Prevalence, Severity and Determinants of Cancer-related Fatigue (CRF) in Asian Breast Cancer Patients

September 10, 2020 updated by: Alexandre Chan, National University of Singapore
There is a paucity of studies that focus on the symptom burden of cancer patients in Singapore, particularly the clinical effects of cancer-related fatigue (CRF). Knowing that early-stage breast cancer is curable, it is of paramount importance to evaluate the clinical and biological determinants of lingering symptoms in breast cancer survivors so that appropriate psychosocial interventions can be formulated.

Study Overview

Status

Unknown

Conditions

Detailed Description

The investigators hypothesize that variations in clinical and biological determinants contribute to different severities of CRF among Asian breast cancer patients. Through this study, the investigators aim to evaluate the prevalence and severity of CRF among Asian breast cancer patients, and to identify the biological and clinical determinants of CRF among these patients.

This will be a multicenter, prospective, longitudinal, observational study conducted at the National Cancer Centre Singapore and KK Women's and Children's Hospital. Informed consent will be obtained from participants before the investigators proceed with data collection.

The study participants will be assessed at relevant time points. Biological determinants and symptoms associated with CRF will be assessed. The associations between changes in CRF, plasma cytokines levels, serum cortisol levels, and other clinical determinants will be elucidated.

Study Type

Observational

Enrollment (Anticipated)

194

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117543
        • Alexandre Chan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The proposed study will be a multicenter, prospective, longitudinal, observational study conducted at the National Cancer Centre Singapore (NCCS) and KK Women's and Children's Hospital (KKH).

Description

Inclusion Criteria:

  • At least 21 years of age
  • Stage I-III breast cancer
  • Chinese, Malay or Indian ethnics
  • Surgical treatment has been performed
  • Scheduled to receive four cycles of chemotherapy (doxorubicin/cyclophosphamide [AC], docetaxel/cyclophosphamide [TC], 5-fluorouracil/epirubicin/cyclophosphamide [FEC]) (total duration of 3 months) and/or radiotherapy and/or hormonal therapy
  • No prior history of chemotherapy and/or radiotherapy
  • Able to read and understand either English or Mandarin

Exclusion Criteria:

  • Physically or mentally unable to provide verbal/written consent
  • Symptomatically ill (such as infection or an allergic reaction to chemotherapy)
  • Presence of another condition for which fatigue is a prominent symptom (e.g. AIDS, fibromyalgia, or rheumatoid arthritis)
  • Newly started on any medications that can cause general fatigue and body weakness (e.g. a beta-blocker or antidepressant, antihistamine, or antipsychotic medication)
  • Presence of neurologic or immune-related medical condition or behavior known to influence the immune system (e.g. smoking or heavy drinking)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy control
Early-stage breast cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cancer-related fatigue
Time Frame: One year post chemotherapy
MFSI-SF will be used. This is a multidimensional questionnaire for measuring fatigue in cancer patients that has been validated in a group of breast cancer patients undergoing anticancer treatment. It consists of 30 items and has five subscales, each with six items: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor. The MFSI-SF measures different dimensions of fatigue, which can be combined to obtain an overall score. It has favorable psychometric properties with internal consistency reliability within the range of 0.87 to 0.96 and established convergent and divergent validity. As such, it is an appropriate tool for measuring fatigue.
One year post chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cognitive impairment
Time Frame: One year post chemotherapy
FACT-Cog will be used. The FACT-Cog was created to investigate the perceived impact of chemotherapy on cognitive functioning and associated impairments in quality of life. It is known in studies to assess broader aspects of cognitive complaints, thereby providing greater information about the types of cognitive complaints patients are experiencing. The qualitative data were examined using a thematic content analysis and the following domains were identified: Cognitive Problems (Cognitive), Impact on Functioning (IOF), and Impact on Quality of Life (QOL). Fifty items were written to assess these domains.
One year post chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 21, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/754/B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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