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Completed

NCT Number: NCT02352623

Quality of Life and Surgical Late Effects of Melanoma Treatment

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

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Key information

Conditions

Melanoma Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cicatrix Depression Fibrosis Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Mental Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Neurologic Manifestations Nevi and Melanomas Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Plastic Surgery, Herlev Hospital

Herlev, 1815, Denmark

About this study

The aim of the PhD-study is to evaluate, in a large cohort of Danish melanoma patients:

  • Health-related quality of life assessing psychological, physical and social well-being
  • Physical long term side effects (lymphoedema, scarring and neuropathic pain)
  • Lymphoedema assessed by clinical examination and DXA scans

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DXA scan

Radiation

DXA scan

Clinical examination

Procedure

Clinical examination

Primary outcomes

  1. Global Health Score

    Time frame: 12 months

    Quality of life will be assessed with the questionnaire EORTC QLQ-C30 v.3.0

Secondary outcomes

  1. Anxiety

    Time frame: 12 months

    Anxiety will be assessed with the questionnaire Hospital Anxiety and Depression Scale (HADS)

  2. Depression

    Time frame: 12 months

    Depression will be assessed with the questionnaire Hospital Anxiety and Depression Scale (HADS)

  3. Lymphoedema

    Time frame: 12 months

    Lymphoedema will be assessed with a questionnaire including the LYMQOL questionnaire, clinical examination and DXA scan

  4. Neuropathic pain

    Time frame: 12 months

    Neuropathic pain will be assessed with a questionnaire including painDetect

  5. Volume and tissue composition assessed with DXA scan

    Time frame: 12 months

    DXA scan

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • Danish Cancer Society

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2015
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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