RecruitingACTRN12623000052639

Preparing, Planning and Prehab for Stem Cell Transplant: A Multidisciplinary Approach

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.


Sponsor

RAH Haematology Clinical Trials & Cancer Haematology

Enrollment

20 participants

Start Date

Jul 12, 2023

Study Type

Interventional

Conditions

Summary

This study aims to develop and test a multidisciplinary prehabilitation (prehab) program for patients with acute myeloid leukaemia and myelodysplastic syndromes who are being offered an allogeneic haematopoietic cell transplantation (allo-HSCT) at the Royal Adelaide Hospital (RAH). Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), you are being treated at the RAH and you have been offered a stem cell transplant (allo-HSCT) procedure as a treatment. Study details All participants who choose to enrol in this study will be given access to the specially designed prehab program. The program will commence immediately after completion of chemotherapy and prior to the scheduled stem cell transplantation procedure. The program will involve multiple areas, including diet and nutrition guidance, a supervised twice-weekly exercise program, advice from a social worker, an educational and occupational therapy needs assessment session, and a session with a psychologist. These sessions will be delivered over an 8-week period and participants will continue to receive their treatment as usual from allied health staff both before, during and after consenting to partake in this project. Participants may 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. It is hoped this research will demonstrate that the prehabilitation program is feasible and has a positive effect on participants physical and mental wellbeing. If the program is feasible, this study will provide key findings to inform a future large scale randomised controlled trial, and provide information required to underpin ongoing prehab for allo-HSCT patients. This innovative model of multi-disciplinary prehab has strong potential to be adapted for other patient populations across the cancer program at the RAH.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

A stem cell transplant (also called allogeneic haematopoietic cell transplantation, or allo-HSCT) is one of the most intensive treatments in medicine. Used for blood cancers like acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS), it involves high-dose chemotherapy followed by receiving donor stem cells. The period before the transplant is a critical window where a patient's physical and mental fitness can significantly affect how they cope with the procedure and recover afterwards. This study at the Royal Adelaide Hospital is developing and testing a structured prehabilitation (prehab) program to help patients get in the best possible shape before their transplant. The program runs for 8 weeks and includes twice-weekly supervised exercise, nutrition guidance, sessions with a psychologist, occupational therapy assessment, and social work support — all specifically designed for people in this situation. You may be eligible if you are 18 or older, have been diagnosed with AML or MDS, are being treated at the Royal Adelaide Hospital, and have been offered a stem cell transplant. You must be medically stable enough to exercise, with written clearance from your haematologist. People with severe cognitive impairment or absolute exercise contraindications are not eligible. This pilot study will guide the design of a future larger clinical trial.

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Interventions

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

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.


Locations(1)

The Royal Adelaide Hospital - Adelaide

SA, Australia

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ACTRN12623000052639


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