NCT04591340

Brief Summary

To analysis a standardized stepped nutritional treatment process for patients with hematopoietic stem cell transportation, including nutritional risk screening and assessment, standardized nutritional treatment implementation, therapeutic effect follow-up and monitoring, family nutritional treatment follow-up, etc

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

October 19, 2020

Status Verified

September 1, 2020

Enrollment Period

12 months

First QC Date

October 9, 2020

Last Update Submit

October 9, 2020

Conditions

Keywords

HSCT; Nutrtion

Outcome Measures

Primary Outcomes (2)

  • Improvement of nutritional status

    We collect the body composition and grip strength of every HSCTpatients. Body composition include the muscle and fat contents.They are all measured as kilogram. (kg). Specific nutritional guidelines will be provided based on body composition results

    4 months

  • Improvement of quality of life

    We asked each patient to complete the quality of life scale for every HSCTpatient. There are 32 questions in the scale, and each question has 4-7 options. The higher the score, the heavier it is.We will decide whether to give psychological intervention based on the score.

    4 months

Study Arms (1)

test group

all the patients treated with HSCT are with nutrition risk, so they will be all included to accept nutrition therapy.

Dietary Supplement: dietary advice, oral nutritional supplement, supplementary parenteral nutrition or total parenteral nutrition

Interventions

All HSCT(hematopoietic stem cell transplantation) patients should be accepted dietary advice or oral nutritional supplement, if their energy intake will not reach 60% of the goal level during the transplanting, then supplementary parenteral nutrition or total parenteral nutrition.

test group

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Both female and male patients and between 10 to 79 years old treated with HSCT can be included.

You may qualify if:

  • Patients treated with HSCT

You may not qualify if:

  • nothing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feng

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Interventions

Nutrition AssessmentDietary SupplementsParenteral Nutrition, Total

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesParenteral NutritionFeeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 19, 2020

Study Start

January 1, 2021

Primary Completion

December 31, 2021

Study Completion

July 1, 2022

Last Updated

October 19, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations