- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05352789
Nutrition and Metabolic Prehabilitation in HSCT Patients UK and ROI. BSBMT Multi-centre Survey.
Exploration of Nutrition and Metabolic Prehabilitation Practices for Haematopoietic Stem Cell Transplant (HSCT) in UK and ROI Transplant Centres: A BSBMT Multi-centre Survey
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
- Nottingham University Hospitals NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To understand the routine screening, assessment and management practices of nutritional and metabolic parameters prior to haematopoeitic stem cell transplantation in UK centres
Time Frame: Aug 20- March22
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full survey completion: see parameters below
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Aug 20- March22
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Differences in frequency of glycaemic screening prior to HSCT across UK and ROI HSCT centres and between health professionals
Time Frame: Aug 20-March22
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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)
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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
Time Frame: Aug 20-March22
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b. Lipid parameters: How often would you measure blood glucose and urinary glucose prior to HSCT? (likert scale - Always, often, sometimes, rarely, never)
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Aug 20-March22
|
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Differences in frequency of assessments of liver and renal function prior to HSCT across UK and ROI HSCT centres and between health professionals
Time Frame: Aug 20-March22
|
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)
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Aug 20-March22
|
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Differences in nutritional screening and assessment practices done prior to HSCT across UK and ROI HSCT centres and between health professionals
Time Frame: Aug 20-March22
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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.
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Aug 20-March22
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Differences in body composition assessments given prior to HSCT across UK and ROI HSCT centres and between health professionals
Time Frame: Aug 20-March22
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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.
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Aug 20-March22
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Differences in dietary advice given prior to HSCT across UK and ROI HSCT centres and between health professionals
Time Frame: Aug 20-March22
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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)
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Aug 20-March22
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Differences in enteral feeding practices prior to HSCT across UK and ROI HSCT centres and between health professionals
Time Frame: Aug 20-March22
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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)
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Aug 20-March22
|
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Differences in specialist dietary advice given prior to HSCT across UK and ROI HSCT centres and between health professionals
Time Frame: Aug 20-March22
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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.
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Aug 20-March22
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Differences in physical assessment, advice and delivery prior to HSCT across UK and ROI HSCT centres and between health professionals
Time Frame: Aug 20-March22
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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.
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Aug 20-March22
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To understand perceptions on the role and value of prehabilitation in HSCT
Time Frame: Aug 20-March22
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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.
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Aug 20-March22
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Perceptions on best composition of prehabilitation programme prior to HSCT.
Time Frame: Aug 20-March22
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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)
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Aug 20-March22
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Description of current HSCT prehabilitation services in adult services in UK and ROI
Time Frame: Aug 20-March22
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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?
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Aug 20-March22
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDBSBMT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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