Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001070426
Ethics application status
Approved
Date submitted
4/07/2025
Date registered
1/10/2025
Date last updated
1/10/2025
Date data sharing statement initially provided
1/10/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Moving Without Fear When Living with a Stoma: A Consumer-Led Physical Activity Study
Scientific title
Moving Without Fear When Living with a Stoma: Assessing the Feasibility, Efficacy and Safety of a Consumer-Led Physical Activity Study (FOXTROT X)
Secondary ID [1] 314815 0
None
Universal Trial Number (UTN)
Trial acronym
FOXTROT X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 338069 0
Stoma 338070 0
Ostomate 338071 0
Inflammatory Bowel Disease 338974 0
Condition category
Condition code
Cancer 334368 334368 0 0
Ovarian and primary peritoneal
Cancer 334371 334371 0 0
Stomach
Cancer 334372 334372 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 334373 334373 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 334374 334374 0 0
Womb (Uterine or endometrial cancer)
Oral and Gastrointestinal 335175 335175 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pilot study (FOXTROT) is currently underway in Australia to assess the feasibility of a stoma-specific exercise program delivered via telehealth.

The current project, FOXTROT X, is a multiphase mixed-methods study to evaluate whether a co-adapted, stoma-specific, telehealth-delivered exercise intervention is feasible, acceptable and safe. The study involves four phases, with each phase aligned to the research objectives.

Objective 1 is to stimulate and support consumer capability in stoma research and advocacy. Ten consumers with lived experience of a stoma will participate in a series of three workshops to build skills to equip them with the foundation and research knowledge to support their meaningful involvement in Objective 2a. Each workshop will run for a maximum of 4 hours.

Objective 2a is to co-adapt the FOXTROT exercise program into FOXTROT X with the 10 consumers from Objective 1 and 10 healthcare professionals with experience in stomal care. In one workshop (maximum time is 4 hours), the consumers and healthcare professionals will collaboratively refine the content, structure and delivery of the program to ensure acceptability. Specifically, the workshop will invovle a presentation of the current FOXTROT intervention, followed by group discussion and activities with consumers and healthcare professionals.

Objective 2b is to deliver and evaluate the co-adapted FOXTROT X exercise intervention over 24 weeks using a pre-post mixed-methods design with 60 participants. While the co-adaptation process will determine the final content and format, it is anticipated that the program will follow a structure similar to the original FOXTROT intervention. This includes a 12-week telehealth-delivered program, consisting of weekly one-to-one 60-minute supervised sessions with an Accredited Exercise Physiologist delivered via Teams. During these sessions, participants will complete stoma-specific strengthening, aerobic, and resistance exercises, including floor-based abdominal exercises such as 'heel-taps', resistance band exercises, such as 'standing rows', and low-impact cardiovascular activities, such as 'stepping', tailored to individual stoma considerations. 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.

Adherence will be assessed through multiple strategies, including a prescribed exercise program via Physitrack, session attendance records, self-reported participant exercise collected weekly at each supervised session, and pre-planned exercise and independent exercise discussed with the exercise physiologist during weekly supervised sessions.

Quantitative data will be collected at Baseline, 12-Weeks, and 24-Weeks to assess feasibility, safety and acceptability. A sub-sample of participants will be invited to take part in a semi-structured interview (approximately 1 hour) to provide their experience in the intervention.

Objective 4 is to develop a pragmatic dissemination and translation plan for evidence-based, stoma-specific guidance that can be implemented upon project completion. Consumers who participated in Objective 1 and 2a will be invited to re-engage in this phase to co-produce dissemination strategies and knowledge translation outputs via an online focus group (1-1.5 hours).
Intervention code [1] 331418 0
Lifestyle
Intervention code [2] 331991 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342051 0
Feasibility
Timepoint [1] 342051 0
Baseline following consent (timepoint 0)
Primary outcome [2] 342054 0
Feasibility
Timepoint [2] 342054 0
Week 12 (timepoint 1) post intervention completion
Primary outcome [3] 342056 0
Feasibility
Timepoint [3] 342056 0
12 weeks from baseline following intervention completion
Secondary outcome [1] 449427 0
Feasibility
Timepoint [1] 449427 0
Week 12 (timepoint 1) post-intervention completion
Secondary outcome [2] 449429 0
Feasibility
Timepoint [2] 449429 0
Timepoint 0 (baseline), 1 (post-intervention completion), & 2 (12-weeks post intervention completion).
Secondary outcome [3] 449430 0
Acceptability
Timepoint [3] 449430 0
Timepoint 0 (baseline), 1 (post-intervention completion), & 2 (12-weeks post intervention completion).
Secondary outcome [4] 449431 0
Acceptability
Timepoint [4] 449431 0
Week 12 (timepoint 1) post-intervention completion
Secondary outcome [5] 449432 0
Acceptability
Timepoint [5] 449432 0
Week 12 (timepoint 1) post-intervention completion
Secondary outcome [6] 449433 0
Acceptability
Timepoint [6] 449433 0
Weekly between timepoint 0 and 1. Calculated per participant at timepoint 1 (week 12 following intervention completion).
Secondary outcome [7] 449434 0
Safety
Timepoint [7] 449434 0
Weekly between timepoint 0 and 1. Calculated per participant at timepoint 1 (week 12 following intervention completion).
Secondary outcome [8] 449435 0
Physical activity (PA)
Timepoint [8] 449435 0
Timepoint 0 (baseline), 1 (12 weeks - post-intervention completion), & 2 (24 weeks)
Secondary outcome [9] 449436 0
Quality of life (QoL)
Timepoint [9] 449436 0
Timepoint 0 (baseline), 1 (12 weeks - post-intervention completion), & 2 (24 weeks)
Secondary outcome [10] 449437 0
Health care usage
Timepoint [10] 449437 0
We will request these data 12 months prior to baseline and after baseline to determine any cost differences after the intervention period

Eligibility
Key inclusion criteria
The FOXTROT X Study will recruit for three participant groups:
Consumer Participants (Australians with Lived Experience of a Stoma):
- Men and Women 18 years and older who have received a stoma as a result of/or during treatment for Inflammatory Bowel Disease (IBD) or cancer-related conditions.
- Are residing in Australia
- Own or have access to the internet, a computer or tablet device or smartphone.
- Able to speak and read English or have access to English translation support.
- Be willing and able to comply with all study requirements including the dates and timing of workshops and contribute to discussion.

Healthcare Professional Participants:
- Health professionals such as gastroenterologists, oncologists, radiation oncologists, colorectal surgeons, other surgeons who perform stoma surgery, nurses, allied health professionals and exercise specialists.

Intervention Participants:

- Individuals 18 years and over who have received a stoma as a result of/or during treatment for Inflammatory Bowel Disease (IBD) or cancer-related conditions.
- For participants following a cancer diagnosis, primary active treatment must be completed, such as chemotherapy or radiotherapy, but may still be receiving maintenance therapy.
- The stoma must be permanent or expected to remain in place for at least 26 weeks.
- The stoma must have been in place for more than six weeks but less than five years.
- Are residing in Australia
- Own or have access to the internet, a computer or tablet device or smartphone.
- Able to speak and read English or have access to English translation support.
- Be willing and able to comply with all study requirements including the intervention, timing and nature of assessments.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Intervention Participants

1. Any clinical contraindication that precludes safe completion of the program in the judgment of the project team

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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2026
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319376 0
Government body
Name [1] 319376 0
Department of Health, Disability and Ageing Medical Research Future Fund
Country [1] 319376 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 321860 0
None
Name [1] 321860 0
Address [1] 321860 0
Country [1] 321860 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317950 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 317950 0
Ethics committee country [1] 317950 0
Australia
Date submitted for ethics approval [1] 317950 0
20/08/2025
Approval date [1] 317950 0
16/09/2025
Ethics approval number [1] 317950 0
2025/630

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

Contacts
Principal investigator
Name 142658 0
Prof Alexandra McCarthy
Address 142658 0
Griffith University Health Executive Group. 1 Parklands Dr, Southport QLD 4215
Country 142658 0
Australia
Phone 142658 0
+61 7 567 89603
Fax 142658 0
Email 142658 0
[email protected]
Contact person for public queries
Name 142659 0
Dr Janine Porter-Steele OAM
Address 142659 0
Griffith University Health Executive Group. 1 Parklands Dr, Southport QLD 4215
Country 142659 0
Australia
Phone 142659 0
+61 7 567 89603
Fax 142659 0
Email 142659 0
[email protected]
Contact person for scientific queries
Name 142660 0
Dr Janine Porter-Steele OAM
Address 142660 0
Griffith University Health Executive Group. 1 Parklands Dr, Southport QLD 4215
Country 142660 0
Australia
Phone 142660 0
+61 7 567 89603
Fax 142660 0
Email 142660 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.