QUALITY OF LIFE AND PATIENT EXPERIENCE DURING NEOADJUVANT THERAPY: RESULTS OF A PROSPECTIVE COHORT STUDY
Alexander H. Shannon*1, Angela Sarna1, Luke Bressler2, Christina Monsour1, Heena P. Santry1, Emily Huang1, Desmond D'Souza1, Peter J. Kneuertz1, Aslam Ejaz1, Timothy M. Pawlik1, Jordan Cloyd1
1The Ohio State University Wexner Medical Center, Columbus, OH; 2Ohio University Heritage College of Osteopathic Medicine, Athens, OH
OBJECTIVES: Neoadjuvant therapy (NT) is increasingly used for many localized gastrointestinal (GI) cancers. However, there is a paucity of data assessing patient experience during NT and its impact on health-related quality of life (HRQOL). Given the limitations of traditional surveys administered at regularly scheduled physician appointments, we customized a smartphone app for prospective real-time assessment of patient experience during NT.
METHODS: Patients with locally GI cancers receiving NT were prospectively enrolled if age>18, English-speaking, owned a smartphone, and were treatment naive. A customized version of the SeamlessMD mobile application was developed with engagement from patient and physician stakeholders. HRQOL, measured using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire, was pushed directly through the smartphone app at baseline, every 30 days, and at completion of NT. Participants were also encouraged to use the mood tracker, symptom tracker, and free-text journaling as often as desired during NT. Mean total overall and sub-section HRQOL scores were calculated at each time point during NT and differences assessed using one way repeated measured ANOVA. Statistical significance was achieved if p<0.05.
RESULTS: Among 104 enrolled patients, mean age was 60.4±11.5 years and 55.2% were male. The most common cancer diagnoses were rectal (38.5%), pancreatic (37.5%), and esophageal (15.4%). After a mean 3.0 months of NT, 71 patients (68.3%) underwent surgical resection whereas 10 (9.6%) had a complete clinical response resulting in active surveillance, and 25 (24.0%) were unable to have surgery because of disease progression, unresectable disease, or poor performance status. Main side effects of NT were nausea, neutropenia, and fatigue (11.5%, 9.6%, 6.7%, respectively). Mean overall FACT-G scores did not significantly change during NT (Figure 1, p=0.73). Functional wellbeing (FWB) scores were consistently the lowest (mean score 15.0) whereas social wellbeing (SWB) scores were the highest (mean score 21.5) at all time points. FACT subscores did not change significantly during NT. The most common symptoms reported during NT were fatigue, trouble sleeping, and anxiety (39.3%, 34.5%, and 28.3% of patient entries, respectively). Qualitative analysis of free-text journaling entries identified anxiety, fear, and frustration as the most common themes, but also the importance of social support systems and confidence in their health care providers.
CONCLUSIONS: While patient symptom burden remains high, results of this prospective cohort study suggest HRQOL is maintained during NT for localized GI cancers. Future research will evaluate whether patient-reported measures are associated with outcomes of NT and/or surgical resection.
HRQOL: Health-Related Quality of Life, NT: Neoadjuvant Therapy, GI: Gastrointestinal, FACT-G: Functional Assessment of Cancer Therapy-General, PWB: Physical Well Being, SWB: Social Well Being, EWB: Emotional Well Being, FWB: Functional Well Being
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