None listed
Conditions
Brief summary
The aim of the ‘Measure It!’ trial is to investigate whether very brief measurement of physical activity on 5 occasions over 6-months is more effective than usual care in improving physical activity in people with cancer undergoing chemotherapy. Who is it for? You may be eligible for this study if you are 18 years or older and have any cancer diagnosis that is suitable for chemotherapy treatment for more than 4-6 months. Study details Participants in this study will be allocated to one of the following two groups, by chance: Group 1: Participants will receive the 5-minute physical activity intervention (Measure It!) approximately every 6 weeks (5 times) over 6 months in their chemotherapy sessions or via phone, The Measure It! intervention will be delivered by one of their cancer care clinicians, for example, nurse, physiotherapist, exercise physiologist, or oncologist, Group 2: Participants will continue to receive chemotherapy treatment as part of their usual care. All participants will be asked to complete questionnaires and wear an activity monitor for one week at the beginning of the study and at 3 and 6 months after starting the study. This study will provide preliminary data to indicate if Measure It! is more effective in improving physical activity than usual care over 6-months to inform a larger trial. Ultimately, we hope that our results will drive changes in current practice, encouraging more clinicians across Australia to deliver Measure It! in Chemotherapy Day Units, leading to improved health for many Australians with cancer undergoing chemotherapy.
Interventions
Measure It! intervention:
Measure It! includes a self-report and objective measure of physical activity plus brief tailored physical activity advice provided by their cancer care clinician. Participants will be asked about their current level of physical activity using the Physical Activity Vital Sign (On average how many days per week do you engage in moderate or greater physical activity?; On average how many minutes per day do you engage in activity at this level?), taking less than 30 second
Measure It! intervention: Measure It! includes a self-report and objective measure of physical activity plus brief tailored physical activity advice provided by their cancer care clinician. Participants will be asked about their current level of physical activity using the Physical Activity Vital Sign (On average how many days per week do you engage in moderate or greater physical activity?; On average how many minutes per day do you engage in activity at this level?), taking less than 30 seconds to complete. Participants will also be asked to provide the average number of steps per day they completed in the last week according to their wearable activity tracker or smartphone app or Fitbit. The physical activity guidelines will be very briefly discussed (2 minutes) at each measurement. An example of the very brief physical activity advice provided is ‘moderate intensity physical activity means you should be able to talk in full sentences but not sing’, or ‘any activity is better than none’, or ‘if you feel no worse after 5-10 minutes of walking, it’s ok to keep walking’. Participants will be encouraged to safely increase their physical activity levels during the 6-month intervention period aiming to progress towards the public health physical activity guidelines, that is, accumulate 150 to 300 minutes of moderate intensity aerobic physical activity or 75 to 150 minutes of vigorous intensity aerobic physical activity or a combination of both each week. Intervention participants will receive 5 Measure It! interventions from cancer care clinicians over 6-months. Measure It! sessions received will be recorded on a checklist. The Measure It! intervention will be delivered face-to-face during chemotherapy treatment but may be delivered via telehealth. From our pilot (ACTRN12616000566437) and type I hybrid (ACTRN12622001187730) trials in general and cardiac rehabilitation populations, the total time required for measuring physical activity and provision of brief advice was < 5 mins, classifying this as a very brief intervention.
Sponsors
Prof Nicole Freene, University of Canberra
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants must: - be greater than or equal to 18 years old, - have any cancer diagnosis suitable for chemotherapy, - a life expectancy greater than or equal to 6 months, - receiving chemotherapy treatment for greater than or equal to 4-6 months, - have a wearable activity tracker OR smartphone (step tracker app) OR computer/tablet, - have no serious medical conditions that could limit participation in moderate physical activity, - have no severe functional impairments due to medical and psychiatric conditions, - have adequate English and cognitive skills to participate in the study.
Exclusion criteria
Participants will be excluded if they have unstable medical conditions or are unable to wear an accelerometer due to disability, for example, if they are confined to a wheelchair.
Outcome results
None listed