Quality of Life and Psychological Well-being in Patients With Malignant Melanoma
Side-effect Management for Patients With Malignant Melanoma Undergoing Treatment With Interferon Alpha (IFN-α)- Diagnosis and Therapy -
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Sponsor
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
General Publications
- Reuter K, Albrecht K, Seelig H, Meiss F, Mauch C, Kreuzberg N, Nashan D. Health-related quality of life, fatigue, and depression under low-dose IFN-alpha therapy in melanoma patients. J Immunother. 2014 Nov-Dec;37(9):461-7. doi: 10.1097/CJI.0000000000000057.
- Albrecht KJ, Nashan D, Meiss F, Bengel J, Reuter K. Shared decision making in dermato-oncology: preference for involvement of melanoma patients. Melanoma Res. 2014 Feb;24(1):68-74. doi: 10.1097/CMR.0000000000000030.
- Albrecht K, Droll H, Giesler JM, Nashan D, Meiss F, Reuter K. Self-efficacy for coping with cancer in melanoma patients: its association with physical fatigue and depression. Psychooncology. 2013 Sep;22(9):1972-8. doi: 10.1002/pon.3238. Epub 2013 Jan 3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.