Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000363583
Ethics application status
Approved
Date submitted
14/02/2024
Date registered
28/03/2024
Date last updated
19/10/2024
Date data sharing statement initially provided
28/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Prehabilitation Closer to Home Study: Novel Evaluation of a Co-designed Pre-habilitation Exercise service for Haematological Cancer Patients Preparing for Bone Marrow Transplantation.
Scientific title
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.
Secondary ID [1] 310816 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haematological Cancer 331806 0
Condition category
Condition code
Cancer 328549 328549 0 0
Hodgkin's
Cancer 328550 328550 0 0
Leukaemia - Acute leukaemia
Cancer 328551 328551 0 0
Leukaemia - Chronic leukaemia
Cancer 328552 328552 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 328553 328553 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 328554 328554 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.


Intervention code [1] 327226 0
Lifestyle
Intervention code [2] 327227 0
Behaviour
Intervention code [3] 327228 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336360 0
Efficacy and Acceptability
Timepoint [1] 336360 0
Post-intervention, within two weeks prior to bone marrow transplantation.
Nb. The intervention period is the period between baseline and the bone marrow transplant procedure. The follow-up measure occurs within two weeks prior to the bone marrow transplant.
Secondary outcome [1] 428003 0
Safety
Timepoint [1] 428003 0
Assessed at follow-up.
The follow-up measure occurs within two weeks prior to the bone marrow transplant.
Secondary outcome [2] 428004 0
Exercise Capacity
Timepoint [2] 428004 0
Assessed at baseline and post-intervention (i.e., pre-procedure: within two weeks prior to bone marrow transplantation). Nb. The intervention period is the period between baseline and the bone marrow transplant procedure. The follow-up measure occurs within two weeks prior to the bone marrow transplant.
Secondary outcome [3] 428005 0
Handgrip Strength
Timepoint [3] 428005 0
Assessed at baseline and post-intervention (i.e., pre-procedure: within two weeks prior to bone marrow transplantation). Nb. The intervention period is the period between baseline and the bone marrow transplant procedure. The follow-up measure occurs within two weeks prior to the bone marrow transplant.
Secondary outcome [4] 428006 0
Frailty
Timepoint [4] 428006 0
Assessed at baseline and post-intervention (i.e., pre-procedure: within two weeks prior to bone marrow transplantation). Nb. The intervention period is the period between baseline and the bone marrow transplant procedure. The follow-up measure occurs within two weeks prior to the bone marrow transplant.
Secondary outcome [5] 428007 0
Health related quality of life
Timepoint [5] 428007 0
Assessed at baseline and post-intervention (i.e., pre-procedure: within two weeks prior to bone marrow transplantation). Nb. The intervention period is the period between baseline and the bone marrow transplant procedure. The follow-up measure occurs within two weeks prior to the bone marrow transplant.
Secondary outcome [6] 428008 0
Self-reported physical activity
Timepoint [6] 428008 0
Assessed at baseline and post-intervention (i.e., pre-procedure: within two weeks prior to bone marrow transplantation). Nb. The intervention period is the period between baseline and the bone marrow transplant procedure. The follow-up measure occurs within two weeks prior to the bone marrow transplant.
Secondary outcome [7] 428009 0
Length of hospital stay
Timepoint [7] 428009 0
Collected within one month post hospital discharge.
Secondary outcome [8] 428010 0
Self-efficacy
Timepoint [8] 428010 0
Assessed at baseline and post-intervention (i.e., pre-procedure: within two weeks prior to bone marrow transplantation). Nb. The intervention period is the period between baseline and the bone marrow transplant procedure. The follow-up measure occurs within two weeks prior to the bone marrow transplant.
Secondary outcome [9] 428011 0
Habit strength
Timepoint [9] 428011 0
Assessed at baseline and post-intervention (i.e., pre-procedure: within two weeks prior to bone marrow transplantation). Nb. The intervention period is the period between baseline and the bone marrow transplant procedure. The follow-up measure occurs within two weeks prior to the bone marrow transplant.
Secondary outcome [10] 428012 0
Autonomy supportive exercise environment
Timepoint [10] 428012 0
Assessed immediately post-intervention. Nb. The intervention period is the period between baseline and the bone marrow transplant procedure. The follow-up measure occurs within two weeks prior to the bone marrow transplant.
Secondary outcome [11] 429773 0
Acceptability
Timepoint [11] 429773 0
Assessed immediately post-intervention. Nb. The intervention period is the period between baseline and the bone marrow transplant procedure. The follow-up measure occurs within two weeks prior to the bone marrow transplant.
Secondary outcome [12] 429774 0
Feasibility of intervention delivery
Timepoint [12] 429774 0
Software and staff costs will be recorded as incurred. A final review of costs will be completed after the final participant completed post-intervention follow-up.
Secondary outcome [13] 429775 0
Fidelity of intervention delivery (staff) and participation (patients)
Timepoint [13] 429775 0
Fidelity will be assessed using routinely collected data (e.g., attendance records, module completion, hospital records) and by self-report in the immediate post-intervention follow-up survey.
Secondary outcome [14] 429903 0
Identity Leadership perceptions among participants
Timepoint [14] 429903 0
Assessed immediately post-intervention. Nb. The intervention period is the period between baseline and the bone marrow transplant procedure. The follow-up measure occurs within two weeks prior to the bone marrow transplant.

Eligibility
Key inclusion criteria
Patient Inclusion Criteria
• Aged 18 years or older
• Awaiting a bone marrow transplant
• Diagnosis of a haematological malignancy
• Able to ambulate independently
• Willing to complete baseline and pre-transplant study related assessments
• Proficient in English to understand exercise testing and training instructions as well as to complete study consent form and questionnaires – or have someone who can assist with this.

Staff Inclusion Criteria (qualitative study only)
• Aged 18 years or older
• Proficient in English to complete study consent form and interview – or have someone who can assist with this.
• Involved in delivery or management of the exercise prehabilitation service for patients with a haematological malignancy during the trial period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient Exclusion Criteria
• More than one active malignancy, or receiving BMT for non-haematological disease
• Severe or unstable neurological, cardiorespiratory or musculoskeletal disease or mental illness that might compromise ability to perform exercise
• Less than 2 weeks between recruitment and scheduled admission for transplant.

Staff Exclusion criteria (qualitative study only)
• Is a named investigator on the trial. Investigators involved in service delicery can provide feedback during the co-design meeting but will not be invited to participate in the qualitative interviews.

Study design
Purpose of the study
Educational / counselling / training
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/efficacy
Statistical methods / analysis
A pragmatic optimisation protocol will be employed using sequential single-arm Bayesian optimal phase II adaptive trial designs, with nested qualitative studies.

Baseline characteristics of all study participants for each will be described using means and standard deviations for normally distributed variables, medians and 25th and 75th percentiles for non-normally distributed variables, and frequencies and percentages for binary and categorical variables.

The primary composite endpoint, and its components, will be estimated with 95% credible intervals using a Bernoulli likelihood with minimally informative Beta prior distributions.
Secondary endpoints will be analysed using statistical methods that are appropriate to the endpoint (e.g. means and medians for continuous endpoints, proportions for binary endpoints), with 95% credible intervals.
Missing outcome data is expected to be minimal, and analyses will be performed on a complete case basis.
All statistical analyses will be performed using the statistical package R (or other relevant programming environment) by a qualified and experienced biostatistician.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2024
Actual
Date of last participant enrolment
Anticipated
30/12/2026
Actual
Date of last data collection
Anticipated
29/01/2027
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25766 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 41591 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 315056 0
Charities/Societies/Foundations
Name [1] 315056 0
Victorian Cancer Agency
Country [1] 315056 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 317109 0
None
Name [1] 317109 0
Address [1] 317109 0
Country [1] 317109 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314010 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 314010 0
Ethics committee country [1] 314010 0
Australia
Date submitted for ethics approval [1] 314010 0
18/12/2023
Approval date [1] 314010 0
07/10/2024
Ethics approval number [1] 314010 0
HREC/91280/PMCC

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

Contacts
Principal investigator
Name 130110 0
A/Prof Camille Short
Address 130110 0
University of Melbourne, Melbourne School of Psychological Sciences, Tin Alley, Parkville VIC 3052
Country 130110 0
Australia
Phone 130110 0
+61 408288786
Fax 130110 0
Email 130110 0
[email protected]
Contact person for public queries
Name 130111 0
Camille Short
Address 130111 0
University of Melbourne, Melbourne School of Psychological Sciences, Tin Alley, Parkville VIC 3052
Country 130111 0
Australia
Phone 130111 0
+61 408288786
Fax 130111 0
Email 130111 0
[email protected]
Contact person for scientific queries
Name 130112 0
Camille Short
Address 130112 0
University of Melbourne, Melbourne School of Psychological Sciences,, Tin Alley, Parkville VIC 3052
Country 130112 0
Australia
Phone 130112 0
+61 408288786
Fax 130112 0
Email 130112 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual data will be shared where consent has been given by the participant and the participating health service.
When will data be available (start and end dates)?
Data will be available March 2026. Data will be retained for a five-year period.
Available to whom?
Appropriately qualified researchers who have a research plan and ethics approval.
Available for what types of analyses?
Re-running analyses, IPD meta-analyses, secondary data-analysis (with permission).
How or where can data be obtained?
Contact principal investigator. [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.