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

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ClinicalTrials.gov Identifier: NCT02734797
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
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.

Condition or disease
Malnutrition Obesity

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant
Study Start Date : November 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

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.



Primary Outcome Measures :
  1. Feasibility of comprehensive nutrition assessments in pediatric HCT patients [ Time Frame: 1 year post-HCT ]
    Feasibility is defined as completion of comprehensive nutrition assessment by at least 50% of participants.


Secondary Outcome Measures :
  1. Dietary intake [ Time Frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT ]
  2. Determination of lean body mass measured using air displacement plethysmography (BOD POD) [ Time Frame: baseline (pre-HCT); day 100 and 1 year post-HCT ]
  3. Hand grip strength [ Time Frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT ]
  4. PedsQL Pediatric Quality of Life Inventory [ Time Frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT ]
    Participants 10 years or older

  5. PedsQL Cognitive Functioning Scale [ Time Frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT ]
    Participants 10 years or older

  6. Dietary Patient Self-Efficacy Survey [ Time Frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT ]
    Participants 10 years or older



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Ages Eligible for Study:   2 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric hematopoietic cell transplant patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734797


Contacts
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Contact: Sung Won Choi, MD, MS 734-615-5707 sungchoi@med.umich.edu

Locations
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United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Sung Choi, MD, MS    734-615-5707    sungchoi@med.umich.edu   
Principal Investigator: Sung Choi, MD, MS         
Sponsors and Collaborators
University of Michigan Rogel Cancer Center

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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT02734797     History of Changes
Other Study ID Numbers: UMCC 2015.108
HUM00102331 ( Other Identifier: The University of Michigan )
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders