By Joanna Marks
Ask any woman who has undergone a risk-reducing salpingo oophorectomy (RRSO) about recovery and you will hear about both the physical and emotional challenges of this process. If ovaries are removed prior to a woman’s natural menopause transition, she will likely enter premature menopause. For many women, cognitive complaints (like difficulty concentrating and remembering important things) may emerge during this hormonal transition. Researchers at the University of Pennsylvania are conducting a study called IMPRES investigating whether a stimulant medication approved by the FDA for the treatment of Attention Deficit Hyperactivity Disorder is more effective than placebo in reducing certain types of cognitive complaints among women who have undergone RRSO. During study participation, all women receive the active study medication in one phase and a placebo in the other phase. Neither the participant or the research staff know when the participant is receiving the active versus the placebo medication. The goal is to determine in an unbiased way whether the individual experiences a difference in their cognition and brain imaging outcomes in one phase versus the other. The study, led by pioneer women’s health researcher Dr. Neill Epperson, is called “IMProving Executive Functioning Study” or IMPRES.
A FORCE member participated in IMPRES last year. We spoke to her to find out her thoughts on the experience of being a research participant. Here is what she had to say:
1. What motivated you to participate in IMPRES?
I completed my prophylactic bilateral mastectomy and risk-reducing salpingo-oophorectomy in the spring of 2009 due to an inherited BRCA1 genetic mutation. Over the years, I noticed a steady decline in my executive function, especially my short-term memory. I noticed that I had to write myself notes to recall basic information about a conversation, especially dates and times. I began using my smartphone to enter reminders to myself for simple tasks. I also know how important research and clinical trials are for the hereditary breast, ovarian, pancreatic, prostate and related cancers community. I wanted to participate to contribute to this important research and possibly help other women with options for their menopausal cognitive symptoms.
2. Did you have any hesitations beforehand?
My only hesitation was a fear of finding out I had a serious medical problem.
3. What was your favorite part of participating?
I enjoyed working with the research team. Everyone was extremely friendly and passionate about their work. I really enjoyed the whole study process including all of the memory tests that were repeated throughout the study. I knew without the actual results of the various cognitive tests that my scores were better when I was on the arm of the study where I took the active medication. My recall of information and details were definitely better.
4. If there was a part of IMPRES you found most challenging, what made it easier?
One challenge I experienced was the drive to the testing site, but I was aware of the distance prior to signing up and was happy to make the 106 mile roundtrip drive to be able to participate. I also experienced side effects during one phase of the study when the dosage was increased. My side effects during that phase of the study included difficulty sleeping and an anxious feeling. The study doctor was in contact with me to see how I was feeling on the increased dosage, and it was determined that I should remain on the lower dose for the remainder of that part of the study.
5. What was the most interesting thing you learned while participating in IMPRES?
In the phase of the study, which I found out later was the active drug phase, I could tell immediately that I was more focused. I was able to think clearly, the “fog” that left me searching for words, phrases or details was gone. I felt like my pre-surgical self again. I was so pleased to know that my cognitive function really was a symptom of menopause, and not an age-related issue.
6. What would you tell a friend who is thinking of participating in IMPRES?
For someone who is experiencing executive function issues after surgical menopause, this study is really worth the time and effort to participate. You are always monitored by a healthcare provider from the research team, checking in by phone and email consistently throughout the study. You always have someone to reach out to for any questions or concerns.
7. Any final words about your experience participating in research?
It is exciting to participate in research that may lead to new options for women experiencing executive function issues post-surgical menopause. I’m looking forward to hearing about the results of this study.
If you have any questions about the IMPRES study or are interested in participating, you can take a quick eligibility survey by clicking the following link. https://redcap.med.upenn.edu/surveys/index.php?s=W34TK3DL3F A research coordinator will then be in touch to follow up.
Joanna Marks is a Clinical Research Coordinator at the University of Pennsylvania’s Penn Center for Women’s Behavioral Wellness. In addition to the IMPRES study, her work at PCWBW focuses on PMS and stress response. In the fall, Joanna will start her graduate training to become a Psychiatric Nurse Practitioner with a focus on women’s wellness.