Quality of Life and Surgical Late Effects of Melanoma Treatment

Depression Clinical Trial

Official title:

Quality of Life and Surgical Late Effects of Melanoma Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352623
• Other study ID #: H-4-2014-127
• Status: Completed
• Phase: N/A
• First received: January 19, 2015
• Last updated: May 25, 2016
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: May 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Radiation:
• DXA scan
DXA scan

Procedure:
• Clinical examination
Clinical examination

Locations

Country	Name	City	State
Denmark	Department of Plastic Surgery, Herlev Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Health Score	Quality of life will be assessed with the questionnaire EORTC QLQ-C30 v.3.0	12 months	No
Secondary	Anxiety	Anxiety will be assessed with the questionnaire Hospital Anxiety and Depression Scale (HADS)	12 months	No
Secondary	Depression	Depression will be assessed with the questionnaire Hospital Anxiety and Depression Scale (HADS)	12 months	No
Secondary	Lymphoedema	Lymphoedema will be assessed with a questionnaire including the LYMQOL questionnaire, clinical examination and DXA scan	12 months	No
Secondary	Neuropathic pain	Neuropathic pain will be assessed with a questionnaire including painDetect	12 months	No
Secondary	Volume and tissue composition assessed with DXA scan	DXA scan	12 months	No