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)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fatigue severity
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Quality of life functions and symptoms
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LIFT
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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