Long Term Quality of Life in Melanoma Patients in Netherlands

Completed

• Conditions: Melanoma
• Interventions: Other: Non-Interventional

• Registration Number: NCT03450876
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-12-15
• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-01
• Primary Completion: 2020-06-17
• Study Completion: 2020-06-17
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Control	Non-Interventional	Individuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort
≥ 48 months post-ipilimumab treatment	Non-Interventional	Greater than 48 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab between 2011 and 2012 in one of the 14 melanoma centers in the Netherlands
24 to < 36 months post-ipilimumab treatment	Non-Interventional	24 to 36 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab in 2014 in one of the 14 melanoma centers in the Netherlands
≥ 36 to < 48 months post-ipilimumab treatment	Non-Interventional	36 to 48 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab in 2013 in one of the 14 melanoma centers in the Netherlands

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
EuroQOL-5D (EQ-5D) survivors	Baseline up to 3 years	Generic health status will be assessed with the EuroQOL-5D (EQ-5D) survivors
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)
Functional Assessment of Cancer Therapy-Melanoma questionnaire (FACT-M)	Baseline up to 3 years	51-item measurement of quality of life

Trial Locations

Locations (1)

Local Institution; 🇳🇱 Amsterdam, Netherlands