NCT05352789

Brief Summary

To explore current practices of nutrition and metabolic screening, assessment and management prior to Haematopoietic Stem Cell Transplant (HSCT) in UK and ROI transplant centres. Nutrition and metabolic parameters assessed in the survey include glycaemic control, lipid function, liver function, nutritional screening, nutritional assessment, nutrition intervention (tube feeding, diet, micronutrient) and exercise. This work will be used to inform the design of a UK dual centre feasibility study of personalised nutrition and metabolic care for HSCT patients prior to transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

1.6 years

First QC Date

March 24, 2021

Last Update Submit

October 2, 2023

Conditions

Keywords

nutritionmetabolismexercisebone marrow transplantstem cell transplantautologous transplantallogeneic transplantprehabilitation

Outcome Measures

Primary Outcomes (10)

  • To understand the routine screening, assessment and management practices of nutritional and metabolic parameters prior to haematopoeitic stem cell transplantation in UK centres

    full survey completion: see parameters below

    Aug 20- March22

  • Differences in frequency of glycaemic screening prior to HSCT across UK and ROI HSCT centres and between health professionals

    a) Glycaemic screening will be assessed by 2 responses: How often would you measure blood glucose and urinary glucose prior to HSCT? (likert scale - Always, often, sometimes, rarely, never)

    Aug 20-March22

  • Differences in frequency of assessments of lipid profile screening prior to HSCT across UK and ROI HSCT centres and between health professionals

    b. Lipid parameters: How often would you measure blood glucose and urinary glucose prior to HSCT? (likert scale - Always, often, sometimes, rarely, never)

    Aug 20-March22

  • Differences in frequency of assessments of liver and renal function prior to HSCT across UK and ROI HSCT centres and between health professionals

    c. Liver and renal function screening frequency will be asked: 1. How often would you measure liver/kidney function as blood samples prior to HSCT? (likert scale - Always, often, sometimes, rarely, never); 2. How often would you measure liver/kidney function using a scan prior to HSCT? (likert scale - Always, often, sometimes, rarely, never)

    Aug 20-March22

  • Differences in nutritional screening and assessment practices done prior to HSCT across UK and ROI HSCT centres and between health professionals

    d. Nutritional screening and assessment: Routine inclusion of nutritional screening and assessment practices prior to HSCT will be assessed using 4 mandatory questions, 3 - yes/no/unsure and 1 categorical question. Practical details of strategies of assessment and measurement will be assessed using 5 categorical questions and 6 free text questions.

    Aug 20-March22

  • Differences in body composition assessments given prior to HSCT across UK and ROI HSCT centres and between health professionals

    e. Assessment of body composition: Routine inclusion of body composition assessment prior to HSCT will be assessed using 2 mandatory questions, 1 - yes/no/unsure and 1 categorical question. Practical details of strategies of assessment and measurement will be assessed using 2 categorical questions and 3 free text questions.

    Aug 20-March22

  • Differences in dietary advice given prior to HSCT across UK and ROI HSCT centres and between health professionals

    f. Dietary advice: Routine inclusion of dietary advice prior to HSCT will be assessed using 3 mandatory questions, 1 - yes/no/unsure and 2 - five point likert scales (definitely = 4, very probably = 3, probably=2, probably not = 1, definitely not =0). Practical details of types of dietary advice and strategies for implementation will be assessed using 2 categorical questions, 2 free text questions and 3 - six point likert scaled consensus statements (Always= 5, very frequently = 4, occasionally = 3, rarely = 2, very rarely = 1, never = 0)

    Aug 20-March22

  • Differences in enteral feeding practices prior to HSCT across UK and ROI HSCT centres and between health professionals

    g. Enteral feeding: Routine inclusion of enteral feeding prior to HSCT will be assessed using 2 mandatory questions, 1 - categorical. Practical details of types of enteral feeding tubes 2 questions (1 - categorical questions, 1 free text)

    Aug 20-March22

  • Differences in specialist dietary advice given prior to HSCT across UK and ROI HSCT centres and between health professionals

    h. Micronutrient supplementation: Routine inclusion of micronutrient advice prior to HSCT will be assessed using 1 mandatory question, yes/no/unsure format. Practical details of micronutrient supplementation practices using 1 categorical questions and 1 free text question.

    Aug 20-March22

  • Differences in physical assessment, advice and delivery prior to HSCT across UK and ROI HSCT centres and between health professionals

    i. Exercise: As part of routine practice how often do patients receive exercise advice prior to HSCT? (likert response: Always, often, sometimes, rarely, never); As part of "routine practice" how often do your patients have their activity levels measured prior to HSCT i.e. questionnaire or physical assessment? response: Always, often, sometimes, rarely, never); and 2 multi select questions to determine professionals delivering care.

    Aug 20-March22

Secondary Outcomes (3)

  • To understand perceptions on the role and value of prehabilitation in HSCT

    Aug 20-March22

  • Perceptions on best composition of prehabilitation programme prior to HSCT.

    Aug 20-March22

  • Description of current HSCT prehabilitation services in adult services in UK and ROI

    Aug 20-March22

Interventions

Overall inclusion of metabolic and nutritional parameters in prehabilitation practices will be assessed as the proportion of each parameter conducted from the mandatory queries presents as yes/no/unsure responses for each centre. Intervention or process details for included parameters will be described based on the response variable. The survey presents 4 question formats; free text (thematic qualitative analysis), 5 and 6 point likert scales (proportional response), categorical data (proportional response) and yes/no/unsure response sets (Binary response (no and unsure - grouped). All categorical data versions are parameter dependent and response variables can be requested from the research team.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Health care professionals working within an adult HSCT setting

You may qualify if:

  • BSBMT registered adult HSCT centres (including TYA services where patients have opted to be treated in an adult service pathways)
  • Centres delivering either autologous or allogeneic stem cell transplants

You may not qualify if:

  • All paediatric HSCT services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Hematologic NeoplasmsMetabolic DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNutritional and Metabolic DiseasesBehavior

Study Design

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

Study Record Dates

First Submitted

March 24, 2021

First Posted

April 29, 2022

Study Start

August 1, 2020

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

October 5, 2023

Record last verified: 2023-10

Locations