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

Sponsor

National University, Singapore (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02304640

Collaborator

(none)

194

Enrollment

Location

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Fatigue Chemotherapy Breast Cancer Supportive Care

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 Design

Study Type:

Observational

Anticipated Enrollment :

194 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Early-stage breast cancer patients
Healthy control

Outcome Measures

Primary Outcome Measures

Incidence of cancer-related fatigue [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.

Secondary Outcome Measures

Incidence of cognitive impairment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)