Chemotherapy-Induced Peripheral Neuropathy (CIPN) Clinical Trial
Do you have numbness, tingling, burning or other symptoms in your hands or feet from your recent chemotherapy treatments? You might have nerve damage called “neuropathy.”
REMOTE MONITORING AND MANAGEMENT OF CIPN (REMOTE CIPN): A Treatment Study
The UVM Cancer Center is currently recruiting participants to study a new way to provide treatment for people with a kind of nerve damage called chemotherapy induced peripheral neuropathy (CIPN). The study uses close remote monitoring of symptoms
so that treatment can be given as soon as it becomes necessary and can be adjusted as the symptoms change.
WHY ARE WE DOING THIS STUDY?
Chemotherapy induced peripheral neuropathy (CIPN) causes nerve pain and loss of sensation in the hands and feet, and these symptoms can be quite bothersome. CIPN frequently leads to chemotherapy treatment changes, pain, fall risk and negative impacts
on quality of life. Sometimes CIPN goes away shortly after chemotherapy and other times it can last for years. There are treatments for these symptoms but sometimes there is a delay in getting those treatments and the treatment options are often
This study investigates a new way of helping people who have CIPN after they complete chemotherapy, by checking on symptoms daily and using a specially trained nurse practitioner to select the right treatment at the time bothersome symptoms are reported. If
your symptoms change, the nurse practitioners can quickly adjust your medications or try new solutions to improve how you feel.
We hope to show that providing care to patients based on daily reported symptoms (which the patients can do from their home) will reduce CIPN symptoms over a 12-week period, improve quality of life, and reduce disability.
WHAT IS INVOLVED IF I DECIDE TO PARTICIPATE IN THIS STUDY?
If you have developed chemotherapy induced peripheral neuropathy (CIPN) from your current or recently completed chemotherapy, you may be eligible to participate in this study.
- Study staff will look at your medical record to determine if you are eligible and you will have a conversation with someone from the study team to answer any questions you may have.
- You’ll be asked to complete some questionnaires about your CIPN symptoms and how those symptoms are affecting you. You will also undergo a brief physical assessment to evaluate your neuropathy.
- You’ll be taught how to use the system through which you’ll report your symptoms every day. This can be done using a telephone, a smartphone application, or a website. You can decide which one you’d like to use on any given day.
- You’ll record your symptoms every day for one (1) week. After that week, if you’re eligible to continue in the study based on your symptom reporting, you’ll be randomly assigned to either a group that will receive calls from
a nurse practitioner to treat your symptoms, or a group that will not receive calls from a nurse practitioner but can work with their doctors to treat their symptoms.
- You’ll continue to record your symptoms daily for an additional twelve (12) weeks.
- There will be two (2) more in-person visits, one at approximately the 6-week timepoint and one at approximately the 12-week timepoint. At these visits you’ll be asked some of the same questionnaires you completed at the first visit.
- You will be compensated for your participation in the study.
We expect about 140 participants will be enrolled in this study at UVM, which is one of three places in the country where the study is happening.
FOR MORE INFORMATION
Please reach out to the clinical trial study staff below or speak to your oncologist.
Hannah Taylor at 802-656-9442 or firstname.lastname@example.org
Mary Healey at 802-656-9427 or email@example.com
DISCRIMINATION IS AGAINST THE LAW
The UVM Medical Center is committed to providing care to all members of its community without regard to race, color, sex, sexual orientation , gender identity or expression, ancestry, place of birth, HIV status, national origin, religion, marital status, age, language, socioeconomic status, physical or mental disability, protected veteran status or obligation for service in the armed forces.