Quality of Life and Psychological Well-being in Patients With Malignant Melanoma
Recruitment status was Recruiting
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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 - |
- Changes in quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Katrin Reuter, PhD | +497612706986 | katrin.reuter@uniklinik-freiburg.de |
| Contact: Karoline Albrecht, dipl. psych. | +497612706990 | karoline.albrecht@uniklinik-freiburg.de |
| 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 | |
| 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
| 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 Interferons Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 22, 2013