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Exercising Right for Bowel Cancer

Exercising Right for Bowel Cancer: A Feasibility Study

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000836134
Acronym
ERBC
Enrollment
30
Registered
2019-06-11
Start date
2019-07-01
Completion date
2019-09-27
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In Tasmania, bowel cancer is the second most commonly diagnosed type of cancer. Appropriately prescribed exercise during cancer treatment is recommended as an important component of cancer care, but few people take up exercise during their treatment. Often the reasons given for not exercising during cancer treatment are access to exercise experts and affordability. This study will explore the effectiveness of exercise counselling and prescription delivered by an Accredited Exercise Physiologist using app-based technology in people with bowel cancer Who is it for? The study is adults over 18 years who are in primary or adjuvant therapy for localised (non-metastasised) bowel cancer (chemo, radiation or post colostomy surgery). Inclusion criteria includes people who are a maximum of 6 months post treatment for stage I to III colorectal cancer. Study details: Participants will volunteer for the Home Exercise (intervention) group or the Usual Care (control) group. The Usual Care group will receive standard care as directed by their general practitioner and/ or oncologist.. The Home Exercise group will be involved in an unsupervised home exercise program with 4 x fortnightly education sessions around positive lifestyle changes during treatment for bowel cancer. The program will be delivered via an app using a video conferencing feature. It will cover exercising and eating recommendations for bowel cancer as well as managing stress. The intervention will run for 8 weeks and involve questionnaires and vital sign measurements (heart rate, oxygen saturation, BMI). What do we expect will happen? We expect that participants in the Home Exercise group will improve their understanding of the importance of regular exercise in managing the ongoing health effects of cancer and its’ treatments. After 8 weeks of structured and individualised exercise, we expect participants in the Home Exercise group will have improved quality of life, increased strength and aerobic fitness and be more confident in the ongoing self-management of their health, compared to the Usual Care group.

Interventions

There will be two groups of participants, "Home Exercise" and "Usual Care". Participants in both groups will be screened for risk to participate in exercise testing by an Accredited Exercise Physiologist (AEP) and be asked standardised questions about their health history related to their current medical condition. Surveys and questionnaires are: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (QLQ-CR29 and QLQ-CR30), The Active Australia questionnaire

There will be two groups of participants, "Home Exercise" and "Usual Care". Participants in both groups will be screened for risk to participate in exercise testing by an Accredited Exercise Physiologist (AEP) and be asked standardised questions about their health history related to their current medical condition. Surveys and questionnaires are: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (QLQ-CR29 and QLQ-CR30), The Active Australia questionnaire, The Exercise Confidence Survey, The Cancer Fatigue Scale, and the CSIRO Health Diet Score. Then, if safe to proceed, each participant will undertake an assessment of their body composition (height, weight and body mass index), cardiovascular measures (blood pressure, heart rate, and oxygen saturation), and physical fitness (a Six Minute Walk test, a handgrip test, and a 30 second sit-to-stand test). These assessments will be undertaken by all participants, by the same AEP research assistant at "baseline" (before any intervention), and "follow up" after an 8 week intervention period. Participants in both groups will be given information handouts at the baseline session on "exercising right for bowel cancer", "eating well with bowel cancer", and "looking after your bowel". These baseline information handouts are publicly available from advocacy websites located: - "Exercising and Colon Cancer" can be found at Exercise is Medicine - http://exerciseismedicine.com.au/wp-content/uploads/2016/11/2014-Colon-Cancer-FULL.pdf - "Eating well with Bowel Cancer" located at: http://www.mediafire.com/download/29q69ghc92nu6lk/Eating_Well_Living_with_Bowel_Cancer_Bowel_Cancer_Australia.pdf - "Looking after your bowel" can be found at: https://www.continence.org.au/download_attachment.php/72e6c1218d4a5a359ad08be1dcef0f5f/01tA0000001b1daIAA/00PG0000003NBs6MAG/looking-after-your-bowel-booklet.pdf People volunteering to join the "Home Exercise" group will be prescribed an individualised exercise program by the same AEP who undertakes their baseline and follow up assessments, which will be completed unsupervised at the participants own home over an 8 week intervention period. The home exercise program will be delivered using an exercise prescription and education program called "PhysiTrack", with a user interface app called "PhysiApp". Because each exercise prescription will be individualised for the participant's physical and emotional circumstances, it cannot be stated exactly what the sessions will encompass in terms of specific exercises, sessions per week, and duration of each session. However, prescriptions will be written according to a standard operating procedure guidebook developed for the study which uses the American College of Sports Medicines 2018 Guidelines for Exercise Testing and Prescription "recommendations for individuals with cancer". Aerobic exercise which may include outdoor walking, in-home aerobic stepping, indoor or outdoor cycling (dependent on what exercise equipment each participant owns at home), or swimming, will be prescribed according to individual preferences with a goal of meeting 150 minutes of moderate intensity aerobic activities over the week. Resistance exercise will be prescribed with a goal of commencing with low intensity, at least one set, and between 8-12 repetitions per exercise. Exercises will be individualised but may involve sit-to-stands, calf raises, bicep curls, chest press, and shoulder rows. Every participant will be offered 1-2 resistance bands of different strengths, at no cost, prescribed to suit their baseline strength (determined by hand grip testing) for use during the study, and to keep after the study has concluded. Flexibility exercises will be prescribed to meet individual needs and limitations and may include stretches for common areas of tightness including chest, hamstrings, shoulders and neck. Each individual exercise session will have a warm up component, an aerobic component, a resistance component, a flexibility component, and a relaxation component. The relaxation component of the home exercise program will involve 3-5 minutes of supine rest with deep breathing and mindfulness practice. The concepts of mindfulness and relaxation practice will be taught to participants in the Home Exercise Group during week 2, in the first Educational telehealth session, and will center around the Cancer Council's CD "Mindful Meditation for People with Cancer". Copies of this CD will be given to participants in the Home Exercise group at their baseline testing session for use during the study (and to keep afterwards). A copy of the Mindfulness CD can be ordered from: https://www.cancercouncil.com.au/901/uncategorized/mindful-meditation/ Participants in the Home Exercise group will attend one face to face session with the AEP to be inducted into the use of the smartphone exercise prescription app, and to be coached in their home exercise program. When at home, the exercise program will be delivered using the app that will show the participant a video with coaching of how to undertake their specific exercises. Adherence to exercise prescriptions, and thereby, success and feasibility of the program will be monitored via the app data as frequency of exercise session completions, pain and fatigue monitoring at every exercise session, and by the voluntary participation in a separate baseline and follow up interview / discussion group where participants in the Home Exercise group will be asked their thoughts, beliefs, likes and dislikes about exercise and the use of technology to support health and lifestyle changes, before and after the 8 week exercise intervention. These discussion groups will be led by a researcher not connected with the study and experienced in qualitative research. People in the "Home Exercise" group will also have 4 x fortnightly, 10-15 minute education chat/question and answer sessions around topics related to the management of their conditions that will be delivered by the lead investigator, via the app using a one - to - one video conferencing feature with topics on: - Managing stress and Mindfulness during cancer treatment - Exercising Right for bowel cancer - Eating right for bowel cancer - Motivation for exercise and planning for setbacks These topics will be developed for the study using best practice evidence and presented in plain language for the participants. A brief "workbook" style handout will be given to the participants via email prior to each session, and video links and pdf. handouts will be delivered via the app. Exact timing for the educational telehealth consults will be determined by availability of the lead investigator and the individual participant. Participants in the Home Exercise group will also receive one weekly text via the app, as a reminder and encouragement to exercise, and the opportunity to ask questions of the researchers about their exercises. People in the "Usual Care" group will undertake their usual self-care strategies without any further guidance from the research team for the 8 week intervention period. "Usual Care" in this study is defined as following the recommendations of the participants general practitioner and/or oncologist, and/or stoma nurses where appropriate. This may include self-directed activity. All participants will undertake an activity questionnaire (The Active Australia Survey) to quantify their activity levels before and after the 8-week intervention period.

Sponsors

The University of Tasmania
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion: Individuals aged over 18 years who: • Are in primary or adjuvant treatment (treatment is defined as chemotherapy, radiation, or are post uncomplicated sub-total colectomy and/or colostomy surgery); OR • Are maximum 6 months post-treatment for Stage I to III colorectal cancer; • Are not regularly active (defined as achieving less than 60 mins/week moderate-intensity physical activity or less than 20 mins vigorous physical activity); • Are medically stable with local (non-metastasised) colorectal cancers; • Can walk unassisted; • Have medical clearance to engage in individualised physical activity; • Are able to read and write in English; • Have access to a smart phone, tablet, or computer with internet access; and • Are available to attend a maximum of five sessions at an Exercise Physiology Clinic closest to their home.

Exclusion criteria

Exclusion criteria include: • Any contraindication to regular, unsupervised physical activity (a contraindication to exercise may include unstable cardiovascular, metabolic, renal, musculoskeletal, neurological, or pulmonary conditions); • Total colectomy or ileostomy • History of other primary cancer • Any cognitive impairment or intellectual disability that prevents them from providing informed voluntary consent to participate.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026