Employment and Quality of Life in Patients With Malignant... | NCT02668887

Studies
Employment and Quality of Life in Patients With Malignant Melanoma

NCT02668887

Sponsor

Fachklinik Hornheide an der Universität Münster

Status

Completed

Last Update Posted

Feb 15, 2019Actual

Enrollment

221Actual

Phase

Not provided

Conditions

Malignant Melanoma of Skin
Quality of Life
Work Ability

Interventions

Quality of Life, status of employment

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016Actual

Primary Completion Date

Aug 2018Actual

Completion Date

Feb 2019Actual

First Submitted Date

Jan 27, 2016

First Submission Date that Met QC Criteria

Jan 28, 2016

First Posted Date

Jan 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2019

Last Update Posted Date

Feb 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Susanne Dugas-Breit, M.D., Fachklinik Hornheide an der Universität MünsterPrincipal Investigator

Lead Sponsor

Fachklinik Hornheide an der Universität MünsterOTHER

Collaborators

Name	Class
Universität Münster	OTHER
Deutsche Rentenversicherung	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Within the first year after diagnosis, data on employment and quality of life will be collected and evaluated in patients with malignant melanoma

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

221Actual

Name	Type	Description	Arm Group Labels	Other Names
Quality of Life, status of employment	Behavioral

Measure	Description	Time Frame
Quality of life questionnaire		one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

first diagnosis of malignant melanoma stage 0 to stage IIIC within the last 6 weeks
written informed consent

Exclusion Criteria:

diagnosis of malignant melanoma stage IV
inability to follow the protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with malignant melanoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans-Joachim Schulze, M.D.	Fachklinik Hornheide	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fachklinik Hornheide		Münster		48157	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011788	Quality of Life

Ancestor Terms

ID	Term
D006304	Health Status
D003710	Demography
D015991	Epidemiologic Measurements
D011634	Public Health

Browse Leaves

Not provided

Browse Branches

Not provided