Measuring Clinical, Biological, and Behavioral Variables to Elucidate Trajectories of Patient-Reported Outcomes: The PROFILES Registry

Abstract

To take cancer survivorship research to the next level, it’s important to gain insight in trajectories of changing patient (reported) outcomes and impaired recovery after cancer. This is needed as the number of survivors is increasing and a large proportion is confronted with changing health after treatment. Mechanistic research can facilitate the development of personalized risk-stratified follow-up care and tailored interventions to promote healthy cancer survivorship. We describe how these trajectories can be studied by taking the recently extended Dutch population-based PROFILES (Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship) registry as an example. PROFILES combines longitudinal assessment of patient-reported outcomes with novel, ambulatory and objective measures (e.g., activity trackers; blood draws; hair samples; online food diaries; online cognitive tests; weighing scales; online symptoms assessment), and cancer registry and pharmacy databases. Furthermore, we discuss methods to optimize the use of a multidomain data collection like return of individual results to participants which may not only improve patient empowerment but also long-term cohort retention. Also, advanced statistical methods are needed to handle high-dimensional longitudinal data (with missing values) and provide insight into trajectories of changing patient (reported) outcomes after cancer. Our coded data can be used by academic researchers around the world. Registries like PROFILES, that go beyond boundaries of disciplines and institutions, will contribute to better predictions of who will experience changes and why. This is needed to prevent and mitigate long-term and late effects of cancer (treatment) and to identify new interventions to promote health.

A Narrative Review on the Collection and Use of Electronic Patient-Reported Outcomes in Cancer Survivorship Care with Emphasis on Symptom Monitoring

“…A very large number of generic and cancer-specific ePROMs are available. For research purposes, e.g., the Dutch ‘Patient-Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship’ (PROFILES) registry incorporates 60+ ePROMs for cancer patients [ 6 , 7 ]. For use in routine cancer care, guidance in choices for ePROMs was recently published by Cancer Care Ontario.…”

“…In the future, ePRO-symptom monitoring applications can be made more patient-centered and relevant by adding a dynamic list of symptoms to be reported during specific treatment phases such as surgery, radiotherapy, or systemic therapy [ 7 , 64 , 65 , 66 ]. For the latter, symptom incidences vary highly between, for instance, chemotherapy and immunotherapy.…”

Cancer survivor late-effects, chronic health problems after cancer treatment: what’s the evidence from population and registry data and where are the gaps?

“…Studies that included PROs increase the quality of information and measure the personal impact of symptoms on survivors HRQOL rather than what is documented in routine clinical records [44]. Random sample study populations collecting PROs [23▪,45] gave greater granularity and understanding of late effects that complemented the data linkage to clinical records but encountered challenges with increasing missing PROs data over time.…”

Effectiveness of the online Acceptance and Commitment Therapy intervention “Embrace Pain” for cancer survivors with chronic painful chemotherapy-induced peripheral neuropathy: study protocol for a randomized controlled trial

“…Questionnaires will be completed online via the PRO-FILES Registry [38]. Patients will receive reminders via email to promote participant retention and complete follow-up.…”