MelanomaNCT02352623
Quality of Life and Surgical Late Effects of Melanoma Treatment
An observational study of Melanoma and Quality of Life, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Health-related Quality of life in Danish stage IB-III cutaneous melanoma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma, Quality of Life, Lymphedema
- What is being tested?
- DXA scan and Clinical examination
- Type of treatment
- Surgery or procedure
- How many people
- 435 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2015to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- AJCC stage IB-III cutaneous melanoma patients
- At least one year follow-up after melanoma surgery
Who cannot join
- Pregnancy
- Bilateral axilla or groin melanoma surgery
Trial locations and contacts
1 site in 1 country.
About this study
Health-related Quality of life in Danish stage IB-III cutaneous melanoma patients.
Read the detailed description
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
- Conditions
- Melanoma, Quality of Life, Lymphedema, Depression, Anxiety, Pain
- Being tested
- DXA scan, Clinical examination
- Medical subject headings
- Melanoma, Lymphedema, Depression, Anxiety Disorders, Pain, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXA scanRadiation
DXA scan
Clinical examinationProcedure or surgery
Clinical examination
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: DXA scan; Procedure: Clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Health Score
Quality of life will be assessed with the questionnaire EORTC QLQ-C30 v.3.0
Measured: 12 months
Secondary outcomes (5)
Anxiety
Anxiety will be assessed with the questionnaire Hospital Anxiety and Depression Scale (HADS)
Measured: 12 months
Depression
Depression will be assessed with the questionnaire Hospital Anxiety and Depression Scale (HADS)
Measured: 12 months
Lymphoedema
Lymphoedema will be assessed with a questionnaire including the LYMQOL questionnaire, clinical examination and DXA scan
Measured: 12 months
Neuropathic pain
Neuropathic pain will be assessed with a questionnaire including painDetect
Measured: 12 months
Volume and tissue composition assessed with DXA scan
DXA scan
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, caroline gjørup, Herlev Hospital
- Investigators
- Caroline Asirvatham Gjørup, MD, Principal investigator, Department of Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352623
- Sponsor's protocol ID
- H-4-2014-127
- Status last verified
- May 2016
- First submitted
- 19 Jan 2015
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 28918186
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Surgical Late Effects of Melanoma Treatment
- ClinicalTrials.gov ID
- NCT02352623
- Acronym / sponsor ID
- H-4-2014-127
- Conditions
- Melanoma, Quality of Life, Lymphedema, Depression, Anxiety, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Health-related Quality of life in Danish stage IB-III cutaneous melanoma patients.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cutaneous melanoma AJCC stage IB-III | – | Radiation: DXA scan, Procedure: Clinical examinationPatients treated for cutaneous melanoma (AJCC stage IB-III) will fill out a questionnaire, undergo clinical examination and DXA scan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- AJCC stage IB-III cutaneous melanoma patients
- At least one year follow-up after melanoma surgery
Key exclusion criteria (2 listed)
- Pregnancy
- Bilateral axilla or groin melanoma surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DXA scanDXA scan | Radiation | Cutaneous melanoma AJCC stage IB-III |
| Clinical examinationClinical examination | Procedure or surgery | Cutaneous melanoma AJCC stage IB-III |
Primary outcome
Global Health Score
Time frame: 12 months
Quality of life will be assessed with the questionnaire EORTC QLQ-C30 v.3.0
5 secondary outcomes
Anxiety
Time frame: 12 months
Depression
Time frame: 12 months
Lymphoedema
Time frame: 12 months
Neuropathic pain
Time frame: 12 months
Volume and tissue composition assessed with DXA scan
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Derived from this study: PubMed 28918186Gjorup 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Asirvatham Gjørup, MD principal investigator
Department of Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Quality of Life, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Health Score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02352623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.