Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001254785
Ethics application status
Approved
Date submitted
12/09/2022
Date registered
19/09/2022
Date last updated
19/09/2022
Date data sharing statement initially provided
19/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise during breast cancer chemotherapy: A telehealth pilot feasibility study
Scientific title
Investigating the effect of multidisciplinary interventions on exercise uptake during early breast cancer treatment: a feasibility study
Secondary ID [1] 307943 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 327598 0
Condition category
Condition code
Cancer 324685 324685 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multidisciplinary exercise induction program delivered by telehealth, to improve exercise, self-efficacy and quality of life in breast cancer patients undergoing chemotherapy.
The program aims to assist participants to meet the Clinical Oncology Society of Australia guidelines for exercise which involve at least 150 minutes of moderate intensity aerobic exercise per week in addition to two to three resistance exercise sessions per week. There will be bi-weekly, virtual exercise classes across a 12 week period delivered through Microsoft Teams which will be supervised by a physiotherapist. Classes will commence once three participants have been recruited and the maximum group size will be five participants at any one time. The exercises completed during the classes will be individualized according to each patient depending on their baseline fitness and comorbidities during an initial physiotherapy assessment and will be based off the exercises recommended in the Cancer Council booklet, 'Exercise for People Living with Cancer'. Each exercise class will be 45 minutes in duration and will consist of a warm up and warm down component and a combination of the aerobic exercises prescribed, examples include jumping jacks and brisk walking on the spot and strength based exercises prescribed, examples of these include, bird-dog, pelvic tilt and bicep curl with dumbells. Attendance will be measured through a session attendance checklist and reason for absence will also be documented. In addition, to meet the 150 minutes of exercise recommended by COSA, participants will be encouraged to complete a daily exercise routine in their own time at home and record the type and quantity of exercise, either in a paper-based logbook or via the Physitrack app, for the duration of the study. This home exercise will consist of the same types of resistance and aerobic exercise completed in the bi-weekly classes.
There will be also fortnightly, virtual educational classes to supplement the exercise classes, six in total, each delivered by a clinical member of a multidisciplinary team through Microsoft Teams. These educational sessions will discuss topics that are pertinent to cancer. Three sessions will be delivered by the clinical psychologist, one will be talk about mindfulness, the other session will be a talk about body image and another session will be a talk about anxiety education and management. There will be one session delivered by a dietician who will present a talk about nutrition during cancer treatment. There will be one session delivered by an occupational therapist who will present a talk about fatigue management. There will be one session delivered by a physiotherapist who will present a talk about maintaining physical activity. There will be informational materials provided from the Cancer Council website. These sessions will last for approximately 1 hour, including 15 minutes dedicated to a Q&A component. Attendance will be measured through a session attendance checklist and reason for absence will also be documented.
After these 12 weeks of exercise and educational classes, there will be tapered phone calls by the research assistant to encourage maintenance of exercise levels and continual recording of daily exercise via the logbook/Physitrack app and to communicate back with the study physiotherapist if modifications need to be made to the exercise program. These phone calls will span a 12 week period and will begin at one phone call a week for four weeks, then one phone call once a month for two months. There will be six phone calls in total.

Intervention code [1] 324400 0
Rehabilitation
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332504 0
To assess the feasibility of an online group exercise program, measured in terms of attendance at classes offered over a 12 week period, for women with breast cancer receiving concomitant chemotherapy treatment. Attendance will be assessed through a review of session attendance checklist.
Timepoint [1] 332504 0
12 weeks post commencement of exercise program.
Secondary outcome [1] 413761 0
To assess participant satisfaction with the telehealth exercise program and user acceptability of the intervention as a whole measured through a composite of attendance and a Likert Satisfaction Survey.
Timepoint [1] 413761 0
12 weeks post commencement of exercise program.
Secondary outcome [2] 413762 0
To scope rehabilitation needs in this participant group, namely women undergoing chemotherapy treatment for breast cancer measured through a rehabilitation assessment with a rehabilitation physician.
Timepoint [2] 413762 0
Baseline and 12 weeks post commencement of the exercise classes.
Secondary outcome [3] 413763 0
To measure adherence to a home exercise program, among women undergoing chemotherapy for breast cancer through the use of a logbook.
Timepoint [3] 413763 0
12 weeks post commencement of the exercise classes.
Secondary outcome [4] 413764 0
To assess whether the intervention can impact self-reported participant fatigue measured through the Functional Assessment of Chronic Illness Therapy – Fatigue Scale (FACIT Fatigue Scale).
Timepoint [4] 413764 0
Baseline and 12 weeks post commencement of exercise classes.
Secondary outcome [5] 413766 0
To assess whether the intervention can result in changes to health-related quality of life through the Functional Assessment of Cancer Therapy- Breast Version 4 (FACT-B+4).
Timepoint [5] 413766 0
Baseline and 12 weeks post commencement of exercise classes.
Secondary outcome [6] 413767 0
To assess whether the intervention results in a change in cardiovascular fitness measured through a composite of the 5 x sit-to-stand and 30 second sit-to-stand tests.
Timepoint [6] 413767 0
Baseline, 6 and 12 weeks post commencement of exercise classes.
Secondary outcome [7] 413793 0
To assess whether the intervention results in a change of mood assessed using the Depression Anxiety Stress Scales (DASS-21).
Timepoint [7] 413793 0
Baseline and 12 weeks post commencement of exercise classes.
Secondary outcome [8] 413794 0
To assess whether the intervention results in changes to levels of physical activity through the International Physical Activity Questionnaire.
Timepoint [8] 413794 0
Baseline and 12 weeks post commencement of exercise classes.
Secondary outcome [9] 413920 0
To scope goal attainment in this participant group, namely women undergoing chemotherapy treatment for breast cancer measured through a Goal Attainment Scale.
Timepoint [9] 413920 0
Baseline and 12-weeks post commencement of exercise classes.

Eligibility
Key inclusion criteria
• Adults aged 18 years and over
• Early stage female breast malignancy (stage I, II or IIIA)
• Planned for chemotherapy but has not yet commenced it; or is within 4 weeks of commencement of chemotherapy
• Able to provide written informed consent
• Access to an internet connection with camera and audio to enable telehealth (e.g. via a smartphone, tablet, desktop or laptop device)
• Able to utilise telehealth technology
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Medically unfit to participate in a home-based exercise programme, as assessed by either a medical oncologist or rehabilitation physician
• New York Heart Association Class IV heart failure
• Type I or type 2 respiratory failure
• Cardiac, respiratory or neurological symptoms that are being actively investigated
• Unable to mobilise independently (i.e. requires assistance to stand and walk)
• Non-English speaking patients. Because in-depth communication between participants and physiotherapist, and attendance at group education sessions by telehealth, are an essential component of this study, and due to the limited budget of this pilot study, using a translator will be not be feasible.
• Severe uncorrected hearing impairment – as this will prevent effective engagement in the group telehealth intervention

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Given this is a pilot feasibility study, a convenience sample of 20 participants will be recruited. This will ensure that sufficient data is collected upon which to assess the feasibility and acceptability of the proposed intervention, and to design and power a larger future study if indicated. Acceptability will be measured through a Likert scale response.

Attendance will be quantified for each participant as the proportion of total sessions attended (out of 24). For assessments of feasibility, good/adequate attendance will be considered attending >=75% of all possible physiotherapy sessions.

Descriptive statistics including mean, range, standard deviation, proportions and 95% confidence intervals will be used to describe the study population in terms of demography and clinical variables. Analyses will be conducted using intention-to-treat methodology. Related samples t-tests (or non-parametric equivalents) will be used to examine changes over time from pre to post intervention, for the pooled cohort. Any side effects or adverse events associated with the intervention (such as falls or other injuries) will be reported descriptively, as will patient satisfaction data. Statistical analyses will be conducted in SPSS software (v23, IBM), and results will be considered significance when p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/09/2022
Date of last participant enrolment
Anticipated
4/10/2023
Actual
Date of last data collection
Anticipated
17/01/2024
Actual
Sample size
Target
20
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23128 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 38488 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 312211 0
Charities/Societies/Foundations
Name [1] 312211 0
St Vincent's Hospital Curran Foundation
Country [1] 312211 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
390 Victoria St, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 313740 0
None
Name [1] 313740 0
Address [1] 313740 0
Country [1] 313740 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311592 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 311592 0
Ethics committee country [1] 311592 0
Australia
Date submitted for ethics approval [1] 311592 0
01/02/2021
Approval date [1] 311592 0
23/06/2021
Ethics approval number [1] 311592 0

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

Contacts
Principal investigator
Name 121642 0
Prof Steven Faux
Address 121642 0
St Vincent's Hospital Sydney
390 Victoria St, Darlinghurst NSW 2010
Country 121642 0
Australia
Phone 121642 0
+61 0416141125
Fax 121642 0
Email 121642 0
[email protected]
Contact person for public queries
Name 121643 0
Steven Faux
Address 121643 0
St Vincent's Hospital Sydney
390 Victoria St, Darlinghurst NSW 2010
Country 121643 0
Australia
Phone 121643 0
+61 0416141125
Fax 121643 0
Email 121643 0
[email protected]
Contact person for scientific queries
Name 121644 0
Steven Faux
Address 121644 0
St Vincent's Hospital Sydney
390 Victoria St, Darlinghurst NSW 2010
Country 121644 0
Australia
Phone 121644 0
+61 0416141125
Fax 121644 0
Email 121644 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
Individual participant data will not be made available for sharing, in accordance with the ethically approved study protocol.


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.