About the WRITE Symptoms Study
Who is carrying out this research study?
The Written Representational Intervention To Ease Symptoms, or WRITE Symptoms research study is being conducted by researchers at the University of Pittsburgh School of Nursing. Funding for the study comes from the National Institutes of Health, National Institute of Nursing Research.
What is the study about?
The goal of the WRITE Symptoms research study is to see whether an educational program provided by nurses over the Internet can help women with recurrent ovarian cancer better manage ovarian cancer symptoms and side effects of treatment. WRITE Symptoms research nurses will discuss symptom management with participants and provide self-care recommendations for symptom management. The study is also designed to look at the use of secure Internet message boards as a way of providing this information. No direct patient care, prescriptions or recommendations about medications or dosages will be given to study participants. Our aim is to support and facilitate communication between participants and their healthcare providers.
Medical Disclaimer
The information provided in this study should never be used as a replacement for direct and specific consultation with healthcare providers. It is important that all women contact or see their professional healthcare team if they have any specific questions about symptoms, ovarian cancer, medication or possible drug reactions. If there is a new symptom or increase in severity of an existing symptom, this should be reported to the healthcare team or emergency medical services immediately.
Who is eligible for the study?
Generally speaking, women are eligible for the study if they have three or more symptoms, are over 18 years of age, and have access to the Internet and email. Some restrictions may apply based on state of residence.
What is involved with study participation?
There will be 110 women in the study and each woman will participate for eighteen weeks.
Once enrolled in the study, each woman will be assigned to one of two study groups: education-first, or wait-list control. A computer program will make this assignment on a random basis, so each study participant has a 50/50 chance of being in either group. All study participants will receive a letter that they can take to their cancer care physicians explaining the research and detailing the study activities.
Those participants who are assigned to the education-first group will be given access to a private Internet message board for communication with their research nurse. They will have a series of interactions over the message boards with the research nurse about the symptoms they are having. The nurse will begin by posting questions about the symptoms and their current management. Participants will then respond to the questions on the message board. This process will take place over several days to a week. After that, the nurse will provide symptom management information and work with each participant on goals and specific self-care strategies to reach those goals. The research nurses will provide a summary of the conversation, goals and strategies and participants will be encouraged to share this summary with their healthcare provider. There will be a two week break for the participants to implement these strategies and evaluate the effect. At the end of this two week period, the research nurse will re-contact each participant on her private message board to follow up on the recommendations and outcomes. The nurse and study participant will work together to make any necessary changes to the self-care plans during this final set of interactions.
Those research participants who are assigned to the wait-list control group will not receive any education for the first 9 weeks of the study. At that point they will be given their own private message board and will receive the SAME educational program as those in the education-first group.
