Quality of Life and Surgical Late Effects of Melanoma Treatment

NCT ID: NCT02352623

Last Updated: 2016-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

435 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-05-31

Brief Summary

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

Detailed Description

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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

Conditions

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Melanoma Quality of Life Lymphedema Depression Anxiety Pain Cicatrix

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

DXA scan

Intervention Type RADIATION

DXA scan

Clinical examination

Intervention Type PROCEDURE

Clinical examination

Interventions

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DXA scan

DXA scan

Intervention Type RADIATION

Clinical examination

Clinical examination

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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caroline gjørup

M.D. ph.d. student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caroline Asirvatham Gjørup, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Plastic Surgery

Locations

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Department of Plastic Surgery, Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 28918186 (View on PubMed)

Other Identifiers

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H-4-2014-127

Identifier Type: -

Identifier Source: org_study_id

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