AzTrials
AzTrials

Haematological MalignancyNCT05352789

Nutrition and Metabolic Prehabilitation in HSCT Patients UK and ROI. BSBMT Multi-centre Survey.

An observational study of Haematological Malignancy and Bone Marrow Transplant Complications, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Non validated Survey
How many people
66 participants
Where
1 siteUnited Kingdom
Study dates
1 Aug 2020to 1 Mar 2022
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Health care professionals working within an adult HSCT setting

Who may be able to join

  • 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

Who cannot join

  • All paediatric HSCT services

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Nottingham University Hospitals NHS Trust

    Nottingham, Nottinghamshire, NG5 1PB

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
Non validated Survey
Keywords
nutrition, metabolism, exercise, bone marrow transplant, stem cell transplant, autologous transplant, allogeneic transplant, prehabilitation
Medical subject headings
Hematologic Neoplasms, Metabolic Diseases, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non validated SurveyOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Aug 20- March22

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

    1. 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)

    Measured: Aug 20-March22

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

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

    Measured: Aug 20-March22

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

    1. 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)

    Measured: Aug 20-March22

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

    1. 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.

    Measured: Aug 20-March22

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

    1. 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.

    Measured: Aug 20-March22

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

    1. 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)

    Measured: Aug 20-March22

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

    1. 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)

    Measured: Aug 20-March22

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

    1. 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.

    Measured: Aug 20-March22

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

    1. 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.

    Measured: Aug 20-March22

Secondary outcomes (3)
  1. To understand perceptions on the role and value of prehabilitation in HSCT

    1. 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.

    Measured: Aug 20-March22

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

    1. 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)

    Measured: Aug 20-March22

  3. 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?

    Measured: Aug 20-March22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2022
  2. Study start1 Aug 2020
  3. Primary completion1 Mar 2022
  4. Study completion1 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05352789
Sponsor's protocol ID
IDBSBMT
Status last verified
Oct 2023
First submitted
24 Mar 2021
Last updated
5 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in