Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Inflammation

Fatigue

Breast Diseases

Skin Diseases

Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.

The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.

Each session will last 20 to 60 minutes depending on the stage of progression (shorter duration in the first few weeks). Sessions will occur on nonconsecutive days of the week. Moderate-intensity, continuous aerobic exercise will be used to target large muscle groups (e.g., legs) with the principal goal of increasing cardiorespiratory fitness. Exercise intensity will be gradually increased. To mitigate stagnation and support continued improvement of cardiorespiratory fitness, high-intensity interval exercise will be added in later weeks of the intervention.

Aerobic Exercise Training

The flexibility/toning control condition will be delivered using the same frequency as the aerobic condition (i.e., 3 times per week) and use light resistance bands of least difficulty. The flexibility/toning sessions will last about 40 minutes, be led by trained exercise specialists. Flexibility/toning activities will target the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, and ankle/foot. The progression of activities over the 10-week period will involve performing additional exercises and sets along with using progressively thicker elastic resistance bands (i.e., Thera-bands) that provide minimal resistance.

Attention Control

Laura Q Rogers, MD, MPH

Ildiko Nyikos, M.A., ACSM-RCEP

Laura Q Rogers, MD

Gary Hunter, PhD

Bulent Turan, PhD

Helen Krontiras, MD

Elliot Lefkowitz, PhD

Robert Motl, PhD

Nianjun Liu, PhD

Stephen J Carter, PhD

The primary goal of this project is to determine the effects of exercise on the gut microbiome in breast cancer survivors and determine how these changes may relate to psychosocial symptoms such as fatigue.

Cancer survivors are at increased risk of gut bacteria communities that can negatively impact health and energy level and it is possible that exercise can cause healthy changes in these communities. Through careful design, this study will use a controlled-feeding diet and 10 weeks of exercise training to determine exercise effects on the number, distribution, and types of bacteria in the gut of breast cancer survivors. These changes will then be linked to fatigue and physiologic effects of exercise to determine how the information can be used to enhance exercise benefits and identify new treatment strategies leveraging changes in gut bacteria communities.

Assessors will be blinded to participant study group allocation

Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors

Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study)

Any data collected with National Institutes of Health (NIH) funding and made public through publication in a peer-reviewed format will thereafter be available on request to faculty of institutions with Public Health Service (PHS) assurance. For sharing data and specimens from individual human subjects, the investigators will comply with all relevant policies including the "Standards for Privacy of Individually Identifiable Health Information" rule of the Health Insurance Portability and Accountability Act (HIPAA). For sharing data, the investigators will comply with the requirements of the Final NIH Statement on Sharing Research Data (NOT-OD-03-032), the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) (NOT-OD-07-088), the NIH Genomic Data Sharing Policy (NOT-OD-14-124), and all other existing, updated, and new requirements as stated by NIH policy.

Cardiorespiratory fitness test on a treadmill

Motion sensor measures physical activity not observed during intervention activities

Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life

Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy.

Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress.

Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory.

Using standard diversity and taxa comparison metrics

Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)

Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly

Hormone change that is associated with stress

Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue

National Cancer Institute (NCI)

University of Alabama at Birmingham

Principal Investigator

Behaviors and Mental Disorders

Blood and Lymph Conditions

Nervous System Diseases

Rare Diseases

Depression

Depressive Disorder

Hematologic Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Hematologic Diseases

Quality of Life

Brain Tumor, Childhood

The study participants will be 5 to 21 years old children with newly diagnosed brain tumors presenting with any stage, who have not undergone any treatment

The study participants will be 5 to 21 years old children with newly diagnosed blood cancer presenting with any stage, who have not undergone any treatment

Neurocognitive tools

Nida Zahid

Andreas Martensson

Nick Brown

Syed Ather Enam

Naureen Mushtaque

Muhammad Nouman Mughal

Mariya Moochaala

Sadaf Altaf

Salman Kiramani

Lal Rehman

Farrukh Javed

This will be the first in-depth study to evaluate pretreatment and 12 months post-treatment, neurocognitive and psychological outcomes of children with brain tumor and blood cancer in Pakistan. The investigators will also determine the socioeconomic burden of pediatric brain tumors in low middle-income region and the association of micro RNA and protein markers with neurocognitive outcomes in PBT and blood cancer children. A prospective cohort study with a follow-up of 12 months at the Aga Khan University Hospital, Karachi, Pakistan and Jinnah postgraduate Medical Centre , Karachi, Pakistan will be conducted. After taking consent/ assent the investigators will recruit 80, 5-21 years old children with newly diagnosed brain tumors presenting with any stage, who have not undergone any treatment. Trained psychologist will assess the neurocognitive outcomes by the Slosson scale, Raven's progressive matrices and Wechsler Intelligence Scale for children (WISC V) and Wechsler Adult Intelligence Scale (WAIS-IV) tools. The Quality of life and depression of the children will be determined by PedQL and Revised Children's Anxiety and Depression Scale (RCADS) and hospital anxiety and depression scale (HADs) respectively . The financial burden of the disease on the family will be measured on a visual analog scale ranging from no burden (0) to very large burden (100) and the parents QoL and disrupted schedule, financial problems, lack of family support, health problems and the impact of caregiving on caregiver's self-esteem will be assessed by Pediatric Quality of Life Inventory PedQl (family module) and Caregiver Reaction Assessment (CRA) tools respectively. The serum micro RNA (mi-21, mi-10b and mi-210) and protein markers (GFAP, NSE and S100β) will be assessed by qRT-PCR and ELISA.

Rationale: The synergy between poverty, socio-cultural, psychosocial and biological risk factors influences neurocognitive outcomes in children. In a LMIC like ours where children are growing up at a disadvantage, it is important the child's future potential and productivity. To the best of the investigators knowledge limited information, there is no data in this area from Pakistan. Data to assess the neurocognitive and psychological outcomes of children during this vulnerable period and to design interventions which may help to improve from this study will be enable the assessment of direction and magnitude of effects, identify high risk children whom would benefit from individual treatment and, with this knowledge, enhance family support Study Design and Site A prospective cohort study with a follow-up of 12 months. The study will be conducted at the Aga Khan University Hospital (AKUH) and Jinnah post graduate Medical Centre (JPMC). The participants will be recruited from the neurosurgery/oncology clinics.

Study Participants The study participants will be 5 to 21 years old children with newly diagnosed brain tumors and blood cancer presenting with any stage, who have not undergone any treatment

Sampling strategy Purposive sampling technique will be used for selecting the participants. The target population, that is, brain tumor and blood cancer children who have not received cancer treatment, will be approached by trained psychologist.

Sample size: With a mean difference of neurocognitive outcome ranging from 15 to 23 and difference of standard deviation ranging from 14 to 27, from pretreatment to 12 months post treatment .And with a mean difference of Quality of life ranging from 9 to 16 and difference of standard deviation ranging from 18 to 19 . With a power of 80% and level of significance of 5%. However, the investigators calculated the sample size using two population mean in order to compare the mean neurocognitive and psychological scores of the two groups. With an anticipated mean difference of 6, a standard deviation of 15 for the two groups, a level of significance of 5%, and power of 80%. Therefore the final sample size will be 80 patients ( 40 pediatric brain tumor patients and 40 blood cancer patients), with a 10% inflation for loss to follow-up

Data collection The children with brain tumor and blood cancer will be recruited from the surgery/ pediatric oncology clinics AKUH. Screening tool will be administered for eligibility of the study participant for the study. The Pediatric Quality of Life Inventory , PedsQL family information form will be completed by the parents that contains demographic information required to calculate Hollingshead socioeconomic status (SES). Information will also be collected on; tumor and treatment related factors, histopathology, family history, nutritional status, consanguinity and perinatal risk factors and molecular expression analysis chart on a structured questionnaire for pediatric brain tumor patients and blood cancer patients

The neurocognitive outcomes of the eligible children will be assessed by a psychologist at baseline i.e., before treatment and 12 months post-treatment. It will be assessed by the Slosson Intelligence tool Revised 3rd edition (SIT-R3) and Raven's Progressive Matrices (RPM).The progressing speed will be assessed by Wechsler Intelligence Scale for children (WISC V) and Wechsler Adult Intelligence Scale (WAIS-IV)

Plan of Analysis Data will be analyzed using STATA version 15. Results will be presented as mean and standard error/ median , interquartile range (IQR) for cognitive outcomes, quality of life (QoL) scores and financial burden scores. Pretreatment and 12 months post treatment scores will be assessed by paired t test/ wilcoxon sign rank test as appropriate. Categorical variables will be reported as frequency and percentages and will be assessed by chi-square/ fisher exact test. Correlation analysis will be preformed to assess relationship of child's neurocognitive outcome scores with QoL scores and child's QoL scores with the parents QoL scores. Unadjusted and adjusted beta coefficient with 95% CI will be reported by using Linear mixed effects models (LMEMs) to determine the association of various independent factors such as child factors (demographic factors), parental factors (educational status, socioeconomic status, prenatal exposure/ infections) , tumor and treatment related factors with the neurocognitive outcomes and QoL. We will adjust for the independent variables and determine the association of factors causing a greater decline in outcomes by multivariable Linear mixed effects models (LMEMs) . Plausible interactions will also be assessed. A p value of \< 0.05 will be considered as significant throughout the study

Serum will be stored to assess microRNA and Protein markers

Neurocognitive and Psychosocial Outcomes Among Pediatric Brain Tumor and Blood Cancer Patients

Neurocognitive and Psychosocial Outcomes Among Pediatric Brain Tumor and Blood Cancer Patients Presenting to a Tertiary Care Hospital of Karachi, Pakistan: A Prospective Cohort Study

The Verbal component of neurocognition will be assessed by slosson scale.A higher score means a better outcome

The non verbal component of neurocognition will be assessed by Raven tool (non verbal) a higher score means good neurocognition

The non verbal component i.,e processing speed of neurocognition will be assessed by Wechler scale . A high score means good neurocognition

Pediatric Quality of Life Inventory tools ( generic, brain module and cancer module); Score 0-100; higher scores means good Quality of life

Revised Children's Anxiety and Depression Scale and hospital anxiety and depression scale; score 0-141 a higher score mean high depression and anxiety; 0-7 mild depression and anxiety; 8=10 moderate depression and anxiety and 11-21 severe depression and anxiety

Pediatric Quality of Life™ Family Impact Module will be used to assess parents quality of life ; a higher score means a good Quality of life

serum micro RNA (mi-21, mi-10b and mi-210) and will be assessed by qRT-PCR

protein markers S100β will be assessed by ELISA

protein markers NSE will be assessed by ELISA

protein markers GFAP will be assessed by ELISA

visual analog scale ranging from no burden (0) to very large burden (100). high score and means higher burden of the disease

The questionnaire consists of 24 items measuring five subscales: impact on disrupted schedule, financial problems, lack of family support, health problems and impact on self-esteem. Caregivers have to indicate their level of agreement using a 5-point Likert-type Scale ranging from 1 (strongly disagree) to 5 (strongly agree). For each subscale, a score is calculated by taking the average of the items. Higher scores indicate a greater impact (either beneficial or detrimental).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors	NCT04088708	Breast Cancer Gut Microbiome Exercise Fatigue	Aerobic Exercis... Attention Contr...	18 Years - 74 Years	University of Alabama at Birmingham
Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors	NCT04088708	Breast Cancer Gut Microbiome Exercise Fatigue	Aerobic Exercis... Attention Contr...	18 Years - 74 Years	University of Alabama at Birmingham
Neurocognitive and Psychosocial Outcomes Among Pediatric Brain Tumor and Blood Cancer Patients	NCT05709522	Brain Tumor, Pe... Blood Cancer	Neurocognitive ...	5 Years - 21 Years	Aga Khan University
Neurocognitive and Psychosocial Outcomes Among Pediatric Brain Tumor and Blood Cancer Patients	NCT05709522	Brain Tumor, Pe... Blood Cancer	Neurocognitive ...	5 Years - 21 Years	Aga Khan University

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