Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001020673
Ethics application status
Approved
Date submitted
15/05/2023
Date registered
20/09/2023
Date last updated
22/09/2024
Date data sharing statement initially provided
20/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
MEDITATion for thE management of psycho-existential distress and anxiety in people with advanced cancer who are receiving Palliative Care (MEDITATEPallCare)
Scientific title
A multi-centre, single-arm, phase II feasibility study of the feasibility and acceptability of meditation on symptoms of psycho-existential distress and anxiety in people with advanced cancer who are receiving palliative care.
Secondary ID [1] 308761 0
nil known
Universal Trial Number (UTN)
Trial acronym
MEDITATEPallCare
Linked study record

Health condition
Health condition(s) or problem(s) studied:
advanced cancer (stage III or IV) 328706 0
psycho-existential distress 328707 0
anxiety 328708 0
Condition category
Condition code
Cancer 325719 325719 0 0
Any cancer
Alternative and Complementary Medicine 325720 325720 0 0
Other alternative and complementary medicine
Alternative and Complementary Medicine 325721 325721 0 0
Spiritual care
Mental Health 327831 327831 0 0
Anxiety
Mental Health 327832 327832 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325216 0
Behaviour
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333568 0
Feasibility:
the proportion of participants who are enrolled in the study who complete at least 6 meditation sessions over a period of 3 weeks and complete endpoint assessments. A completion rate of 80% is considered feasible.
Weekly 'Facilitator notes' worksheets with the date and Participant ID of each person and attendance and completion data will be collected. Participant diaries will also collate daily data regarding participant adherence to their schedule of face-to-face meditation sessions with thier facilitator as well as their home practice sessions.
Timepoint [1] 333568 0
3 weeks (day 21) post-intervention commencement
Secondary outcome [1] 417543 0
Feasibility
1. To determine the number of eligible participants who are enrolled within 18 months of the study opening.
A de-identified pre-screening form for each participant screened will be used at each site to capture the ratio of patients screened to those who enroll in the study.
Timepoint [1] 417543 0
baseline to 18 months post-study commencement
Secondary outcome [2] 417544 0
Feasibility:
2. To determine the ratio of participants enrolled and who complete the study to those screened
Screening log data from each site will be entered into REDCap and collated. Endpoint data will be collected on day 21, and a withdrawal worksheet will also be used to collate the date of exit from the study for any participants who choose to withdraw. Participant diaries will be collected, de-identified, and uploaded into REDCap for analysis by the research team. Facilitator notes collected at each face-to-face session will be de-identified and collected and cross-checked with participant diaries to ensure the accuracy of the data.
Timepoint [2] 417544 0
3 weeks (day 21) post-intervention commencement
Secondary outcome [3] 417545 0
Feasibility:
3. To determine the completeness of data collected for all measures at all time points.
The percentage of patients with a complete dataset during the first 21 days will be calculated. A rate of 80% or more of patients with a complete data set is considered feasible.
Timepoint [3] 417545 0
3 weeks (day 21) post-intervention commencement
Secondary outcome [4] 417546 0
Feasibility
4. To determine the percentage of meditation sessions attempted at days 3, 8, 15 and 21
Participant diaries and meditation facilitator worksheets will used to collate participant data on the number of sessions attempted.
Timepoint [4] 417546 0
3 weeks (Day 21) post-intervention commencement
Secondary outcome [5] 417548 0
Feasibility
5. Average duration of mediation practice at week 1, week 2, and week 3.
Participant diaries and meditation facilitator worksheets will be used to collect data on the duration of each meditation session.
Timepoint [5] 417548 0
week 3 (day 21) post-intervention commencement
Secondary outcome [6] 417549 0
Feasibility:
6. Number of meditation sessions attempted at follow-up time points (week 4 and week 6).
Participant diaries and meditation facilitator worksheets will be used to collate participant data on the number of sessions attempted.
Timepoint [6] 417549 0
Day 28 and day 42 post-intervention commencement
Secondary outcome [7] 417550 0
Feasibility
8. Time taken to complete key components of study assessment.
The duration of each study nurse visit will be included on worksheets for every data collection time point.
Timepoint [7] 417550 0
Days 9, 16, 21, 28, and 42 post-intervention commencement
Secondary outcome [8] 417551 0
9. Time taken for pastoral care and bereavement counselors or other allied health staff to deliver the intervention. Facilitator worksheets will be scanned and sent to the trials nurse. These data will be used to determine the duration of each face-to-face facilitated meditation session for each participant.
Timepoint [8] 417551 0
Days 1,2,3, 8, and 15 post-intervention commencement
Secondary outcome [9] 417552 0
Acceptability
1. To determine the acceptability of the meditation intervention and study design to participants delivering the intervention (sub-study).
Participants will be invited to participate in an optional semi-structured interview via phone, teleconference, or face-to-face according to their preference.
Timepoint [9] 417552 0
Participant interviews are to take place up to 14 days post-intervention (i.e., up to day 35 post-intervention commencement)
Secondary outcome [10] 417553 0
Acceptability
2. To determine clinicians’ perspectives on intervention fidelity
Timepoint [10] 417553 0
Semi-structured clinician interviews will take place at the end of the study (i.e. after the last patient has completed the intervention at each site). Interviews will be conducted by a member of the research team who is not involved in delivering the intervention. Interviews will take place via phone, online teleconferencing platform (e.g. Zoom or Teams), or face-to-face according to the participant's preferences.
Secondary outcome [11] 417554 0
Preliminary effects
3. To assess for changes in sleep quality.
Overall sleep quality will be assessed using the Sleep Quality Scale (SQS) (Snyder et al. 2018).
Timepoint [11] 417554 0
Days 9, 16, 21, 28 and 42 post-intervention commencement
Secondary outcome [12] 417555 0
Preliminary effects
1. To assess changes in psycho-existential distress in palliative care cancer patients who participate in a meditation intervention. The Psycho-existential Symptom Assessment Scale (PESAS) (Kissane et al. 2020) will be used to assess patient-reported changes in psycho-existential distress.
Timepoint [12] 417555 0
Days 9, 16, 21, 28, and 42 post-intervention commencement
Secondary outcome [13] 417556 0
Preliminary effects
2. To assess changes in anxiety in palliative care cancer patients who participate in a meditation intervention. The Hospital Anxiety and Depression Scale (Anxiety) subscale will be used to assess for changes in anxiety symptoms.
Timepoint [13] 417556 0
Days 9, 16, 21, 28, and 42 post-intervention commencement
Secondary outcome [14] 417557 0
Health outcomes and health service utilization:
1, To obtain preliminary data on health services utilization associated with a meditation intervention in patients with a life-limiting illness. Health service utilisation data including admission and discharge details will be collected retrospectively from the patient's medical record using the Australian Refined Diagnosis Related Group (AR-DRG) Version 8. Additional data on the use of health services including pastoral care, medical, psychology, bereavement, psychiatry, or other allied health provider consultations will be collected.
Timepoint [14] 417557 0
Days 21, 28, and 42 post-intervention commencement
Secondary outcome [15] 425880 0
Feasibility
7. To determine the percentage of meditation sessions completed at days 9, 16, and 21.
Participant diaries and meditation facilitator worksheets will be used to collate participant data on the number of sessions completed.
Timepoint [15] 425880 0
week 3 (day 21) post-intervention commencement
Secondary outcome [16] 425883 0
Feasibility:
The number of meditation sessions completed at follow-up time points (week 4 and week 6).
Timepoint [16] 425883 0
day 28 and day 42 post-intervention commencement
Secondary outcome [17] 425884 0
Preliminary effects
4. To assess for changes in Interoceptive Awareness in palliative care cancer patients. Interoceptive Awareness will be measured using the validated Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 (Mehling et al. 2018).
Timepoint [17] 425884 0
Days 9, 16, 21, 28, and 42 post-intervention commencement
Secondary outcome [18] 425886 0
Preliminary effects
5. To assess for changes in Self-Transcendence in palliative care advanced cancer patients. Self-Transcendence will be assessed using the Questionnaire on Self-Transcendence (QUEST) (Fishbein et al. 2022).
Timepoint [18] 425886 0
Days 9, 21 and 42 post-intervention commencement
Secondary outcome [19] 426274 0
Acceptability
3. To determine the acceptability of the meditation intervention and study design to clinicians delivering the intervention (sub-study).
Clinicians will be invited to participate in a semi-structured interview either face-to-face, by phone, or via teleconference according to the participants' preferences.
Timepoint [19] 426274 0
Clinician interviews will take place at the end of the study (after the last patient has completed at each site).
Secondary outcome [20] 426912 0
Preliminary effects:
3. To assess changes in psycho-existential distress in palliative care cancer patients who participate in a meditation intervention. The Structured Interview of Symptoms and Concerns (Wilson et al. 2004) will be used to assess clinician-reported changes in psycho-existential distress
Timepoint [20] 426912 0
Days 9, 16, 21, 28, and 42 post-intervention commencement

Eligibility
Key inclusion criteria
1. Aged greater than or equal to 18 years
2. Clinician responds ‘no’ to the surprise question ‘Would you be surprised if the patient were to die within the next 12 months
3. The patient has a life expectancy of at least 3 months in the opinion of the treating clinician
4. Screen positive for psycho-existential distress (PESAS subscale score greater than or equal to 4)
5. Sufficient English to participate in interviews, study interventions and complete questionnaires
6. Able to maintain attention for 20 minutes
7. Willing to provide informed written, digital or audio-recorded consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Cognitive impairment to the extent that it impairs patients from completing questionnaires and interviews describing their experiences
2. Pre-existing severe psychotic illness (e.g., poorly controlled psychosis, schizo-affective disorder, manic bipolar disorder)
3. New onset or re-occurrence of post-traumatic stress disorder within the last month
4. Delirium (clinician assessed)
5. Terminal phase (Palliative care Outcomes Collaboration (PCOC) Phase 4.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Feasibility study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
No formal power calculation has been performed as this is a feasibility study. It has been suggested, however, that in feasibility studies, a sample size of 30 patients is considered acceptable (Newcombe et al. 1998). In line with systematic analyses of meditation and advanced cancer (Zimmerman et al. 2018) studies, we will account for a dropout rate of 40%, which increases the total sample size to 42 patients.
The primary endpoint is feasibility, measured by the proportion of participants who are enrolled into the study who complete at least 6 meditation sessions over a period of 3 weeks and complete endpoint assessments. A completion rate of 80% is considered feasible. The study completion rate will be calculated by the number of participants who complete at least 6 meditation sessions over a 3-week period and complete the week 3 endpoint assessments, as a percentage of the total number of participants enrolled into the study. Descriptive statistics will be examined for the quantitative data; the mean and SD for continuous measures and the frequency and percentage for categorical measures will be calculated overall and subgroups. The primary feasibility outcomes, the recruitment, will be summarised with rate and the retention with the proportion. Confidence intervals will be also calculated to reflect the uncertainty of the feasibility outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2024
Actual
1/07/2024
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
11/02/2026
Actual
Sample size
Target
42
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27055 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 40353 0
2217 - Kogarah
Recruitment postcode(s) [2] 40354 0
2050 - Camperdown
Recruitment postcode(s) [3] 40355 0
2170 - Liverpool
Recruitment postcode(s) [4] 40356 0
2137 - Concord
Recruitment postcode(s) [5] 43122 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 312984 0
Other Collaborative groups
Name [1] 312984 0
Sydney Partnership for Health, Education, Research and Enterprise Palliative Care Clinical Academic Group (SPHERE PC-CAG)
Country [1] 312984 0
Australia
Funding source category [2] 313853 0
University
Name [2] 313853 0
Cancer Symptoms Trials Group, University of Technology Sydney
Country [2] 313853 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
PO Box 123Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 314669 0
None
Name [1] 314669 0
not applicable
Address [1] 314669 0
not applicable
Country [1] 314669 0
Other collaborator category [1] 282681 0
Other Collaborative groups
Name [1] 282681 0
Psycho-Oncology Co-operative Research Group
Address [1] 282681 0
University of SydneyCity Road, Camperdown, NSW 2006
Country [1] 282681 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312248 0
South Eastern Sydney Human Research Ethics Committee
Ethics committee address [1] 312248 0
Ethics committee country [1] 312248 0
Australia
Date submitted for ethics approval [1] 312248 0
04/11/2022
Approval date [1] 312248 0
01/03/2023
Ethics approval number [1] 312248 0
2022/ETH02236

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123986 0
Dr Angela Rao-Newton
Address 123986 0
Research DepartmentCalvary Health Care Kogarah91-111 Rocky Point Road Kogarah NSW 2217
Country 123986 0
Australia
Phone 123986 0
+61 2 9553 3106
Fax 123986 0
+61 2 9553 3483
Email 123986 0
[email protected]
Contact person for public queries
Name 123987 0
Angela Rao-Newton
Address 123987 0
Research DepartmentCalvary Health Care Kogarah91-111 Rocky Point Road Kogarah NSW 2217
Country 123987 0
Australia
Phone 123987 0
+61 2 9553 3106
Fax 123987 0
+61 2 9553 3483
Email 123987 0
[email protected]
Contact person for scientific queries
Name 123988 0
Angela Rao-Newton
Address 123988 0
Research DepartmentCalvary Health Care Kogarah91-111 Rocky Point Road Kogarah NSW 2217
Country 123988 0
Australia
Phone 123988 0
+61 2 9553 3106
Fax 123988 0
+61 2 9553 3483
Email 123988 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
to be decided by the investigator team
When will data be available (start and end dates)?
Data will be available at the completion of the trial, after publication of the results manuscript. Data will be available for 5 years post-publication.
Available to whom?
To be decided by the investigator team
Available for what types of analyses?
to be decided by the investigator team
How or where can data be obtained?
By contacting the principal investigator via email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19166Study protocol  [email protected]



Results publications and other study-related documents

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