NCT03013972

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

November 16, 2016

Last Update Submit

January 6, 2017

Conditions

ColoRectal Cancer

Keywords

ColoRectal CancerAdjuvant ChemotherapyCancer-related FatigueBrief fatigue inventory (BFI)Functional Assessment of Cancer Therapy-General 7 (FACT-G7)

Outcome Measures

Primary Outcomes (1)

  • Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T)

    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)

    Change from baseline quality of life at 12 chemotherapy cycles(24 weeks).

Study Arms (1)

Colorectal cancer patients

Colorectal cancer patients during adjuvant chemotherapy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Colorectal cancer patients during adjuvant chemotherapy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan, 104, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Hsi-Hsien Hsu, M.D., Ph.D.

    Mackay Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsi-Hsien Hsu, M.D., Ph.D.

CONTACT

886-975-835784hsu5936@ms3.hinet.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

November 16, 2016

First Posted

January 9, 2017

Study Start

November 1, 2015

Primary Completion

November 1, 2017

Study Completion

February 1, 2018

Last Updated

January 9, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)