Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Fatigue

Breast Diseases

Skin Diseases

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.

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.

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

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.

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.

National University of Singapore

Associate Professor and Specialist Pharmacist (Oncology Pharmacy)

Behaviors and Mental Disorders

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Cognitive Dysfunction

Lymphoma

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Lymphosarcoma

Germ Cells Tumors

Patients (aged between 15-39) diagnosed with breast cancer, lymphoma or germ cell tumor

Alexandre Chan, Pharm D

This study aims to evaluate the prevalence, biological mechanism and survivorship impact of cognitive toxicity among adolescent and young adult (AYA) patients diagnosed with curable cancers. The hypothesis is that cognitive impairment is clinically significant among AYA cancer patients treated with chemotherapy and that there will be detectable structural and functional changes in the brain for this patient group.

A prospective longitudinal cohort study will be conducted at National Cancer Centre Singapore (NCCS) and KK Women's and Children's Hospital (KKH) from April 2018 to April 2021. Eligible cancer patients aged between 15-39 years old will be recruited and followed up for a period of 12 months. In addition, healthy individuals will also be recruited into the control arm of the study. The prevalence of cognitive impairment will be assessed via objective cognitive functional assessments in the form of the Cambridge Neuropsychological Test Automated Battery (Cantab) test scores and Functional Assessement of Cancer-Therapy Cognitive Function (FACT-Cog v3.0). The overall cognitive performance and post-treatment health issues measured by the assessment tools used would be compared between AYA cancer patients and healthy controls at baseline and 6 months after baseline.

Other post-treatment health issues will be assessed in relation to cognitive impairment with a series of questionnaires including Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) for cancer-related fatigue, the Rotterdam Symptom Checklist (RSCL) for symptom burden, the Paediatrics Quality of Life Inventory (PedsQL 4.0) for psychosocial outcomes, InCharge questionnaire for perceived financial distress and a work/education questionnaire respectively.

To enhance the understanding of the biological mechanism behind cognitive impairment, levels of biomarkers and genetic determinants will also be correlated with overall cognitive impairment. Blood plasma samples drawn from patients will be assessed for Brain-derived neutrotrophic factor (BDNF) levels, hormone levels and pro-inflammatory cytokines such as IL-1β, IL-4, and IL-6 using multiplex immunoassay. MRI scans and relevant neuroimaging techniques will be used to assess structural changes and functional connectivities in brain. Lastly, wearable devices will be utilized to track activity and lifestyle data among AYA cancer patients to investigate on the extent of impact of cognitive impairment and to assess the feasibility of using these wearables devices to personalize symptom management.

Findings from this proposed study will enhance understanding of cognitive toxicity and post-treatment health issues faced by the AYA patient group, which will facilitate the development of effective interventions to better cope with their daily lives.

Whole blood processed into plasma and buffy coat.

Adolescent and Young Adult Cancer Patients: Cognitive Toxicity on Survivorship (ACTS)

Compare the prevalence of overall cognitive impairment at 6 months from baseline, between AYA cancer patients and healthy controls. Cognitive impairment is measured by the overall cognitive performance using the objective computer-based Cambridge Neuropsychological Test Automated Battery (Cantab ®).

The objective computer-based Cambridge Neuropsychological Test Automated Battery (Cantab ®) measures the domains attention, memory, executive function, response speed and processing speed.

Functional Assessment of Cancer Therapy-Cognition Function (FACT-Cog) a 37-item questionnaire which measures six cognitive domains: memory, concentration, mental acuity, verbal fluency, functional interference and multitasking ability. The response is based on the perceived cognitive function within the past 7 days using a 5-point Likert scale ranging from 0 as "never" to 4 as "several times a day". The individual subscales scores are summed to determine the FACT-Cog total score, ranging from 0 to 148, with higher scores indicating better cognitive functioning. Self-reported cognitive impairment is measured using the minimal clinically important difference of 10.6 points.

Multi-dimensional Fatigue Symptom Inventory-Short Form (MSFI-SF) is a 30-item questionnaire to assess the five domains of fatigue: general, emotional, vigour, physical and mental. The total score of the questionnaire is obtained by subtracting vigor from the sum of all domains. It ranges from -24 to 96, with a higher total score indicating increased fatigue. Cancer-related fatigue is defined using the minimal clinically important difference of 10.8 points.

Rotterdam Symptom Checklist (RSCL) is used to measure symptom-related distress. It It uses a 4-point Likert-type scales (not at all, a little, quite a bit, very much) and contains 39 items in four domains: physical symptom distress, psychological distress, activity level and overall global life quality. The higher the score, the higher the level of burden or impairment.

Pediatrics Quality of Life Inventory (PedsQL) will be used to measure health-related quality of life in adolescents, with domains to assess both physical and psychosocial health. The psychosocial health summary score ranges from 0-100, whereby a higher score suggests a better HRQOL.

The InCharge Financial Distress/Financial Well-Being Scale is an 8-item scale designed to assess perceived financial distress. The score is obtained by summing the number of points of each of the items and dividing the total by 8. The scale ranges from a continuum from 1 to 10 where 1 represents overwhelming financial distress/lowest financial well-being and 10 being no financial distress/highest financial well-being.

Patients' plasma samples will be assessed for levels of BDNF, hormones and cytokines (IL1b, IL4, IL6) using multiplex immunoassay kits.

Neuroimaging using MRI (Functional-MRI, Diffusion Weighted, T1-Weighted and T2-Weighted sequences) will be used to determine functional and structural changes in brain such as gray matter volume, which are then correlated to cognitive impairment

Wearable devices will be used to track patients' lifestyle data such as steps per day, intensity and duration of exercise and caloric expenditure.

Study title	NCT ID	Conditions	Eligibility	Organization
Prevalence, Severity and Determinants of Cancer-related Fatigue (CRF) in Asian Breast Cancer Patients	NCT02304640	Fatigue Chemotherapy Breast Cancer Supportive Care	21 Years -	National University of Singapore
Prevalence, Severity and Determinants of Cancer-related Fatigue (CRF) in Asian Breast Cancer Patients	NCT02304640	Fatigue Chemotherapy Breast Cancer Supportive Care	21 Years -	National University of Singapore
Adolescent and Young Adult Cancer Patients: Cognitive Toxicity on Survivorship (ACTS)	NCT03476070	Breast Cancer Lymphoma Germ Cell Tumor Cognitive Impai...	15 Years - 39 Years	National University of Singapore

Spots Global Cancer Trial Database for singapore

Every month we try and update this database with for singapore cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for singapore

Every month we try and update this database with for singapore cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for singapore cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.