ColoRectal CancerNCT03013972
A Longitudinal Study of Cancer-related Fatigue Among Colorectal Cancer Patients During Adjuvant Chemotherapy
An observational study of ColoRectal Cancer, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- ColoRectal Cancer
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2015to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colorectal cancer patients during adjuvant chemotherapy
Who may be able to join
- Patients who signed the informed consent form
- Aged 20 years and older
- Patients who have been given a diagnosis of stage II-IV colorectal cancer
- Scheduled to receive adjuvant chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Able to communicate verbally and completely fill out the questionnaires
Who cannot join
- Female patients are pregnant or breast-feeding
- Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening
- Patients who have been given a diagnosis of cognitive impairment are unable to complete the questionnaires
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Mackay Memorial Hospital
Taipei, Taiwan, 104
Hsi-Hsien Hsu, M.D., Ph.D., 886-975-835784, hsu5936@ms3.hinet.net
Hsi-Hsien Hsu, M.D., Ph.D.
About this study
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.
Read the detailed description
This study will enroll colorectal cancer patients with adjuvant chemotherapy about 1 year (estimated 60 patients). Brief fatigue inventory-Taiwanese form (BFI-T) and functional assessment of cancer therapy-general 7 (FACT-G7) will be used to evaluate patients' fatigue and quality of life. Patients will be thoroughly informed about all aspects of the study activity schedule and all regulatory requirements that must be satisfied for informed consent. Only patients who give consent to participate in this study and meet all other inclusion and exclusion criteria will be eligible to enroll into this study. The questionnaire survey will be carried out before first chemotherapy treatment (baseline), and every four chemotherapy cycles (i.e. at cycle 4, 8 and 12) after chemotherapy treatment at outpatient department (OPD) or ward during adjuvant chemotherapy treatment period. All patients will receive standard chemotherapy which continued for 24 weeks (12 cycles) or until disease progression, whichever came first. Subject demographic and disease-related information will also be collected for analysis.
- Conditions
- ColoRectal Cancer
- Keywords
- ColoRectal Cancer, Adjuvant Chemotherapy, Cancer-related Fatigue, Brief fatigue inventory (BFI), Functional Assessment of Cancer Therapy-General 7 (FACT-G7)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer patients | Colorectal cancer patients during adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T)
Measured: Change from baseline cancer-related fatigue at 12 chemotherapy cycles(24 weeks).
Secondary outcomes (1)
Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)
Measured: Change from baseline quality of life at 12 chemotherapy cycles(24 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColoRectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsi-Hsien Hsu, Mackay Memorial Hospital
- Investigators
- Hsi-Hsien Hsu, M.D., Ph.D., Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013972
- Sponsor's protocol ID
- CRF-CRC01
- Status last verified
- Jan 2017
- First submitted
- 16 Nov 2016
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of Cancer-related Fatigue Among Colorectal Cancer Patients During Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03013972
- Acronym / sponsor ID
- CRF-CRC01
- Conditions
- ColoRectal Cancer
- Keywords
- ColoRectal Cancer, Adjuvant Chemotherapy, Cancer-related Fatigue, Brief fatigue inventory (BFI), Functional Assessment of Cancer Therapy-General 7 (FACT-G7)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will enroll colorectal cancer patients with adjuvant chemotherapy about 1 year (estimated 60 patients). Brief fatigue inventory-Taiwanese form (BFI-T) and functional assessment of cancer therapy-general 7 (FACT-G7) will be used to evaluate patients' fatigue and quality of life. Patients will be thoroughly informed about all aspects of the study activity schedule and all regulatory requirements that must be satisfied for informed consent. Only patients who give consent to participate in this study and meet all other inclusion and exclusion criteria will be eligible to enroll into this study. The questionnaire survey will be carried out before first chemotherapy treatment (baseline), and every four chemotherapy cycles (i.e. at cycle 4, 8 and 12) after chemotherapy treatment at outpatient department (OPD) or ward during adjuvant chemotherapy treatment period. All patients will receive standard chemotherapy which continued for 24 weeks (12 cycles) or until disease progression, whichever came first. Subject demographic and disease-related information will also be collected for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer patients | – | –Colorectal cancer patients during adjuvant chemotherapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal cancer patients during adjuvant chemotherapy
Key inclusion criteria (6 listed)
- Patients who signed the informed consent form
- Aged 20 years and older
- Patients who have been given a diagnosis of stage II-IV colorectal cancer
- Scheduled to receive adjuvant chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Key exclusion criteria (3 listed)
- Female patients are pregnant or breast-feeding
- Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening
- Patients who have been given a diagnosis of cognitive impairment are unable to complete the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T)
Time frame: Change from baseline cancer-related fatigue at 12 chemotherapy cycles(24 weeks).
1 secondary outcome
Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)
Time frame: Change from baseline quality of life at 12 chemotherapy cycles(24 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsi-Hsien Hsu, M.D., Ph.D. principal investigator
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ColoRectal Cancer, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsi-Hsien Hsu, M.D., Ph.D. (886-975-835784, hsu5936@ms3.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T) (time frame: Change from baseline cancer-related fatigue at 12 chemotherapy cycles(24 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.