- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03766945
Fatigue and QoL Among Gastric Cancer Patients Undergoing Abdominal Surgery
A Survey of Fatigue and QoL Among Gastric Cancer Patients Undergoing Major Abdominal Surgery
Background: Cancer-related fatigue (CRF), one of the indicators of QoL, is one of the most common side effects of cancer and its treatment. However, the pathophysiological mechanisms involved in CRF among cancer patients are not completely understood. Therefore, more in-depth researches on CRF of surgical patients suffering from gastric cancer are needed in Taiwan.
Purpose: The purpose of this study is to examine the incidence rate and correlated factors (QoL and immune biomarkers) of CRF among gastric cancer patients undergoing major abdominal surgery.
Method: A longitudinal study was conducted to recruit gastric cancer patients who scheduled to operate at surgical clinics from a northern medical center in Taiwan. The data will be collected with a structured questionnaire and Immune markers assessments via purposive sampling of 120 subjects. Before operation, on day 1 after operation, and on day 7 after operation, the biomarkers will be measured. The BFI-T questionnaire will be filled out before surgery and on day 1, 2, 7, 28 after surgery; The EORTC QLQ-C30 and EORTC QLQ-STO22 questionnaire will be filled out before surgery and on day 7, 28 after surgery; Type D scale-14(Taiwanese version) questionnaire will be filled out before surgery and on day 28 after surgery. Data will be analyzed by using descriptive statistics, paired t-test, Chi square test, Pearson's correlation, and the generalized estimating equation (GEE) was used to identify significant factors with QoL after operation.
Anticipated achievement: The anticipated achievement of this study is to provide healthcare providers with more knowledge about CRF, and help them to enhance the quality of life on gastric cancer patients in the future.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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-
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Taipei, Taiwan, 100
- Rekruttering
- National Taiwan University Hospital
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Kontakt:
- Hui-Ting Yang, MSN
- Telefonnummer: +886930005267
- E-mail: sophy790303@gmail.com
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Ledende efterforsker:
- Jin-Ming Wu, PhD
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Underforsker:
- Shiow-Ching Shun, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of gastric cancer and schedule for major abdominal surgery
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Exclusion Criteria:
- Severe multiple organ impairment, comorbidities or immune disorder before surgery
- Undergoing chemotherapy or radiotherapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Fatigue
Tidsramme: Change from baseline fatigue at 1 month
|
Brief Fatigue Inventory-Taiwan Form (BFI-T).
The questionnaire includes 10 items to assess fatigue.
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Change from baseline fatigue at 1 month
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Quality of Life
Tidsramme: Change from baseline quality of life at 1 month
|
Quality of Life Questionnaire(EORTC QLQ-C30 and EORTC QLQ-STO22 questionnaire).
The questionnaire includes 52 items to assess quality of life.
|
Change from baseline quality of life at 1 month
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jin-Ming Wu, PhD, National Taiwan University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Patologiske processer
- Infektioner
- Neoplasmer
- Neoplasmer efter sted
- Postoperative komplikationer
- Sår og skader
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Mavesygdomme
- Neoplasmer i maven
- Træthed
- Kirurgisk sår
- Kirurgisk sårinfektion
- Sårinfektion
Andre undersøgelses-id-numre
- 201705112RINB
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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