THRIVE Study

BY ARNOLD POTOSKY, MHS, PhD, AND HEATHER DERRY-VICK, PhD
Investigators at the Lombardi Comprehensive Cancer Center at Georgetown University, in collaboration with investigators at the California and New Jersey Departments of Health,
MedStar Health, Hackensack Meridian Health, Duke University, and the Ruesch Center, are currently engaged in a study that is vital to all people living with metastatic colorectal cancer (mCRC).

With advances in cancer treatment, individuals with metastatic cancer are now living longer. However, their survivorship needs are not well understood, despite it being recognized that their supportive care needs are different from those with early-stage disease. Until now, there have not been any large studies on the quality of life of people with metastatic colorectal cancer, and this has slowed progress in addressing the specific needs of these individuals.

As people with mCRC and their caregivers are well aware, this malignancy requires numerous therapies, causing severe and persistent symptoms and side effects, including pain, difficulty sleeping, neuropathy, and gastrointestinal (GI) problems. People with mCRC may also experience symptoms from their cancer and other co-occurring chronic conditions that impact their day-to-day
lives. It stands to reason that these symptoms and side effects go hand in-hand with emotional, physical, and social challenges. These emotional, physical, and social aspects of well-being make up “Health-Related Quality of Life (HRQOL).” Although we know that cancer and its treatments can adversely affect HRQOL, we do not know the nature or extent of these effects. “Real world” data on symptoms, side effects, and HRQOL that are collected over time(longitudinally) are really important to make sure that the specific supportive care needs of people with mCRC are well understood. This “real-world” data will help researchers and clinicians find the best ways to reduce some of the negative impacts of cancer on daily functioning and well-being.

The goal of the THRIVE study is to learn about the experience of people living with metastatic colorectal cancer. For this, the research team needs to collect information on patient-reported
outcomes (PROs) from a large number of people, including symptoms and side effects and HRQOL data. We will also learn about ways that people and healthcare systems manage their health to help them maintain their HRQOL over time. In the long term, the data from this project will help us know
the best ways and when to put them into effect to improve people’s well-being and functioning with metastatic colorectal cancer. We plan to study about 1600 participants, selected from registries in New Jersey and Greater California. These registries were chosen due to the large number and variety of people they include in terms of social, cultural, and economic situations.

We will collect meaningful mCRC PROs from these participants over one year. To ensure that the survey addresses topics that are important to those with mCRC, the research team is working with a Stakeholder Advisory Board, which includes people living with metastatic colorectal cancer and their caregivers. These people will be surveyed for their HRQOL at about 6-9 months after initial diagnosis and again at 4, 8, and 12 months after that. Symptom and side effect assessment methods are novel and will recognize that more than one symptom or side effect can occur at the same time. This project will be the first and largest to survey community members living with mCRC specifically for their needs, as this group has been underrepresented in other quality-of-life research studies of people living with cancer.

First, we aim to identify and describe treatment-related physical symptoms and side effects and examine their variation according to social, cultural, and economic factors. Second, we will measure the relationship between separate or groups of symptoms and side effects and physical, emotional,
and social function, as well as cancer-related financial distress. Third, we will study to what degree an individual’s way of managing their health and social support makes a difference, along with the healthcare system’s level of care coordination and use of, and experiences with, palliative and supportive care services.

The study will use data obtained from medical records to help capture treatment information that may be related to participants’ symptoms, side effects, and HRQOL. These data will be collected from cancer registries, medical charts, and billing claims for persons enrolled in New Jersey and
California. By carrying out this study, we hope to build enough knowledge to guide or inform the next generation of interventional strategies and thereby make a difference in the health and
well-being of people dealing with this disease on a daily basis.