Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001199505p
Ethics application status
Submitted, not yet approved
Date submitted
29/08/2024
Date registered
1/10/2024
Date last updated
1/10/2024
Date data sharing statement initially provided
1/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility testing Of telehealth-delivered eXercise TheRapy for Ostomates Treated for cancer (FOXTROT)
Scientific title
Feasibility testing Of telehealth-delivered eXercise TheRapy for Ostomates Treated for cancer patients who received a stoma
Secondary ID [1] 312845 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 334976 0
Stoma 334977 0
Condition category
Condition code
Cancer 331497 331497 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 331806 331806 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 331807 331807 0 0
Ovarian and primary peritoneal
Cancer 331808 331808 0 0
Stomach
Cancer 331809 331809 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will comprise of a stoma-specific exercise intervention that can be delivered in a remote, telehealth setting. Intervention material will include an exercise manual, web-based exercise videos and guides, and a one-hour individual telehealth exercise and coaching session each week with a stoma-trained exercise professional (ExP), for 12-weeks. Participants will also be encouraged to undertake self-managed sessions twice weekly, to accumulate three organised exercise sessions and progress towards a minimum physical activity target of equal to or greater than 150 minutes per week, consistent with Australian Physical Activity and Exercise Guidelines for Adults. Initial exercise dose and progression will be prescribed based on a baseline assessment that will address the participants needs, stoma specific considerations or barriers to exercise, current ability, and current exercise efficacy. These consults will also allow for ExP-mediated discussions to identify and address current perceived barriers to exercise and safety concerns.

Each exercise session will constitute three primary components: Stoma-specific strengthening, aerobic exercise, and resistance exercise. Stoma-specific exercises have been developed and tested elsewhere, and will be adapted for inclusion in the present study aligned with participant capability and goals. Exercise equipment including TheraBands and dumbbells will be provided as needed. Aerobic and resistance-based exercise prescription will adhere to Exercise and Sports Science Australia recommendations. In the present study, resistance training will utilise repetitions in reserve (RIR) to regulate intensity, with 1-4 used as a target intensity for a given set. For the aerobic component, moderate intensity exercise or physical activity prescription may be utilised by ExPs in cases where high intensity interval training (HIIT) is considered either not suitable or is not a preferred modality of a participant. Attention will be extended to perceived barriers to exercise and risk factor management through education and exercise counselling.

FOXTROT Exercise Training Session Outline
Stoma Specific Strength: 2-3 sets of 2-3 stoma-specific strengthening exercises. Progress from Level 1 to Level 3 across the intervention. Participants will be given materials that include videos demonstrating exercises for activating the body core and abdominal muscles and instructions on techniques and breathing for these exercises, as per the Hernia Active Living Trial (Hubbard et al,. 2020)
Resistance Exercise: 2 – 3 sets of 8-12 repetitions; 30-60 seconds of rest between sets; Target intensity: 1-4 RIR; utilising upper and lower body strength exercises e.g., push-up and squat.
Aerobic Exercise: HIIT, MICT, or PA
HIIT:
5 min warm up
4 min HII
3 min recovery
4 min HII
3 min cooldown
MICT:
20-30 min moderate intensity (50-80% HR peak)
PA:
Accumulate
150 minutes of MVPA
HII, High intensity interval; HIIT, High intensity interval training; HR, Hear rate; MICT, Moderate intensity continuous training; MVPA, Moderate to vigorous physical acidity; PA, Physical activity; RIR, Repetitions in reserve; 1RM, One repetition maximum

Exercise attendance and adherence will be recorded during exercise consults by the delivering ExP. This will include recording of the current exercise session, with notation of exercise dose and exercise selection (intensity, sets, reps, time of aerobic exercise), as well as prescription of an unsupervised session to be conducted in the same week. At the subsequent exercise consult, the ExP will retrospectively record participant adherence and attendance to this unsupervised session via participant self-report. Reasons for non-adherence will be recorded, and stoma specific barriers and concerns that may contribute to either modification of exercise prescription or non-adherence will also be recorded. Any AEs will also be recorded during ExP consults and facilitate identification of study relatedness and severity.

One-week additional time may be allocated to participants that need to postpone exercise for any reason during the intervention; i.e., 13-weeks will be allowed to complete the 12-week intervention. Any exercise consults or “missed” exercise sessions that cannot be included in this time will inform the feasibility and acceptability assessment of the program
Intervention code [1] 329391 0
Lifestyle
Intervention code [2] 329577 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339236 0
Feasible
Timepoint [1] 339236 0
12 weeks from baseline following intervention completion
Primary outcome [2] 339237 0
Feasibilty
Timepoint [2] 339237 0
12 week at end of intervention
Primary outcome [3] 339239 0
Feasibility
Timepoint [3] 339239 0
12 weeks from baseline following intervention completion
Secondary outcome [1] 439184 0
Feasibility
Timepoint [1] 439184 0
24 weeks from baseline assessment
Secondary outcome [2] 439185 0
Feasiblity
Timepoint [2] 439185 0
12 weeks from baseline assessment
Secondary outcome [3] 439187 0
Feasibility
Timepoint [3] 439187 0
24 weeks from baseline assessment
Secondary outcome [4] 439188 0
Acceptability
Timepoint [4] 439188 0
12 weeks from baseline assessment
Secondary outcome [5] 439190 0
Acceptability
Timepoint [5] 439190 0
12 weeks from baseline assessment
Secondary outcome [6] 439192 0
Acceptability
Timepoint [6] 439192 0
24 weeks from baseline assessment
Secondary outcome [7] 439193 0
Safety
Timepoint [7] 439193 0
12 weeks from baseline assessment
Secondary outcome [8] 439195 0
Safety
Timepoint [8] 439195 0
12 weeks from baseline assessment
Secondary outcome [9] 439197 0
Quality of life
Timepoint [9] 439197 0
At 12-week and 24-week from baseline assessment

Eligibility
Key inclusion criteria
1. Men and women 18 years and older, treated for cancer and who have received a stoma in the five years prior to enrolment (stoma formed at Uniting Care hospital)
2. More than six weeks since stoma surgery
3. Stoma is either permanent or long-term (in situ for greater than or equal to 26 weeks)
4. Stoma was received as a result of cancer and/or its treatments
5. Cancer treatment may be completed or ongoing
6. Reside in Australia
7. Have access to the internet and own, or have access to, a computer or tablet device
8. Willing and able to comply with all study requirements, including intervention, timing and nature of required assessments
9. Able to speak and read in English, or have access to English translation via a friend or family member, to ensure consent is informed and documentation of participant-reported outcomes measures can be adhere do.
10. Can provide voluntary informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Stoma was received in treatment of a diagnosis alternative to cancer (e.g. Irritable Bowel Disease, Crohn’s disease)
2. Any clinical contraindication that precludes safe completion of the program in the judgement of the project team

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
To assess primary and secondary outcomes, participant characteristics and responses will be summarised using frequencies and percentages (categorical data) and descriptive statistics (i.e. mean [SD] or median [IQR]) for continuous data. The target rates will be summarised as frequency (%) and 95% confidence interval estimates. Each target outcome will be classified as met if the rate exceeds the cut-off, and the intervention will be considered feasible, acceptable and safe if all target outcomes are met at Week 12. Descriptive statistics including the mean and SD will be generated for each secondary outcome and each time-point. The mean and SD for the change between weeks 0-12; weeks 0-24 and weeks 12-24 will be generated. An exploratory analysis to assess the effect of the program on secondary as the change from Week 0 to Weeks 12 and 24 (time treated as categorical term) will be undertaken using Tobit mixed effects models to account for the potential ceiling and/or floor effects of the quality of life measure.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 27044 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 43113 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 317283 0
Other Collaborative groups
Name [1] 317283 0
Wesley Medical Research Institute
Country [1] 317283 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Wesley Research Institute
Address
Country
Australia
Secondary sponsor category [1] 319562 0
None
Name [1] 319562 0
Address [1] 319562 0
Country [1] 319562 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316020 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 316020 0
Ethics committee country [1] 316020 0
Australia
Date submitted for ethics approval [1] 316020 0
02/09/2024
Approval date [1] 316020 0
Ethics approval number [1] 316020 0

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

Contacts
Principal investigator
Name 136530 0
Dr Janine Porter-Steele
Address 136530 0
Griffith University G40, Southport QLD 4215
Country 136530 0
Australia
Phone 136530 0
+61466 269 562
Fax 136530 0
Email 136530 0
[email protected]
Contact person for public queries
Name 136531 0
Janine Porter-Steele
Address 136531 0
Griffith University G40, Southport QLD 4215
Country 136531 0
Australia
Phone 136531 0
+61466 269 562
Fax 136531 0
Email 136531 0
[email protected]
Contact person for scientific queries
Name 136532 0
Janine Porter-Steele
Address 136532 0
Griffith University G40, Southport QLD 4215
Country 136532 0
Australia
Phone 136532 0
+61466 269 562
Fax 136532 0
Email 136532 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.