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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Malnutrition

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 23 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric hematopoietic cell transplant patients

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pediatric patients; 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?

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

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2016
• Primary Completion (Actual): February 10, 2020
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimated): April 12, 2016

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: UMCC 2015.108; HUM00102331 (Other Identifier: The University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO