Quality of Life and Psychological Well-being in Patients With Malignant Melanoma

June 24, 2010 updated by: University Hospital Freiburg

Side-effect Management for Patients With Malignant Melanoma Undergoing Treatment With Interferon Alpha (IFN-α)- Diagnosis and Therapy -

The purpose of this study is to analyse the physical and psychological side-effects in the course of treatment with IFN-alpha. The effectiveness of a specific intervention for the management of these side-effects is evaluated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Today, the consideration of the side effects of intensive treatment measures and their influence on quality of life are regarded as standard procedures in oncology. Quality of life measurements have found their way into clinical studies as patient-reported outcomes. In comparison to other tumor types, the field of dermato-oncology has had less research activity concerning quality of life. However, in recent years more attention has been paid to health related quality of life in malignant melanoma patients, especially under adjuvant treatment with interferon-alpha. Data about high dose IFN-α treatment, especially from the USA, show that there are significant physical and psychological side effects, such as fatigue and depression, which often lead to dosage reduction or termination of treatment. As yet, there are very few systematic studies about low dose IFN-α treatment, especially in regard to the side effects during the course of the disease.

Concerning treatment side-effects it is known throughout various areas of oncology that specific psycho-oncological interventions assist in the patients' adaptation to the illness and handling of the side effects of therapy.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

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

  • Germany
      • Freiburg, Germany, 79104
        • Recruiting
        • University Medical Center Freiburg, Department of Dermatology
        • Contact:
          • Dorothee Nashan, MD
        • Principal Investigator:
          • Katrin Reuter, PhD
      • Köln, Germany, 50937
        • Recruiting
        • University Medical Center Collogne, Department of Dermatology
        • Contact:
          • Cornelia Mauch, MD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documented and proven stage Ib up to stage IIIc malignant melanoma
  • No clinical and radiological evidence or suspicion of persistent disease
  • Treatment with IFN-α within a study or analog treatment schedule with IFN-α
  • ECOG performance status < 2
  • Constant after care
  • Informed consent to participate in the study
  • melanoma diagnosis within the last 5 years or therapy, recurrence or progression within this period of time.

Exclusion Criteria:

  • Inoperable lymph nodes- or distant metastases
  • Tumors of other origins or localisations within the past 10 years
  • Severe and permanent infectious diseases, e. g. HIV or hepatitis
  • Participation in other treatment studies apart from IFN-α
  • Insufficient knowledge of German language

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Experimental: psycho-oncological intervention
stepped care psycho-oncological intervention
Behavioral: psycho-oncological intervention
stepped care treatment program with different elements (patient information, exercise, psychoeducation, individual and group therapy, psycho-pharmacology)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in quality of life
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in fatigue
Time Frame: 1 year
1 year
Changes in psychological distress
Time Frame: 1 year
1 year
Changes in depressive syndrome
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

University Hospital Freiburg

Collaborators

Universitätsklinikum Köln
Essex Pharma GmbH

Investigators

  • Principal Investigator: Katrin Reuter, PhD, University Medical Center Freiburg, Department of Psychiatry and Psychotherapy
  • Principal Investigator: Dorothee Nashan, MD, University Medical Center, Department of Dermatology

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

April 1, 2009

Primary Completion (Anticipated)

February 1, 2011

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

August 20, 2009

First Submitted That Met QC Criteria

August 20, 2009

First Posted (Estimate)

August 21, 2009

Study Record Updates

Last Update Posted (Estimate)

June 25, 2010

Last Update Submitted That Met QC Criteria

June 24, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO5098

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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