None listed
Conditions
Brief summary
The BeCALM study is for people who will be having radiotherapy and may be feeling anxious about it. Who is it for? You may be eligible for this study if you are aged 18 years or over, and will be undergoing 2 or more radiotherapy sessions at Calvary Mater Newcastle. Study details You will be randomly allocated (like drawing your name out of a hat) to receive a form of anxiety monitoring or support. We will also ask you to complete three surveys. These will include questions about how you are feeling about having radiotherapy going forward, and how you have found the experience so far. The questionnaires will take about 10 minutes to complete. You will also be asked to wear a small device on your fingertip to measure your pulse during your first two treatments. It is hoped that this research will show if a certain type of monitoring or support, is a useful way to manage procedural anxiety without medication.
Interventions
Participants in the 'BeCALM intervention' group will receive treatment as usual, as well as the intervention.
Radiotherapy (RT) treatment session 1 - Each participant will receive pre-treatment education with a radiation therapist to discuss what to expect during treatment. During the pre-treatment education, the radiation therapist will provide a brief explanation of the biofeedback device (pulse oximeter) and how to use it. The radiation therapist will allow the participant to test the device
Participants in the 'BeCALM intervention' group will receive treatment as usual, as well as the intervention. Radiotherapy (RT) treatment session 1 - Each participant will receive pre-treatment education with a radiation therapist to discuss what to expect during treatment. During the pre-treatment education, the radiation therapist will provide a brief explanation of the biofeedback device (pulse oximeter) and how to use it. The radiation therapist will allow the participant to test the device and will briefly coach the participant on biofeedback techniques. The participant will be taken to the treatment bunker to commence RT. The participant will be provided with the pulse oximeter in the treatment bunker which they will wear for the duration of the treatment session. Sound will be enabled on the device (beep sound reflecting pulse rate), and it will be adjusted to a volume that is comfortable for the participant. Radiation therapists will provide breathing prompts during the treatment session at their discretion (via the speaker). The breathing prompts were designed, based on mindfulness exercises described in Khazan (2019) Biofeedback and Mindfulness in Everyday Life: Practical Solutions for Improving Your Health and Performance RT treatment session 2 – Each participant will be taken straight from waiting room to the treatment bunker to commence RT. The participant will be provided the pulse oximeter in the treatment bunker which they will wear for the duration of the treatment session. Sound will be enabled on the device (beep sound reflecting pulse rate), and it will be adjusted to a volume that is comfortable for the participant. Radiation therapists will provide breathing prompts during the treatment session at their discretion (via the speaker). RT treatment sessions generally occur five days a week (week days) for a number of weeks. Therefore, it is likely the first two sessions will occur on consecutive days. The duration of each session is varied dependent on the type and location of the cancer. Adherence: Radiation therapists will be required to complete a 'Treatment Observations' form at the end of each participant treatment session to record adherence to the intervention, including: whether the pulse oximeter was worn; whether the sound was on or off; if not, why?; whether breathing prompts were delivered and; if not, why?
Sponsors
University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged at least 18 years • Scheduled to undergo RT at the Calvary Mater Newcastle, Department of Radiation Oncology • Undergoing 2 or more fractions of RT • Having sufficient comprehension of English to be able to understand and complete the study documents, and the verbal instructions to use a biofeedback device • Score greater than or equal to 4 on distress thermometer post SIM
Exclusion criteria
• Patients with breast cancer receiving treatment that involves deep inhalation breath hold • Patients scheduled to undergo less than 2 fractions of RT • Patients scheduled to undergo RT using Optical Surface Monitoring • Inability to provide informed consent or complete the eligibility screening
Outcome results
None listed