Quality of Life and Surgical Late Effects of Melanoma Treatment

May 25, 2016 updated by: caroline gjørup, Herlev Hospital
Health-related Quality of life in Danish stage IB-III cutaneous melanoma patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

435

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 1815
        • Department of Plastic Surgery, Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Procedure: Clinical examination
Clinical examination
Radiation: DXA scan
DXA scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Health Score
Time Frame: 12 months
Quality of life will be assessed with the questionnaire EORTC QLQ-C30 v.3.0
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Collaborators

Danish Cancer Society

Investigators

  • Principal Investigator: Caroline Asirvatham Gjørup, MD, Department of Plastic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Estimate)

May 26, 2016

Last Update Submitted That Met QC Criteria

May 25, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2014-127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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