FatigueNCT02304640
Prevalence, Severity and Determinants of Cancer-related Fatigue (CRF) in Asian Breast Cancer Patients
An observational study of Fatigue and Chemotherapy, run by National University of Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Chemotherapy, Breast Cancer
- How many people
- 194 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2014to Dec 2020
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fatigue, Chemotherapy, Breast Cancer, Supportive Care
- Keywords
- fatigue, chemotherapy, breast cancer, supportive care, Singapore
- Medical subject headings
- Fatigue, Breast 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 |
|---|---|---|
| Early-stage breast cancer patients | Not described | |
| Healthy control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cancer-related fatigue
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.
Measured: One year post chemotherapy
Secondary outcomes (1)
Incidence of cognitive impairment
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.
Measured: One year post chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Chan, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304640
- Sponsor's protocol ID
- 2014/754/B
- Status last verified
- Sep 2020
- First submitted
- 21 Nov 2014
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Severity and Determinants of Cancer-related Fatigue (CRF) in Asian Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02304640
- Acronym / sponsor ID
- 2014/754/B
- Conditions
- Fatigue, Chemotherapy, Breast Cancer, Supportive Care
- Keywords
- fatigue, chemotherapy, breast cancer, supportive care, Singapore
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Dec 2014 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early-stage breast cancer patients | – | – |
| Healthy control | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
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
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.
1 secondary outcome
Incidence of cognitive impairment
Time frame: One year post chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fatigue and Chemotherapy, run by National University of Singapore at 1 site in Singapore.
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 7 inclusion and 5 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 11 Sep 2020. 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 Singapore. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cancer-related fatigue (time frame: One year post chemotherapy). 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 11 Sep 2020.