Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000898752
Ethics application status
Approved
Date submitted
6/06/2022
Date registered
23/06/2022
Date last updated
23/06/2022
Date data sharing statement initially provided
23/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing treatment outcomes after gynaecological cancer (ACUMEN For ALL): Using telehealth exercise delivery to promote health after cancer therapy
Scientific title
Enhancing treatment outcomes after gynaecological cancer (ACUMEN For ALL): Investigating the effect of telehealth exercise on health-related quality of life after cancer therapy
Secondary ID [1] 307159 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ACUMEN For ALL
Linked study record
ACTRN12621000050853
This is sub-study of the main trial ACUMEN.

Health condition
Health condition(s) or problem(s) studied:
Gynaecological cancer 326379 0
Condition category
Condition code
Cancer 323672 323672 0 0
Ovarian and primary peritoneal
Cancer 323673 323673 0 0
Cervical (cervix)
Cancer 323674 323674 0 0
Womb (Uterine or endometrial cancer)
Cancer 323675 323675 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The total study period is 24 weeks. It comprises of a 12-week exercise training intervention and a 12-week maintenance period. After participant screening and baseline assessment, participants will be randomised to either the intervention or waitlist-control group.

Participants in the delayed intervention control group will complete a 12-week control period, they will then be eligible for the intervention and the same outcome assessments will be repeated.

The telehealth intervention has two components, an exercise component underpinned by a behavioural component. Both will be delivered via video-link by an accredited exercise physiologist or physiotherapist (AEPP) trained in cancer care. The exercise component is structured over 12 weeks and adheres to Exercise and Sports Science Australia recommendations, including Adult Pre-Exercise Screening System (APPS form) for risk of adverse event due to exercise. Goals will be prioritised and set, and the prescription co-designed with the participant, including strategies for longer-term maintenance.
The intervention will adhere to ESSA guidelines:

1. The goal is to enhance neuromuscular strength, endurance, balance, flexibility, and cardiorespiratory fitness. The AEPP will individually tailor exercise to the functional capacity of each participant towards these goals, cognisant of participant restrictions.
2. Up to 3 x 60-minute exercise sessions per week, individually prescribed by an AEPP. The session will aim for an aerobic component (up to 40 minutes moderate-to-vigorous intensity based on a percentage range of age-predicted heart rate maximum) such as jogging -on-the-spot or fast walking and resistance component (2 x 8-12+ repetitions of major muscle group exercises at >6-10 on the OMNI perceived exertion scale, where 0=extremely easy to 10=extremely hard) such as push-ups, lunges, squats, rowing. High-intensity aerobic exercise may be prescribed during the intervention, individualised to the participants’ cardiorespiratory fitness and closely monitored by the AEPP. Exercise intensity during exercise sessions will be monitored by heart rate on the Fitbit watch, and by rating of perceived exertion using the 6-20 Borg Scale.
3. For the first six-weeks, the AEPP will directly supervise and prescribe two individual 60 minute sessions per week via Zoom (Zoom Video Communications, USA) and provide prescription for one self-managed home session.
4. In Weeks 7-12, participants will be asked to attend one supervised 60 minute Zoom session per week. Participants will also complete two self-managed, home based exercise sessions.
5. The AEPP will deliver all sessions from Wesley Choices, Wesley gym, UQ, or a private and undisturbed location using a laptop, while participants will be asked to participate from their home or another location of their choosing.
The exercise intervention will be complemented by a behavioural component integrated within each exercise session. The behavioural component will enable the AEPP to help the participant define realistic achievable goals and facilitate exercise maintenance beyond the study period. The exercise intervention will therefore be complemented by a behavioural component. The aim of the behavioural component is to instil exercise self-efficacy, which refers to the person’s willingness to respond to challenges, how hard they will work at challenges, and the extent to which they will persist despite adversity or set-backs. The behavioural component will enable the AEPP to help the participant define realistic achievable goals, encourage them to achieve the desired exercises, give participants insights into the success of others in similar circumstances, and facilitate exercise maintenance beyond the study period. The AEPP will be trained in the following specific strategies demonstrated to promote self-efficacy:
1. Collaborating with the participant to define realistic goals that are specific, achievable and measurable. As the individual successfully reaches those goals (performance accomplishment), this in turn promotes optimism and willingness to persist despite set-backs.
2. Providing information about success of others (vicarious experience), which instils the notion of “If they can do it, so can I”.
3. Encouragement by the AEPP (verbal persuasion), which is demonstrated to increase motivation.
4. Attention to emotional arousal including cognitive distortions, and challenging preconceived ideas or misperceptions about exercise that can otherwise pose a barrier.

Intervention training for AEPPs will be multimodal. First, a self-directed training manual will describe the common physical and psychological consequences of the diagnosis and treatment of reproductive cancer. This will be supplemented by a day-long skills development session that will focus on empathic engagement, the principles of chronic disease self-management, motivational interviewing, encouraging exercise self-efficacy and techniques to challenge cognitive distortions. Third, clinical supervision from experienced psycho-oncology clinicians and specialist oncology AEPPs will be available for AEPPs as our previous research has demonstrated that this is a central aspect of promoting the confidence of health professionals to deliver this type of intervention.

Duration and intensity of daily physical activities will be tracked during the monitoring period. All participants will be required to wear a FitBit throughout their maintenance period to accurately track the intensity of daily physical activities, including the unsupervised exercise sessions.
Intervention code [1] 323621 0
Treatment: Other
Intervention code [2] 323622 0
Rehabilitation
Intervention code [3] 323623 0
Lifestyle
Comparator / control treatment
Participants in the delayed intervention control group will receive the same allocation as those in the control group of the main trial. This will be supplemented with general advice about self-managed exercise, a Fitbit to monitor physical activity, and the Exercise is Medicine guideline for gynaecological cancer. However, after they have completed a 12-week control period, they will then be eligible for the intervention and the same outcome assessments will be repeated. The control group will undergo all assessment outcomes at baseline, week 12 and week 24. This includes a 7-day physical activity assessment at each time-point by wearing the Fitbit watch. Participants will also be encouraged at the start of the study to wear the Fitbit device throughout the 24 week period so they can self-manage levels of physical activity.
Control group
Active

Outcomes
Primary outcome [1] 331465 0
Feasibility of the exercise intervention delivered via video technology will be assessed as a composite outcome determined by percentage of patients who register interest and are recruited into the study via audit of study screening and enrolment logs.
Attendance at the scheduled exercise sessions will be recorded by the AEPP via intervention session sheets, capturing the participant attendance for each of the 36 planned sessions.
Adherence and compliance with the exercise prescription (measured by heart rate monitoring and perceived exertion) will be recorded by the AEPP via intervention session sheets, capturing the participant heart-rate response, perceived exertion rating, load and repetitions of every exercise for each of the 36 planned sessions.
Timepoint [1] 331465 0
Cumulative data will be assessed at the conclusion of the study.
Primary outcome [2] 331466 0
Safety will be measured by data collected on adverse events.
Number, type and severity of adverse events reported. Participants will be advised that they should report any spontaneous adverse events that may occur during the study, and will be provided with contact details for reporting. AEPP will monitor and report adverse events during the intervention period, and participants will be regularly contacted during trial for monitoring of adverse events.
Timepoint [2] 331466 0
Any adverse events that occur throughout the 24 weeks of the study will be recorded in the study adverse event log for cumulative review at the conclusion of the study.
Secondary outcome [1] 409806 0
Exercise self-efficacy as measured by the Exercise Self-efficacy Scale (ESES)
Timepoint [1] 409806 0
Baseline (pre-intervention), week 12 (end of intervention) and week 24 (longer-term maintenance).
Secondary outcome [2] 409807 0
Participants perceived benefits and barriers to exercise as measured by the Exercise Benefits / Barriers Scale (EBBS).
Timepoint [2] 409807 0
Baseline, week 12, and week 24.
Secondary outcome [3] 409808 0
Aerobic fitness (6 minute walk test) will assess the participant’s exercise capacity.
Timepoint [3] 409808 0
Baseline, week 12, and week 24.
Secondary outcome [4] 409809 0
Body composition measured via waist-hip ratio with a measuring tape according to WHO STEPwise Approach to Surveillance (STEPS) protocol for consistent measurement.
Timepoint [4] 409809 0
Baseline, week 12, and week 24.
Secondary outcome [5] 409810 0
Dynamic upper body muscle strength (timed repetition test).
Timepoint [5] 409810 0
Baseline, week 12, and week 24.
Secondary outcome [6] 409817 0
Balance (assessed via centre of pressure displacement techniques).
Timepoint [6] 409817 0
Baseline, week 12, and week 24.
Secondary outcome [7] 409828 0
Frequency of physical activity levels as assessed by the Fitbit watch.
Timepoint [7] 409828 0
Baseline, week 12, and week 24.
Secondary outcome [8] 409829 0
Intensity of physical activity levels as assessed by the Fitbit watch.
Timepoint [8] 409829 0
Baseline, week 12, and week 24.
Secondary outcome [9] 409830 0
Duration of physical activity levels as assessed by the Fitbit watch.
Timepoint [9] 409830 0
Baseline, week 12, and week 24.
Secondary outcome [10] 409832 0
The telehealth intervention will be assessed for its acceptability, appropriateness, and feasibility as a composite to determine the implementation potential of telehealth video collected via Acceptability, Appropriateness and Feasibility of Intervention Measures (AFFIMs) questionnaire. The AAFIMs collectively assess the factors that indicate implementation potential to patients, clinicians and organisational decision-makers. Each measure contains four items that assess the extent to which respondents consider an intervention or implementation strategy is acceptable, appropriate, and feasible. Higher scores indicate greater acceptability, appropriateness, and feasibility. As a suite, the measures have confirmed validity and reliability.
Timepoint [10] 409832 0
Completed by AEPP and participant at the conclusion of the final intervention session.
Secondary outcome [11] 409833 0
Attendance will be measured as the number of video-supervised sessions attended. The number of video-supervised sessions attended by will be recorded via intervention session sheets completed for each individual session.
Timepoint [11] 409833 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [12] 409990 0
The mean difference on the physical component summary (PCS) scores of health-related quality of life between intervention and control in this trial, as measured by the Short Form-36 (SF36).
Timepoint [12] 409990 0
Baseline, week 12, and week 24.
Secondary outcome [13] 409991 0
The mean difference on the mental component summary (MCS) scores of health-related quality of life between intervention and control in this trial, as measured by the SF36.
Timepoint [13] 409991 0
Baseline, week 12, and week 24.
Secondary outcome [14] 410754 0
Dynamic lower body muscle strength (timed repetition test).
Timepoint [14] 410754 0
Baseline, week 12, and week 24.
Secondary outcome [15] 411004 0
Adherence will be measured as the percentage of the prescription completed during these sessions, divided into modalities. Adherence and compliance with the exercise session will also be assessed through remote heart rate monitoring via a fitbit device. The number of non-supervised home-based sessions completed will also be recorded. Reasons for non-adherence will also be captured.
Timepoint [15] 411004 0
Cumulative data will be assessed at the conclusion of the study.

Eligibility
Key inclusion criteria
1. Women aged 18 years or older diagnosed with cancer of the ovary, cervix, Fallopian tubes, placenta, endometrium, vagina or vulva in the previous 60 months, including early, recurrent, advanced or metastatic cancer.
2. > 1 month since end of intensive cancer treatment (including surgery, radiotherapy, chemotherapy). Supportive therapies such as bisphosphonate, pain medication and hormone replacement allowable.
3. Resident in Australia.
4. Have access to the internet.
5. Own, or have access to, a computer or mobile device.
6. Willing and able to comply with all study requirements, including intervention, timing and nature of required assessments.
7. Able to speak and read in English to ensure consent is informed and documentation of participant-reported outcome measures can be adhered to.
8. Can provide voluntary written informed consent.
9. Unable or unwilling to attend face-to-face exercise training and objective outcome assessment.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any clinical contraindication that precludes safe completion of the program in the judgement of the project team.
2. No intensive cancer treatments while enrolled.
3. In the care of an exercise professional at the time of enrolment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who is "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Differences in diagnosis and treatment characteristics between gynaecological cancer stages may influence patient reported outcomes, including quality of life and physical activity levels. A poorer health-related quality of life has been found in patients with a higher tumour stage, and women with advanced disease report smaller positive changes in health-related quality of life following treatment for gynaecological cancer. For this reason, we will stratify by cancer stage in this study. Patients in each stratum was determined by using probability proportion to size approach, based on the number of gynaecological cancer cases registered at QCGC [Queensland Centre for Gynaecological cancer] by stages over the past five years 2013-2017. Patients in each stratum will then be randomly allocated into one of the two groups using a block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used to evaluate intervention feasibility. Based on previous feasibility studies in exercise oncology adherence and compliance of greater than or equal to 70% would demonstrate feasibility of video-delivered exercise intervention and will be assessed as the primary metrics of feasibility in this study.

Secondary feasibility metrics assessed via duration and completion of exercise testing delivery via video. Analysis of acceptability and feasibility, and enjoyment of the exercise intervention and testing sessions (measured using AAFIMS, EBBS exercise benefits and barriers scale, and the PACES exercise enjoyment questionnaires). Number, type and severity of adverse events reported, qualitative analysis of free text survey asking participants to comment on strengths or weaknesses of the intervention, experience of accessing the intervention, perceptions of the video-delivered exercise sessions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/12/2023
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22409 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 37573 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 311462 0
Charities/Societies/Foundations
Name [1] 311462 0
Wesley Medical Research
Country [1] 311462 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia
Brisbane
QLD 4072
Country
Australia
Secondary sponsor category [1] 312879 0
None
Name [1] 312879 0
Address [1] 312879 0
Country [1] 312879 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310932 0
Uniting Care Health Human Research Ethics Committee
Ethics committee address [1] 310932 0
Ethics committee country [1] 310932 0
Australia
Date submitted for ethics approval [1] 310932 0
22/03/2022
Approval date [1] 310932 0
01/04/2022
Ethics approval number [1] 310932 0
2024

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

Contacts
Principal investigator
Name 119398 0
Prof Alexandra McCarthy
Address 119398 0
School of Nursing Midwifery and Social Work
The University of Queensland
St Lucia, QLD 4072
Country 119398 0
Australia
Phone 119398 0
+61 428566283
Fax 119398 0
Email 119398 0
[email protected]
Contact person for public queries
Name 119399 0
Alexandra McCarthy
Address 119399 0
School of Nursing Midwifery and Social Work
The University of Queensland
St Lucia, QLD 4072
Country 119399 0
Australia
Phone 119399 0
+61 428566283
Fax 119399 0
Email 119399 0
[email protected]
Contact person for scientific queries
Name 119400 0
Alexandra McCarthy
Address 119400 0
School of Nursing Midwifery and Social Work
The University of Queensland
St Lucia, QLD 4072
Country 119400 0
Australia
Phone 119400 0
+61 428566283
Fax 119400 0
Email 119400 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Aggregate data will be available on application to other researchers.


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.