Malignant MelanomaNCT00963261
Quality of Life and Psychological Well-being in Patients With Malignant Melanoma
A study testing psycho-oncological intervention in people with Malignant Melanoma, run by University Hospital Freiburg at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- psycho-oncological intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2009to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University Medical Center Collogne, Department of Dermatology
Cologne, 50937
Cornelia Mauch, MD
- Recruiting
University Medical Center Freiburg, Department of Dermatology
Freiburg im Breisgau, 79104
Dorothee Nashan, MD
Katrin Reuter, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Malignant Melanoma
- Being tested
- psycho-oncological intervention
- Keywords
- melanoma, interferon-a, quality of life, psychological distress, depressive symptoms, side effects
- Medical subject headings
- Melanoma, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psycho-oncological interventionBehavioural
stepped care treatment program with different elements (patient information, exercise, psychoeducation, individual and group therapy, psycho-pharmacology)
| Study group | Role | What they receive |
|---|---|---|
| psycho-oncological intervention | Experimental | stepped care psycho-oncological intervention Receives: Behavioral: psycho-oncological intervention |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quality of life
Measured: 1 year
Secondary outcomes (3)
Changes in fatigue
Measured: 1 year
Changes in psychological distress
Measured: 1 year
Changes in depressive syndrome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2011 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- Essex Pharma GmbH, Universitätsklinikum Köln
- Investigators
- Katrin Reuter, PhD, Principal investigator, University Medical Center Freiburg, Department of Psychiatry and PsychotherapyDorothee Nashan, MD, Principal investigator, University Medical Center, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963261
- Sponsor's protocol ID
- PO5098
- Status last verified
- Jun 2010
- First submitted
- 20 Aug 2009
- Last updated
- 25 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25304729Albrecht 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.
PubMed 24136099Albrecht 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.
PubMed 23288588
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side-effect Management for Patients With Malignant Melanoma Undergoing Treatment With Interferon Alpha (IFN-α)- Diagnosis and Therapy -
- ClinicalTrials.gov ID
- NCT00963261
- Acronym / sponsor ID
- PO5098
- Conditions
- Malignant Melanoma
- Keywords
- melanoma, interferon-a, quality of life, psychological distress, depressive symptoms, side effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- Essex Pharma GmbH, Universitätsklinikum Köln
- Study start
- Apr 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 21 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psycho-oncological intervention | Experimental | Behavioral: psycho-oncological interventionstepped care psycho-oncological intervention |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psycho-oncological interventionstepped care treatment program with different elements (patient information, exercise, psychoeducation, individual and group therapy, psycho-pharmacology) | Behavioural | psycho-oncological intervention |
Primary outcome
Changes in quality of life
Time frame: 1 year
3 secondary outcomes
Changes in fatigue
Time frame: 1 year
Changes in psychological distress
Time frame: 1 year
Changes in depressive syndrome
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2010.
- Derived from this study: PubMed 25304729Reuter 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.
- Derived from this study: PubMed 24136099Albrecht 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.
- Derived from this study: PubMed 23288588Albrecht 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrin Reuter, PhD principal investigator
University Medical Center Freiburg, Department of Psychiatry and Psychotherapy
Dorothee Nashan, MD principal investigator
University Medical Center, Department of Dermatology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psycho-oncological intervention in people with Malignant Melanoma, run by University Hospital Freiburg at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrin Reuter, PhD (+497612706986, katrin.reuter@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quality of life (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00963261, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2010.