Implementation and impact of an electronic patient reported outcomes system in a phase II multi-site adaptive platform clinical trial for early-stage breast cancer.

OBJECTIVES: We describe the development and implementation of a system for monitoring patient-reported adverse events and quality of life using electronic Patient Reported Outcome (ePRO) instruments in the I-SPY2 Trial, a phase II clinical trial for locally advanced breast cancer. We describe the administration of technological, workflow, and behavior change interventions and their associated impact on questionnaire completion. MATERIALS AND METHODS: Using the OpenClinica electronic data capture system, we developed rules-based logic to build automated ePRO surveys, customized to the I-SPY2 treatment schedule. We piloted ePROs at the University of California, San Francisco (UCSF) to optimize workflow in the context of trial treatment scenarios and staggered rollout of the ePRO system to 26 sites to ensure effective implementation of the technology. RESULTS: Increasing ePRO completion requires workflow solutions and research staff engagement. Over two years, we increased baseline survey completion from 25% to 80%. The majority of patients completed between 30% and 75% of the questionnaires they received, with no statistically significant variation in survey completion by age, race or ethnicity. Patients who completed the screening timepoint questionnaire were significantly more likely to complete more of the surveys they received at later timepoints (mean completion of 74.1% vs 35.5%, P < .0001). Baseline PROMIS social functioning and grade 2 or more PRO-CTCAE interference of Abdominal Pain, Decreased Appetite, Dizziness and Shortness of Breath was associated with lower survey completion rates. DISCUSSION AND CONCLUSION: By implementing ePROs, we have the potential to increase efficiency and accuracy of patient-reported clinical trial data collection, while improving quality of care, patient safety, and health outcomes. Our method is accessible across demographics and facilitates an ease of data collection and sharing across nationwide sites. We identify predictors of decreased completion that can optimize resource allocation by better targeting efforts such as in-person outreach, staff engagement, a robust technical workflow, and increased monitoring to improve overall completion rates. TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT01042379.

Characterizing attitudes related to future child-bearing in young women diagnosed with early-stage breast cancer.

PURPOSE: This study characterizes attitudes and decision-making around the desire for future children in young women newly diagnosed with early-stage breast cancer and assesses how clinical factors and perceived risk may impact these attitudes. METHODS: This is a prospective study in women < 45 years with newly diagnosed stage 1-3 breast cancer. Patients completed a REDCap survey on fertility and family-building in the setting of hypothetical risk scenarios. Patient, tumor, and treatment characteristics were collected through surveys and medical record. RESULTS: Of 140 study patients [median age = 41.4 (range 23-45)], 71 (50.7%) were interested in having children. Women interested in future childbearing were younger than those who were not interested (mean = 35.2 [SD = 5.2] vs 40.9 years [3.90], respectively, p < 0.001), and more likely to be childless (81% vs 31%, p < 0.001). 54 women (77.1% of patients interested in future children) underwent/planned to undergo oocyte/embryo cryopreservation before chemotherapy. Interest in future childbearing decreased with increasing hypothetical recurrence risk, however 17% of patients wanted to have children despite a 75-100% hypothetical recurrence risk. 24.3% of patients wanted to conceive < 2 years from diagnosis, and 35% of patients with hormone receptor positive tumors were not willing to complete 5 years of hormone therapy. CONCLUSION: Many young women diagnosed with early-stage breast cancer prioritize childbearing. Interest in having a biologic child was not associated with standard prognostic risk factors. Interest decreased with increasing hypothetical recurrence risk, though some patients remained committed to future childbearing despite near certain hypothetical risk. Individual risk assessment should be included in family-planning discussions throughout the continuum of care as it can influence decision-making.

Concordance between patient-reported and physician-documented comorbidities and symptoms among Stage 4 breast cancer patients.

BACKGROUND: Comorbidities and symptoms in metastatic breast cancer patients impact treatment decisions and influence prognosis and quality of life. The objective of this study is to examine the concordance between physician documentation and patient reports of comorbidities and symptoms to understand their comparative effectiveness. METHODS: New patients with metastatic breast cancer completed an electronic intake survey assessing patient health history and symptoms. Physician documentation across 54 comorbidities and 42 symptoms was abstracted from notes for the corresponding clinic visits between November 2016 and March 2020. Concordance between patient reports and medical records for each condition and hazards ratios for each patient versus physician reported comorbidity and symptom were assessed. RESULTS: A total of 168 patients were included in the analysis (age, median = 56 years, range = 29-86 years; 131 white [78.9%]). Twenty-three of 54 comorbidities had a moderate to high level of agreement between patients and physicians (κ ≥ 0.40). Physicians documented higher numbers of comorbidities that can be objectively measured which also had higher concordance (e.g., diabetes [κ = 0.83] and hypertension [κ = 0.79]) while patients reported higher numbers of comorbidities that are more subjective which also had lower concordance (anxiety [κ = 0.30], GERD [κ = 0.36]). One physician-documented and two patient-reported comorbidities were significantly associated with survival (p < 0.05). Only 2 of 42 symptoms had a moderate to high level of agreement between patients and physicians. One physician-documented and nine patient-reported symptoms were significantly associated with decreased survival (p < 0.05). CONCLUSION: Agreement between patients' and physicians' reporting of comorbidities varies substantially, and patient reports can complement physician documentation. Physicians significantly underreported symptoms versus patients; thus, concordance was also low. Multiple patient-reported symptoms were predictive of survival; thus, incorporating them can provide more informative estimates of predicted survival.

Evaluation of the Pathways for Survivors Program to Address Breast Cancer Survivorship-Associated Distress: Survey Study.

BACKGROUND: Patients with breast cancer frequently experience escalation of anxiety after completing curative treatment. OBJECTIVE: This study evaluated the acceptability and psychological impact of a 1-day workshop to emphasize behavioral strategies involving intention and self-efficacy. METHODS: Breast cancer survivors who attended a 1-day Pathways for Survivors workshop provided feedback and completed electronic quality of life (QOL) questionnaires at baseline, 1 and 6 weeks, and 6 months after the workshop. Attendees' baseline QOL scores were compared to follow-up (FUP) scores. Scores from patients receiving routine FUP care were also compiled as a reference population. RESULTS: In total, 77 patients attended 1 of 9 workshops. The mean satisfaction score was 9.7 out of 10 for the workshop and 9.96 out of 10 for the moderator. Participants' baseline mean Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scores were 57.8 (SD 6.9) and 55.3 (SD 7.5), respectively, which were significantly higher than those of patients receiving routine FUP care (49.1, SD 8.3 and 47.3 SD 8.0, respectively). PROMIS anxiety and depression scores decreased, and the Happiness Index Profile (HIP-10) score-measuring intention and resiliency-increased significantly at 1- and 6-week FUPs. CONCLUSIONS: The Pathways for Survivors program was favorably received. Anxiety and depression decreased significantly at 1- and 6-weeks after the workshop and remained below baseline at 6 months. Increased HIP-10 scores suggest that patients acquired and implemented skills from the workshop. A 1-day workshop led by a lay moderator significantly improved several psychological measures, suggesting that it may be a useful and time-efficient strategy to improve QOL in breast cancer survivors. We are investigating whether an abbreviated "booster" of the intervention at a later date could further improve and maintain QOL gains.