Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000052639
Ethics application status
Approved
Date submitted
30/11/2022
Date registered
17/01/2023
Date last updated
14/01/2024
Date data sharing statement initially provided
17/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Preparing, Planning and Prehab for Stem Cell Transplant: A Multidisciplinary Approach
Scientific title
Investigating the effect of multidisciplinary prehabilitation on deconditioning, hospital acquired complications and length of stay in patients offered Haematopoietic allogenic stem cell transplant: A feasibility trial.
Secondary ID [1] 308510 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute myeloid leukaemia 328331 0
Myelodysplastic syndromes 328332 0
Allogeneic haematopoietic cell transplantation 328333 0
Deconditioning 328354 0
Hospital acquired complications 328355 0
Condition category
Condition code
Cancer 325370 325370 0 0
Leukaemia - Acute leukaemia
Physical Medicine / Rehabilitation 325371 325371 0 0
Occupational therapy
Physical Medicine / Rehabilitation 325372 325372 0 0
Other physical medicine / rehabilitation
Physical Medicine / Rehabilitation 325373 325373 0 0
Physiotherapy
Diet and Nutrition 325395 325395 0 0
Other diet and nutrition disorders
Musculoskeletal 325396 325396 0 0
Other muscular and skeletal disorders
Mental Health 325397 325397 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multi-disciplinary Prehabilitation program
The multidisciplinary prehab program comprises of functional, nutritional, and psychosocial assessment and support from the cancer allied health team. The 8-week intervention will commence immediately following the completion of induction chemotherapy and for those patients offered allogenic haematopoietic stem cell transplant (allo-HSCT), once remission has been achieved and the timing of the transplant has been identified. Implementing the exercise intervention post-induction therapy will provide a standardised variable across various treatment regimens for Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) and represents a period where patients experience a significant decline in function. Chemotherapy cycles are 28 days (with the potential to extend beyond 28 days to allow for count recovery or infection). Therefore, an 8-week program will allow those patients proceeding to transplant following the 2nd cycle of consolidation therapy to participate.

Dietetics intervention “Optimising Nutrition”
One 45-60min initial assessment will be conducted face to face at the beginning of the intervention to determine each patient’s nutritional status. There are no further sessions planned unless clinically indicated. This assessment will include pre-transplant education to discuss strategies to maintain or improve nutrition status prior to allo-HSCT (this includes education on food safety guidelines and eating a high energy, high protein diet to minimise weight loss). Participants assessed to be at risk of malnutrition or malnourished using the Patient-Generated Subjective Global Assessment (PGSGA)8, or deemed high nutritional risk, will be followed up via phone or telehealth two weeks after completing the baseline assessment to monitor compliance with the dietary education completed. On admission, naso-enteric feeding will commence as per usual dietetic care to maintain nutritional intake in the acute phase post-HSCT. At the completion of the study the number of dietetics sessions attended will be tallied and divided by the number of sessions prescribed to calculate adherence.

Exercise Program “Time to get Moving”
Participants will complete two supervised sessions per week for 8 weeks (total of 16 supervised exercise sessions). Exercise sessions will be conducted either in the Royal Adelaide Hospital gymnasium, on the ward or via telehealth and will be supervised by an Accredited Exercise Physiologist/Physiotherapist with experience in prescribing exercise to individuals with cancer. The exercise prescription will be based on current national and international recommendations for individuals with cancer (from Exercise and Sports Science Australia & American College of Sports Medicine): each participant will be asked to complete 6-8 resistance exercises and 20-40 mins of aerobic exercise during each session. Each session will be 60 minutes. Resistance exercise will involve performing a combination of free weight/dumbbells, body weight, resistance band and machine exercise for 2-3 sets of 8-12 repetitions per exercise. Aerobic exercise will involve walking or jogging on the treadmill or cycling on the cycle ergometer. Exercise intensity will be 12-14 RPE (13 = “Somewhat hard”) on the Borg Rating of Perceived Exertion Scale (RPE)9. If a participant cannot achieve this exercise goal (e.g., due to low fitness levels or presence of treatment-related side effects), then the exercise will be modified on an individual basis by the Exercise Physiologist/Physiotherapist. To ensure safety, at the beginning of each session, participants will complete a comprehensive safety questionnaire (Please refer to Appendix 2 in the Study Protocol document). Safety will be monitored using the common terminology for adverse events (Version 5.0. Common Terminology Criteria for Adverse Events (CTCAE)). Any issues scored as grade 3 or above will be discussed with the treating team. Oxygen saturation, heart rate (pulse oximetry) and blood pressure will be assessed immediately prior to, during and immediately following all exercise sessions. Exercise prescription will be recorded electronically. Clinician field notes with be evaluated at the end of the intervention for feasibility/safety information and provide information on exercise prescription adherence.

Social Work “Legal and Financial Support”
The social work service currently provides patients with therapeutic-based assessment and intervention including, initial psychosocial assessments, analysing and implementing solution focused practice, and working collaboratively with patients and family members to support their stem cell journey. Additionally, 2-4 weeks into the intervention, social work will deliver a single 45-60min face-to-face education session to provide pre-transplant participants with information on legal documents, and finances. The presentation will include information on completing a Will, Enduring Power of Attorney and Advanced Care Directive (documents and information available at https://www.sa.gov.au/topics/family-and-community/planning-ahead/power-of-attorney-and-advance-directives and https://advancecaredirectives.sa.gov.au/), and accessing Centrelink, Superannuation, financial counselling, and carer support (documents will be specifically designed by the social work team with information referencing https://www.unitingcommunities.org/service/financial-and-energy-services/financial-support-services, https://www.servicesaustralia.gov.au/centrelink?context=1, and https://www.carerssa.com.au/). Following the presentation, a pack will be provided with the legal documents discussed and relevant contact numbers. Social work will then arrange a 30min face-to-face, follow-up appointment at week 6-8 of the intervention with the patient to discuss questions and concerns, directly related to the pack information (and if required, to facilitate the completion of legal documents). At the completion of the study the number of social work sessions attended will be tallied and divided by the number of sessions prescribed to calculate adherence.

Occupational Therapy intervention “Preparing for Transplant”
Occupational therapy (OT) input will include an education, assessment and intervention component (60min session delivered face to face or via phone/telehealth). The OT assessment component will be an adapted version of the standardized acute OT initial assessment. The OT initial assessment will gather information about social history, home set up, premorbid and current physical and cognitive functional status, supports and more. This assessment will support identifying any environmental/personal /occupational barriers, risks and functional changes to inform or identify any equipment or service needs. The intervention component will include equipment provision, referrals to other allied health disciplines (i.e., social work, psych), referrals to other required services and communication with the inpatient OT team for follow up of high-risk patients. The educational component will be focused on energy conservation/cancer related fatigue education, this will be delivered in the form of a discussion with the therapist with 2 parts. Part 1 of the discussion will include standardized questions regarding the patient’s current perception and reporting of their current level of fatigue, with the intent to gather specific information regarding fatigue levels throughout a 24-hour period of the day in relation to activities of daily living (ADLs). From this information the OT will complete part 2 which will be to provide tailored energy conservation education which will be guided with the use of the ‘Cancer related fatigue education booklet’ which will be given to the patient at the end of the session to take home. The OT education, assessment and intervention will aim to be completed in weeks 1-3 in a singular session. At the completion of the study the number of OT sessions attended will be tallied and divided by the number of sessions prescribed to calculate adherence.

Psychology “Enhancing coping skills”
A single 60-90min face-to-face psychology education session will be provided to participants during weeks 6-8 of the program. The psychology session will be focussed on providing psychoeducation and strategies to enhance their coping in the lead up to and during their planned stem cell transplant. Topics covered will include (1) psychoeducation about the emotional impact of a stem cell transplant, (2) strategies for mood management and anxiety, (3) practical strategies for coping with a stem cell transplant admission (including what to bring into hospital, the importance of social support and physical activity). Patients will also be provided with a copy of a booklet created by the RAH Cancer Psychology Team titled “Skills for coping with a Stem Cell Transplant”, it is 5 pages, and the estimated reading time is 10mins. At the completion of the study the number of psychology sessions attended will be tallied and divided by the number of sessions prescribed to calculate adherence.

Patients will receive treatment as usual from allied health staff both before, during and after consenting to partake in this project. They will be referred to social work, physiotherapy, occupational therapy, exercise physiology, cancer psychology or other available allied health services at any point following their cancer diagnosis depending on their needs. Participants in the prehab program may therefore already be known to the individual disciplines and may continue to receive ongoing input from allied health staff beyond their completion of the program.
Intervention code [1] 324947 0
Rehabilitation
Intervention code [2] 324968 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333228 0
Program feasibility will be evaluated by assessing 1) program uptake,
1) Program uptake will be determined as the percentage of participants approached versus the number of patients enrolled into the prehab program by reviewing the study screening and enrolment logs.
Timepoint [1] 333228 0
Data collected during intervention and at the end of the 8 week intervention.
Primary outcome [2] 333319 0
Program feasibility will be evaluated by assessing 2) retention,
2) Retention will be determined as the percentage of enrolled participants who complete the 8-week study by reviewing the enrolment logs and attendance checklists/off study documentation.
Timepoint [2] 333319 0
Data collected during intervention and at the end of the 8 week intervention.
Primary outcome [3] 333320 0
Program feasibility will be evaluated by assessing 3) adherence,

3) Adherence will be determined as the number of sessions attended versus the number of sessions prescribed by reviewing the attendance checklists/reviewing clinician case notes.
Timepoint [3] 333320 0
Data collected during intervention and at the end of the 8 week intervention.
Secondary outcome [1] 416241 0
Any change in functional capacity assessed as Leg strength: 30-second chair stand
Timepoint [1] 416241 0
Baseline and at end of 8 week intervention.
Secondary outcome [2] 416242 0
Any change in functional capacity assessed as Upper-body strength: Grip strength determined using a dynamometer
Timepoint [2] 416242 0
Baseline and at end of 8 week intervention
Secondary outcome [3] 416243 0
Any change in functional capacity assessed as Aerobic fitness: 2-minute step test
Timepoint [3] 416243 0
Baseline and at end of 8 week intervention
Secondary outcome [4] 416244 0
Any change in functional capacity assessed as Falls risk: 8-Foot Up-and-Go
Timepoint [4] 416244 0
Baseline and at end of 8 week intervention
Secondary outcome [5] 416245 0
Any change in anthropometry: Body Mass Index (BMI, height determined by stadiometer, and weight determined using balance scales) and Bioelectrical Impendence to determine lean muscle mass
Timepoint [5] 416245 0
Baseline and at end of 8 week intervention
Secondary outcome [6] 416246 0
Any change in Nutritional status: Patient-Generated Subjective Global Assessment (PGSGA)
Timepoint [6] 416246 0
At baseline and at end of 8 week intervention
Secondary outcome [7] 416248 0
Any change in European Organisation for Research and Treatment of Cancer Care Quality of Life Questionnaire score (EORTC QLQ C30)
Timepoint [7] 416248 0
Baseline and at end of 8 week intervention
Secondary outcome [8] 416249 0
Any change in Hospital Anxiety and Depression Scale (HADS)
Timepoint [8] 416249 0
Baseline and at end of 8 week intervention
Secondary outcome [9] 416250 0
Any change in psychosocial symptoms assessed using the Cancer Behavior Inventory (Brief Form)
Timepoint [9] 416250 0
Baseline and at end of 8 week intervention
Secondary outcome [10] 416251 0
Any change in psychosocial symptoms assessed using the National Comprehensive Cancer Network Distress Thermometer
Timepoint [10] 416251 0
Baseline and at end of 8 week intervention
Secondary outcome [11] 416252 0
Any change in number of hospital-acquired complications

Falls, pressure injuries and any other hospital-acquired complications will be assessed post-discharge from transplant. Hospital-related outcomes will be gathered via a case note review and from extrapolating data from Safety and Quality to capture and count hospital acquired complications experienced by each patient.
Timepoint [11] 416252 0
Post discharge from allo-HSCT
Secondary outcome [12] 416611 0
Any change in length of stay.

Length of stay will be assessed post-discharge from transplant. It will be gathered via a case note review and from extrapolating data from Safety and Quality to capture length of stay experienced by each patient.
Timepoint [12] 416611 0
Post discharge from allo-HSCT
Secondary outcome [13] 416612 0
PRIMARY OUTCOME

Program feasibility will be evaluated by assessing 4) acceptability
4) Acceptability of the prehab program to patients/families/health staff will be assessed using a purpose-built questionnaire administered at the end of the 8-week prehab phase.
Timepoint [13] 416612 0
Data collected during intervention and at the end of the 8 week intervention.
Secondary outcome [14] 416613 0
PRIMARY OUTCOME

Program feasibility will be evaluated by assessing and 5) safety.
5) Safety will be assessed as the number, grade and causality of adverse events (this will be graded via the Common Terminology Criteria for Adverse Events (CTCAE) and will be monitored and recorded throughout the prehab program. Clinician field notes will also be reviewed to gather information on safety throughout the research.
Timepoint [14] 416613 0
Data collected during intervention and at the end of the 8 week intervention.

Eligibility
Key inclusion criteria
• Participants must be aged 18 years of age or older.
• Diagnosed with Acute myeloid leukemia (AML)/Myelodysplastic Syndrome (MDS) and offered allo-HSCT at the RAH.
• Medically stable (as determined by absolute contraindications to exercise as per national and international exercise guidelines (Exercise and Sports Science Australia, American College of Sports Medicine)) and have written clearance from their consultant haematologist.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Cognitive impairment severe enough to limit participation in the prehab program (as determined by a medical practitioner).
• Any absolute contraindications to exercise (as per written medical clearance), for example unstable angina or uncontrolled heart failure. Patients with permanent pacemaker will be excluded from bio-electrical impedance spectroscopy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The aim is to recruit 20 patients into this study. The target sample of 20 will be sufficient to address the research aims regarding feasibility and safety and will provide evidence on the preliminary efficacy of the MD prehab intervention.

As the primary endpoints of this pilot study are safety and feasibility of the intervention, most of the statistics will be descriptive in nature. As the study does not involve inferential statistical analysis, there is no need for power calculations.

Safety data will be compiled and analysed in terms of frequency of adverse events. As already stated, the trial may be terminated early if grade three to five adverse events are encountered.

Acceptability will be based on data collected during the training sessions (i.e. pain, adherence, rate of uptake). These data will be complied and analysed using descriptive statistics (mean pain score, SD, range).

Preliminary efficacy will be determined on the basis of change between pre- and post-intervention in 30-second chair stand, Grip strength, 2-minute step test, 8-Foot Up-and-Go, Body Mass/Bioelectrical Impedance, PGSGA, EORTC QLQ C30, HADS, The Cancer Behaviour Inventory and the National Comprehensive Cancer Network Distress Thermometer. Mean change, and 95% confidence intervals will be reported. P values will not be reported, as per CONSORT pilot study recommendations.

Hospital-related outcomes (complications and length of stay) will be reported by descriptive analysis.

Data obtained from this feasibility study will be used to inform clinical practice, as well as power calculations and sample size for a subsequent, adequately powered RCT.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
12/07/2023
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/01/2025
Actual
Sample size
Target
20
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 23649 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 39069 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 312750 0
Other
Name [1] 312750 0
Haematology Clinical Trials & Cancer Haematology
Country [1] 312750 0
Australia
Funding source category [2] 315571 0
Other
Name [2] 315571 0
Allied Health, Pharmacy and Nursing Clinical Research Grant
Country [2] 315571 0
Australia
Primary sponsor type
Hospital
Name
RAH Haematology Clinical Trials & Cancer Haematology
Address
Central Adelaide Local Health Network Research Finance Team: Research Office
Level 3 Roma Mitchel Building
136 North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 314377 0
None
Name [1] 314377 0
Address [1] 314377 0
Country [1] 314377 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312054 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 312054 0
Ethics committee country [1] 312054 0
Australia
Date submitted for ethics approval [1] 312054 0
12/01/2023
Approval date [1] 312054 0
14/06/2023
Ethics approval number [1] 312054 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123294 0
Mrs Karlee Naumann
Address 123294 0
Royal Adelaide Hospital
Mail DP 46 (6E-351)
Port Rd, Adelaide SA 5000
Country 123294 0
Australia
Phone 123294 0
+61 407168145
Fax 123294 0
Email 123294 0
karlee.naumann@sa.gov.au
Contact person for public queries
Name 123295 0
Karlee Naumann
Address 123295 0
Royal Adelaide Hospital
Mail DP 46 (6E-351)
Port Rd, Adelaide SA 5000
Country 123295 0
Australia
Phone 123295 0
+61 407168145
Fax 123295 0
Email 123295 0
karlee.naumann@sa.gov.au
Contact person for scientific queries
Name 123296 0
Karlee Naumann
Address 123296 0
Royal Adelaide Hospital
Mail DP 46 (6E-351)
Port Rd, Adelaide SA 5000
Country 123296 0
Australia
Phone 123296 0
+61 407168145
Fax 123296 0
Email 123296 0
karlee.naumann@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial will be shared, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of Primary Investigator
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator (karlee.naumann@sa.gov.au, 0407168145)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17723Study protocol    385059-(Uploaded-12-01-2023-11-48-54)-Study-related document.docx



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.