Quality of Life and Surgical Late Effects of Melanoma Treatment

Completed

• Conditions: Pain; Depression; Anxiety; Quality of Life; Cicatrix; Lymphedema; Melanoma
• Interventions: Radiation: DXA scan; Procedure: Clinical examination

• Registration Number: NCT02352623
• Lead Sponsor: Herlev Hospital

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

Study Timeline

• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-28
• Study Start: 2015-02
• Study First Posted: 2015-02-02
• Primary Completion: 2016-02
• Status Verified: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 435

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cutaneous melanoma AJCC stage IB-III	Clinical examination	Patients treated for cutaneous melanoma (AJCC stage IB-III) will fill out a questionnaire, undergo clinical examination and DXA scan
Cutaneous melanoma AJCC stage IB-III	DXA scan	Patients treated for cutaneous melanoma (AJCC stage IB-III) will fill out a questionnaire, undergo clinical examination and DXA scan

Primary Outcome Measures

Name	Time	Method
Global Health Score	12 months	Quality of life will be assessed with the questionnaire EORTC QLQ-C30 v.3.0

Secondary Outcome Measures

Name	Time	Method
Lymphoedema	12 months	Lymphoedema will be assessed with a questionnaire including the LYMQOL questionnaire, clinical examination and DXA scan
Volume and tissue composition assessed with DXA scan	12 months	DXA scan
Depression	12 months	Depression will be assessed with the questionnaire Hospital Anxiety and Depression Scale (HADS)
Anxiety	12 months	Anxiety will be assessed with the questionnaire Hospital Anxiety and Depression Scale (HADS)
Neuropathic pain	12 months	Neuropathic pain will be assessed with a questionnaire including painDetect

Trial Locations

Locations (1)

Department of Plastic Surgery, Herlev Hospital; 🇩🇰 Herlev, Denmark