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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Observational


Primary Outcome

Prevalence of cognitive impairment in AYA cancer patients

Secondary Outcome

 Prevalence of impairment in each individual Cantab ® cognitive domain

Condition

Breast Cancer


Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

236

Start Date

June 18, 2018

Completion Date

September 1, 2021

Primary Completion Date

June 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  between 15-39 years of age

          -  newly diagnosed with breast cancer, lymphoma or germ cell tumor with treatment intent
             determined as curative by medical oncologist

          -  scheduled for chemotherapy with or without non-cranial radiotherapy

          -  no prior history of chemotherapy and/or radiotherapy

          -  able to read and understand English

          -  capable of giving informed consent (or obtaining parents' consent if required)

        Exclusion Criteria:

          -  physically or mentally incapable of providing verbal/written consent

          -  diagnosed with primary or metastatic brain tumor(s) or relapsed disease

          -  treatment includes intrathecal or intraventricular chemotherapy

          -  evidence of psychosis or underlying neuropsychiatric illness that may impair cognitive
             abilities

          -  have immediate family member who is enrolled as in the healthy control arm

          -  any contraindication to MRI as stated in the study protocol including: pregnancy,
             metal fragments/implants in body, known claustrophobia, and non-removable metal
             orthodontic braces, metallic retainers and oral wires
      

Gender

All

Ages

15 Years - 39 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Alexandre Chan, Pharm D, 65-81688672, [email protected]

Location Countries

Singapore

Location Countries

Singapore

Administrative Informations


NCT ID

NCT03476070

Organization ID

CIRB Ref. No: 2017/3139


Responsible Party

Principal Investigator

Study Sponsor

National University, Singapore


Study Sponsor

Alexandre Chan, Pharm D, Principal Investigator, National University of Singapore, National Cancer Centre Singapore


Verification Date

September 2020