- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01018004
Comparing Follow-Up Schedules in Patients With Newly Diagnosed Stage IB or Stage II Melanoma
Prospective Randomized Trial for the Evaluation of a Theoretical Follow-Up Schedule in Cutaneous Melanoma Patients, the MELFO-Study.
RATIONALE: Gathering information over time from follow-up visits may help doctors plan the best follow-up schedule. It is not yet known which follow-up schedule is more effective in improving patient quality of life.
PURPOSE: This randomized clinical trial is comparing follow-up schedules to see how well they work in patients with newly diagnosed stage IB or stage II melanoma.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
- To determine the difference between conventional versus experimental follow-up schedules, in terms of patient well-being, expressed health-related quality of life, level of anxiety, and satisfaction with the follow-up schedule in patients with newly diagnosed stage IB or II cutaneous melanoma.
- To determine the ability of these schedules to detect recurrences and second primary melanomas in these patients.
OUTLINE: Patients are stratified according to AJCC stage (I vs II). Patients are randomized to 1 of 2 follow-up arms.
Arm I (experimental follow-up schedule): Patients undergo a thorough history and physical examination periodically for 5 years. Patients are followed up according to the experimental schedule:
- For stage IB disease: Patients are followed up annually for 5 years.
- For stage IIA disease: Patients are followed up biannually for years 1 and 2 and annually for years 3, 4, and 5.
- For stage IIB or IIC disease: Patients are followed up every 4 months during years 1 and 2, every 6 months during year 3, and annually during years 4 and 5.
Arm II: (conventional follow-up schedule): Patients undergo a thorough history and physical examination periodically for 5 years. Patients are followed up according to the conventional schedule:
- For all stage disease: Patients are followed up every 3 months for year 1, every 4 months for year 2, and every 6 months for years 3-5.
In both arms, patient well-being is measured at 0, 6, 12, 24, 36, 48, and 60 months after primary diagnosis, using the following questionnaires: the health-related quality of life questionnaire (RAND-36), the anxiety questionnaire (STAI version DY-1 [state] and DY-2 [trait]), the Cancer Worry Scale, and Follow-up Satisfaction questionnaire, and the self-designed specific questions regarding self-examination and follow-up satisfaction.
All patients are instructed at primary diagnosis and receive the Melanoma-Patient-Education-Package (MPEP), which consists of information on melanoma (KWF folder "melanoma") and additional instruction on self-examination. Data on type of recurrence (locoregional versus distant), the person detecting the recurrence, progression of recurrence at time of detection, the way the recurrence was detected (e.g., self-examination, accidentally, or at follow-up by physical examination or imaging) and information regarding treatment and further follow-up are collected at each follow-up visit and the outcomes are compared in both groups. Outcomes of independent questionnaires are also compared in both groups.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Enschede, Olanda, 7500 KA
- Reclutamento
- Medisch Spectrum Twente
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Contatto:
- Contact Person
- Numero di telefono: 31-53-487-2000
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Groningen, Olanda, 9700 RB
- Reclutamento
- University Medical Center Groningen
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Contatto:
- Contact Person
- Numero di telefono: 31-50-361-2317
- Email: h.j.hoekstra@chir.umcg.nl
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Leeuwarden, Olanda, 8934 AD
- Reclutamento
- Medisch Centrum Leeuwarden - Zuid
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Contatto:
- Contact Person
- Numero di telefono: 31-58-286-6666
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Zwolle, Olanda, NL-8000 GM
- Reclutamento
- Isala Klinieken - Locatie Weezenlanden
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Contatto:
- Contact Person
- Numero di telefono: 31-38-424-2000
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
Pathologically confirmed newly diagnosed cutaneous melanoma
- AJCC stage IB or II disease
- Received curative treatment
- Completed the first set of questionnaires
PATIENT CHARACTERISTICS:
- Able to speak and understand Dutch or English
- Must be able to participate in the follow-up schedule (e.g., permanently living in the Netherlands)
- No known second malignancy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Piano di studio
Come è strutturato lo studio?
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Patient well-being expressed in 4 questionnaires
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Misure di risultato secondarie
Misura del risultato |
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Occurrence and type of recurrence (locoregional versus distant metastases) that develop
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Person detecting the recurrences and the exact way of detection
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Progress of recurrent disease and consequences for its treatment
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Well-being of patients per group and of recurred patients
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Harald J. Hoekstra, MD, PhD, University Medical Center Groningen
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CDR0000659310
- UMCG-MELFO
- EU-20988
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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