Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant

Study Overview
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Brief Summary
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Children who receive hematopoietic cell transplants (HCT) are at high nutritional risk due to comorbidities and complications that are likely to develop before, during and after transplant. Prior to transplant, many children undergo multiple rounds of chemotherapy which affect appetite and cause gastrointestinal toxicities that limit food intake. During transplant, painful mucositis makes it difficult to consume adequate nutrients and often children will require nutrition support such as parenteral or enteral nutrition. Energy imbalance and physical deconditioning following transplant can result in loss of lean body mass and functional impairment; these nutritional side effects are exacerbated if the child develops graft-versus-host disease. After transplant, a substantial number of childhood cancer survivors become overweight and develop metabolic syndrome. However, little is known about the prevalence and distribution of pediatric malnutrition (under-nutrition as well as obesity), the psychosocial factors that affect dietary intake and how the quality of the child's food intake and physical activity level throughout the transplant process might affect body composition and clinical outcomes. In this exploratory study, we will monitor nutritional status in pediatric patients undergoing HCT. This study will test the feasibility of collecting patient-reported dietary intake data along with anthropometric, body composition, functional status and psychosocial measurements that may influence dietary intake in pediatric patients undergoing HCT. The data collected in this preliminary analysis will inform future interventional studies.

Official Title
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Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant

Conditions
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Malnutrition, Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric hematopoietic cell transplant patients, aged 2-25 years. Participants and/or at least one caregiver must speak, read and understand English. Exclusion Criteria: Children younger than 2 years old at the time of their transplant or any child who is still breastfeeding will not be eligible due to the nature of the questionnaires and measurements.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric patients<br>This is an observational study. Validated measures of nutritional status, dietary intake, body composition, functional status and psychosocial factors will be used to measure outcomes in study patients at 4 time-points: (1) pre-HCT (Baseline), (2) 30-days post-HCT, (3) 100-days post-HCT and (4) one year post-HCT. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of comprehensive nutrition assessments in pediatric HCT patients | Feasibility is defined as completion of comprehensive nutrition assessment by at least 50% of participants. | 1 year post-HCT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary intake |  | baseline (pre-HCT); day 30, day 100 and 1 year post-HCT | 
| Determination of lean body mass measured using air displacement plethysmography (BOD POD) |  | baseline (pre-HCT); day 100 and 1 year post-HCT | 
| Hand grip strength |  | baseline (pre-HCT); day 30, day 100 and 1 year post-HCT | 
| PedsQL Pediatric Quality of Life Inventory | Participants 10 years or older | baseline (pre-HCT); day 30, day 100 and 1 year post-HCT | 
| PedsQL Cognitive Functioning Scale | Participants 10 years or older | baseline (pre-HCT); day 30, day 100 and 1 year post-HCT | 
| Dietary Patient Self-Efficacy Survey | Participants 10 years or older | baseline (pre-HCT); day 30, day 100 and 1 year post-HCT |