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

September 2, 2021 updated by: Alexandre Chan, National University of Singapore
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.

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Anticipated)

236

Contacts and Locations

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

Study Contact

  • Name: Alexandre Chan, Pharm D
  • Phone Number: 65-81688672
  • Email: phaac@nus.edu.sg

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National Cancer Centre Singapore
      • Singapore, Singapore
        • Recruiting
        • KK Women's and Children's Hospital
      • Singapore, Singapore
        • Not yet recruiting
        • National University of Singapore

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

15 years to 39 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of cognitive impairment in AYA cancer patients
Time Frame: 6 months post recruitment
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 ®).
6 months post recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of impairment in each individual Cantab ® cognitive domain
Time Frame: 1 year post recruitment
The objective computer-based Cambridge Neuropsychological Test Automated Battery (Cantab ®) measures the domains attention, memory, executive function, response speed and processing speed.
1 year post recruitment
Prevalence of self-reported cognitive impairment
Time Frame: 1 year post recruitment
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.
1 year post recruitment
Incidence and trajectory of cancer-related fatigue
Time Frame: 1 year post recruitment
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.
1 year post recruitment
Extent of symptom burden
Time Frame: 1 year post recruitment
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.
1 year post recruitment
Psychosocial outcomes
Time Frame: 1 year post recruitment
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.
1 year post recruitment
Extent of Financial Distress
Time Frame: 1 year post recruitment
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.
1 year post recruitment
Biomarker levels in relation to cognitive impairment
Time Frame: 1 year post recruitment
Patients' plasma samples will be assessed for levels of BDNF, hormones and cytokines (IL1b, IL4, IL6) using multiplex immunoassay kits.
1 year post recruitment
Neuroimaging scans
Time Frame: 6 months post recruitment
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
6 months post recruitment
Lifestyle and activity data
Time Frame: 1 year post recruitment
Wearable devices will be used to track patients' lifestyle data such as steps per day, intensity and duration of exercise and caloric expenditure.
1 year post recruitment

Collaborators and Investigators

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

Sponsor

National University of Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 18, 2018

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRB Ref. No: 2017/3139

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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