ColoRectal Cancer Clinical Trial
Official title:
A Longitudinal Study of Cancer-related Fatigue Among Colorectal Cancer Patients During Adjuvant Chemotherapy
Worldwide, nearly 1.25 million patients are diagnosed with and more than 600,000 patients
die from colorectal cancer each year. The third leading cause of death is colorectal cancer
in Taiwan 2012. The current treatments for colorectal cancer including surgery, chemotherapy
and/or radiotherapy are prescribed to improve survival and lower the risk of recurrence.
However, disease and treatment-related toxicities in cancer patients may result in fatigue
and interfered quality of life (QoL). Previous studies have reported that cancer-related
fatigue (CRF) is the most common symptom experienced by patients at all stage of diseases,
it can occur during treatment, in advanced disease and in disease-free survivors; the
prevalence of fatigue is reported to be between 59-96% in patients undergoing chemotherapy,
65-100% in patients receiving radiation therapy, and 30% in long term survivors. Also, CRF
has been reported as the most frequent and distressing toxicity of colon and rectal
chemotherapy. The National Comprehensive Cancer Network (NCCN) has published guidelines for
the definition of CRF as ''a persistent subjective sense of physical, emotional, and/or
cognitive tiredness or exhaustion related to cancer or cancer treatment that is not
proportional to recent activity and that significantly interferes with usual functioning."
Besides, CRF could dynamically change with the interactions among disease progression,
treatment regimen, tumor site, nutrition, infection or other factors. Therefore, to minimize
the impact of CRF on cancer patients, more in-depth researches on CRF are needed.
The aim of this longitudinal study is to examine the dynamic changes, correlated factors and
QoL of CRF among colorectal cancer patients during adjuvant chemotherapy. Furthermore, the
results will supply physicians with more understanding about CRF, and help them to enhance
the quality on cancer care to being perfected in the future.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | February 2018 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients who signed the informed consent form 2. Aged 20 years and older 3. Patients who have been given a diagnosis of stage II-IV colorectal cancer 4. Scheduled to receive adjuvant chemotherapy 5. Eastern Cooperative Oncology Group (ECOG) performance status = 2 6. Able to communicate verbally and completely fill out the questionnaires Exclusion Criteria: 1. Female patients are pregnant or breast-feeding 2. Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening 3. Patients who have been given a diagnosis of cognitive impairment are unable to complete the questionnaires |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Taiwan | Mackay Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Mackay Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T) | Change from baseline cancer-related fatigue at 12 chemotherapy cycles(24 weeks). | No | |
Secondary | Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7) | Change from baseline quality of life at 12 chemotherapy cycles(24 weeks). | No |
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