Meditation Mobile App Developed for Patients With and Survivors of Cancer: Feasibility Randomized Controlled Trial.

BACKGROUND: To address the unmet need for a commercial cancer-specific meditation app, we leveraged a long-standing partnership with a consumer-based app (ie, Calm) to develop the first commercial meditation app prototype adapted specifically for the needs of patients with cancer. Input was obtained at both the individual user and clinic levels (ie, patients with and survivors of cancer and health care providers). OBJECTIVE: This study aimed to determine the feasibility of a cancer-specific meditation app prototype. METHODS: Patients with and survivors of cancer who were recruited and enrolled in the feasibility randomized controlled trial were asked to use the prototype app daily (≥70 minutes per week) for 4 weeks. Participants completed web-based weekly questionnaires and a final poststudy questionnaire and were asked to participate in an optional web-based poststudy interview. The questionnaires and interviews covered the following feasibility categories: acceptability, demand, practicality, and adaptation. RESULTS: A total of 36 patients with and survivors of cancer completed the baseline questionnaire, 18 completed the final questionnaire, and 6 completed the optional interviews. Weekly and poststudy questionnaires indicated high overall enjoyment, ease of use, and satisfaction with the app content, aesthetics, and graphics. The objective use data indicated that the average total app use rate was 73.39 (SD 7.12) minutes per week. Interviews (N=6) revealed positive and mixed responses to the app prototype and informative differences related to preferences for narrators, emotional content, and meditation teaching but an overall appreciation for the variety of options. CONCLUSIONS: The most likely candidates for moving from cancer-specific meditation apps to dissemination are through partnering with the industry, in which name recognition and market distribution are already established (even showing a base of users from the targeted population with cancer). This study established the feasibility of a cancer-specific mobile meditation app prototype for patients with and survivors of cancer, using a commercially available app. The quantitative and qualitative data demonstrated the acceptability, demand, practicality, and adaptation of the prototype. Improvements suggested by the participants will be considered in the final app design before testing the efficacy of the app in a future study. TRIAL REGISTRATION: Clinicaltrials.gov NCT05459168; https://clinicaltrials.gov/ct2/show/record/NCT05459168.

Insomnia as an Unmet Need in Patients With Chronic Hematological Cancer: Protocol for a Randomized Controlled Trial Evaluating a Consumer-Based Meditation App for Treatment of Sleep Disturbance.

BACKGROUND: To address the need for long-term, accessible, nonpharmacologic interventions targeting sleep in patients with chronic hematological cancer, we propose the first randomized controlled trial to determine the effects of a consumer-based mobile meditation app, Calm, on sleep disturbance in this population. OBJECTIVE: This study aims to test the efficacy of daily meditation delivered via Calm compared with a health education podcast control group in improving the primary outcome of self-reported sleep disturbance, as well as secondary sleep outcomes, including sleep impairment and sleep efficiency; test the efficacy of daily meditation delivered via Calm compared with a health education podcast control group on inflammatory markers, fatigue, and emotional distress; and explore free-living use during a 12-week follow-up period and the sustained effects of Calm in patients with chronic hematological cancer. METHODS: In a double-blinded randomized controlled trial, we will recruit 276 patients with chronic hematological cancer to an 8-week app-based wellness intervention-the active, daily, app-based meditation intervention or the health education podcast app control group, followed by a 12-week follow-up period. Participants will be asked to use their assigned app for at least 10 minutes per day during the 8-week intervention period; complete web-based surveys assessing self-reported sleep disturbance, fatigue, and emotional distress at baseline, 8 weeks, and 20 weeks; complete sleep diaries and wear an actigraphy device during the 8-week intervention period and at 20 weeks; and complete blood draws to assess inflammatory markers (tumor necrosis factor-α, interleukin-6, interleukin-8, and C-reactive protein) at baseline, 8 weeks, and 20 weeks. RESULTS: This project was funded by the National Institutes of Health National Cancer Institute (R01CA262041). The projects began in April 2022, and study recruitment is scheduled to begin in October 2022, with a total project duration of 5 years. We anticipate that we will be able to achieve our enrollment goal of 276 patients with chronic hematological cancers within the allotted project time frame. CONCLUSIONS: This research will contribute to broader public health efforts by providing researchers and clinicians with an evidence-based commercial product to improve sleep in the long term in an underserved and understudied cancer population with a high incidence of sleep disturbance. TRIAL REGISTRATION: ClinicalTrials.gov NCT05294991; https://clinicaltrials.gov/ct2/show/NCT05294991. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/39007.

Leveraging a Consumer-Based Product to Develop a Cancer-Specific Mobile Meditation App: Prototype Development Study.

BACKGROUND: Mobile meditation apps may offer a long-term, accessible, and effective solution for ongoing symptom management in cancer patients/survivors. However, there are currently no commercial cancer-specific meditation apps that reflect cancer specialist expertise, input from cancer patients/survivors, and features and content specific to cancer patients'/survivors' needs. OBJECTIVE: The aim of this study was to gain insight (via surveys, daily journals, and focus groups) from cancer patients/survivors, health care providers, and current subscribers of Calm (a consumer-based mobile meditation app) who were patients/survivors to develop a prototype of a mobile meditation app specifically designed for cancer patients/survivors. METHODS: Participants were recruited via prior partnerships, word-of-mouth referrals, and recruitment posts on Facebook and Instagram. Cancer patients/survivors and health care providers were instructed to download and use the Calm app for at least 10 minutes a day for 7 days, complete an online daily journal for 7 days, and participate in a virtual focus group (one for cancer patients/survivors and one for providers). Current Calm subscribers who were cancer patients/survivors completed an online survey about different aspects of the Calm app and participated in a third virtual focus group. Data were qualitatively analyzed using a combination of deductive and inductive coding. RESULTS: A total of 27 participants (11 cancer patients/survivors, 10 health care providers, 6 current Calm subscribers) completed the study. Similar themes and subthemes were found across surveys, daily journals, and focus groups, and fell into two major categories, content and functionality, with cancer-specific and noncancer-specific themes identified within each category. The majority of content preferences and suggestions that arose were cancer-specific, such as content related to negative emotions or feelings (eg, anxiety, grief, trauma/posttraumatic stress disorder, fear of recurrence, isolation), positive feelings and finding meaning (eg, gratitude, storytelling, acceptance), scenarios and experiences (eg, waiting, treatment-specific mediations), type and stage of cancer journey, and movement modifications. Some of the noncancer-specific themes under app content included sleep, music, and visualizations. In terms of app functionality, the majority of participants expressed interest in having a section/tab/area of the app that was specifically geared toward cancer patients/survivors. Preferences and suggestions for cancer-specific functionality features included options based on symptoms or journey, being able to communicate with other patients or survivors to share suggestions for specific meditations, and having an emergency toolkit for patients/survivors. CONCLUSIONS: Findings from cancer patients/survivors, health care providers, and current Calm subscribers who were patients/survivors to be incorporated into the development of the prototype fell into two major categories: (1) content of the app and (2) functionality of the app. The prototype's form and function will be pilot-tested among 30 cancer patients/survivors in a 4-week study, and the resulting feasibility data will be used to inform the final app design and an efficacy study.

Fostering spirituality and psychosocial health through mind-body practices in underserved populations.

BACKGROUND: This study examined changes in spirituality and psychosocial outcomes among African American and rural adults participating in a culturally-adapted mind-body intervention. METHODS: African American (n = 22) and rural (n = 38) adults in Harmony & Health attended mind-body sessions twice a week for eight weeks and completed questionnaires on spirituality and psychosocial distress at baseline and post-intervention. Linear regression and repeated measures analyses were used to examine associations between intervention attendance and spirituality. RESULTS: Attendance was significantly associated with increased spirituality (ß=0.168, p = 013). Repeated measures analyses revealed a significant three-way interaction between attendance, spirituality, and study site (F(9,31)=2.891, p = 013). Urban African American participants who attended ≥75% of sessions reported greater increases in spirituality. CONCLUSION: Findings suggest that mind-body practices may foster spirituality in urban African American adults. Additional adaptations are needed to strengthen spirituality in rural residents and to improve psychosocial health and wellbeing in this underserved population.

Associations Between Rural or Urban Status, Health Outcomes and Behaviors, and COVID-19 Perceptions Among Meditation App Users: Longitudinal Survey Study.

BACKGROUND: Rural and urban differences in health outcomes and behaviors have been well-documented, with significant rural health disparities frequently highlighted. Mobile health (mHealth) apps, such as meditation apps, are a novel method for improving health and behaviors. These apps may be a critical health promotion strategy during the COVID-19 pandemic and could potentially be used to address rural health disparities. However, limited research has assessed whether meditation app health outcomes are associated with rural and urban residence, and it is unclear whether disparities in health and behaviors between rural and urban populations would persist among meditation app users. OBJECTIVE: We aimed to explore associations between rural or urban status, psychological outcomes, and physical activity among users of a mobile meditation app. We further aimed to explore associations between rural or urban status and perceived effects of COVID-19 on stress, mental health, and physical activity, and to explore changes in these outcomes in rural versus urban app users over time. METHODS: This study was a secondary analysis of a national survey conducted among subscribers to the meditation app Calm. Eligible participants completed online baseline surveys from April to June 2020, and follow-up surveys from June to September 2020, assessing demographics, psychological outcomes, physical activity, and perceived effects of COVID-19 on stress, mental health, and physical activity. RESULTS: Participants (N=8392) were mostly female (7041/8392, 83.9%), non-Hispanic (7855/8392, 93.6%), and White (7704/8392, 91.8%); had high socioeconomic status (income ≥US $100,000: 4389/8392, 52.3%; bachelor's degree or higher: 7251/8392, 86.4%); and resided in a metropolitan area core (rural-urban commuting area code 1: 7192/8392, 85.7%). Rural or urban status was not associated with baseline stress, depression, anxiety, pre-COVID-19 and current physical activity, or perceived effects of COVID-19 on stress, mental health, and physical activity. Repeated-measures models showed overall decreases in depression, anxiety, and perceived effects of COVID-19 on physical activity from baseline to follow-up, and no significant changes in stress or perceived effects of COVID-19 on stress and mental health over time. Models also showed no significant main effects of rural or urban status, COVID-19 statewide prevalence at baseline, or change in COVID-19 statewide prevalence. CONCLUSIONS: We did not find associations between rural or urban status and psychological outcomes (ie, stress, depression, and anxiety), physical activity, or perceived effects of COVID-19 on stress, mental health, and physical activity. Rural or urban status does not appear to drive differences in outcomes among meditation app users, and the use of mHealth apps should continue to be explored as a health promotion strategy in both rural and urban populations. Furthermore, our results did not show negative cumulative effects of COVID-19 on psychological outcomes and physical activity among app users in our sample, the majority of whom were urban, White, female, and of high socioeconomic status. Further research is needed to investigate meditation app use as a health promotion strategy in rural and urban populations.

A faith-based mind-body intervention to improve psychosocial well-being among rural adults.

Churches are well positioned to promote better mental health outcomes in underserved populations, including rural adults. Mind-body (MB) practices improve psychological well-being yet are not widely adopted among faith-based groups due to conflicting religious or practice beliefs. Thus, "Harmony & Health" (HH) was developed as a culturally adapted MB intervention to improve psychosocial health in urban churchgoers and was adapted and implemented in a rural church. The purpose of this study was to explore the feasibility, acceptability, and efficacy of HH to reduce psychosocial distress in rural churchgoers. HH capitalized on an existing church partnership to recruit overweight or obese (body mass index [BMI] ≥25.0 kg/m2) and insufficiently active adults (≥18 years old). Eligible adults participated in an 8 week MB intervention and completed self-reported measures of perceived stress, depressive symptoms, anxiety, and positive and negative affect at baseline and postintervention. Participants (mean [M] age = 49.1 ± 14.0 years) were mostly women (84.8%), non-Hispanic white (47.8%) or African American (45.7%), high socioeconomic status (65.2% completed ≥bachelor degree and 37.2% reported an annual household income ≥$80,000), and obese (M BMI = 32.6 ± 5.8 kg/m2). Participants reported lower perceived stress (t = -2.399, p = .022), fewer depressive symptoms (t = -3.547, p = .001), and lower negative affect (t = -2.440, p = .020) at postintervention. Findings suggest that HH was feasible, acceptable, and effective at reducing psychosocial distress in rural churchgoers in the short-term. HH reflects an innovative approach to intertwining spirituality and MB practices to improve physical and psychological health in rural adults, and findings lend to our understanding of community-based approaches to improve mental health outcomes in underserved populations.

Feasibility and acceptability of a faith-based mind-body intervention among African American adults.

Physical activity reduces cancer risk, yet African American adults remain insufficiently active, contributing to cancer health disparities. Harmony & Health (HH) was developed as a culturally adapted mind-body intervention to promote physical activity, psychosocial well-being, and quality of life among a church-based sample of overweight/obese, insufficiently active African American adults. Men and women were recruited to the study through an existing church partnership. Eligible participants (N = 50) were randomized to a movement-based mind-body intervention (n = 26) or waitlist control (n = 24). Participants in the intervention attended 16 mind-body sessions over 8 weeks and completed a physical assessment, questionnaires on moderate-to-vigorous physical activity (MVPA) and psychosocial factors, and accelerometry at baseline (T1), post-intervention (T2), and 6 week follow-up (T3). Eighty percent of participants (94% women, M age = 49.7 ± 9.4 years, M body mass index = 32.8 ± 5.2 kg/m2) completed the study, and 61.5% of intervention participants attended ≥10 mind-body sessions. Participants self-reported doing 78.8 ± 102.9 (median = 40.7, range: 0-470.7) min/day of MVPA and did 27.1 ± 20.7 (median = 22.0, range: 0-100.5) min/day of accelerometer-measured MVPA at baseline. Trends suggest that mind-body participants self-reported greater improvements in physical activity and psychosocial well-being from baseline to post-intervention than waitlist control participants. HH is feasible and acceptable among African American adults. Trends suggest that the mind-body intervention led to improvements in physical activity and psychosocial outcomes. This study extends the literature on the use of mind-body practices to promote physical and psychological health and reduce cancer disparities in African American adults.