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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University Hospital Freiburg.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Essex Pharma GmbH
University Hospital Köln
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00963261
First received: August 20, 2009
Last updated: June 24, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Malignant Melanoma
Behavioral: psycho-oncological intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Side-effect Management for Patients With Malignant Melanoma Undergoing Treatment With Interferon Alpha (IFN-α)- Diagnosis and Therapy -

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Changes in quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in fatigue [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Changes in psychological distress [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Changes in depressive syndrome [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: April 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
No Intervention: control group

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963261

Contacts
Contact: Katrin Reuter, PhD +497612706986 katrin.reuter@uniklinik-freiburg.de
Contact: Karoline Albrecht, dipl. psych. +497612706990 karoline.albrecht@uniklinik-freiburg.de

Locations
Germany
University Medical Center Freiburg, Department of Dermatology Recruiting
Freiburg, Germany, 79104
Contact: Dorothee Nashan, MD         
Principal Investigator: Katrin Reuter, PhD         
University Medical Center Collogne, Department of Dermatology Recruiting
Köln, Germany, 50937
Contact: Cornelia Mauch, MD         
Sponsors and Collaborators
University Hospital Freiburg
Essex Pharma GmbH
University Hospital Köln
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
  More Information

No publications provided by University Hospital Freiburg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Katrin Reuter, PhD; Dorothee Nashan, MD, University Medical Center Freiburg
ClinicalTrials.gov Identifier: NCT00963261     History of Changes
Other Study ID Numbers: PO5098
Study First Received: August 20, 2009
Last Updated: June 24, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Freiburg:
melanoma
interferon-a
quality of life
psychological distress
depressive symptoms
side effects

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 19, 2014