Abstract

Abstract Background At the Penn State Cancer Institute (PSCI), there is currently a lack of patient education materials regarding self-management of cytotoxic chemotherapy related side effects, thus leading to use of disreputable sources (online searches) by cancer patients. A standardized brochure developed by our team aims to educate patients about commonly experienced chemotherapy related side effects. It also provides patients with tools to address these problems themselves, information on when to contact their medical oncologist, and brief guidance on when it is appropriate to visit the Emergency Department. We hypothesize that effective patient education through the brochure will improve patient related outcomes and quality of life. Moreover, empowering patients with such a trustworthy resource will decrease anxiety and distress related to their treatments. If this intervention is found to be impactful, it could be expanded to other cancer types within PSCI and eventually to other institutions across the country. Trial design • Recruitment and Screening: Chemotherapy naïve patients with breast cancer are recruited from our institution, screened, and enrolled on a rolling basis • Baseline Visit: Consent, receive the brochure, and complete the following questionnaires: the Patient Education Material Assessment Tool (PEMAT), Emotional Thermometer Scales (ETS), and Memorial Symptom Assessment Scale (MSAS) • PEMAT is utilized to evaluate if a teaching material is understandable and promotes action, which will help determine if the brochure itself is an effective education tool • ETS is utilized to evaluate the mental health, specifically measuring distress, anxiety, depression, and anger • MSAS is a validated patient rated instrument for evaluation of diverse group of symptoms commonly seen with chemotherapy • Follow Up Visits: Fill out the same 3 surveys again at their 6-week and 12-week visits • Patients will fill out the same questionnaires to assess changes over time, a surrogate for effectiveness of the brochure • Surveys take about 12 minutes to complete on average Eligibility Criteria 1. Adult with Breast cancer >18 years of age 2. Chemotherapy naive, will either start cytotoxic chemotherapy in the next 6 weeks or have started cytotoxic chemotherapy in the past 6 weeks prior to enrollment 3. May receive multiple forms of therapy such as immunotherapy, targeted treatment, endocrine therapy or radiation as long as they receive concurrent cytotoxic chemotherapy 4. Ability to understand and read written English or Spanish without any functional difficulty 5. ECOG performance status 0-3 6. May be involved with other cancer trials being offered at the PSCI Specific Aims • Primary Outcome: Determine if effective patient education through a standardized brochure will improve patient related outcomes and quality of life • Secondary Outcome: Drop-out rate after the baseline visit Statistical methods • Outcome variables from survey-based questionnaires will be measured at all three time points • Their distribution at time points will be summarized using numerical and graphical methods • Paired-sample tests will be used to compare the difference between visits’ data • Linear mixed-effect models for repeated measures will be used to examine the overall pattern by using data from all three time points • All tests will be two-sided with a significance level of 0.05 • We do not plan to do adjustments for multiple testing Present accrual and target accrual: • 24 total accrued, 14 completed • 60 target accrual • Plan to approach 70-75 patients and anticipate a 10-15% dropout rate which was considered in determining accrual goals Contact: • Corresponding Author: Shelby Labe SLabe1@pennstatehealth.psu.edu • PI: Monali Vasekar, MD MVasekar@pennstatehealth.psu.edu Citation Format: Shelby Labe, Monali Vasekar, Daniella Mikhail, Gavin Jones, Joanna Bhasker, Pritika Singh, Rhea Kanwar, Sonia Hafiz, Junjia Zhu, Hannah Dailey. Diminishing Chemotherapy Related Side Effects through Patient Education [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT3-06-01.

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