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1.
Blood ; 138:4023, 2021.
Article in English | EMBASE | ID: covidwho-1582390

ABSTRACT

BACKGROUND: Autologous stem cell transplantation (ASCT) for multiple myeloma (MM) entails sudden life changes including acute symptom burden, changes in physical function, and shifting caregiver dynamics. Several studies have shown that anxiety, insomnia, and distress rise in the initial weeks following ASCT before slowly recovering. Long-term consequences of these acute exacerbations include persistent quality of life (QOL) impairments (El-Jawahri 2016), post-traumatic stress disorder (Griffith 2020), and the usage of potentially inappropriate medications (PIMs) for symptom management (Banerjee 2021). We have recently completed a pilot study of digital life coaching (DLC), whereby life coaches work with patients via phone calls and text messages to provide longitudinal support, education, and accountability to meet wellbeing-related goals. Our pilot study of 15 patients demonstrated the feasibility of DLC during this period, with bidirectional patient-coach engagement occurring every 5-7 days even during index hospitalizations for ASCT (Banerjee 2021). Based on these positive results, we have now launched a randomized Phase 2 study of DLC versus usual care among patients with MM undergoing ASCT. STUDY DESIGN: Our study is registered at clinicaltrials.gov as NCT04589286. We plan to enroll 60 adult patients with MM undergoing first ASCT at our institution. Inclusion criteria include English language proficiency and ownership of a personal cellphone. However, neither smartphones nor specific mobile apps are required for study participation. All patients, including those in the control arm, receive brief wellness-related tips with each request for PRO data as outlined below. As shown in the Figure, patients in the DLC arm are paired with a trained life coach beginning at Day -10 before ASCT. Coaches use structured frameworks to assist patients longitudinally with identifying and accomplishing wellbeing-related goals. Specific coaching topics can vary from week to week and are set by each patient. In addition to weekly coach-led phone calls, patients are encouraged to maintain bidirectional communication via phone/text/email as often as desired. Patients in the control arm do not receive access to DLC. Our primary endpoint is the total usage of sedative-class PIMs - including lorazepam, temazepam, zolpidem, and other similar medications - prescribed for anxiety or insomnia during each of 4 four-week study subperiods identified in the Figure. Secondary endpoints include patient-reported outcome (PRO) assessments of QOL (PROMIS Global Health), distress (NCCN Distress Thermometer), and insomnia (PROMIS Sleep Disturbances 4A). PRO assessments are collected exclusively using automated REDCap emails every 1-2 weeks as shown in the Figure. PROGRESS TO DATE: As of the data cutoff (7/31/21), 19 patients have enrolled onto our study and 5 have completed all follow-up. The median age of enrolled patients is 62 (range: 31-77), with 26% of patients aged 70 or older. As shown in our pilot study (Banerjee 2021), PRO collection via automated REDCap emails is feasible. Specifically, of 93 email-based requests for PRO assessments as of the data cutoff, 92 (99%) have been completed. Analyses of PRO assessment responses and PIM usage will be conducted after study completion. DISCUSSION: Improving patient wellbeing during the acute peri-ASCT period is an unmet need in multiple myeloma. Published supportive strategies during this time include music therapy (Bates 2017), acupuncture (Deng 2018), palliative care (El-Jawahri 2017), and programmed hospital room lighting (Valdimarsdottir 2018). DLC may offer unique advantages given its easy accessibility and unified patient-facing interface across hospital/clinic/home transitions. These strengths may be particularly relevant in light of the COVID-19 pandemic, where home-based follow-up after ASCT has become more common. That being said, broadening the accessibility of DLC to include patients with limited English proficiency or patients without personal cell phones are important priorities for fu ure studies. In summary, our randomized Phase 2 study of DLC versus usual care is ongoing. If shown to reduce PIM prescription rates while improving wellbeing-related PRO trajectories longitudinally, DLC may become a standard of care for patients with hematologic malignancies undergoing ASCT. [Formula presented] Disclosures: Banerjee: Pack Health: Research Funding;SparkCures: Consultancy;Sanofi: Consultancy. Knoche: Amgen: Honoraria. Brassil: Abbvie: Research Funding;Astellas: Research Funding;BMS: Research Funding;Daiichi Sankyo: Research Funding;Genentech: Research Funding;GSK: Research Funding;Sanofi: Research Funding;Pack Health: Current Employment. Jackson: Pack Health: Current Employment. Patel: Pack Health: Current Employment. Lo: Oncopeptides: Consultancy;EUSA Pharma: Consultancy. Chung: Caelum: Research Funding. Wong: Amgen: Consultancy;Genentech: Research Funding;Fortis: Research Funding;Janssen: Research Funding;GloxoSmithKlein: Research Funding;Dren Biosciences: Consultancy;Caelum: Research Funding;BMS: Research Funding;Sanofi: Membership on an entity's Board of Directors or advisory committees. Wolf: Adaptive Biotechnologies: Consultancy;Teneobio: Consultancy;Sanofi: Consultancy;Amgen: Consultancy. Martin: Oncopeptides: Consultancy;Sanofi: Research Funding;Amgen: Research Funding;Janssen: Research Funding;GlaxoSmithKline: Consultancy. Shah: Bluebird Bio: Research Funding;GSK: Consultancy;Janssen: Research Funding;Indapta Therapeutics: Consultancy;BMS/Celgene: Research Funding;CareDx: Consultancy;CSL Behring: Consultancy;Kite: Consultancy;Nektar: Research Funding;Karyopharm: Consultancy;Amgen: Consultancy;Oncopeptides: Consultancy;Poseida: Research Funding;Precision Biosciences: Research Funding;Sanofi: Consultancy;Sutro Biopharma: Research Funding;Teneobio: Research Funding.

2.
Blood ; 138:4051, 2021.
Article in English | EMBASE | ID: covidwho-1582228

ABSTRACT

Background: Tyrosine kinase inhibitors (TKIs) enable patients with chronic phase chronic myeloid leukemia (CP-CML) to achieve similar overall survival to the general population, but can cause side effects that negatively impact quality of life (QOL) and contribute to distress. Since most CP-CML patients remain on TKIs indefinitely, there is a need to develop targeted interventions to address their physical and psychosocial complications. Mindfulness meditation interventions have improved QOL and decreased distress, depression, anxiety, fatigue, and pain in patients with solid tumors;however, such interventions have not previously been evaluated in patients with CP-CML. In Being Present-CML, we sought to determine if a mindfulness meditation-based program is feasible and acceptable to patients with CP-CML, and to explore its preliminary efficacy. Methods: Being Present-CML is a prospective, single-arm clinical trial of an 8-week, online mindfulness meditation-based intervention effective in patients with gastrointestinal cancers (Atreya, et al. PLoS One, 2018). Participants were recruited from a single academic institution. Eligibility included adult patients with CP-CML taking TKIs. Participants were instructed to independently play audio-guided meditations at least 5 times per week on a secure website and to participate in once weekly, instructor-led meditation classes on Zoom in assigned cohorts. Qigong was incorporated into the classes to target fatigue, a common TKI side effect. Class content was recorded and uploaded to the website for those unable to attend live. Feasibility was assessed through measurement of recruitment and attrition. Adherence was determined by web capture. Acceptability was determined by feedback from study surveys and qualitative interviews. Preliminary efficacy was evaluated using patient-reported outcome measures (PROMs) at baseline (week 0) and post-intervention (week 8) using the NCCN Distress Thermometer (DT) and Patient-Reported Outcomes Measurement Information System (PROMIS) short forms for anxiety, depression, fatigue, pain interference, and sleep disturbance. A DT score ≥4 is consistent with moderate to severe distress. PROMIS scores use T-scores where the mean score for the general population is 50 (standard deviation [SD] +/-10);higher scores indicate worse symptoms. Descriptive statistics and two-tailed paired t-tests (p <0.05) were used to summarize the data. Results: Between October 2020-April 2021, 98 eligible participants were approached to participate in the study;88 (89.8%) patients agreed to learn more, and 37 (37.8%) patients provided consent. The median age was 51 (range 23-72), 51.5% (n=19/37) were male, and 89.1% (n=33/37) were non-Hispanic White. At time of study start, 83.7% (n=31/37) had a BCR-ABL1 PCR transcript ≤1% and a median time since diagnosis of 71 months (range 2-234) (Table 1). Of 37 participants, 29 (78.4%) completed end of study procedures;4 (10.8%) dropped out, and 4 (10.8%) did not complete week 8 surveys. The median number of audio meditations listened to per participant was 34 with an average of 4.3 per week. The median number of weekly classes attended and/or recordings viewed per participant was 7 (range 1-8). At baseline, participants had a median DT score of 5 (range 2-8). Average baseline PROMIS scores were slightly worse than the general population in depression (51.4, SD 8.8), anxiety (55.9, SD 7.8), sleep disturbance (51.8, SD 6.9), fatigue (53.9, SD 10.6), and pain interference (52.2, SD 9.9). By week 8, the median DT score improved to 3 (p=0.003) (Figure 1). Post-study PROMIS scores improved in sleep disturbance (p=0.001) and depression (p=0.01) (Figure 2), but not anxiety (p=0.12), fatigue (p=0.10), or pain interference (p=0.98). Of those who conducted post-study interviews, 77% (n=20/26) reported their symptoms during the study were not influenced by the COVID-19 pandemic. Nearly all participants found the study helpful (Figure 3) and would recommend it to others (median score of 8 on a 1-10 scale;10=extremely likely). Concl sions: Patients with CP-CML taking TKIs found the mindfulness meditation-based intervention to be feasible and acceptable. PROM results suggest promise of clinical benefit in this patient population, including patients with well-controlled disease and a long history of CML. A randomized controlled trial is being planned to validate these findings. [Formula presented] Disclosures: Smith: Astellas Pharma: Consultancy, Research Funding;FUJIFILM: Research Funding;Daiichi Sankyo: Consultancy;Revolutions Medicine: Research Funding;AbbVie: Research Funding;Amgen: Honoraria. Shah: Bristol-Myers Squibb: Research Funding. Atreya: Guardant Health: Research Funding;Pionyr Immunotherapeutics: Membership on an entity's Board of Directors or advisory committees;Array Biopharma: Membership on an entity's Board of Directors or advisory committees;Merck: Research Funding;Bristol-Meyers Squibb: Research Funding;Gossamer Bio: Research Funding;Novartis: Research Funding.

3.
Blood ; 136:2-3, 2020.
Article in English | EMBASE | ID: covidwho-1348286

ABSTRACT

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 it 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. [Formula presented] 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.

4.
Journal of Clinical Oncology ; 39(15 SUPPL), 2021.
Article in English | EMBASE | ID: covidwho-1339304

ABSTRACT

Background: Patients with multiple myeloma (MM) experience acute quality of life (QOL) exacerbations following autologous stem cell transplantation (ASCT) that can lead to long-term complications. Life coaching can improve QOL in a structured & personalized manner. We investigated the feasibility of a digital life coaching (DLC) platform, where coaching is accomplished through phone calls and text messages, for patients with MM during ASCT. Methods: Our pilot study (clinicaltrials.gov ID: NCT04432818) enrolled adult patients with MM, English proficiency, and cellphone ownership (smartphone not required). The 16-week DLC program, beginning at Day -5 before ASCT, included unlimited digital access to a certified life coach to help with identifying and accomplishing wellness-related goals. Our primary outcome was ongoing DLC engagement (≥ 1 bidirectional conversation every 4 weeks). Secondary outcomes were ePRO assessments of QOL (PROMIS Global Health), insomnia (PROMIS Sleep Disturbances), and distress (NCCN DT). Electronic patient-reported outcome (ePRO) assessments were delivered via automated REDCap emails every 1-2 weeks. Results: Of 18 screened patients, 15 (83%) enrolled in our study;2 patients dropped out before initiating DLC (including 1 who was unable to connect with her coach between Day -5 and 0). Of 13 remaining patients, median age was 65 (range 50-81) and 23% had an ECOG performance status of 1 (remainder 0). DLC conversations occurred a mean of every 7.6 days (range 3-28) overall and every 6.5 days (range 2.8-14) during the initial 28- day period including high-dose melphalan and hospitalization. 80% of patients maintained ≥ 1 conversation every 4 weeks. Selected ePRO results (mean ± standard error) are shown in the table. Conclusions: Certain MM patients are able to engage digitally with a life coach and complete email-based ePRO assessments during and after ASCT. Limitations of our study include selection bias and the Day -5 start date, which may be too late logistically and symptom-wise (given our ePRO findings suggestive of peak distress pre- ASCT). DLC may play an innovative and scalable role given the emphasis on remotely delivered care during the COVID-19 pandemic. A Phase II randomized study of DLC versus usual care is under way (clinicaltrials.gov ID:.

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