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Quality of Life and Surgical Late Effects of Melanoma Treatment

Quality of Life and Surgical Late Effects of Melanoma Treatment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02352623
Enrollment
435
Registered
2015-02-02
Start date
2015-02-28
Completion date
2016-05-31
Last updated
2016-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma, Quality of Life, Lymphedema, Depression, Anxiety, Pain, Cicatrix

Brief summary

Health-related Quality of life in Danish stage IB-III cutaneous melanoma patients.

Detailed description

The aim of the PhD-study is to evaluate, in a large cohort of Danish melanoma patients: 1. Health-related quality of life assessing psychological, physical and social well-being 2. Physical long term side effects (lymphoedema, scarring and neuropathic pain) 3. Lymphoedema assessed by clinical examination and DXA scans

Interventions

RADIATIONDXA scan

DXA scan

PROCEDUREClinical examination

Clinical examination

Sponsors

Danish Cancer Society
CollaboratorOTHER
Herlev Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* AJCC stage IB-III cutaneous melanoma patients * At least one year follow-up after melanoma surgery

Exclusion criteria

* Pregnancy * Bilateral axilla or groin melanoma surgery

Design outcomes

Primary

MeasureTime frameDescription
Global Health Score12 monthsQuality of life will be assessed with the questionnaire EORTC QLQ-C30 v.3.0

Secondary

MeasureTime frameDescription
Anxiety12 monthsAnxiety will be assessed with the questionnaire Hospital Anxiety and Depression Scale (HADS)
Depression12 monthsDepression will be assessed with the questionnaire Hospital Anxiety and Depression Scale (HADS)
Lymphoedema12 monthsLymphoedema will be assessed with a questionnaire including the LYMQOL questionnaire, clinical examination and DXA scan
Neuropathic pain12 monthsNeuropathic pain will be assessed with a questionnaire including painDetect
Volume and tissue composition assessed with DXA scan12 monthsDXA scan

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026