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Longitudinal Investigation of Cancer-related Fatigue (LIFT)

22. august 2019 opdateret af: German Cancer Research Center

A Prospective, Observational Study to Investigate Longterm Courses, Patterns, Determinants and State of Treatment of Cancer-related Fatigue in Germany (LIFT)

In the LIFT study 2000 cancer patients will be recruited at 6 months after diagnosis and extensively surveyed over five years on factors that are associated with fatigue.

Studieoversigt

Status

Trukket tilbage

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients newly diagnosed with breast, ovarian or colon cancer

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fatigue severity
Tidsramme: from diagnosis to 1 year post-diagnosis
assessed by EORTC QLQ-FA12 (European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire)
from diagnosis to 1 year post-diagnosis
Impact of fatigue
Tidsramme: from diagnosis to 1 year post-diagnosis
assessed by the Brief Fatigue Inventory (BFI)
from diagnosis to 1 year post-diagnosis
State of fatigue management
Tidsramme: from diagnosis to 1 year post-diagnosis
Questionnaire assessing the adherence to the National Comprehensive Cancer Network (NCCN) guidelines regarding management of cancer-related fatigue
from diagnosis to 1 year post-diagnosis

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of life functions and symptoms
Tidsramme: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
assessed by EORTC QLQ-C30
6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Sleep problems
Tidsramme: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
assessed by Pittsburgh Sleep Quality Index (PSQI)
6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Depression
Tidsramme: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
assessed by Patient Health Questionnaire (PHQ-9)
6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Body mass index
Tidsramme: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
calculated from weight and height
6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Total physical activity
Tidsramme: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
assessed by a questionnaire regarding walking, cycling, and exercise behavior
6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Diurnal cortisol rhythm
Tidsramme: 1 year post-diagnosis
assessed in saliva
1 year post-diagnosis
Return to work
Tidsramme: 6, 12 months and 2, 3, 4, and 5 years post-diagnosis
assessed by a questions regarding occupational issues
6, 12 months and 2, 3, 4, and 5 years post-diagnosis
Hot flashes
Tidsramme: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
assessed only for women
6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Anxiety
Tidsramme: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7)
6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

German Cancer Research Center

Samarbejdspartnere

University Hospital Heidelberg

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. marts 2019

Primær færdiggørelse (Forventet)

1. juni 2021

Studieafslutning (Forventet)

1. juni 2025

Datoer for studieregistrering

Først indsendt

3. juli 2017

Først indsendt, der opfyldte QC-kriterier

6. juli 2017

Først opslået (Faktiske)

7. juli 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LIFT

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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