Focus group invitation – Medicinal cannabis

Researchers from Western Sydney University and the University of New South Wales are interested in finding out more about the potential use of medicinal cannabis to manage endometriosis pain and related symptoms, and are running focus groups to explore participant concerns or barriers pertaining to its use, which ultimately will inform the design of a clinical trial. It is very important that we get input from people in the community who have endometriosis so we can be sure that we are designing an appropriate trial.  If you reside in Australia or New Zealand, are between the ages of 18 and 55, have been told by your medical doctor that you have endometriosis and are willing to share your opinions and concerns around medicinal cannabis use, please register your interest by emailing Justin Sinclair at 19948081@student.westernsydney.edu.au

 

Participant Information Sheet

Project Title: Development of a clinical trial investigating the safety, tolerability and effectiveness of medicinal cannabis for endometriosis: Co-design focus groups.

Project Summary:

Researchers from Western Sydney University and the University of New South Wales are interested in investigating how cannabis use impacts endometriosis pain and associated symptoms.  As part of this study, we are running focus groups of women who experience significant endometriosis symptoms. The aim of the focus groups is to ensure that our upcoming medicinal cannabis clinical trial(s) are designed so that the types of interventions we are examining are relevant and that the outcomes we measure are those that are important to women with endometriosis.

It is very important that we get input from people in the community who have endometriosis so we can be sure that we are designing an appropriate trial. This information will help us better understand the role that cannabis may play in the management of endometriosis symptoms.

The researchers involved with this project are Mr Justin Sinclair (PhD Candidate), Dr Mike Armour (Primary Supervisor), Prof Jerome Sarris, Adj Prof David Pate, all from the NICM Health Research Institute of Western Sydney University, Australia, and Professor Jason Abbott from the University of New South Wales, Australia.

This research project has been approved by the Western Sydney University Ethics Committee (H14115).

How is the study being paid for?

This research project has been funded by a Western Sydney University Postgraduate Research Scholarship, forming part of Mr Sinclair’s PhD degree program.

What will I be asked to do?

These focus groups are open to people from Australia and New Zealand who must fulfil the following:

  • You must have been told by your medical doctor you have endometriosis;
  • You must be aged between 18-55; and
  • You are willing to anonymously discuss your opinions on the use of medicinal cannabis to manage endometriosis.

You will be asked to participate in a focus group conducted anonymously online through conferencing software (Zoom) with 5-6 other women. Whilst discussion during the focus groups will cover topics such as identifying any potential barriers or concerns regarding medicinal cannabis usage, the pre-focus group survey will identify what endometriosis symptoms you find most bothersome, what prescribed and non-prescribed medications and self-management strategies you use to manage symptoms and questions about previous cannabis use. We will also gather evidence of the severity and scope of your endometriosis through two questionnaires, the Endometriosis Health Profile-30 and the Pelvic Pain Impact Questionnaire.

Discussion on the day of the focus group can vary, depending on the group, but will cover topics like what are women’s current self-management strategies for endometriosis, any potential barriers or concerns regarding medicinal cannabis usage, what outcomes should we be tracking and how we can make participation in research easiest for you. The facilitator will ensure that you have a chance to give your opinion on each topic raised during the discussion. However, you do not need to participate in every question if you do not wish.

How much of my time will I need to give?

The focus groups will take about 60-70 minutes but may go slightly over or under this time depending on the conversation. The anonymous online questionnaire that you will need to complete prior to the focus groups will take between 5 and 10 minutes.

 

What benefits will I, and/or the broader community, receive for participating?

Our goal is to co-design a clinical study to test the safety, tolerability and effectiveness of medicinal cannabis for the management of endometriosis pain and associated symptoms. As you are someone who is affected by endometriosis, your experiences and views will contribute to the design of this future clinical study. It will shape what kind of medicinal cannabis interventions we might investigate, what concerns or barriers to its use that may exist and what outcomes are important to you, all of which will later be assessed in the study. This is very important as we want to make sure that it’s not just us, the researchers, who decide how the research is done, but that women have a voice and help shape what we do. This will improve how the study can be translated for clinical practice with the ultimate goal being to help benefit women affected by endometriosis. By participating in the focus group, you may benefit from the chance to interact and share common experiences with other women with endometriosis.

 

Will the study involve any risk or discomfort for me? If so, what will be done to rectify it?

We do not foresee any risk to you from participating in this study, and all your answers to any cannabis related questions will be completely anonymous. Based on our previous focus group work with this population, there may be some distress while discussing your experience with endometriosis due to its often significant negative impact on women’s lives. Our facilitators are experienced in conducting focus groups on health issues and will ensure that you feel safe and respected during the discussion. During the focus group itself, you will be able to take a break and leave the virtual “room” if you find the topic distressing. Should you find discussion about any of the topics in the focus group distressing and would like to speak with a professional, there is a list of counselling services at: https://www.australiacounselling.com.au. For further support, please also consider contacting Endometriosis Australia (https://www.endometriosisaustralia.org) or Endometriosis New Zealand (https://nzendo.org.nz) who have support groups and further resources available.

 

We recognise that discussion surrounding cannabis usage, which is currently illegal in Australia for those without medical prescription, may make you feel unsafe to share information during the session. However, no identifiable information is collected during the focus group as participants are asked to only share their audio (i.e., not video). You can select a completely random User ID when joining the virtual session (to maintain your anonymity) and are also not obligated to share or disclose previous cannabis usage. The resulting audio transcript will be de-identified and kept strictly confidential. Additionally, only the investigator and the participant who consented to be involved in the focus group will have access to the password required to join the session for an added layer of security. Due to the de-identified nature of the transcript, any illegal activity you disclose cannot be linked back to you. We also do not collect any identifiable information from the pre-focus group survey questions.

 

How do you intend to publish or disseminate the results?

It is intended that the collective results of this study will be published in journal articles, reports, and presented at conferences and other scientific meetings. Reports regarding safety and health effects, using a combination of the information we collect in the survey, may also be provided to specific groups/organisations to help facilitate safe practice. Only the members of the research team will be able to see the individual answers you provide and only in an anonymous manner. Any publication will not have any information in it that could identify you. Please note that minimum retention period for data collection is five years post publication, but data may be kept for up to 15 years to allow other researchers access to this data.

Will the data and information that I have provided be disposed of?

We will use your personal history and the focus group transcripts for the purposes of this research but please rest assured that only the researchers will have access to the raw data you provide. However, your data may be used in other related projects for an extended period of time. Such projects may include the development of other clinical trials. Please note that minimum retention period for data collection is five years post publication, but data may be kept for up to 15 years to allow other researchers access to this data.

 

Can I withdraw from the study?

Participation is entirely voluntary and you are not obliged to be involved. If you do participate you can withdraw at any time without giving reason. Due to the conversational nature of focus groups, your responses (up until the time of withdrawal) cannot be removed as it may remove important context from other participants’ responses. Whatever your decision, it will not affect your medical treatment or your relationship to anyone involved in this study.

 

Can I tell other people about the study?

Yes, we encourage you to tell other people about the study by providing them with Mr Justin Sinclair’s details. They can then contact Justin Sinclair to discuss their participation in the research project and obtain a copy of the participant information sheet.

What if I require further information?

Please contact Mr Justin Sinclair should you wish to discuss the research further before deciding whether or not to participate.

Justin Sinclair, PhD candidate, email: 19948081@student.westernsydney.edu.au

What if I have a complaint?

If you have any complaints or reservations about the ethical conduct of this research, you may contact the Ethics Committee through Research Engagement, Development and Innovation (REDI) on Tel +61 2 4736 0229 or email humanethics@westernsydney.edu.au.

Any issues you raise will be treated in confidence and investigated fully, and you will be informed of the outcome.

If you agree to participate in this study, you may be asked to sign the Participant Consent Form. The information sheet is for you to keep and the consent form is retained by the researcher/s.

This study has been approved by the Western Sydney University Human Research Ethics Committee. The Approval number is H14115.

 

Post-traumatic stress, anxiety, and depression following endometriosis diagnosis

Their goal is to create awareness among clinicians about early, specific, screening and onset of treatment of potential mental health disorders in those with endometriosis.
To do so, these researchers are trying to find out whether there is a relevant presence of symptoms of PTSD, depression, and/or anxiety in these people’s responses, and whether it is possible to notice differences in these symptoms between those who have different predominant symptoms.

Anyone, regardless of where they live in the world, can participate in this study (see below).

Background to the study

Those with endometriosis may present with mental health issues related to their mood – like

depression and/or anxiety – in a higher proportion than those without endometriosis.

These disorders may be due to the endometriosis-related chronic symptoms, such as pain or infertility (or both), as well as the often significant diagnostic delay, which may enhance the enduring agony and uncertainty of an individual.
Just as with other medical conditions related to chronic pelvic pain (CPP), endometriosis causes significant morbidity and those affected are often submitted to multiple surgeries and other “hit and miss” treatments. Considering the overall burden that endometriosis imposes to those affected, the assessment of endometriosis-associated psychological distress is an essential factor in both initial evaluation and treatment planning.

Who can participate?

Anyone over 18 years old with a previous diagnosis of endometriosis is able to participate in this survey. You can participate no matter where in the world you currently live.

Click here for the Participant Information Sheet

How to participate?

CLICK HERE for access to the survey, which will be available until 15 July 2021. The survey takes approximately 20 minutes.

ENDOCOST Survey

We would like to thank those of you who participated in this incredibly important study.  Your efforts will provide NZ data to support our efforts to improve health outcomes for those with endometriosis and adenomyosis, with Government and the Ministry of Health.  We appreciate this so much.  What happens not is that the manuscripts have to go through a very robust process to analyse the data which will likely take months. We will keep you in touch with developments when we are advised by the lead researchers.

Research

ENZ fosters research and evaluates and audits its programmes through assessment systems, peer review and Quality Assurance controls. Members of the ENZ Trust Board have made a significant contribution to endometriosis related research and investigations and are widely published.


Endometriosis Education in Schools: A New Zealand model.

Endometriosis Education in Schools
The ME Text programme research is now published in ANZJOG (Australia New Zealand Journal Obstetricians and Gynaecologists).

The report is the first piece of literature of its kind globally which examines the outcomes of a health education programme in schools and assesses whether it makes a difference.

ME Text was a concept which sprang to life in 1997 – two decades ago! It is now a proven educational program and well accepted in secondary schools in New Zealand. It has reached hundreds of thousands of students throughout the country. This news will hopefully influence change for girls and young women who have symptoms suspicious of endometriosis.


Endometriosis education in schools: A New Zealand model examining the impact of an education program in schools on early recognition of symptoms suggesting endometriosis.


Endometriosis New Zealand

Endometriosis NZ Research

Our CEO Deborah Bush is a co-author of the widely acclaimed ‘The $6 Billion Woman and the $600 Million Girl’ report released in 2011. This report was an Australian initiative to address human and fiscal burdens associated with conditions causing pelvic pain. Help support ENZ research. Help us help others by contributing to ENZ research projects.  This is a way to bring to the attention of government and decision makers to change ‘what is’ into ‘what should be’.

Patient Partnering at MidCentral DHB has been independently assessed. The outcomes strongly support the programme. (K. Renner and P.V. Stephens.  Post-thesis research. Massey University)  (K. Renner and P.V. Stephens. 2009).


Consensus on current management of Endometriosis

The First global consensus on endometriosis published in Human Reproduction Hum Reprod 2013 [Epub]Johnson NP and Hummelshoj L et al;. Fifty-six representatives of 34 national and international organisations, came together in the consensus meeting in Montpellier in 2011, to agree on the current management of endometriosis. The group met again in Brazil and is working on another manuscript which will add to the literature and pragmatically help patients and clinicians alike.

What is of huge significance is that Endometriosis NZ played a central role in this World Endometriosis Society initiative.  Ms Deborah Bush QSM represented endometriosis organisations worldwide and Dr Neil Johnson was primary author of the consensus document on behalf of the World Endometriosis Society.  Professor Cindy Farquhar was also involved as a presenter. The consensus allowed different perspectives to be heard in one forum around the same table: clinicians, surgeons, scientists, women with endometriosis, and industry – women’s voices which had previously not been heard.  Whilst maintaining its services and programmes, ENZ will continue to work with others at this unprecedented level to ensure improved health outcomes for all women and girls with endometriosis.


Endometriosis.org

www.endometriosis.org/topic/news/research continually updates international research, forums, interviews, papers and articles, providing an in-depth and current overview


World Endometriosis Research Foundation (WERF)

www.endometriosisfoundation.org
The World Endometriosis Research Foundation (WERF) was created in 2006 as the first global charity to foster research in endometriosis to improve knowledge and treatments. It has a vision of a day when no woman is crippled by endometriosis nor prevented by the disease from having children.  ENZ supports the efforts of this global research foundation.


Strength through support - mā te tautoko, ka whai kaha, ka ora

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