- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01603290
Change of Fatigue and Physical Fitness in Hospitalized Hematology Patients
18. maj 2012 opdateret af: National Taiwan University Hospital
Change of Fatigue and Physical Fitness and Their Related Factors in Hospitalized Hematology Patients
The purposes of this study are to (1) explore the severity of symptom of leukemia patients experienced before and after chemotherapy in hospital, (2) investigate the trajectories of the fatigue and physical fitness, and their related factors, and (3) the correlation between fatigue and physical fitness
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Cancer-Related Fatigue (CRF) is one of the common distressed symptoms that leukemia patients experienced during the period of chemotherapy.
Exercise is the most effective non-pharmacologic treatment but inpatients refuse to do exercise in clinical settings in Taiwan.
Decreased physical activity may increase the intensity of fatigue and degenerate the physical fitness; however, there is no study to explore the trajectories of fatigue and physical fitness for leukemia patient during hospitalization.
Therefore, the purposes of this study are to (1) explore the severity of symptom of leukemia patients experienced before and after chemotherapy in hospital, (2) investigate the trajectories of the fatigue and physical fitness, and their related factors, and (3) the correlation between fatigue and physical fitness.
A longitudinal designed study will be conducted to recruit the leukemia patients in a medical center in Taipei.
Eligible patients are those will be going to receive chemotherapy and in hospital at least one week.
Time periods for data collection will be in the first 48 hours after hospitalization (T0) and the 48 hours before the patient discharged (T1).
A set of structured questionnaire will be used to collected data including the Background information form, the Fatigue Symptom Inventory, the Cancer Fatigue Scale, the Symptom Severity Scale, and the Hospital Anxiety and Depression Scale.
Patients will be received physical fitness test including the 6-Minute Walking Test, grip strength, and 30-second chair stand test.
The descriptive statistics will be used to analyze the severity of symptom distress, fatigue, and the change of physical fitness, and the inferential statistics was used to analyze the correlation of the symptom, fatigue, and physical fitness.
Besides, generalized estimating equations (GEE) will be used to analysis the average of population change of fatigue and physical fitness.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
130
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Taipei, Taiwan
- National Taiwan University Hospital
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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
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Acute leukemia inpatients
Beskrivelse
Inclusion Criteria:
- Acute leukemia patients with first complete remission status
- Aged above 20
- Be going to receive chemotherapy and in hospital at least one week.
- Those Who willing to participate in the research
Exclusion Criteria:
- Physician consider the patient was not suitable
- Patients' limbs can not move
- Patients' conscious was unclear during hospitalization
- Patient with pain of joint and can't do 30-second chair stand test and 6-Minute Walking Test
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 |
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Hospitalized Leukemia Patients
leukemia patients with chemotherapy during hospitalization
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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
1. december 2011
Primær færdiggørelse (Forventet)
1. december 2012
Studieafslutning (Forventet)
1. december 2013
Datoer for studieregistrering
Først indsendt
18. maj 2012
Først indsendt, der opfyldte QC-kriterier
18. maj 2012
Først opslået (Skøn)
22. maj 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. maj 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. maj 2012
Sidst verificeret
1. maj 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201111066RIC
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .