Randomized adaptive selection trial of cryotherapy, compression therapy, and placebo to prevent taxane-induced peripheral neuropathy in patients with breast cancer.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating adverse effect of taxane therapy. Small non-randomized studies in patients with early-stage breast cancer (ESBC) suggest both cryotherapy and compression therapy may prevent CIPN. It is unknown which is more effective. METHODS: We conducted a randomized phase IIB adaptive sequential selection trial of cryotherapy vs. compression therapy vs. placebo ("loose" gloves/socks) during taxane chemotherapy. Participants were randomized in triplets. Garments were worn for 90-120 min, beginning 15 min prior and continuing for 15 min following the infusion. The primary goal was to select the best intervention based on a Levin-Robbins-Leu sequential selection procedure. The primary endpoint was a < 5-point decrease in the Functional Assessment of Cancer Therapy Neurotoxicity (FACT-NTX) at 12 weeks. An arm was eliminated if it had four or more fewer successes than the currently leading arm. Secondary endpoints included intervention adherence and patient-reported comfort/satisfaction. RESULTS: Between April 2019 and April 2021, 63 patients were randomized (cryotherapy (20); compression (22); placebo (21)). Most patients (60.3%) were treated with docetaxel. The stopping criterion was met after the 17th triplet (n = 51) was evaluated; success at 12 weeks occurred in 11 (64.7%) on compression therapy, 7 (41.1%) on cryotherapy, and 7 (41.1%) on placebo. Adherence to the intervention was lowest with cryotherapy (35.0%) compared to compression (72.7%) and placebo (76.2%). CONCLUSION: Compression therapy was the most effective intervention in this phase IIB selection trial to prevent CIPN and was well tolerated. Compression therapy for the prevention of CIPN should be evaluated in a phase III study. CLINICAL TRIAL REGISTRATION: ClinicaTrials.gov Identifier: NCT03873272.

Use of a Smartphone Application to Promote Adherence to Oral Medications in Patients With Breast Cancer.

PURPOSE: Medication nonadherence is common among patients with breast cancer (BC) and increases BC mortality and complications from comorbidities. There is growing interest in mobile health interventions such as smartphone applications (apps) to promote adherence. METHODS: Use of Medisafe, a medication reminder and tracking app, was tested over 12 weeks among patients on BC treatment and at least one oral medication. Study participants were instructed to generate adherence reports every 4 weeks through Medisafe and were deemed to have completed the intervention if >50% of reports were generated. The primary end point was feasibility of the intervention, defined as a completion rate of ≥75% of consented patients. Secondary end points included changes in self-reported nonadherence from baseline to 12 weeks and patient-reported outcomes including reasons for nonadherence and satisfaction with Medisafe. We conducted univariable and multivariable analyses to evaluate demographic and clinical factors associated with intervention completion. RESULTS: Among 100 patients enrolled, 78 (78.0%) completed the intervention. Age, race, ethnicity, clinical stage, and type of medication were not associated with odds of intervention completion. Self-reported nonadherence rates did not improve from baseline to postintervention in the overall study population. However, among patients with self-reported nonadherence at baseline, 26.3% reported adherence postintervention; these patients frequently reported logistical barriers to adherence. Study participants reported high levels of satisfaction with Medisafe, noting that the app was highly functional and provided high-quality information. CONCLUSION: Smartphone apps such as Medisafe are feasible and associated with high patient satisfaction. They may improve adherence in nonadherent patients and those who face logistical challenges interfering with medication-taking. Future trials of mobile health interventions should target patients at high risk for medication nonadherence.

A Brief Screening Tool for Assessment of Financial Toxicity.

OBJECTIVES: To explore the utility of brief financial screening items to facilitate the implementation of routine financial toxicity screening. SAMPLE & SETTING: 50 women with breast cancer completed a one-time survey that included the Comprehensive Score for Financial Toxicity (COST): A FACIT Measure of Financial Toxicity, a visual analog scale, and a brief sociodemographic questionnaire. METHODS & VARIABLES: Survey responses were examined to assess the psychometric properties of individual COST items and the visual analog scale by calculating Cronbach's alpha and Pearson's correlation coefficients. RESULTS: The mean COST was 21.4, and 27 respondents met criteria for financial toxicity (a COST lower than 22). As expected, all items correlated strongly to the overall COST, but four items (items 3, 6, 8, and 10) performed strongest (r > 0.8). IMPLICATIONS FOR NURSING: This study provides evidence for individual COST items to be used as brief screening items. Future research should test the utility of these items in larger sample sizes with a more diverse representation of patients by age, race, ethnicity, and tumor type and stage.

Implementation of Systematic Financial Screening in an Outpatient Breast Oncology Setting.

PURPOSE: Implementation of routine financial screening is a critical step toward mitigating financial toxicity. We evaluated the feasibility, sustainability, and acceptability of systematic financial screening in the outpatient breast oncology clinic at a large, urban cancer center. METHODS: We developed and implemented a stakeholder-informed process to systematically screen for financial hardship and worry. A 2-item assessment in English or Spanish was administered to patients through the electronic medical record portal or using paper forms. We evaluated completion rates and mode of completion. Through feedback from patients, clinicians, and staff, we identified strategies to improve completion rates and acceptability. RESULTS: From March, 2021, to February, 2022, 3,500 patients were seen in the breast oncology clinic. Of them, 39% (n = 1,349) responded to the screening items, either by paper or portal, 12% (n = 437) preferred not to answer, and the remaining 49% (n = 1,714) did not have data in their electronic health record, meaning they were not offered screening or did not complete the paper forms. Young adults (18-39 years) were more likely to respond compared with patients 70 years or older (61% v 30%, P < .01). English-preferring patients were more likely to complete the screening compared with those who preferred Spanish (46% v 28%, P < .01). Non-Hispanic White patients were more likely to respond compared with Non-Hispanic Black patients and with Hispanic patients (46% v 39% v 32%, P < .01). Strategies to improve completion rates included partnering with staff to facilitate paper form administration, optimizing patient engagement with the portal, and clearly communicating the purpose of the screening. CONCLUSION: Systematic financial screening is feasible, and electronic data capture facilitates successful implementation. However, inclusive procedures that address language and technology preferences are needed to optimize screening.

Identifying patient decisions and related information needs during decision making related to total knee arthroplasty.

Aim: Research regarding decisions patients make about total knee arthroplasty, apart from having the procedure or not, are limited. Understanding patient decision making and related information needs is essential for shared decision making. Methods: Focus groups with an online community-based sample identified decisions about total knee arthroplasty beyond the decision to have the surgery itself. An online survey was used to determine relative importance of five major decisions and evaluate related information available. Results: Patients did not feel they have enough information to make important decisions of surgeon, device type, surgical approach, facility, or timing, for their total knee arthroplasty. Conclusion: Although further research is needed to generalize these findings, physicians should consider these questions during shared decision making with patients considering total knee arthroplasty.