Improving palbociclib adherence among women with metastatic breast cancer using a CONnected CUstomized Treatment Platform: A pilot study.

OBJECTIVE: To pilot test a mobile health intervention using a CONnected CUstomized Treatment Platform that integrates a connected electronic adherence monitoring smartbox and an early warning system of non-adherence with bidirectional automated texting feature and provider alerts. METHODS: In total, 29 adult women with hormone-receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer and a prescription for palbociclib were asked to complete a survey and participate in a CONnected CUstomized Treatment Platform intervention, including use of a smartbox for real-time adherence monitoring, which triggered text message reminders for any missed or extra dose, and referrals to (a) participant's oncology provider after three missed doses or an episode of over-adherence, or (b) a financial navigation program for any cost-related missed dose. Use of smartbox, number of referrals, palbociclib adherence, CONnected CUstomized Treatment Platform usability measured by System Usability Scale, and changes in symptom burden and quality of life were assessed. RESULTS: Mean age was 57.6 and 69% were white. The smartbox was used by 72.4% of participants, with palbociclib adherence rate of 95.8%±7.6%. One participant was referred to oncology provider due to missed doses and one was referred to financial navigation. At baseline, 33.3% reported at least one adherence barrier including inconvenience to get prescription filled, forgetfulness, cost, and side effects. There were no changes in self-reported adherence, symptom burden or quality of life over 3 months. CONnected CUstomized Treatment Platform usability score was 61.9 ± 14.2. CONCLUSION: The CONnected CUstomized Treatment Platform interventions is feasible, resulting in a high palbociclib adherence rate without any decline in overtime. Future efforts should focus on improving usability.

Treatment out-of-pocket cost communication and remote financial navigation in patients with cancer: a feasibility study.

OBJECTIVE: We conducted a pilot study assessing the feasibility of a personalized out-of-pocket cost communication, remote financial navigation, and counseling (CostCOM) intervention in cancer patients. METHODS: Twenty-three adult, newly diagnosed cancer patients at a single community oncology practice were asked to complete a survey and participate in a CostCOM intervention, including patient-specific out-of-pocket cost communication, remote financial navigation, and counseling. Feasibility was defined as patient participation in CostCOM, and its impact on financial worry measured using the Comprehensive Score for Financial Toxicity (COST) (higher score = less worry) was assessed. Eight patients' and two providers' experience with CostCOM was evaluated using qualitative interviews. RESULTS: Mean patient age was 61 (78.3% female; 100% white). Of 23 CostCOM patients, 86.9% completed CostCOM, 60% of them completed a financial assistance application, and 25% of those who applied were enrolled in a co-pay assistance program. Patients' financial worry significantly improved following CostCOM (COST score of 10.0 ± 9.6 at enrollment vs. 16.9 ± 8.1 at follow-up; p < 0.001). Mean general satisfaction (out of 5) with CostCOM was 4.1 ± 0.7. In qualitative interviews following OOPC communication, 75% felt a positive impact on their mental health, and all patients reported no change in their treatment plan; 83.3% found financial navigation beneficial. In providers' interviews, buy-in from relevant stakeholders, integration of the CostCOM with existing workflow, and larger studies to assess the effectiveness of CostCOM were identified as factors needed for CostCOM implementation in practice. CONCLUSION: CostCOM interventions are feasible and acceptable and decrease financial worry in patients with cancer.

Patient-Specific Out-of-Pocket Cost Communication and Remote Financial Navigation in Patients with Multiple Sclerosis: A Randomized Controlled Feasibility Study.

OBJECTIVE: We conducted a randomized controlled trial evaluating the feasibility of a personalized out-of-pocket cost communication, remote financial navigation and counseling (CostCOM) intervention in decreasing financial hardship among patients with multiple sclerosis (MS). METHODS: Sixty-two adult patients with diagnosis of MS and a prescription for a disease modifying therapy were randomized into: (1) Usual care (n=30) and (2) CostCOM (n=32). CostCOM included patient-specific out-of-pocket cost communication, remote financial navigation and counseling delivered at enrollment and 3 months. Usual care included routine neurology visits, use of available ancillary staff, and internal or external resources for financial assistance per normal clinic procedures. Feasibility outcomes included participation in and satisfaction with CostCOM. Exploratory financial hardship outcomes included cost-related care nonadherence, material hardship, and financial worry using Comprehensive Score for Financial Toxicity (COST). RESULTS: Mean age was 41.5 (81.0% female; 41.4% White and 51.7% Black race). Of 32 CostCOM patients, 96.8% and 68.7% completed baseline and follow-up intervention. A financial assistance application was completed for 80%. Mean general satisfaction (out of 5) with CostCOM was 3.1±1.0. In multivariable analyses, CostCOM patients had less financial worry (i.e., higher COST scores) at 3 months compared to usual care patients (B coefficient, 3.6; 95% CI (0.1 - 7.1). While CostCOM patients had significant decreases in 3 months non-adherence (72.7%) compared to enrollment (50%), their 3 months nonadherence and material hardship were not significantly different between the two arms. CONCLUSION: CostCOM interventions are feasible, acceptable, and yield potential benefits in decreasing financial hardship. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov (NCT04257071).