ABSTRACT: Background and study aims
People living with and beyond cancer are at increased risk of many long-term consequences of cancer and its treatment, including fatigue, pain, sleep disturbance, anxiety and depression. Physical activity has many benefits after a cancer diagnosis, including reduction of these symptoms as well as reduced risk of cancer recurrence and mortality. Cancer patients have reported that they view walking as the type of physical activity they would be most likely to engage with. The aim of this pilot study is to assess whether it is possible to run a randomised controlled trial to test the impact of a walking intervention delivered via smartphone app (with behavioural support) in people affected by breast, prostate or colorectal cancer. This trial will be a small-scale version (a pilot) of a planned larger trial and will examine whether it is feasible and acceptable to conduct this research. The main focus of the pilot study will be on the recruitment rate (how many, of those we invite to participate, choose to do so), how acceptable it is to randomise participants, if it is possible to deliver the intervention as planned and if participants find this acceptable, how many people drop-out of the study, if participants complete the assessments, and how they feel about these.
Who can participate?
Men and women, over the age of 16, who are not currently meeting physical activity guidelines and have been diagnosed with breast, prostate or colorectal cancer at Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust.
What does the study involve?
At the start of the study participants will be asked to complete an online questionnaire about different aspects of their health, including their physical activity, quality of life, fatigue, sleep, anxiety and depression, their confidence about doing physical activity and about managing their cancer, habit strength for walking and health and social care service use. They will also be asked to weigh and measure themselves and to wear a small device (an accelerometer) on their thigh for 7 days. This device measures the amount of time spent sitting, lying down, asleep and moving around. These measures will be repeated 3 months after they are randomised.
Participants will be randomly allocated to an intervention or control group. The control group will continue to receive their usual care. The intervention group will receive a leaflet about physical activity and cancer, and guidance about how to download the app being recommended to participants (the app promotes and tracks brisk walking). Intervention participants will also receive two behavioural support telephone/video calls, focusing on the benefits of brisk walking and how participants may use the app to increase their walking and resolving any problems downloading the app.
Participants may also be invited to participate in an interview to tell the researchers what they thought about participating in the study and, in the intervention group, how they found using the app. Interviews will also be conducted with those who choose not to participate in the study to gain more detailed insight into why this might be and how this can be addressed in future studies.
