brief summary
Study of late physical, psychological and social effects in patients treated with ipilimumab for advanced (stage IV or unresectable stage III) melanoma.
Interventions
OTHERNon-Interventional
Non-Interventional
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- * Patient population: Adults ≥ 18 years of age at diagnosis, diagnosed with histologically confirmed advanced (stage IV or unresectable stage III) melanoma, who have received at least one course of ipilimumab treatment (first, second, or second plus line; routine practice or study treatment) in one of the specified treatment centers, and who have survived at least 2 years after (completion of) ipilimumab treatment (measured from last ipilimumab administration) * Matched healthy control population: Individuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort
Exclusion criteria
* Insufficient understanding of the Dutch language * Other anticancer treatment after ipilimumab or during study entry * Disease recurrence during the study Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ C30) | Baseline up to 3 years | EORTC QLQ-C30 is a self-reported, 30-item generic questionnaire developed to assess 15 domains: global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning) and nine symptom scales (fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multidimensional Fatigue Inventory (MFI) | Baseline up to 3 years | Fatigue will be assessed with the Multidimensional Fatigue Inventory (MFI) |
| Cancer Worry Scale (CWS) | Baseline up to 3 years | 8-item questionnaire will be used to assess the prevalence of cancer-specific distress in melanoma survivors and in healthy controls |
| European Organisation for Research and Treatment of Cancer Quality Of Life (EORTC QLQ) module for sexual health | Baseline up to 3 years | Sexual health will be assessed with the European Organisation for Research and Treatment of Cancer Quality Of Life (EORTC QLQ) module for sexual health |
| Functional Assessment of Cancer Therapy-Melanoma questionnaire (FACT-M) | Baseline up to 3 years | 51-item measurement of quality of life |
| Hospital Anxiety and Depression Scale (HADS) | Baseline up to 3 years | 14-item questionnaire assesses symptoms of mood disturbance, yielding separate scale scores for anxiety and depression, as well as a total score |
| Impact of Cancer Questionnaire (IOCv2) | Baseline up to 3 years | 81 items that present statements regarding specific impacts of cancer to which respondents indicate their level of agreement from 1 (strongly disagree) to 5 (strongly agree). Seventy items apply to all survivors, 3 to currently employed respondents, 4 to respondents not currently partnered, and 4 to currently partnered respondents |
| Work Ability Index questionnaire (WAI) | Baseline up to 3 years | 13-item questionnaire developed to obtain survivors' experiences with return to work and work performance |
| EORTC information module (EORTC QLQINFO25) | Baseline up to 3 years | Information needs will be assessed with the EORTC information module (EORTC QLQINFO25) |
| EuroQOL-5D (EQ-5D) survivors | Baseline up to 3 years | Generic health status will be assessed with the EuroQOL-5D (EQ-5D) survivors |
Countries
Netherlands
Outcome results
None listed