Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000222741
Ethics application status
Approved
Date submitted
28/01/2022
Date registered
8/02/2022
Date last updated
1/06/2022
Date data sharing statement initially provided
8/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Naturopathic Medicine for Endometriosis (NatME) Program: a pilot feasibility trial
Scientific title
Naturopathic Medicine for Endometriosis (NatME) Program: a pilot feasibility trial
Secondary ID [1] 306294 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 325054 0
Condition category
Condition code
Reproductive Health and Childbirth 322488 322488 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed study will investigate a novel approach to delivering naturopathy to people with endometriosis using a group visit model based on the shared medical appointment model. The study will involve 6 x 2-hour group sessions over 12 weeks (one session per fortnight) with 5-10 participants per group. The study intervention will reflect real-world naturopathic practice, so each participant will receive a naturopathic treatment plan which may consist of any of the following or a combination of the following: dietary recommendations, lifestyle and self-care recommendations, natural medicines or nutritional supplements. A program manual has been developed which the naturopathic practitioner will follow which outlines a curriculum for each session within which they will apply their naturopathic treatments to each patient. The curriculum covers patient education about endometriosis, links between digestive system, immune, food and endometriosis, and lifestyle and self-care strategies for managing endometriosis. The program manual was developed based on the available literature, and in consultation with Naturopath practitioner experts in endometriosis and patients living with endometriosis (through focus groups), and in consultation with experts in the field of group medical visits - predominantly Associate Professor John Stevens from Australasian Society of Lifestyle Medicine (who trains clinicians in shared medical appointments across Australia and New Zealand); and Dr Paula Gardiner from the University of Massachusetts (who is the researcher who developed the Our Whole Lives program which uses integrative medicine group visits for chronic pain, has been tested in trials and is now used by clinicians in the US). The program structure is based on that of the Our Whole Lives program and adapted to endometriosis with feedback and guidance from Dr Paula Gardiner. Treatments will include dietary guidance for each patient in the group according to their needs, self-care, and the possibility of herbal or nutritional medicines depending on the needs of the patient and their preference and budget (there is no cost for the intervention but prescribed natural medicines will be paid by the participant should they wish to, and the naturopaths will give them recommendations and low or no-cost options depending on their preference. Examples of self care or lifestyle recommendations will be at the discretion of the naturopath and what they use in their clinical practice and what the needs of the individual patient are (as naturopathy is whole-systems and individualised system of medicine) but the program was designed in consultation with naturopath experts in endometriosis and recommendations may include mindfulness activities, application of castor oil packs (external), dietary adjustments (e.g. increased anti-inflammatory foods minimisation of alcohol and/or caffeine as examples only), herbal medicine or nutritional supplementation ( diet/symptom diaries will be completed by participants which will guide the naturopaths on dietary and nutritional needs of each patient as in real-world practice).
The intervention will be delivered by a naturopath who is registered with an Australian professional association, has over 5 years experience in clinical practice and identifies as specialising in or experienced with endometriosis management. There will be 4 naturopaths in the study who will run one cohort each. The naturopaths have also undertaken training in shared medical appointments through the Australasian Society of Lifestyle Medicine, and will be supported by a co-facilitator will play an administrative role by keeping notes, keeping discussion on topic and to time and ensuring the naturopath has had an opportunity to attend to each participant in the group each session.
Session attendance checklists will be kept and notes will be kept each session about challenges and successes of the participants with implementing the recommendations of the naturopath.
Intervention code [1] 322721 0
Lifestyle
Intervention code [2] 322722 0
Behaviour
Intervention code [3] 322723 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330271 0
Feasibility
Acceptability, or the reaction of patients and practitioners to the intervention will be measured through questionnaires examining how patients and practitioners react to the intervention as well as patient satisfaction with the NatME curriculum, facilitator performance and practitioner performance. Program evaluation questionnaires for patient and practitioner participants have been designed for the study. The final group session also includes a 30 minute focus group for verbal feedback.
Timepoint [1] 330271 0
Measured at week 6 (mid-point) and week 11 (final group session) and weekly record keeping.
Primary outcome [2] 330323 0
Compliance, or the extent to which participants comply with the treatments, will be measured through participant observation and field notes documented by the facilitator.
Timepoint [2] 330323 0
Week 1, week 3, week 5, week 7, week 9 and week 11 (each group session).
Primary outcome [3] 330324 0
Implementation, or the extent to which the intervention could be fully implemented as planned and proposed will be measured through observation and field notes documented by the group facilitator. A form has been designed for the program for debrief from the practitioner at the end of each session, where they will document any challenges that arose or any deviations that were made from the session curriculum and why.
Timepoint [3] 330324 0
Week 1, week 3, week 5, week 7, week 9, week 11 (Each group session).
Secondary outcome [1] 405543 0
General health-related quality of life will be measured using the 36-item Short Form survey (SF-12).
Timepoint [1] 405543 0
Baseline, week 11 (final group session) and follow-up (week 16 post-intervention commencement).
Secondary outcome [2] 405838 0
General health will be measured using the Measure Yourself Medical Outcome Profile (MYMOP)
Timepoint [2] 405838 0
Baseline, week 11 (final group session) and follow-up (week 16 post-intervention commencement).
Secondary outcome [3] 405839 0
Sexual health will be measured using the Sexual health outcomes in women questionnaire (SHOW-Q)
Timepoint [3] 405839 0
Baseline, week 11 (final group session) and follow-up (week 16 post-intervention commencement).
Secondary outcome [4] 405840 0
Participants pain experience will be measured using the Pain Catastrophising Scale (PCS)
Timepoint [4] 405840 0
Baseline, week 11 (final group session) and follow-up (week 16 post-intervention commencement).
Secondary outcome [5] 405841 0
Additional primary feasibility outcome:
Demand, or the reaction to and likelihood that patients and practitioners would utilise the intervention again, will be determined by tracking recruitment and retention rates, and patient reactions to the intervention measured using questionnaires, participant observation and field notes collected by the group facilitator. Program evaluation questionnaires for patient and practitioner participants have been designed for the study.
Timepoint [5] 405841 0
Measured at week 6 (mid-point) and week 11 (final group session) and weekly record keeping.
Secondary outcome [6] 405842 0
Additional primary feasibility outcome:
Adaptation, or the extent to which the intervention was modified to be appropriate for the situation will be measured through a questionnaire completed by the practitioners, observation and field notes documented by the group facilitator. A form has been designed for the program for debrief from the practitioner at the end of each session, where they will document any challenges that arose or any deviations that were made from the session curriculum and why.
Timepoint [6] 405842 0
Week 1, week 3, week 5, week 7, week 9, week 11 (Each group session).
Secondary outcome [7] 406016 0
Endometriosis-specific quality of life will be measured using the Endometriosis Health Profile-5 (EHP-5)
Timepoint [7] 406016 0
Baseline, week 11 (final group session) and follow-up (week 16 post-intervention commencement).

Eligibility
Key inclusion criteria
Patient participants:
Inclusion criteria:
1. Aged 18 years or over
2. Female sex
3. Diagnosis of endometriosis made by a medical doctor
4. Intending to seek naturopathic care for the primary purpose of managing endometriosis-related symptoms
5. Speaks fluent English
6. Willing to commit to attending group visits (i.e. cannot foresee a reason for missing two or more sessions)

Practitioner participants:
Inclusion criteria:
1. Minimum of 5 years experience in naturopathic clinical practice
2. Currently working as a naturopath in part-time or full-time clinical practice (including casual or locum naturopaths who work at least one day per week).
3. Identify as experienced and having a clinical focus in the area of women’s health and/or endometriosis.
4. Member of an Australian professional association covering naturopaths
5. Holds a Bachelor degree or higher in naturopathy or an Advanced Diploma in Naturopathy completed prior to 2016, as their minimum qualification.
6. Holds professional indemnity insurance that covers the practice of naturopathy
7. Speaks fluent English
8. Must be female
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient participants:
Exclusion criteria:
1. Seeking naturopathic services solely or primarily for fertility issues, preconception care or pregnancy
2. Women who are pregnant
3. Currently under the care of a naturopath and/or taking herbal or naturopathic medicines
4. Medical diagnosis of serious mental illness (a clinically diagnosed disorder that significantly interferes with an individual’s cognitive, emotional and social abilities, e.g. bipolar disorder or schizophrenia)
5. Active medically diagnosed substance abuse disorder (i.e. alcohol, prescribed or illicit drugs)

Practitioner participants:
Exclusion criteria:
1. Male practitioners

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
14/02/2022
Actual
17/02/2022
Date of last participant enrolment
Anticipated
6/05/2022
Actual
8/05/2022
Date of last data collection
Anticipated
28/10/2022
Actual
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 310639 0
University
Name [1] 310639 0
Southern Cross University
Country [1] 310639 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
National Centre for Naturopathic Medicine, Southern Cross University
A Block, Military Road, Lismore, NSW, 2480, Australia
Country
Australia
Secondary sponsor category [1] 311852 0
None
Name [1] 311852 0
Address [1] 311852 0
Country [1] 311852 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310240 0
Southern Cross University Human Research Ethics Committee (SCU HREC)
Ethics committee address [1] 310240 0
Ethics committee country [1] 310240 0
Australia
Date submitted for ethics approval [1] 310240 0
20/07/2021
Approval date [1] 310240 0
31/08/2021
Ethics approval number [1] 310240 0

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

Contacts
Principal investigator
Name 116966 0
Prof Jon Wardle
Address 116966 0
Southern Cross University, National Centre for Naturopathic Medicine
A Block, Military Road, Lismore, NSW, 2480
Country 116966 0
Australia
Phone 116966 0
+61 02 6620 3585
Fax 116966 0
Email 116966 0
[email protected]
Contact person for public queries
Name 116967 0
Sophia Gerontakos
Address 116967 0
Southern Cross University, National Centre for Naturopathic Medicine
A Block, Military Road, Lismore, NSW, 2480
Country 116967 0
Australia
Phone 116967 0
+61 424465919
Fax 116967 0
Email 116967 0
[email protected]
Contact person for scientific queries
Name 116968 0
Sophia Gerontakos
Address 116968 0
Southern Cross University, National Centre for Naturopathic Medicine
A Block, Military Road, Lismore, NSW, 2480
Country 116968 0
Australia
Phone 116968 0
+61 424465919
Fax 116968 0
Email 116968 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?
IPD in the form of responses to validated questionnaires may be de-identified and shared upon reasonable request. Additionally, use of MYMOP via Meaningful Measures requires anonymised data sharing as per their data sharing policy. Data collected using the MYMOP outcome measure will be anonymised and shared with Meaningful Measures in accordance with their licence policy.
When will data be available (start and end dates)?
Data won't be made publically available but may be shared by the researchers upon reasonable request if approved by the SCU HREC. If requested, data may be made available from study completion (anticipated Oct 2022) for a period of 5 years (Oct 2027).
Available to whom?
MYMOP outcome measures data will be shared with Meaningful Measures. Other data collected with validated outcome tools may be shared with other researchers upon reasonable request.
Available for what types of analyses?
Quantitative and qualitative analysis.
How or where can data be obtained?
Data can be obtained from the research team contact person (Sophia Gerontakos) email [email protected] or the principal investigator (Prof. Jon Wardle).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14835Ethical approval    383477-(Uploaded-27-01-2022-19-02-39)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.