MEDITATion for thE management of psycho-existential distress and anxiety in people with advanced cancer who are receiving Palliative Care (MEDITATEPallCare)

Study intervention: Meditation practice This meditation practice will include focused attention meditation practices including an introduction from the researcher to let go of distractions and centre the body, relaxation of major muscle groups (body scan); (focused attention to the breath, silence with gentle ambient music, and completion of the meditation and reorientation of the participants back to their body and the room (total 15 minutes). An audio CD, USB, or downloadable online YouTube link will be used by the volunteer, bereavement counselor, psychologist, or pastoral care facilitator to guide participants through the meditation intervention. Participants will receive a total of 5 face-to-face meditation sessions over a period of 3 weeks (3 consecutive sessions of 15 minutes duration in week 1 (days 1, 2, and 3), and 1 weekly session of 15 minutes duration in week 2 (day 8) and week 3 (day 15). Home practice Home meditation practice will occur in between weekly sessions. Participants will be given an identical copy of the 15-minute meditation audio-recording on a CD, USB, or via a free private online YouTube link. The clinical trials nurse at each site will provide each patient with a private YouTube link that will be sent to the individual’s private e-mail address or via text messaging to their mobile phone according to their preference. Participants will be asked to complete home meditation practice once in week 1 and a total of 4 times per week in weeks 2 and 3 (not including facilitator sessions). The research nurse will contact the meditation facilitator via phone or e-mail on the date of enrolment into the study, as soon as practicable, to enable scheduling of the first meditation session within 72 hours of the completion of baseline measures. The meditation facilitator will contact the patient the day before to confirm the time of the first meditation session. The meditation facilitator will record the minutes of meditation practice completed on a case report form for each session delivered and will enter these data into MyCap or REDCap on the same day or within a 48-hour period. A simple daily SMS push notification will be sent to each participant once daily at a time preferred by the patient to prompt participants to complete their paper-based diaries each day during the study period (21 days). Paper diaries will request: 1) a yes/no response to treatment adherence for that day; 2) if discontinued, at what point of the meditation (e.g. focus on breath; ‘body scan’ or silence with ambient music) they discontinued; 3) how distressed they felt at the beginning of the session on a scale out of 10, with 0 being not distressed at all to 10 being extremely distressed; and 4) how distressed they felt at the end of the session on a scale of 1 to 10. The following materials will be provided during the conduct of the study: • A facilitator manual will be provided to facilitators to guide intervention delivery and ensure intervention fidelity, including background information about the study, an outline of the meditation program, an introductory script, and instructions on how to facilitate each session at different study time points. • A ‘do not disturb sign’ for the door of the room where meditation will occur to minimize distractions • Meditation session facilitator notes • Participant diary to record adherence to home practice and any additional sessions they choose to complete. • A private YouTube link to the meditation will be accessed via CD, USB (provided by the research team), or the patient’s smartphone. • Headphones will be provided to each participant to be used for home practice sessions. All consenting volunteers, pastoral care workers, bereavement counselors, or other allied health staff who will be involved in intervention delivery will have at least 3 months of meditation experience or will be willing to develop a personal meditation practice with mentorship from the study investigator. Mentorship will involve the completion of 6 x 1 hour weekly facilitated meditation practice sessions, delivered online. In between these sessions, clinicians will have the option to continue meditation sessions at home. Facilitators will be required to ‘teach back’ the audio-recorded meditation to the facilitator in the final session. This will form the basis of an assessment of competence for meditation delivery prior to the commencement of the study intervention. Facilitator training sessions will be delivered via Zoom, Skype, Pexip, or other teleconferencing platforms with webcam capabilities. All meditation-facilitated sessions will be delivered individually, face-to-face in the privacy of the person’s home, or at their bedside. Where possible, inpatients who are in a shared room will complete their meditation sessions in a private room that is pre-booked for the session, e.g., an interview room near the patient’s bedside. Patient follow-up can be completed either in-person or via telephone, Zoom, Skype, Pexip or other teleconferencing platforms with webcam capabilities. • A qualitative sub-study of patient experience of the intervention. Qualitative data will allow a greater understanding of how to design the definitive trial as well as provide preliminary data which will inform the implementation of meditation according to the definitive study results. • A qualitative sub-study of the meditation facilitators' experience of the intervention. Perspectives of bereavement counsellors and pastoral care workers delivering the meditation intervention are essential to understand intervention fidelity and are likely to impact the acceptability of the intervention to clinicians who will be involved in implementation into clinical practice depending on definitive trial results. The facilitator manual has been developed specifically for this study and has received feedback from clinician facilitators who have been trained to deliver the intervention at each clinical site. Facilitator training will be completed prior to study opening at each site. While there is no minimum time frame specified between the completion of facilitator training and facilitating for a participant at a site, the majority of facilitators have extensive previous meditation and/or relaxation experience and will be assessed on their competency to facilitate meditation and their perception of their readiness to facilitate meditation sessions are ascertained. Further support will be provided as needed by an experienced meditation facilitator who is familiar with the study protocol.