Longitudinal Investigation of Cancer-related Fatigue (LIFT)
A Prospective, Observational Study to Investigate Longterm Courses, Patterns, Determinants and State of Treatment of Cancer-related Fatigue in Germany (LIFT)
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
The LIFT study aims to comprehensively investigate characteristics, determinants, and long-term course of fatigue. In addition, information shall be gained on the current state of fatigue treatment and care in Germany and on the needs of affected patients.
Data will be collected by mailed or online questionnaires at 6, 9, and 12 months as well as 2, 3, 4 and 5 years post-diagnosis from 2000 cancer patients. Besides questionnaires on socio-demographic, clinical and patient reported outcomes, saliva samples will be collected in order to gain new insights into biological mechanisms. Moreover, detailed data on screening, diagnosis and counseling as well as therapies offered and administered to reduce fatigue will be surveyed, as well as the patients' state of knowledge, perception and prevailing needs regarding fatigue. Tumor and cancer therapy data will be extracted from the Epidemiological Cancer Registry.
The results of the LIFT study aim to contribute to an improved, evidence-based and individualized treatment to avoid and ease cancer-related fatigue and will further promote patient-oriented offers and treatments.
Studientyp
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- ≥ 18 years of age
- Diagnosed with a primary tumor of breast, ovarian, or colon cancer
- Time since first diagnosis is 4 - 6 months
- Having received or currently receiving at least one of the following treatments: surgery, chemotherapy, radiotherapy, hormone therapy, or immune therapy.
- Able to understand and follow the study protocol.
Exclusion Criteria:
• Any additional malignant or unclear neoplasm or carcinoma in situ at or since time of diagnosis of the considered primary tumor
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Patient cohort
Newly diagnosed breast, ovarian or colon cancer patients recruited 6 months post-diagnosis and followed up to 5 years post-diagnosis.
No intervention.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Fatigue severity
Zeitfenster: from diagnosis to 1 year post-diagnosis
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assessed by EORTC QLQ-FA12 (European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire)
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from diagnosis to 1 year post-diagnosis
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Impact of fatigue
Zeitfenster: from diagnosis to 1 year post-diagnosis
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assessed by the Brief Fatigue Inventory (BFI)
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from diagnosis to 1 year post-diagnosis
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State of fatigue management
Zeitfenster: from diagnosis to 1 year post-diagnosis
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Questionnaire assessing the adherence to the National Comprehensive Cancer Network (NCCN) guidelines regarding management of cancer-related fatigue
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from diagnosis to 1 year post-diagnosis
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Quality of life functions and symptoms
Zeitfenster: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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assessed by EORTC QLQ-C30
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6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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Sleep problems
Zeitfenster: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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assessed by Pittsburgh Sleep Quality Index (PSQI)
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6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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Depression
Zeitfenster: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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assessed by Patient Health Questionnaire (PHQ-9)
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6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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Body mass index
Zeitfenster: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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calculated from weight and height
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6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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Total physical activity
Zeitfenster: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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assessed by a questionnaire regarding walking, cycling, and exercise behavior
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6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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Diurnal cortisol rhythm
Zeitfenster: 1 year post-diagnosis
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assessed in saliva
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1 year post-diagnosis
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Return to work
Zeitfenster: 6, 12 months and 2, 3, 4, and 5 years post-diagnosis
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assessed by a questions regarding occupational issues
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6, 12 months and 2, 3, 4, and 5 years post-diagnosis
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Hot flashes
Zeitfenster: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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assessed only for women
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6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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Anxiety
Zeitfenster: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7)
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6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- LIFT
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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