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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05352789
Other study ID # IDBSBMT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date March 1, 2022

Study information

Verified date October 2023
Source Nottingham University Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date March 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - All paediatric HSCT services

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non validated Survey
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.

Locations

Country Name City State
United Kingdom Nottingham University Hospitals NHS Trust Nottingham Nottinghamshire

Sponsors (4)

Lead Sponsor Collaborator
Nottingham University Hospitals NHS Trust Sheffield Teaching Hospitals NHS Foundation Trust, University of Nottingham, University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 To understand perceptions on the role and value of prehabilitation in HSCT a. Point of effectiveness: using responses from three questions; Do you think prehabilitation should be considered as part of future services for HSCT? (Yes/no/unsure); When in the HSCT pathway do you think a prehabilitation service could be introduced? Assessed via categorical data (Prior to diagnosis, at diagnosis prior to chemotherapy, during induction chemotherapy, end of induction chemotherapy, maintenance chemo, during HSCT assessment clinic, other than listed); Do you think any changes are needed to the Silver et al (2013) prehabilitation definition in order for it to be relevant to HSCT?* (yes/no/unsure); 2 x free text answers for concerns and barriers to implementation. Aug 20-March22
Secondary Perceptions on best composition of prehabilitation programme prior to HSCT. a) This would be answered with two questions: How important do you think exercise, nutrition and psychological care are in prehabilitation programme for HSCT? (very important, important, moderately important, slightly important, not important) ; Are there any other components that you think should be considered as part of a prehabilitation programme for HSCT? (free text) Aug 20-March22
Secondary Description of current HSCT prehabilitation services in adult services in UK and ROI 2 x single select; What components of prehabilitation does your service include? (nutrition, psychology, exercise, other); Do you have a dedicated prehabilitation service for HSCT at your unit? (yes/no/unsure); Which other components are included as part of your prehabilitation programme for HSCT? Aug 20-March22
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