BACKGROUND: Patients undergoing autologous stem cell transplantation (ASCT) for multiple myeloma (MM) face sudden exacerbations of anxiety, insomnia, and other symptoms within the initial weeks following ASCT. Even as these symptoms abate in subsequent months, long-term consequences include post-traumatic stress disorder (Griffith 2020), quality of life (QOL) impairments (El-Jawahri 2016), and chronic reliance on higher-risk medications such as benzodiazepines (Banerjee 2020). These findings are particularly relevant to MM patients given their older age at diagnosis, longer expected post-ASCT survival, and poorer QOL at baseline compared with other cancer patients (Kent 2015). Compared to other integrative interventions in the peri-ASCT setting, life coaching transcends a symptomatic focus while directly addressing the root determinants of impaired QOL. Life coaches work with patients using structured frameworks (Figure 1A) to provide longitudinal support, education, and accountability to meet patient-identified wellness goals. Digital life coaching (DLC) combines the strengths of life coaching with the capabilities of digital health by channeling patient-coach communication through patients' personal phones. Compared to in-person coaching, DLC is location-agnostic and allows patients to work their coaches more conveniently and frequently. DLC is feasible among ASCT survivors (Chen 2016) but has not yet been studied in the active peri-ASCT setting. We are conducting a pilot study of a 16-week DLC subscription to assess its feasibility and effects on QOL during an intensive period spanning from pre-ASCT hospitalization through Day +100 after ASCT. If successful, we plan to then pursue a randomized Phase II study comparing DLC versus usual care in the peri-ASCT setting. METHODS: Our study is registered at clinicaltrials.gov as NCT04432818. We plan to enroll 27 adult patients with MM undergoing first ASCT at our institution. Inclusion criteria include English language proficiency and ownership of a personal cellphone. Notably, neither ownership of a smartphone nor installation of a specific mobile app is required for patient enrollment. Enrolled patients will receive unlimited access to a certified life coach beginning at Day -5 before ASCT; bidirectional communication is encouraged via phone, text, or email. The life coaches will reach out at least once per week to help patients accomplish self-identified goals such as symptom management, stress reduction, and physical activity. Our study's primary endpoint is ongoing patient engagement, defined as least one patient-initiated outreach to their coach during each of four 4-week study subperiods. Our study's secondary endpoints include patient-reported outcome (PRO) assessments of QOL, distress, and sleep disturbances (to be collected using electronic surveys every 1-2 weeks as shown in Figure 1B). Exploratory endpoints include benzodiazepine usage and rates of electronic/phone communication with patients' treatment teams. We will analyze endpoints using descriptive methods, including stratification of secondary & exploratory endpoints by DLC usage and specific 4-week study subperiod. PROGRESS TO DATE: Of 18 approached patients as of the data cutoff (8/1/20), 15 (83%) have expressed interest. Reasons for non-enrollment include skepticism about the value of interactions with coaches who do not themselves have MM. Of the 15 patients who have expressed interest in the study, the median age is 65 (range: 50-81) and all but one patient report owning a personal smartphone. All 6 patients with finalized ASCT hospitalization dates have been enrolled and paired with life coaches. Adherence to weekly electronic PRO assessments has been 100% (n = 9 timepoints) to date, consistent with previous studies (Wood 2013). CONCLUSIONS: Our pilot study is ongoing. Our findings to date suggest that certain MM patients are phone-savvy and would be interested in digital health tools, which will continue to gain prominence in light of the ongoing COVID-19 pandemic. Strengths of DLC include its scalability across institutional lines and its ability to reach patients at home in an integrative manner. Results of this study will inform innovative approaches to support the wellbeing of patients with hematologic malignancies, both in the peri-transplantation setting and beyond. Disclosures Brassil: Pack Health: Current Employment. Patel:Pack Health: Current Employment. Jackson:Pack Health: Current Employment. Wong:Janssen: Research Funding; Roche: Research Funding; Amgen: Consultancy; Sanofi: Membership on an entity's Board of Directors or advisory committees; GSK: Research Funding; Bristol Myers Squibb: Research Funding; Fortis: Research Funding. Wolf:Adaptive: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Martin:Seattle Genetics: Research Funding; AMGEN: Research Funding; GSK: Consultancy; Sanofi: Research Funding; Janssen: Research Funding. Shah:BMS, Janssen, Bluebird Bio, Sutro Biopharma, Teneobio, Poseida, Nektar: Research Funding; GSK, Amgen, Indapta Therapeutics, Sanofi, BMS, CareDx, Kite, Karyopharm: Consultancy.
Background For patients with multiple myeloma receiving high-dose chemotherapy followed by autologous stem cell transplantation (SCT), acute life disruptions and symptom burden may lead to worsened quality of life (QOL) and increased emotional distress. Digital life coaching (DLC), whereby trained coaches deliver personalized well-being–related support via phone calls and SMS text messaging, has been shown to improve QOL among SCT survivors. However, DLC has not been investigated during the acute peri-SCT period, which is generally characterized by symptomatic exacerbations and 2-week hospitalizations. Objective We launched a single-arm pilot study to investigate the feasibility of patient engagement with DLC during this intensive period. Methods We approached English-speaking adult patients with multiple myeloma undergoing autologous SCT at our center. Enrolled patients received 16 weeks of virtual access to a life coach beginning on day −5 before SCT. Coaches used structured frameworks to help patients identify and overcome personal barriers to well-being. Patients chose the coaching topics and preferred communication styles. Our primary endpoint was ongoing DLC engagement, defined as bidirectional conversations occurring at least once every 4 weeks during the study period. Secondary endpoints were electronic patient-reported outcome assessments of QOL, distress, and sleep disturbances. Results Of the 20 patients who were screened, 17 (85%) chose to enroll and 15 (75%) underwent SCT as planned. Of these 15 patients (median age 65 years, range 50-81 years), 11 (73%) demonstrated ongoing DLC engagement. The median frequency of bidirectional conversations during the 3-month study period was once every 6.2 days (range 3.9-28 days). During index hospitalizations with median lengths of stay of 16 days (range 14-31 days), the median frequency of conversations was once every 5.3 days (range 2.7-15 days). Electronic patient-reported outcome assessments (94% adherence) demonstrated an expected QOL nadir during the second week after SCT. The prevalence of elevated distress was highest immediately before and after SCT, with 69% of patients exhibiting elevated distress on day −5 and on day +2. Conclusions DLC may be feasible for older patients during intensive hospital-based cancer treatments such as autologous SCT for multiple myeloma. The limitations of our study include small sample size, selection bias among enrolled patients, and heterogeneity in DLC use. Based on the positive results of this pilot study, a larger phase 2 randomized study of DLC during SCT is underway to investigate the efficacy of DLC with regard to patient well-being. Trial Registration ClinicalTrials.gov NCT04432818; https://clinicaltrials.gov/ct2/show/NCT04432818.
Multiple myeloma patients undergoing autologous stem cell transplantation (ASCT) may receive benzodiazepine or zolpidem-class (B/Z) medications despite their risks in older patients. Of 205 myeloma patients (36% aged 65+
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