RecruitingACTRN12624000363583

Prehabilitation Closer to Home Study: Novel Evaluation of a Co-designed Pre-habilitation Exercise service for Haematological Cancer Patients Preparing for Bone Marrow Transplantation.

Multi-Phase Optimisation of a Pre-habilitation Exercise service for Haematological Cancer Patients Preparing for Bone Marrow Transplant: A sequential single-arm Bayesian optimal phase II adaptive trials, with nested co-design sessions.


Sponsor

The University of Melbourne

Enrollment

120 participants

Start Date

Mar 14, 2025

Study Type

Interventional

Conditions

Summary

This study aims to enhance the efficacy and acceptability of a Pre-habilitation Exercise service for Haematological Cancer Patients Preparing for Bone Marrow Transplant at The Peter MacCallum Cancer Centre (Peter Mac). The Prehabilitation Exercise service has been established at the Peter Mac for several years. Our research team engaged in a co-design process with former patients and Peter Mac staff to identify priority areas for improvement and design solutions. This research study will implement the co-designed solutions, evaluate them and make additional improvements where necessary. Who is it for? You may be eligible to join this study if you are aged 18 years and over, have been diagnosed with a Haematological Cancer and are awaiting Bone Marrow Transplant at The Peter MacCallum Cancer Centre, and have been referred to the prehabilitation program. Study details All participants will have access to the prehabilitation exercise service as part of standard care. This includes access to an individualised exercise program and supervised exercise sessions delivered either face-to-face or via telehealth. Improvements developed as part of co-design include staff training modules focused on delivering trauma-informed exercise support and delivering engaging online exercise classes, additional printed resources for patients to support uptake of exercise, support for staff to better utilise exisiting exercise prescription software (simple set), and an online education hub. This study will be implemented in two stages: Package 1 will include standard care plus all of the co-designed components, except for the online education hub, while Package 2 will include standard care plus all co-designed components and the online education hub. Package 2 will be implemented 9-12 months after the study commences, after Package 1 completion. Participants will be followed-up within two weeks prior to their bone marrow transplant to assess efficacy and acceptability of each package. The majority of the assessments completed (e.g., 6 minute walk test) are completed as part of standard care. Study specific assessments include questionnaires on intervention acceptability. It is hoped that this research project will lead to an optimised prehabilitation model of care at the Peter Mac, and pave the way for trialling the optimised model of care across multiple health services.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

For people with blood cancers preparing for a bone marrow transplant, being as physically fit as possible beforehand — a process called 'prehabilitation' — has been shown to reduce complications and speed up recovery. The prehabilitation exercise service at Peter MacCallum Cancer Centre has been running for several years, but patients and staff identified areas where it could be improved. This study implements and evaluates a series of co-designed improvements including staff training in trauma-informed exercise support, better patient resources, improved use of exercise prescription software, and the addition of an online education hub. The program is delivered either in person or via telehealth and includes individualised exercise sessions. Outcomes are assessed before the transplant. You may be eligible if you are 18 or older, have a haematological (blood) cancer, are awaiting a bone marrow transplant at Peter MacCallum Cancer Centre, have been referred to the prehabilitation program, and are able to walk independently. People with more than one active cancer, severe cardiac or neurological conditions, or who are less than 2 weeks from their scheduled transplant are not eligible. This research aims to create a model of care that can be rolled out more broadly across Australian cancer centres.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Standard care: All bone marrow transplant patients at Peter Mac are offered a face-to-face exercise assessment, and then some level of support for exercise depending on their risk level. Medium and

Standard care: All bone marrow transplant patients at Peter Mac are offered a face-to-face exercise assessment, and then some level of support for exercise depending on their risk level. Medium and High-risk patients are offered supervised sessions; Three days a week face-to-face, two days via tele-health. Patients are encourage to attend 2-3 sessions per week. All patients are offered an individualised home-based exercise program based on the in-person assessment. The program generally includes a prescription of aerobic and resistance-based activity, with a focus on working towards exercise and cancer guidelines (see ACSM Exercise Guidelines for Cancer Survivors e.g., activities include moderate intensity walking and strength exercises using major muscle groups, such as a sit-to-stand). The home-based program is delivered via simple set, which is a software package health care professionals can you to prescribe and exercise program that is printed out as an exercise diary for patients to take home and complete. The frequency of follow-up depends on the risk category (weekly, fortnightly, monthly for high, medium and low risk, respectively). Co-designed components to be integrated into standard care. Additions to standard care were developed as part of a co-design process. Co-designed components include: Package 1: • New training module for staff on delivering exercise services using a trauma-informed approach. This is a 20 minute online module that explains the concept and prevalence of trauma, explores the ket elements of trauma informed care, and provides scenario-based learning opportunities, including two videos to watch and multiple choice questions. All staff involved in delivering the exercise service will be directed to complete this module within two weeks of trial commencement by the clinical lead of the service. • New training module for staff on delivering engaging online exercise classes This is a 15 minute online module developed based on Social Identity Leadership Theory and consumer suggestions for how to improve online exercise classes. It covers patient concerns about online exercise classes (from our survey research and other published research), effective leadership styles, and consumer-suggested strategies that map to successful leadership approaches. All staff involved in delivering the exercise service will be directed to complete this module within two weeks of trial commencement by the clinical lead of the service. • Update to staff operating procedure documents (Prehabilitation Manual and Online Exercise Class Manual) to reflect key points in training modules and direct staff to online training modules - to be implemented at least two weeks prior to trial commencement. • New patient-facing printed materials (designed specifically for this study) providing educational content and behaviour change support (e.g., tips for overcoming barriers, education on exercise benefits). Package 2: * Same components as above, as well as a: •. New Patient-facing website (designed specifically for this study) providing educational content and behaviour change support. Participants will be informed of the website during their initial appointment and provided with a document containing the URL and a QR code. There is no set intended usage for the website. Participants can look at it as needed. (Mirrors printed booklet with increased interactivity, and multi-media). Iterative optimisation protocol: Package 1 will be implemented first, and continue until either 60 people are recruited or the trial is stopped early due to too few promising responses (determined in an interim analysis at 30 people). The package 1 trial period is estimated to be 6 months. After package 1 has been trialed, the co-design team will optimise Package 2 by making intervention or implementation refinements where possible (if necessary) based on all available data (as per Ethics approval HREC/81951/PMCC). Package 2 will then be implemented to a new cohort of participants, with the same evaluation protocol as the Package 1 trial. The package 2 trial period is estimated to be 6 months. Adherence Training Modules: A link to the training modules is included in the standard of care manual. The lead physiotherapist will also encourage staff to complete the training. Staff use of modules, as well as generally acceptability will be obtained via staff interview at the end of the trial period. Printed booklets (patient) participants will be asked via survey at follow-up if they were given the printed booklet and if they read it. Website (patient): participants will be asked via survey at follow-up if they were given information about the website and if they used it. The number of users of the website and what pages are visited will also be tracked.


Locations(1)

Peter MacCallum Cancer Centre - Melbourne

VIC, Australia

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ACTRN12624000363583


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