None listed
Conditions
Brief summary
---Why are we doing this research?--- This study aims to find out whether a digital physical activity program can help reduce fatigue and improve wellbeing in colorectcal cancer (CRC) survivors. The program (I-FIT) delivers personalised activity prompts on a smartphone, and uses a wrist-worn activity monitor to support day-to-day exercise. ---Who is it for?--- You may be eligible if you are 18 years or older, have a history of colorectal cancer and have completed treatment, and are able to take part in light-to-moderate physical activity. People with medical reasons that make exercise unsafe will not be able to join. ---Study details--- Participants will be randomly allocated by chance (similar to flipping a coin) to one of two groups. One group will receive usual care. The other group will use the I-FIT digital program for 12 weeks, which includes short smartphone prompts to help build regular physical activity, and guidance and wearing a wrist activity monitor to track daily movement. All participants will complete online questionnaires and brief functional assessments at baseline, week 6, week 12 (end of program), and 4-week follow-up (week 16). Questionnaires ask about fatigue, quality of life, physical activity and sedentary time. The activity monitor will record movement and sleep patterns to help us understand daily activity. We will also ask participants in the I-FIT group about their experience using the app and device (e.g., ease of use and acceptability). It is hoped that this research will provide new information about the feasibility, acceptability and early effectiveness of a digital physical activity program to help manage and improve fatigue in colorectal cancer survivors.
Interventions
Intervention (I-FIT) — Mobile app and wearables:
Following written informed consent, participants will be randomised (1:1) to either the I-FIT intervention or usual care. Intervention participants will wear a Garmin Vivosmart 5 and install the mEMA10 mobile application on their personal device.
During the 12-week intervention, the app will prompt a short questionnaire at least once daily and up to five times per day. Each prompt (ecological momentary assessment) will assess current fatigue, rece
Intervention (I-FIT) — Mobile app and wearables: Following written informed consent, participants will be randomised (1:1) to either the I-FIT intervention or usual care. Intervention participants will wear a Garmin Vivosmart 5 and install the mEMA10 mobile application on their personal device. During the 12-week intervention, the app will prompt a short questionnaire at least once daily and up to five times per day. Each prompt (ecological momentary assessment) will assess current fatigue, recent physical activity, and availability to exercise. The anticipated time to complete each questionnaire is less than 2 minutes. Notifications will be delivered via push messages at pre-specified times tailored to participant availability (for example, between 8:00 a.m. and 6:00 p.m.). The short questionnaire will be presented at each real-time ecological assessment throughout the day. Exercise recommendations delivered via the app are designed by the Accredited Exercise Physiologist (AEP) responsible for the participant’s check-ins and are tailored by an a-priori decision algorithm to the participant’s questionnaire responses. Examples of in-app recommendations include: a 5-minute walk around the block; climbing one to two flights of stairs; a brief mobility sequence such as shoulder rolls and thoracic rotations; or a short seated routine (for example, seated marching and calf raises) when the participant reports limited ability to be active at that time. Adherence monitoring for the app will include counts of ecological momentary assessments completed per week and review of app analytics (for example, log-ins and prompt responses). Daily summaries of activity and sedentary behaviour from the Garmin device will also be available for descriptive monitoring of engagement. Tele-health check-ins and individualised exercise program: An Accredited Exercise Physiologist (AEP) will conduct weekly tele-health check-ins with intervention participants and will design and modify each participant’s individualised exercise program based on these discussions. The anticipated duration of each check-in varies by participant needs: typically up to 20 minutes when few issues arise, and up to 60 minutes when more extensive review or adjustments (for example, questionnaire timing or recommendation preferences) are required. When designing and progressing exercise recommendations, the AEP will consider access to equipment, current exercise habits, preferences, weekly routines (for example, work or volunteering), and reported fatigue. Examples of exercises that may be prescribed include walking sessions, Pilates-style routines, mobility exercises such as shoulder rolls and thoracic rotations, and seated options such as marching in place and calf raises. The intended intensity of activities (low, moderate, or vigorous) is determined by a pre-specified algorithm that uses participant-reported fatigue and confidence to be active at the time of the prompt. As a guide, low intensity is suggested when fatigue ratings are high (for example, 8–10), moderate intensity when fatigue is mid-range (for example, 4–7), and vigorous intensity when fatigue is low (for example, 1–3). If a participant reports they are not currently able to be active (for example, at work or in a waiting room), the app will still provide recommendations based on fatigue level but prioritise feasible options such as brief seated exercises, short breaks in sedentary time, or mobility work. Adherence monitoring for check-ins will include an attendance log documenting completed and attempted weekly contacts. There are no formal adherence measures for the exercise program beyond attendance and descriptive review of Garmin activity data. Program aim: The exercise recommendations aim to gradually increase physical activity toward the Australian Physical Activity Guidelines target of at least 150 minutes of moderate-intensity activity per week, tailored to participant status and preferences.
Sponsors
Caring Futures Institute, College of Nursing and Health Sciences, Flinders University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age greater than or equal to 18 years of age Self-reported diagnosis of colorectal cancer Great than 1-month post-treatment with no anticipated treatment during the study period Experiencing moderate fatigue (as per score of greater than or equal to 4 on the Brief Fatigue Inventory) Access to a compatible mobile phone device for the mEMA software and internet access Able to provide informed consent Able to speak, read and write English
Exclusion criteria
1. Presence of known cardiovascular disease or other condition that places the participant at an unacceptable risk of untoward event occurring during exercise training (as deemed by the chief principal investigator). 2. Currently meeting the physical activity guidelines (150 mins/week of moderate intensity aerobic (cardio) activity which includes 2 sessions/week of resistance training
Outcome results
None listed