Skip to main content
OpenTrials
Completed

NCT Number: NCT03450876

Long Term Quality of Life in Melanoma Patients in Netherlands

Study of late physical, psychological and social effects in patients treated with ipilimumab for advanced (stage IV or unresectable stage III) melanoma.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Amsterdam, 1066 CX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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/exclusion criteria could apply

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  1. European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ C30)

    Time frame: 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 outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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

  2. Multidimensional Fatigue Inventory (MFI)

    Time frame: Baseline up to 3 years

    Fatigue will be assessed with the Multidimensional Fatigue Inventory (MFI)

  3. Cancer Worry Scale (CWS)

    Time frame: 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

  4. European Organisation for Research and Treatment of Cancer Quality Of Life (EORTC QLQ) module for sexual health

    Time frame: 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

  5. Functional Assessment of Cancer Therapy-Melanoma questionnaire (FACT-M)

    Time frame: Baseline up to 3 years

    51-item measurement of quality of life

  6. EuroQOL-5D (EQ-5D) survivors

    Time frame: Baseline up to 3 years

    Generic health status will be assessed with the EuroQOL-5D (EQ-5D) survivors

  7. Impact of Cancer Questionnaire (IOCv2)

    Time frame: 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

  8. Work Ability Index questionnaire (WAI)

    Time frame: Baseline up to 3 years

    13-item questionnaire developed to obtain survivors' experiences with return to work and work performance

  9. EORTC information module (EORTC QLQINFO25)

    Time frame: Baseline up to 3 years

    Information needs will be assessed with the EORTC information module (EORTC QLQINFO25)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Prospective Multicenter Cohort Study of Late Physical Psychological and Social Effects in Patients Treated With Ipilimumab for Advanced Melanoma

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 1, 2018
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.