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)
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Fatigue severity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of life functions and symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LIFT
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