Quality of Life and Surgical Late Effects of Melanoma Treatment

NCT02352623 | Completed DMC

• 1 other identifier: H-4-2014-127
• Study Type: observational
• Target: 435
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Global Health Score

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

  12 months

Secondary Outcomes (5)

• Anxiety

  12 months

• Depression

  12 months

• Lymphoedema

  12 months

• Neuropathic pain

  12 months

• Volume and tissue composition assessed with DXA scan

  12 months

Study Arms (1)

Cutaneous melanoma AJCC stage IB-III

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

Radiation: DXA scan; Procedure: Clinical examination

Interventions

DXA scan RADIATION

DXA scan

Cutaneous melanoma AJCC stage IB-III

Clinical examination PROCEDURE

Clinical examination

Cutaneous melanoma AJCC stage IB-III

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients treated for cutaneous melanoma (AJCC stage IB-III) with wide local excision (WLE) and sentinel lymph node biopsy (SNB) and/ or complete lymph node dissection in the axilla and/or groin will be included in the study.

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Bilateral axilla or groin melanoma surgery

Sponsors & Collaborators

• Herlev Hospital: lead
• Danish Cancer Society: collaborator

Study Sites (1)

Department of Plastic Surgery, Herlev Hospital

Herlev, 1815, Denmark

Location

Related Publications (1)

• Gjorup CA, Groenvold M, Hendel HW, Dahlstroem K, Drzewiecki KT, Klausen TW, Holmich LR. Health-related quality of life in melanoma patients: Impact of melanoma-related limb lymphoedema. Eur J Cancer. 2017 Nov;85:122-132. doi: 10.1016/j.ejca.2017.07.052. Epub 2017 Sep 15.

  PMID: 28918186 DERIVED

MeSH Terms

Conditions

Melanoma; Lymphedema; Depression; Anxiety Disorders; Pain; Cicatrix

Interventions

Absorptiometry, Photon; Restraint, Physical

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Behavior Control; Therapeutics; Immobilization

Study Officials

• Caroline Asirvatham Gjørup, MD

  Department of Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. ph.d. student

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: February 2, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 26, 2016

Record last verified: 2016-05

Locations

DK (1)