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Fatigue and QoL Among Gastric Cancer Patients Undergoing Abdominal Surgery

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03766945
Collaborator
(none)
120
Enrollment
1
Location
23.9
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    Official Title:
    A Survey of Fatigue and QoL Among Gastric Cancer Patients Undergoing Major Abdominal Surgery
    Actual Study Start Date :
    Jul 27, 2017
    Anticipated Primary Completion Date :
    Jul 25, 2019
    Anticipated Study Completion Date :
    Jul 25, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Fatigue [Change from baseline fatigue at 1 month]

      Brief Fatigue Inventory-Taiwan Form (BFI-T). The questionnaire includes 10 items to assess fatigue.

    Secondary Outcome Measures

    1. Quality of Life [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Clinical diagnosis of gastric cancer and schedule for major abdominal surgery

    2. Eastern Cooperative Oncology Group (ECOG) performance status ≤2

    Exclusion Criteria:

    1. Severe multiple organ impairment, comorbidities or immune disorder before surgery

    2. Undergoing chemotherapy or radiotherapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Jin-Ming Wu, PhD, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT03766945
    Other Study ID Numbers:
    • 201705112RINB
    First Posted:
    Dec 6, 2018
    Last Update Posted:
    Dec 6, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Taiwan University Hospital
    Gastric Cancer
    Surgery
    Fatigue
    Quality of Life
    Additional relevant MeSH terms:
    Wound Infection
    Surgical Wound Infection
    Stomach Neoplasms
    Fatigue
    Surgical Wound

    Study Results

    No Results Posted as of Dec 6, 2018