Prospective assessment of a smartphone-app based mindfulness program for patients with metastatic renal cell carcinoma (mRCC).
Authors: Bergerot Cristiane Decat , Malhotra Jasnoor , Bergerot Paulo Gustavo , Philip Errol James , Govindarajan Ameish , Salgia Sabrina , Hsu Joann , Matos Neto Joao Nunes , Molina Lorena Nascimento Manrique , Vasconcellos Vitor Fiorin de , Muddasani Ramya , Chawla Neal Shiv , Castro Daniela V. , Chehrazi-Raffle Alex , Saab Bechara , Carlson Linda E , Pal Sumanta K. 
Published: February 2022

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Background: mRCC is associated with high rates of distress, high levels of symptom burden, and broad impairments in quality of life. In the setting of localized breast cancer, a smartphone application directed at enhancing mindfulness has been developed from a Mindfulness-Based Cancer Recovery program demonstrated to mitigate these factors (Utkarsh et al. Digital Health 2021); we sought to determine if the benefit of a similar application could be translated to patients with mRCC. Methods: Patients were recruited across two sites in the US and Brazil, and were eligible for the study if they had been diagnosed with mRCC, were receiving immunotherapy, reported clinically-relevant anxiety, had a smart phone with internet access, were currently not engaging in meditation, and had not participated in a mindfulness program in the past 5 years. Patients were asked to participate in mindfulness app-based activities for 20-30 minutes each day guided by the Mindfulness-Based Cancer Survivorship Journey program within AM Mindfulness smartphone app (AmDTx™), for a minimum of 4 days per week, over a period of 4 weeks. The application leads the patient through exercises in guided meditation and suggestions for cancer/cancer symptom coping. Patients were assessed at baseline and 2-weeks after using the 4-week smartphone-app based intervention using the Fear of Cancer Recurrence-7 and Functional Assessment of Chronic Illness Therapy-General scales. Reported data is evaluated using paired t-tests with a p-value of < 0.05 considered significant. Results: A total of 23 patients have been recruited to date. Median age was 59 years old; most were male (52%), white/Caucasian (52%), married (69%) and college educated (82%), and primarily receiving treatment with nivolumab (34%) or nivolumab/ipilimumab (30%). The majority of patients (78%) expressed satisfaction and engaged with the intervention; however, a minority (13%) noted that the intervention reminded them of their cancer diagnosis, which was seen as a negative aspect. Preliminary analyses of data after two weeks of the intervention have demonstrated a statistically significant decreases in fear of cancer progression (mean differences: baseline = 22; week 2 = 18, p = 0.012) and increases in quality of life (mean differences: baseline = 77; week 2 = 85, p = 0.001) over time. Physical and emotional well-being also showed significant improvement over time. Complete data with 12 weeks of follow-up will be presented at the meeting. Conclusions: This is the first study to implement an evidence-based, smartphone-accessible psychosocial support tool among mRCC patients. After only two weeks, we noted significant improvements in the fear of cancer progression and quality of life. This preliminary data suggests that this type of low-cost, mobile-app based intervention was acceptable to patients and may be effective at addressing psychosocial distress