Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000188639
Ethics application status
Approved
Date submitted
19/01/2023
Date registered
22/02/2023
Date last updated
27/10/2023
Date data sharing statement initially provided
22/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A digital health education program promoting physical activity for childhood cancer survivors: A hybrid effectiveness-implementation trial of 'Making Moves'
Scientific title
A digital health education program to promote physical activity levels and physical activity self-efficacy for childhood cancer survivors: A type I hybrid effectiveness-implementation trial.
Secondary ID [1] 306568 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood cancer 327835 0
Physical inactivity 329026 0
Condition category
Condition code
Cancer 324907 324907 0 0
Children's - Brain
Cancer 324908 324908 0 0
Children's - Leukaemia & Lymphoma
Cancer 324909 324909 0 0
Children's - Other
Physical Medicine / Rehabilitation 324911 324911 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name:
A digital health education program promoting physical activity for childhood cancer survivors: A hybrid effectiveness-implementation trial of 'Making Moves'.

Physical or informational materials that will be used in the intervention:
This program involves online telehealth consultations with an Accredited Exercise Physiologist complimented with access to a digital program including evidence-based health behaviour educational modules and guided physical activities. Each module focuses on a different topic about physical activity and health. Examples of topics covered in the modules include regular physical activity, sedentary behaviours and healthy eating. The anticipated duration of each module is approximately 10-20 minutes (not including exercise videos). The program aims to engage participants in physical activity via a range of guided home-based physical activities in the form of instructional videos. Physical activity videos range from 1-15 minutes and participants can choose how many they wish to watch/follow. Examples of videos include guided bodyweight strength exercises, stretches, and circuit exercises. Participants will be gifted with an activity tracker to support their physical activity engagement and health behaviour education.

We will assess program adherence (module completion and physical activity videos) via self-report questionnaire.

Each of the procedures, activities, and/or processes used:
a) Up to five online consultations with an accredited exercise physiologist at pre-intervention (week 0), intervention (week 2 or 3) (optional), post-intervention (week 9), ‘booster’ session (3-months post-program completion) and follow-up (6-months post-program completion).
b) Individualised goal setting
c) Guided home-based physical activity videos
d) Age-appropriate evidence-based health behaviour education

Who will deliver the intervention:
An accredited exercise physiologist, and research staff (i.e., study coordinator, research officer).

Mode of delivery:
Exercise physiology consultations will be delivered online via videoconference or telephone (depending on participant preference).

The digital health program will be delivered via a website that can be accessed via computer, phone, or tablet. Participants will each have their own login account to access the website.

The number of times the intervention will be delivered and over what period of time:
The length of the intervention, including the pre-intervention and post-intervention consultations will be 10 weeks. There will be a “booster” consultation at 3-months following program completion and follow up at the 6-month period.

There will be five online video consultations with an Accredited Exercise Physiologist pre-intervention at week 0, an optional consultation at week 2 or 3 of the intervention, post-intervention at week 9, 3-month booster session and at follow up 6 months following program completion. Each will be approximately 60 minutes. Each consultation will be individualised to the participant and will include exercise assessments, health behaviour education, tailored goal-setting, and discuss participant barriers and facilitators to exercise.

Participants will also complete a questionnaire pack (approx. 10-15 min) at three time points (pre-intervention, post-intervention, and at 6-month follow-up).

Participants will be provided access to our digital program throughout the intervention period. The program is self-guided. Participants will be encouraged to complete one module per week for eight weeks, and can follow the physical activity videos as much as they would like. Participants will be given the autonomy over what educational content they would like to access and what physical activities they would like to complete.

Location where the intervention occurs:
The intervention is home-based and will be distance delivered.

Implementation component:
As a Type 1 Hybrid Effectiveness-Implementation trial, our secondary aim is to explore the barriers and facilitators to implementation and scale-up from multiple levels (i.e., individual, provider, organisational and community) that will inform our future implementation strategies. We will conduct a process evaluation guided by two implementation frameworks: the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF). The purpose of the CFIR is to facilitate synthesis of research findings across studies and contexts. The CFIR includes 39 constructs arranged over five domains (intervention characteristics, outer setting, inner setting, process, and characteristics of individuals). The purpose of the TDF is used to promote the development of interventions to enhance implementation. The TDF includes 128 constructs in 14 domains including knowledge, skills, social/professional role and identity, beliefs about capabilities, beliefs about consequences, motivation and goals, memory, attention and decision processes, environmental context and resources, social influences, emotion, behavioural regulation, and nature of the behaviour. Our rationale for using two frameworks is because the TDF focuses on individual-level behaviour change, whilst the CFIR focuses on implementation determinants at the organisational level. When combined, these two frameworks will help to address multiple levels of behaviour change in healthcare. Therefore, we will use the CFIR to explore what works, where, and why across various contexts and we will use the TDF to identify and describe patient barriers and facilitators that can affect implementation and scale-up of the intervention.

Implementation outcomes (judging the implementation success of our program)
We will collect implementation data for our process evaluation throughout the intervention and at post-intervention, including:
1) Resources relating to the intervention will be recorded in an Excel spreadsheet to identify and value costs. Resources may include any distance-delivery technology used to deliver the program, program development, educational material, and activity trackers.
2) Intervention costs (costs related to the delivery and uptake of the program). The study exercise physiologist who delivers the pre-, post- and follow-up consultations will also complete a detailed log of costs throughout the intervention (e.g., cost of study equipment for each participant).
3) Changes in environmental context that may impact participant opportunities to be physically active will be recorded by study staff as potential influences of engagement in the intervention.
We will additionally conduct semi-structured interviews with research staff (e.g., study exercise physiologist) to seek feedback regarding the implementation potential in their setting, adaptation needs for better fit in their context, and potential implementation strategies needed to support uptake.
The study coordinator and exercise physiologist involved in delivering the intervention will also keep detailed notes throughout the intervention on any barriers and facilitators to the delivery of the program, and potential improvements or strategies that may be important for future implementors.

Factors that affect implementation to inform future scale-up
We will conduct TDF-guided semi-structured interviews with participants and their parents at post-intervention to explore barriers and facilitators to implementing our digital health intervention to promote physical activity self-efficacy.

We will conduct CFIR-guided semi-structured interviews with healthcare professionals (e.g., nurses, exercise physiologists, and physiotherapists), and community organisations who may be involved in the future implementation of our program.

Who will be involved in this component: participants and their parents, healthcare professionals, community organisations, study staff.

Timing of this component relative to the intervention: Throughout the intervention period and at post-program completion.
Intervention code [1] 324673 0
Rehabilitation
Intervention code [2] 324674 0
Lifestyle
Intervention code [3] 324675 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333567 0
Primary Outcome: Physical activity self-efficacy assessed by the Physical Activity Self-Efficacy Scale (PASES).

Instrument used to assess primary outcome: The 8-item PASES. Items are scored on a 3-point Likert scale ranging from “No” (0), “Not sure” (1), to “Yes” (2), with higher total scores indicating greater self-efficacy.
Timepoint [1] 333567 0
We will assess our primary outcome at three timepoints: Pre-intervention (week 0)/baseline, post-intervention (week 9), and at follow-up (6 months post-intervention completion).
Secondary outcome [1] 417540 0
Subjective physical activity levels assessed using the modified International Physical Activity Questionnaire for Adolescents (IPAQ-A). The IPAQ-A covers four domains of physical activity: i) school-related physical activity, ii) transportation, iii) housework, and iv) leisure time.


Timepoint [1] 417540 0
Subjective physical activity levels will be collected at pre-intervention (week 0), post-intervention (week 9), 3-months post-intervention, and at follow-up (6 months) after intervention completion.
Secondary outcome [2] 417541 0
Objective physical activity levels using the GENEActiv accelerometer (Activinsights).
Timepoint [2] 417541 0
Objective physical activity levels will be collected at pre-intervention (week 0), post-intervention (week 9) and at follow-up (6 months) after intervention completion. Participants will be asked to wear the wrist accelerometer for 7 consecutive days at each time point.
Secondary outcome [3] 418514 0
Sub-maximal aerobic fitness level using the 6-Minute Walk Test (6MWT).
Timepoint [3] 418514 0
Sub-maximal aerobic fitness will be collected at pre-intervention (week 0), post-intervention (week 9) and at follow-up (6 months) after intervention completion.
Secondary outcome [4] 418521 0
Muscular strength 5 repetition sit-to-stand test.
Timepoint [4] 418521 0
Muscular strength will be collected at pre-intervention (week 0), post-intervention (week 9) and at follow-up (6 months) after intervention completion.
Secondary outcome [5] 418522 0
Participant readiness to exercise assessed using the Transtheoretical Model of behaviour change questionnaire.
Timepoint [5] 418522 0
Participant readiness to exercise will be collected at pre-intervention (week 0), post-intervention (week 9) and at follow-up (6 months) after intervention completion.
Secondary outcome [6] 418525 0
Perceived enjoyment of physical activity assessed using the Physical Activity Enjoyment Scale (PACES).
Timepoint [6] 418525 0
Perceived enjoyment of physical activity will be collected at pre-intervention (week 0), post-intervention (week 9) and at follow-up (6 months) after intervention completion.
Secondary outcome [7] 418526 0
Health-related quality of life (HRQoL) assessed using the 5-item EQ-5D-Y-5L. The EuroQOL Group’s visual analogue scale accompanies the EQ-5D-Y-5L where participants self-report their overall health on a scale from 0 to 100 (0=worst health you can imagine, 100=best health you can imagine).
Timepoint [7] 418526 0
Health-related quality of life will be collected at pre-intervention (week 0), post-intervention (week 9) and at follow-up (6 months) after intervention completion.
Secondary outcome [8] 418527 0
Resources relating to the intervention to identify and value costs (recorded by study staff and the exercise physiologist). Resources may include any distance-delivery technology used to deliver the intervention, program development, educational material, and activity trackers.
Timepoint [8] 418527 0
Throughout the intervention period and at post-intervention,
Secondary outcome [9] 418532 0
Intervention costs (costs related to the delivery and uptake of the program). The study exercise physiologist who delivers the consultations will complete a detailed log of costs throughout the intervention (e.g., cost of study equipment for each participant). Participants will also complete a study-specific questionnaire at post-intervention to calculate costs incurred during the intervention.
Timepoint [9] 418532 0
Throughout the intervention period and post-intervention.
Secondary outcome [10] 418553 0
Changes in environmental context that may impact participant opportunities to be physically active (e.g., global pandemic) will be recorded by study staff as potential influences of engagement in the intervention.
Timepoint [10] 418553 0
Throughout the intervention period
Secondary outcome [11] 418556 0
We will conduct Theoretical Domains Framework (TDF)-guided semi-structured interviews with participants and their parents to explore barriers and facilitators to implementing our digital health intervention to promote physical activity self-efficacy.
Implementation outcomes based on the TDF include:
1) Knowledge (i.e., an awareness of the existence of the intervention)
2) Skills (i.e., an ability acquired through practice)
3) Social/professional role and identity (i.e., a set of behaviours of an individual in a social or work setting)
4) Beliefs about capabilities (i.e., self-efficacy)
5) Beliefs about consequences (i.e., beliefs, consequences)
6) Intentions (i.e., a conscious decision to perform a behaviour)
7) Goals (i.e., end points that an individual wants to achieve)
8) Memory, attention, and decision processes (i.e., the ability to retain information)
9) Environmental context and resources (i.e., barriers and facilitators)
10) Social influences (i.e., interpersonal processes that cause the individual to change their thoughts or behaviours)
11) Emotion (e.g., fear, anxiety, stress)
Timepoint [11] 418556 0
Post-intervention semi-structured interview
Secondary outcome [12] 418557 0
Consolidated Framework Implementation Research (CFIR)-guided semi-structured interviews with healthcare professionals (e.g., nurses, exercise physiologists, and physiotherapists), and community organisations who may be involved in the future implementation of our program.

Implementation outcomes based on the CFIR include:
1) Intervention characteristics (i.e., key attributes of the intervention that influence the success of implementation)
2) Outer Setting (i.e., the setting in which the ‘inner setting’ exists e.g., the hospital system)
3) Inner Setting (i.e., the setting in which the intervention is implemented e.g., hospital)
4) Characteristics of Individuals (i.e., the roles and characteristics of individuals)
5) Implementation process (i.e., the activities and strategies used to implement the intervention).
Timepoint [12] 418557 0
Interviews with healthcare professionals and representatives from community organisations will be conducted during and/or after the effectiveness trial. Each participant will complete one interview only.
Secondary outcome [13] 428253 0
Mental wellbeing assessed using the CES-D-12-NLSCY (12-item version of the CES-D used in the National Longitudinal Study of Children and Youth)52. The CES-D short-form includes measures of depression, including depressed mood, fatigue, and sleep disturbance. Statements (e.g., ‘I felt depressed’, ‘I felt like I was too tired to do things’, ‘My sleep was restless’) are rated on a 4-point Likert scale from 0 (rarely/none of the time) to 3 (most/all the time). Total scores of the CES-D short form range from 0 to 36, with higher scores representing greater depressive symptom severity. The scale has good internal reliability (Cronbach a =.85).
Timepoint [13] 428253 0
Secondary outcome [14] 428254 0
Mental wellbeing assessed using the CES-D-12-NLSCY (12-item version of the CES-D used in the National Longitudinal Study of Children and Youth)52. The CES-D short-form includes measures of depression, including depressed mood, fatigue, and sleep disturbance. Statements (e.g., ‘I felt depressed’, ‘I felt like I was too tired to do things’, ‘My sleep was restless’) are rated on a 4-point Likert scale from 0 (rarely/none of the time) to 3 (most/all the time). Total scores of the CES-D short form range from 0 to 36, with higher scores representing greater depressive symptom severity. The scale has good internal reliability (Cronbach a =.85).
Timepoint [14] 428254 0
Mental wellbeing will be collected at pre-intervention (week 0), post-intervention (week 9) and at the 6-month follow up (6 months after intervention completion).

Eligibility
Key inclusion criteria
For the effectiveness portion of the study, study inclusion criteria are defined as any individual who:
i) Was diagnosed with cancer as a child prior to age 18 years.
ii) Is aged 8-21 years at the time of study participation.
iii) Has completed active cancer treatment at least 6 months prior to the time of study participation OR is receiving maintenance therapy.

For the implementation component, the inclusion criteria are defined as any individual* who is a:
i) Parent or caretaker of a child or adolescent diagnosed with cancer, OR
ii) Healthcare professional specialising in or working in paediatric oncology, OR
iii) A representative from a community organisation relevant to health, children and adolescents, and/or oncology.
iv) Member of the research team
*There is no maximum age for participation.
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Study exclusion criteria are defined as any individual who:
i) Was diagnosed with cancer when they were over 18 years of age
ii) Is currently receiving active cancer treatment
iii) Has a current medical condition that would prohibit exercise or physical activity.

For the implementation component there are no exclusion criteria

Study design
Purpose of the study
Treatment
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
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Estimation & Justification
A sample of at least 53 participants will provide greater than 80% power to detect a difference in the physical activity self-efficacy score after participating in the Making Moves program. We define a meaningful change in physical activity self-efficacy as one that is a standardised increase of 0.4, informed by previous studies assessing physical activity self-efficacy in adolescents. With 53 participants, if the within-individual correlation in the outcome between baseline and post-intervention is 0.5 or greater, a paired t-test would have at least 80% power to detect a meaningful difference in mean scores between time-points, using a two-sided significance level of 5%. To allow for 30% attrition from pre- to post-intervention (based on our pilot), we aim to initially recruit at least 76 participants for the baseline assessment.

Statistical Methods
Quantitative Analysis (Effectiveness)
We will use descriptive statistics (means, SD, medians, proportions) as appropriate to report on participant characteristics and usage of the online program (via Wix analytics). The change in the primary outcome (physical activity self-efficacy) between pre- and post-intervention will be assessed on an intention-to-treat basis using mixed effects regression models, with random intercepts per individual, and fixed effects for the time points. We will perform similar analyses for the secondary outcomes, modified to suit the outcome measure. A detailed statistical analysis plan will be developed prior to undertaking any analyses.
For the program usage data obtained from Wix, all information will be analysed as aggregate data, reported in groups and will not be identifiable in any way. For the GeneActiv accelerometer data, we will perform our data analysis on R (RStudio). We will extract the binary files from each participant file and analyse each dataset based on physical activity intensities, bouts of physical activity, and length of bouts. We will assess the change in objective physical activity levels between pre- and post-intervention, and at follow-up by quantifying daily time spent in various physical activity intensities.

Qualitative Analysis (Implementation)
Semi-structured interviews will be recorded and transcribed using Microsoft Teams. The transcription feature on Microsoft Teams includes live transcription of the meeting with the text appearing alongside the video or audio meeting with a timestamp. Participants in the meeting can choose whether they want to view the live transcription. After the meeting, recording stops and the transcript is saved and can be downloaded immediately by the meeting organiser. Each transcript will be checked line-by-line by a researcher for accuracy. Interview data will be deductively analysed according to the CFIR determinants (intervention characteristics, outer setting, inner setting, process, and characteristics of individuals) and the TDF domains (e.g., knowledge, skills, beliefs about capabilities, beliefs about consequences, motivation and goals etc.). A detailed analysis plan will be developed prior to undertaking any analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23459 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 38861 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 310901 0
Charities/Societies/Foundations
Name [1] 310901 0
The Kids’ Cancer Project
Country [1] 310901 0
Australia
Primary sponsor type
Individual
Name
Dr Lauren Ha
Address
Behavioural Sciences Unit, Kids Cancer Centre,
Sydney Children’s Hospital
High St, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 314642 0
None
Name [1] 314642 0
Address [1] 314642 0
Country [1] 314642 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310463 0
Sydney Children’s Hospital Network
Ethics committee address [1] 310463 0
Ethics committee country [1] 310463 0
Australia
Date submitted for ethics approval [1] 310463 0
27/03/2023
Approval date [1] 310463 0
25/09/2023
Ethics approval number [1] 310463 0

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

Contacts
Principal investigator
Name 117750 0
Dr Lauren Ha
Address 117750 0
Behavioural Sciences Unit, Kids Cancer Centre,
Sydney Children’s Hospital
High St, Randwick NSW 2031
Country 117750 0
Australia
Phone 117750 0
+61 02 9065 0406
Fax 117750 0
Email 117750 0
[email protected]
Contact person for public queries
Name 117751 0
Lauren Ha
Address 117751 0
Behavioural Sciences Unit, Kids Cancer Centre,
Sydney Children’s Hospital
High St, Randwick NSW 2031
Country 117751 0
Australia
Phone 117751 0
+61 02 9065 0406
Fax 117751 0
Email 117751 0
[email protected]
Contact person for scientific queries
Name 117752 0
Lauren Ha
Address 117752 0
Behavioural Sciences Unit, Kids Cancer Centre,
Sydney Children’s Hospital
High St, Randwick NSW 2031
Country 117752 0
Australia
Phone 117752 0
+61 02 9065 0406
Fax 117752 0
Email 117752 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?
After de-identification; individual participant data underlying published results only (after reasonable request).
When will data be available (start and end dates)?
Immediately following publication.
No end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal and at the discretion of the primary sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Unrestricted access can be accessed via publications related to this project.

Access subject to approvals by Principal Investigator, Dr Lauren Ha ([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.