None listed
Conditions
Brief summary
This study will explore the feasibility of delivering an online 6-week mindfulness-based intervention (MBI) to patients with increased risk of melanoma recurrence. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a melanoma diagnosis of stage 2c, 3a, 3b, or 3c, for which you have completed your last treatment within the past five years. You will also require access to the internet. Study details Participants in this study will be randomly allocated (by chance) to the 6-week online mindfulness based intervention (MBI) or usual care group. The MBI is designed to: (1) help patients understand the potential benefits of using mindfulness in their day to day life; and (2) support the establishment of daily meditation practice. Each week of the program explores a different topic, which builds on the topic explored the week before. The program includes three main components: (1) educational component – weekly themes related to the application of mindfulness; (2) informal practice; and (3) formal meditation practice. Participants allocated to the usual care group will continue to receive their usual care for the first 6 weeks of the study, after which they will be offered the MBI. All participants will be asked to complete questionnaires assessing fear of cancer recurrence, worry, rumination, stress and mindfulness before and after the 6-week study period. Intervention adherence, meditation quality and home tasks will also be assessed weekly. If this intervention proves to be feasible, and trends for changes in outcome measures are observed, a larger randomised-controlled study will be planned to assess intervention efficacy and cost-effectiveness.
Interventions
The intervention is a 6-week online mindfulness-based program designed to: (1) help patients understand the potential benefits of using mindfulness in their day to day life; (2) support the establishment of daily meditation practice. Each week of the program explores a different topic, which builds on the topic explored the week before. The program includes three main components: (1) educational component – weekly themes related to the application of mindfulness. Participants are invited to watch at the beginning of each week, a series of videos (the number varies for each week), each 40 seconds to 60 seconds long. The scripts of those videos can be downloaded if participants wish to refer to the information at a later stage; (2) informal practice. Participants are given a weekly mindfulness-based task to practice during their daily activities; and (3) formal meditation practice. Participants are asked to practice meditation twice daily for 5 minutes each time. This time is increased to 10 minutes each practice from week 3 onwards. Participants will receive an email at the start of each week with a link to a brief questionnaire inquiring about their level of engagement with the program. Following completion of the questionnaire, participants will be directed to a video introducing the theme for the upcoming week. At the end of each video, participants will be reminded to keep up with their daily meditation practice (formal practice), and will be given a specific mindfulness task to practice during their daily activities (informal practice). To support participants with establishing a meditation routine, emails containing a link to a short, guided meditation audio file will be sent to participants twice daily. These emails will serve as reminders to meditate and will provide easy access to the meditation practice of the week. The website will have a section addressing common questions about meditation, which participants will be able to consult at any time throughout the course of the program. The mindfulness program can be accessed at any time via direct login to the Website or via the hyperlink sent to participants in the weekly e-mails. The software used to run the mindfulness program will allow tracking of participants’ online activity, including login date/times, navigation patterns, page views and duration, and features used (video, audio, and document downloads). A set of three questions will be presented weekly to capture information on any use of other types of meditation unrelated to the intervention, and frequency of practice. Another three questions will estimate the amount of informal practice over the past week, and the specific use of the weekly topic, using a 5-point Likert scale. These questions will be presented to users at the end of each week, prior to the introduction of the next weekly topic.
Sponsors
Study design
Eligibility
Inclusion criteria
Eligible patients will meet the following criteria: - Have a melanoma diagnosis of stage 2c, 3a, 3b, or 3c - Have completed their last treatment within the past five years - Aged 18 years or over - Sufficient understanding of English to consent and participate - Have access to internet - Have an email account or willing to create one for the study - Willing to commit to a 6-week program and to completing brief assessment measures.
Exclusion criteria
Patients in the following situation will be not be eligible: - Waiting to start treatment for a melanoma recurrence or another primary - Currently receiving treatment for a melanoma recurrence or another primary - Diagnosed with distant metastasis (stage 4) - Severe cognitive impairment or intellectual disability, as reported in the medical record or determined by the treating clinician or oncology nurse