NCT00963261

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

June 25, 2010

Status Verified

June 1, 2010

Enrollment Period

1.8 years

First QC Date

August 20, 2009

Last Update Submit

June 24, 2010

Conditions

Malignant Melanoma

Keywords

melanomainterferon-aquality of lifepsychological distressdepressive symptomsside effects

Outcome Measures

Primary Outcomes (1)

  • Changes in quality of life

    1 year

Secondary Outcomes (3)

  • Changes in fatigue

    1 year

  • Changes in psychological distress

    1 year

  • Changes in depressive syndrome

    1 year

Study Arms (2)

psycho-oncological intervention

EXPERIMENTAL

stepped care psycho-oncological intervention

Behavioral: psycho-oncological intervention

control group

NO INTERVENTION

Interventions

psycho-oncological interventionBEHAVIORAL

stepped care treatment program with different elements (patient information, exercise, psychoeducation, individual and group therapy, psycho-pharmacology)

psycho-oncological intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Medical Center Collogne, Department of Dermatology

Cologne, 50937, Germany

RECRUITING

University Medical Center Freiburg, Department of Dermatology

Freiburg im Breisgau, 79104, Germany

RECRUITING

Related Publications (3)

  • 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.

    PMID: 25304729DERIVED

  • 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.

    PMID: 24136099DERIVED

  • 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.

    PMID: 23288588DERIVED

MeSH Terms

Conditions

MelanomaDepression

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBehavioral SymptomsBehavior

Study Officials

  • Katrin Reuter, PhD

    University Medical Center Freiburg, Department of Psychiatry and Psychotherapy

    PRINCIPAL INVESTIGATOR

  • Dorothee Nashan, MD

    University Medical Center, Department of Dermatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrin Reuter, PhD

CONTACT

+497612706986katrin.reuter@uniklinik-freiburg.de

Karoline Albrecht, dipl. psych.

CONTACT

+497612706990karoline.albrecht@uniklinik-freiburg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2009

First Posted

August 21, 2009

Study Start

April 1, 2009

Primary Completion

February 1, 2011

Study Completion

April 1, 2012

Last Updated

June 25, 2010

Record last verified: 2010-06

Locations

DE(2)