Letter of Information and Consent to Participate in a Research Study

Study Title: Optimizing Decision-Making for Uterine Fibroid Surgery: Implementation of a multimedia patient decision aid for the management of uterine fibroids

Principal Investigator: Dr. Deborah Robertson, MD

Affiliation: St. Michael's Hospital, Unity Health Toronto — Department of Obstetrics and Gynecology

Conflict of Interest Statement

The principal investigator, co-investigators, and research staff do not have any conflicts of interest, financial or otherwise, related to this study or its outcome.

Introduction

You are being asked to participate in a research study because you have been referred for care related to uterine fibroids at Unity Health Toronto, and your care team believes you may be interested in using a new patient decision aid, MyFibroid Plan.

All research is voluntary — you do not have to participate, and you can withdraw at any time.

Before agreeing to take part in this study, it is important that you read the information in this research consent form. It includes details we think you need to know in order to decide if you wish to take part. If you have any questions, please contact the research team using the information at the end of this form.

You should be aware that it is possible that the Unity Health Toronto study investigator(s) will also be your treating doctor(s). Your treating doctor's role in this study is limited to introducing it to you; the research team, not your treating doctor, will explain the study in full and obtain your consent, and your treating doctor will not know whether you chose to participate. Your choice about whether to participate will not affect the medical care you receive.

Background and Purpose of the Research Study

Uterine fibroids are a common gynecologic condition and are the leading reason for hysterectomy surgery worldwide. People with fibroids often have several possible treatment options, and choosing between them can be difficult — the right choice often depends on your personal symptoms, values, and goals, such as whether you hope to become pregnant in the future. Feeling unsure or conflicted about this decision is common and has been linked to delays in treatment and dissatisfaction with care.

MyFibroid Plan is a web-based decision aid, developed with input from patients and physicians, to help people with fibroids understand their treatment options and make a choice that fits their needs. This study is an observational study comparing patients' experiences before and after the introduction of MyFibroid Plan into routine care; it does not involve being placed into different treatment groups by chance, and it is being conducted to understand how patients use the tool and whether it helps improve their experience of making this decision.

Participant Population and Study Enrollment

This study will enroll a maximum of 100 participants, recruited from St. Michael's Hospital and St. Joseph's Health Centre (Unity Health Toronto) combined.

Study Duration

Overall, this study is expected to run for about six months (June to November 2026). Your involvement in this study will last for about one survey session (approximately 10 minutes); however, you may be contacted up to two additional times over a two-week period if you have not yet completed the survey.

Description of Research Activities

Changes to Standard Care

The care that you receive for your condition will not be changed if you decide to participate in this study. All research interventions and activities will be in addition to the usual care.

Accessing the Decision Aid: You will use the web-based decision aid to learn about treatment options for uterine fibroids.
Tracking Your Participation: To monitor completion rates while keeping your answers anonymous, you will be asked to enter a unique Study ID at the start of the survey. This ID was provided to you by the research team.
Follow-up: If the survey is not completed within two weeks, the research team may contact you via Epic MyChart message or telephone, up to two times, to provide assistance or reminders.

Research Questionnaires and Surveys

A survey is embedded within the decision aid to capture your feedback. It includes questions about: your background and how fibroids affect your life; your experience using the MyFibroid Plan tool; how sure you feel about your treatment choice; and your experience working with your doctor. It will take approximately 10 minutes to complete.

The survey is administered electronically through a secure link (REDCap) embedded within the decision aid. You may complete it on a device of your choosing (phone, tablet, or computer), at a time and place that works for you.

You can skip questions that you do not wish to answer. If you have any questions or concerns while answering these questions, please talk to an investigator or research team member.

Potential Risks

There are no physical risks. Some questions may cause mild emotional discomfort when reflecting on your health experiences. If this happens, you can skip the question, pause, or stop your participation at any time. The study team is available to discuss any concerns.

Potential Benefits

There are no direct medical benefits to you. However, your feedback is helpful for optimizing the tool for future patients.

Alternatives to Participation

This study is not researching ways to provide you with medical treatment for your fibroids, so the alternative to taking part in this study is to not take part. Whether you choose to take part in this study or not, you will receive the same standard and level of care at Unity Health Toronto, and you may discuss your treatment options with your doctor at any time, with or without using the MyFibroid Plan decision aid.

Privacy and Confidentiality of Your Personally Identifying Information and Study Data

This section describes how your personally identifying information and study data will be accessed, disclosed, and stored during this study. All persons involved in the study are committed to respecting your privacy. Other than the individuals or groups described in this section, no persons will have access to your personally identifying information without your consent, unless required by law.

Personally identifying information is any information that could be used to identify you; this includes your name and address. Study data is information that is generated by and/or collected for a study that has been stripped of personally identifying information.

Protecting Your Privacy

The study team will make every effort to keep your personally identifying information private and confidential in accordance with all applicable privacy legislation, including the Personal Health Information Protection Act (PHIPA) of Ontario.

No personally identifying information will be allowed off site in any form, unless required by law or as described in this consent form.

All data collected for research purposes will be labelled with a unique study identification number (Study ID) instead of any of your personally identifying information. The principal investigator (based at St. Michael's Hospital, Unity Health Toronto) is in control of the Master Linking Log that links your Study ID to you personally, and will keep it stored separately from the study data.

By proceeding with this study, you are authorizing access to your medical records by representatives of the Unity Health Toronto Research Ethics Board. Such access will only be used to verify the authenticity and accuracy of the information collected for this study, without violating your confidentiality, to the extent permitted by applicable laws and regulations.

Online Surveys, Third Party Websites, and Web Based Apps

This study uses REDCap (Research Electronic Data Capture), a secure, web-based survey platform, to administer the study survey found at the end of the decision aid tool. REDCap is hosted on secure servers through AHRC, Unity Health Toronto.

No directly identifying information (such as your name, email address, or IP address) is collected by REDCap. You are identified within the survey only by your unique Study ID.

Storage and Retention of Your Personally Identifying Information and Study Data

Personally Identifying Information Storage and Retention

All personally identifying data used in this study will be securely stored. No paper copies of identifiable participant information are collected or stored for this study. Electronic copies (i.e., the Master Linking Log) are stored in a password-protected file on a secure Unity Health Toronto hospital server, accessible only to approved members of the research team.

In accordance with Unity Health Toronto policy, this information will be retained for five years following publication of study results and then securely destroyed.

Study Data Storage and Retention

Your de-identified survey responses (study data) will be securely stored electronically, separately from the Master Linking Log, in a password-protected file on a secure Unity Health Toronto hospital server. Access to study data is strictly restricted to approved members of the research team. In accordance with Unity Health Toronto policy, study data will be retained for five years following publication of study results and then securely destroyed.

Study Results and Study Registration

The results of this study may be presented at a scientific conference or published in a scientific journal.

Some scientific journals may require us to make the study data available to the journal, its reviewers, or to other researchers.

You will never be personally identified in any publication, report, or presentation that may come from this study.

Potential Costs and Reimbursement

There are no costs to you for participation in this study. You will not be paid for your participation in this study.

Participation and Withdrawal

Participation in this Study

Your participation in this study is completely voluntary. If you choose not to participate, there will be no impact to the medical care you receive at, or your relationship with, Unity Health Toronto, now or in the future, for you or your family.

Implied Consent: This study uses an implied consent process. By proceeding to the decision aid and submitting the survey, after having read this information, you are providing your consent to participate in this research.

Withdrawal from this Study

If you choose to take part in this study, you can change your mind without giving a reason, and you may withdraw from this study at any time without any effect on the medical care you or your family receive at Unity Health Toronto. You may stop using the decision aid or exit the survey at any time. If at any time you choose to withdraw from this study, please contact a member of the study team using the information below.

Data Usage: Only fully completed surveys will be used for the primary study analysis. If you exit the survey before clicking "submit," your incomplete answers will not be included in the research results and will be withdrawn from the study.

New Information About this Study

We may make changes to this study as it progresses, such as updates to the decision aid content or survey. We do not anticipate that any such changes would affect your decision to participate; however, if this changes, we will notify you in a timely manner.

Research Ethics Board Contact

If you have any questions regarding your rights as a research participant, you may contact the Unity Health Toronto Research Ethics Board Office at 416-864-6060 ext. 42557, during business hours (9:00 a.m. to 5:00 p.m.).

Study Contacts

If at any time during the study you have questions about the study or the study activities, you should contact the study team at 416-867-7460 ext.48119, during business hours or by email at myfibroidplan@gmail.com.

By clicking "Begin," you acknowledge that you have read this information and agree to participate in this study.

Choosing surgery for uterine fibroids: what's the best option for me?

MyFibroid Plan is a patient-developed tool to help you explore your treatment options and prepare for your visit.

This patient decision aid was developed as part of a quality improvement initiative with patients who have faced similar decisions.

If you'd like, you can print a PDF version of this document to bring with you to your appointment, or you can review a copy available at the clinic.

MyFibroid Plan is for you if:

All of these are true for you:

Your doctor says you have uterine fibroids
•Medications have not helped with your symptoms

or

•You cannot take these medications or are not interested in taking them
You are considering surgery for your fibroids

Uterine fibroids

Uterine fibroids are muscular tumors that develop in the wall of the uterus. These growths vary in size and can cause symptoms such as heavy menstrual bleeding, pelvic pressure, and pain.

Hormone imbalances, genetic factors and family history may all play a part. We do know that hormone levels of estrogen and progesterone can cause fibroids to grow bigger.

Fibroids can cause groups of symptoms:

Heavy periods
Pelvic pressure or discomfort, bloating, or changes to bowel or bladder function
Difficulty becoming pregnant

You can treat symptoms with medications that decrease bleeding or decrease the size of fibroids. If these medications don't work for you or you cannot take them, surgery may be an option.

Where are your fibroids located?

Cross-section of the uterus showing the four main types of fibroids: submucosal, intramural, subserosal and pedunculated

Cross-section of the uterus showing the main types of fibroids by location.

Intramural fibroids: These are the most common type of fibroids. They develop in the uterine wall and may expand.

Pedunculated fibroids: These grow on stalks or stems. The stems are attached to the uterine wall and may grow either outside the uterus or inside the uterine cavity.

Subserosal fibroids: These develop in the outer portion of the uterus and may continue to grow outward.

Submucosal fibroids: These develop within the uterine cavity and may cause heavy and prolonged periods.

Depending on where your fibroids are located, certain surgical options may be more suitable.

In general, what treatment options do you have?

No surgery

Medications or watchful waiting

Hysterectomy

Removing your whole uterus

Myomectomy

Removing only fibroids

Uterine artery embolization

Decreasing blood flow to fibroids

Radiofrequency ablation

Shrinking fibroids (Acessa)

Your options for surgery depend on:

1) Your age and future fertility plans
2) The location, number and size of your fibroids

Based on your future fertility plans, these are the surgical options to discuss with your doctor.

Planning to carry children

Myomectomy

Hysteroscopic myomectomy — may be possible for submucosal fibroids within the uterine cavity.

Open myomectomy — for when there are many or very large fibroids.

Laparoscopic myomectomy (keyhole surgery) — if there are few or small fibroids.

Not planning to carry children

Hysterectomy

Open hysterectomy — if the uterus is very large.

Laparoscopic hysterectomy (keyhole surgery) — when possible.

Myomectomy

Hysteroscopic myomectomy may be considered in some patients who do not plan to have children. Discuss this with your doctor.

Uterine artery embolization

Blocks blood flow to shrink fibroids. Not recommended if you are planning a pregnancy.

Radiofrequency ablation

Uses heat to shrink fibroids. Not recommended if you are planning a pregnancy.

What other health factors may affect your choice?

Check what applies to you to discuss further with your doctor.

Medical history

I have heavy periods

I have high blood pressure

I have a higher weight (body mass index >40)

I have a history of endometriosis or adenomyosis

I had previous vaginal deliveries

I had previous abdominal surgeries

I had previous surgery for my fibroids

I tried previous medications for my fibroids

I had a C-section

Fertility considerations

I would like to become pregnant in the future

I have had difficulty becoming pregnant

Work through these 4 steps to help you decide

Step 1

What are the benefits and risks of each option?

Step 2

For each option, what matters to you most?

Step 3

What else do you need before making a decision?

Step 4

What are the next steps?

Step 1

What are the benefits and risks of each option?

Tap an option to learn more information, then return here to explore others.

No surgery

Medications or watchful waiting

Hysterectomy

Removing your whole uterus

Myomectomy

Removing only fibroids

Uterine artery embolization

Decreasing blood flow to fibroids

Radiofrequency ablation (Acessa)

Shrinking fibroids with heat

No surgery

You don't need to have any treatment at all if you aren't bothered by symptoms. Many patients live with uterine fibroids and do not start treatment. Uterine fibroids are not cancerous, so you do not need to get any treatment for them.

You can try medications to treat heavy bleeding, bulk symptoms or both. Medications can be tried if you have not been on any treatment before, or are not interested in having surgery. Some medications contain hormones while others do not. Talk to your doctor about the best medication for you.

Hysterectomy

A hysterectomy removes your whole uterus, including fibroids.

This means:

You will no longer have any menstrual periods
You will not be able to carry a pregnancy
As long as you keep at least 1 ovary, your hormones will remain the same and you will go through menopause at the same age you normally would

How is a hysterectomy done?

It can be done as laparoscopic surgery (through key hole incisions) or open surgery. This depends on your uterus and other factors.

Laparoscopic (keyhole) surgery

Minimally invasive. It involves removing the uterus and fibroids through a small cut at the top of the vagina. Recovery time: 2 to 4 weeks.

Open surgery

You would have an incision in your belly. Recovery time: 4 to 6 weeks. You should not place anything in the vagina, lift anything over 10 pounds, or submerge yourself in water for 6 weeks.

Step 1

Benefits and risks

Hysterectomy

Factors to consider	Benefits	Risks
How well it works	Removes the fibroids completely along with your uterus. You will no longer have periods.	This is a major surgery. There is a risk of complications such as infection, blood transfusion, blood clots, or injury to surrounding organs like the bowel or bladder.
Long-term outcomes	There is no risk of the fibroids returning. Resolves symptoms like heavy bleeding.	Pain and pressure symptoms may persist if these are not related to your fibroids.
Recovery	If done through laparoscopic surgery, you will have a shorter recovery time (2 to 4 weeks).	Recovery time can be up to 6 weeks. You should not place anything in the vagina, lift over 10 pounds, or submerge in water for 6 weeks.
Future reproductive outcomes	This is a permanent solution if you have no plans to carry a pregnancy in the future.
Hormonal effects	The ovaries can be left inside which avoids early menopause.	If ovaries are removed, you will go through menopause and may have symptoms like hot flashes and mood swings.

Myomectomy

Myomectomy involves removing fibroids. The uterus is left in place and you will continue to have periods after surgery. Fibroids may remain and may grow back.

This option is often chosen by patients who want to get pregnant in the future or want to keep their uterus. In some cases, this surgery may improve chances of pregnancy.

There are 3 main ways to do this surgery. The approach that is chosen depends on the location, size, and number of fibroids.

Myomectomy approaches

Hysteroscopic myomectomy

For fibroids inside the uterine cavity (submucosal)
Performed through the vagina with no incisions
A camera and surgical tools are used to remove the fibroid
Quick recovery (a few days to 2 weeks)
Usually no hospital stay needed

Laparoscopic myomectomy

For smaller, fewer fibroids
Done through small incisions in the belly using a camera and surgical tools
Some patients stay 1–2 nights in the hospital, while others go home the same day
Recovery time: 4–6 weeks

Open myomectomy

For larger or multiple fibroids
Requires larger incision in the belly (size and location of the incision depends on uterus size)
Hospital stay: 1–3 nights
Recovery time: 4–6 weeks

Myomectomy: what to expect

Before having a myomectomy, your surgeon may ask you to take medications to shrink fibroids and the uterus and stop heavy bleeding. The most commonly used medication is called a GnRH agonist (brand name Lupron).

This may:

Improve how successful the surgery is
Reduce your need for a blood transfusion
Allow your surgeon to use a smaller cut during the surgery

If you get pregnant after having a myomectomy, you will likely need to have your baby by a cesarean section rather than a vaginal delivery. Ask your doctor about this.

Step 1

Benefits and risks

Myomectomy

Factors to consider	Benefits	Risks
How well it works	Can remove larger fibroids and relieve symptoms like heavy bleeding and pelvic pressure.	Sometimes, not all of the fibroids can be removed. Some patients will continue to have heavy bleeding and pelvic pressure symptoms.
Long-term outcomes	Keeps the uterus, which can be important if you want to get pregnant in the future or for emotional reasons.	Fibroids can return. 1 in 10 patients will need another surgery. Scar tissue often forms after a myomectomy, which may make future abdominal surgery more complicated.
Future reproductive outcomes	You can become pregnant after a myomectomy. In some cases, myomectomy may improve your chances of pregnancy.	If you have many or large fibroids, your doctor will likely recommend you deliver by cesarean section in the future (rather than a vaginal birth).
Hormonal effects	There is no impact on hormones or menopause.	Hormonal imbalance is not a concern unless the ovaries are damaged or removed during surgery.

Uterine artery embolization (UAE)

UAE treats fibroids by cutting off the blood supply, causing them to shrink. It is a minimally invasive procedure.

Preserves the uterus but is not recommended for those planning pregnancy.

Helps reduce heavy bleeding and fibroid-related pressure symptoms.

How UAE is done

It is done by an interventional radiologist and involves:

Using a local anesthetic and sedation
Making a small cut in your leg and inserting a catheter (thin tube) into the uterine artery
Injecting tiny particles (like grains of sand) to block this artery

Step 1

Benefits and risks

Uterine artery embolization

Factors to consider	Benefits	Risks
How well it works	Effective in shrinking fibroids. Relieves symptoms like heavy bleeding and pelvic pressure in about 3 in 4 women.	May not work for all fibroids, especially large or calcified ones. Not recommended for submucosal or pedunculated fibroids.
Long-term outcomes	Many women experience long-term symptom relief.	Fibroids can return. 1 in 5 women will need another surgery for their fibroids later in life.
Recovery	Shorter recovery time compared to other surgery (usually 1–2 weeks for most patients).	Pain is often significant. There is a rare risk of infection requiring emergency hysterectomy.
Future reproductive outcomes	Pregnancy is not recommended after this procedure. Pregnancy can come with increased risks including preterm labour, miscarriage, or problems with the placenta.
Hormonal effects	No direct impact on hormone production.	Some women may experience early menopause symptoms, if the ovaries are affected by the procedure.

Radiofrequency ablation (Acessa)

Minimally invasive procedure using small incisions in the belly. The surgeon uses ultrasound to target fibroids with heat, shrinking them to reduce symptoms. The uterus remains intact, but pregnancy is not recommended after this procedure.

It is a good choice if:

You have a few fibroids and they are under 10 cm
You had no previous abdominal surgeries, or had minimal surgeries

Symptom improvement peaks at 3 months and can continue for up to a year. Your body mass index must be less than 40 to have this procedure.

Step 1

Benefits and risks

Radiofrequency ablation (Acessa)

Factors to consider	Benefits	Risks
How well it works	Effective in reducing symptoms like heavy bleeding and pelvic pressure by shrinking fibroid size.	May not be as effective for very large fibroids or if fibroids are in certain locations. Some fibroids may not shrink enough to fully relieve symptoms.
Long-term outcomes	Many women experience long-term symptom relief. Can reduce the need for further surgery, especially in patients with smaller fibroids.	Fibroids can grow in the future. About 11% of patients will need another surgery. This is about 1 in 10 patients.
Recovery	Shorter recovery time compared to hysterectomy and myomectomy (usually 1–2 weeks). Most patients can go home the same day of surgery.	Some discomfort after the procedure, including cramping and bloating. This may last for a few days to a week.
Future reproductive outcomes	Keeps the uterus. However currently, pregnancy is not recommended after this procedure. Pregnancy may come with increased risks including miscarriage or problems with the placenta.
Hormonal effects	No direct impact on hormone production.	In rare cases, there may be unintended effects on the ovaries and hormone production.

More information about fibroids

Tap any topic to learn more. These are optional — come back whenever you're ready.

Fibroids and fertility

Fertility and aging

Fibroids and pregnancy

Fibroids and cancer risk

Fibroid morcellation

Vitamin D and fibroids

Community resources

Fibroids and fertility

Most fibroids do not affect your chances of getting pregnant or having a miscarriage. However, this depends on where your fibroids are:

Fibroids inside the uterine cavity (submucosal) can reduce fertility because they may prevent a fertilized egg from implanting. Removing the fibroids may improve pregnancy chances.
Fibroids on the outside of the uterus (subserosal) do not affect fertility. It is not necessary to remove them unless the size causes problems or they are pressing on the kidneys.
Fibroids in the muscle [or wall] of the uterus (intramural) may affect fertility, depending on the size and number. Your doctor can help assess the need for surgery.

Surgery for fibroids may affect fertility if there is scarring. It may also affect how you deliver your baby. If you have an abdominal myomectomy, you will probably need to have a cesarean section for future pregnancies.

Fertility and aging

Women's fertility normally declines after age 30 with a more significant decrease at age 35.

Relative fertility gradually declines from the early 30s, with a steeper drop after age 35.

Fertility treatments are more successful in younger women under age 35. After age 40, success rates decline and risks increase.

If a woman's own eggs are no longer viable, or you are age 41 or older, egg donation is an option. In this process, donated eggs are fertilized with your partner's sperm and implanted into your uterus.

For women who are unable to carry a pregnancy due to age or other health reasons, surrogacy may be an option. This involves another woman carrying the pregnancy using either the couple's own or donor eggs and sperm.

Fertility treatments can be expensive. Ask your doctor if you are interested in seeing a fertility specialist.

Fibroids and pregnancy

Most fibroids stay the same size during pregnancy. However about 1 in 3 may get larger during pregnancy due to hormone changes. After the pregnancy, they tend to shrink in size.

Many people with fibroids have healthy pregnancies. However, the size, number and location of fibroids can affect the risk of complications.

The most common complication is pain from fibroid degeneration. This is when a fibroid grows bigger than its blood supply. It causes sharp pain in a small area, usually in the first half of pregnancy.

A cesarean section may be recommended if:

You have had a previous abdominal or laparoscopic myomectomy
A large fibroid blocks the cervix or causes the baby to be in a breech position

Most patients with fibroids can have a vaginal delivery; however, a cesarean section may be recommended in the cases above.

Fibroids and cancer risk

Uterine fibroids are almost never cancerous and do not increase the risk of uterine cancer.

In 1 in 1,000 cases, a mass looking like a fibroid may in fact be a leiomyosarcoma, a rare cancer. That risk increases with a woman's age.

Your doctor will assess your history and pelvic imaging for any risk factors.

Patients with fibroids and heavy periods may need an endometrial biopsy to check for precancerous or cancerous cells before surgery.

Fibroid morcellation

Morcellation is a process where fibroids or the uterus itself are cut into smaller pieces so they can be removed through smaller incisions. Smaller incisions lead to quicker recovery times, less pain, and smaller scars.

Morcellation is generally safe. In the very small chance that a fibroid contains cancer, morcellation could spread the cancerous cells within the abdomen, leading to worse outcomes.

Before morcellation, patients must have a biopsy of the lining of the uterus (endometrial biopsy) to check that there is no pre-cancer or cancer. This does not guarantee that you don't have cancer but is a good screening test.

If there is any concern that a fibroid could have cancer, morcellation will not be done.

The alternative to morcellation is to have a larger incision so that the fibroid or uterus can be removed as one piece.

Vitamin D and uterine fibroids

Research suggests that Vitamin D may help slow the growth of fibroids and even reduce their size in some cases. Vitamin D is a safe and low-risk option that may help with fibroid management, especially for smaller fibroids. It's not a cure, but maintaining healthy Vitamin D levels benefits overall health.

More research is needed to confirm its effectiveness. Doses used in research studies are higher than what is currently available. Talk to your doctor about checking your Vitamin D levels and finding the right dosage for you.

Community resources

Click to explore community supports suggested by gynecologists at Unity Health Toronto:

The Fibroid Foundation

Care About Fibroids

The White Dress Project

Step 2

What matters most to you?

Rate how important each reason is to you on a scale from 0 to 5. 0 = not important · 5 = very important

Reasons to choose a hysterectomy

How important is it to you to completely eliminate periods?

3