Long Term Quality of Life in Melanoma Patients in Netherlands

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03450876
• Other study ID #: CA209-483
• Status: Completed
• Start date: December 15, 2016
• Est. completion date: June 17, 2020

Study information

• Verified date: September 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: June 17, 2020
• Est. primary completion date: June 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
Netherlands	Local Institution	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ C30)	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).	Baseline up to 3 years
Secondary	Hospital Anxiety and Depression Scale (HADS)	14-item questionnaire assesses symptoms of mood disturbance, yielding separate scale scores for anxiety and depression, as well as a total score	Baseline up to 3 years
Secondary	Multidimensional Fatigue Inventory (MFI)	Fatigue will be assessed with the Multidimensional Fatigue Inventory (MFI)	Baseline up to 3 years
Secondary	Cancer Worry Scale (CWS)	8-item questionnaire will be used to assess the prevalence of cancer-specific distress in melanoma survivors and in healthy controls	Baseline up to 3 years
Secondary	European Organisation for Research and Treatment of Cancer Quality Of Life (EORTC QLQ) module for sexual health	Sexual health will be assessed with the European Organisation for Research and Treatment of Cancer Quality Of Life (EORTC QLQ) module for sexual health	Baseline up to 3 years
Secondary	Functional Assessment of Cancer Therapy-Melanoma questionnaire (FACT-M)	51-item measurement of quality of life	Baseline up to 3 years
Secondary	EuroQOL-5D (EQ-5D) survivors	Generic health status will be assessed with the EuroQOL-5D (EQ-5D) survivors	Baseline up to 3 years
Secondary	Impact of Cancer Questionnaire (IOCv2)	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	Baseline up to 3 years
Secondary	Work Ability Index questionnaire (WAI)	13-item questionnaire developed to obtain survivors' experiences with return to work and work performance	Baseline up to 3 years
Secondary	EORTC information module (EORTC QLQINFO25)	Information needs will be assessed with the EORTC information module (EORTC QLQINFO25)	Baseline up to 3 years

External Links

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