None listed
Conditions
Brief summary
This study aims to co-design and test a telehealth-delivered, stoma-specific exercise and physical activity program to ensure it meets the needs of people living with a stoma. Who is it for? You may be eligible for this study if you are: A male or female age 18 or older, who has received a stoma as a result of Inflammatory Bowel Disease (IBD) or cancer in the five years prior to enrolment. A stoma is either permanent or long-term. Have access to the internet and own, or have access to, a computer or tablet device. or, A health professional working with people who have a stoma Study details: Participants will be involved in different ways depending on their group: Consumers with lived experience of a stoma will help co-adapt and refine the FOXTROT X exercise intervention through an interactive series of workshop sessions. Healthcare professionals will also assist in co-adapting the FOXTROT X exercise intervention during a collaborative workshop with consumers. People with a stoma due to cancer will test the 12-week exercise program (delivered via telehealth), followed by a 12-week maintenance period. Participants will also complete quality of life assessments and may undergo simple health checks, such as surveys. There is no randomisation — all eligible participants will receive the intervention or be involved in its design and evaluation. It is hoped that findings from this study will enhance physical activity and quality of life in the stoma community.
Interventions
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 r
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).
Sponsors
Griffith University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Exclusion criteria
Intervention Participants 1. Any clinical contraindication that precludes safe completion of the program in the judgment of the project team
Outcome results
None listed