Malignant Melanoma of SkinNCT02668887
Employment and Quality of Life in Patients With Malignant Melanoma
An observational study of Malignant Melanoma of Skin and Quality of Life, run by Fachklinik Hornheide an der Universität Münster at 1 site in Germany.
Trial summary
Within the first year after diagnosis, data on employment and quality of life will be collected and evaluated in patients with malignant melanoma Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malignant Melanoma of Skin, Quality of Life, Work Ability
- What is being tested?
- Quality of Life, status of employment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 221 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Feb 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with malignant melanoma
Who may be able to join
- first diagnosis of malignant melanoma stage 0 to stage IIIC within the last 6 weeks
- written informed consent
Who cannot join
- diagnosis of malignant melanoma stage IV
- inability to follow the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort Study on Employment and Quality of Life in Patients With Malignant Melanoma
Within the first year after diagnosis, data on employment and quality of life will be collected and evaluated in patients with malignant melanoma
- Conditions
- Malignant Melanoma of Skin, Quality of Life, Work Ability
- Being tested
- Quality of Life, status of employment
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life, status of employmentBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Melanoma of SkinStudies 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
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fachklinik Hornheide an der Universität Münster
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Münster, Deutsche Rentenversicherung
- Responsible party
- Principal investigator, Susanne Dugas-Breit, Fachklinik Hornheide an der Universität Münster
- Investigators
- Hans-Joachim Schulze, M.D., Study director, Fachklinik Hornheide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668887
- Sponsor's protocol ID
- Hornheide-Derm-001
- Status last verified
- Feb 2019
- First submitted
- 27 Jan 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on Employment and Quality of Life in Patients With Malignant Melanoma
- ClinicalTrials.gov ID
- NCT02668887
- Acronym / sponsor ID
- Hornheide-Derm-001
- Conditions
- Malignant Melanoma of Skin, Quality of Life, Work Ability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Fachklinik Hornheide an der Universität MünsterUniversity, hospital or other
- Collaborators
- Universität Münster, Deutsche Rentenversicherung
- Study start
- Apr 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 29 Jan 2016 (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.
Within the first year after diagnosis, data on employment and quality of life will be collected and evaluated in patients with malignant melanoma
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant melanoma
Key inclusion criteria (2 listed)
- first diagnosis of malignant melanoma stage 0 to stage IIIC within the last 6 weeks
- written informed consent
Key exclusion criteria (2 listed)
- diagnosis of malignant melanoma stage IV
- inability to follow the protocol
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 |
|---|---|---|
| Quality of Life, status of employment | Behavioural | – |
Primary outcome
Quality of life questionnaire
Time frame: one year
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 15 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Hans-Joachim Schulze, M.D. study director
Fachklinik Hornheide
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 Malignant Melanoma of Skin and Quality of Life, run by Fachklinik Hornheide an der Universität Münster at 1 site in Germany.
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 15 Feb 2019. 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 Germany. 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?
Quality of life questionnaire (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2019.