OMM: Online Mobile Mindfulness to Improve the Well-Being of Cancer Survivors

doi:10.21203/rs.3.rs-2074085/v1

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OMM: Online Mobile Mindfulness to Improve the Well-Being of Cancer Survivors

https://doi.org/10.21203/rs.3.rs-2074085/v1

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Purpose: Anxiety and cancer related neuropathy are two persistent effects related to treatment for cancer. Mindfulness meditation has been used with substantial impact as a non-pharmacologic intervention to mitigate side and late effects of treatment. Mobile apps are ubiquitous for most of the general population, yet have a particular relevance for cancer survivors, given that physical and geographic limitations can be present. The goal of the current manuscript is to describe an ongoing trial of the Mindfulness Coach mobile application (“app”) for cancer survivors.

Methods: In this randomized wait-list controlled trial, cancer survivors experiencing anxiety or cancer related neuropathy (200 in each arm) and who have finished primary treatment for cancer are invited to participate. Data are collected at three time points regardless of randomization condition: baseline, 8 weeks, and 16 weeks. Both face-to-face and online recruitment strategies have been employed. In addition to evaluating the impact of mobile mindfulness of anxiety or cancer related neuropathy, other pain, fatigue, trauma, sleep, and satisfaction with the Mindfulness Coach app will also be assessed.

Conclusion: Mindfulness meditation is becoming widely used by the general public, in addition to the use of mobile technology. Finding ways to deliver mindfulness meditation to people who have been treated for cancer allows for the intervention to be accessible to a larger breadth of survivors. The results of this intervention will have implications for further understanding the impact of mindfulness meditation on two persistent side and late effects of treatment of cancer— anxiety and cancer related neuropathy.

Primary ID: BANTUM-2017-1

Secondary ID: NCI-2019-08685

ClinicalTrials.gov ID: NCT03581357

Cancer

cancer survivorship

mindfulness meditation

quality of life

well-being

mHealth

The latest report from the American Cancer Society estimates that there are 16.9 million cancer survivors in the United States [1]. A diagnosis of cancer or recurrence of cancer can cause psychological distress, including symptoms of anxiety and depression [2]. For patients receiving treatment for cancer, 10.3% meet the clinical criteria for an anxiety disorder [3], compared to 7% of those in the general population [4]. Prevalence of anxiety disorders is reported to be even higher for those who have been living with cancer for more than two years, with 17.9% of survivors meeting diagnostic criteria for anxiety [5]. As cancer treatments have become more effective than in previous decades, there are more cancer survivors living longer with cancer [6], yet also living with side and late effects of treatment.

Anxiety can manifest in both physical and psychological symptoms that negatively impact quality of life and are associated with a significantly increased risk of cancer incidence and cancer-specific mortality [7]. Psychological distress can affect a number of cancer outcomes, including quality of life, adherence to treatment, health behaviors, and potentially disease progression and survival, as well as increased utilization of health care resources [2].

Neuropathy is another common symptom of either cancer treatment or, less frequently, cancer itself and can be acute or chronic in nature [6]. There are a wide range of ways in which patients describe this experience, although peripheral neuropathy is often described as the sensation of shooting or stabbing pain and tingling or loss of feeling in the affected areas. This can impact many activities, such as walking, balance, and mood [6]. In patients receiving neurotoxic chemotherapy, such as platinum drugs, taxanes, vinca alkaloids, proteasome inhibitors, and immunomodulatory drugs, approximately 30–40% of patients will develop chemotherapy-induced peripheral neuropathy (CIPN) [8]. CIPN is a common cause of pain and decreased quality of life for cancer patients undergoing treatment as well as cancer survivors [9]. In approximately 50% of people who experience CIPN, this condition will become chronic [10].

Mindfulness meditation

Historically conceptualized in Buddhist spiritual practice with the purpose of cultivating compassion and alleviating suffering, mindfulness meditation has been engaged in for thousands of years [11, 12]. Mindfulness can be described as bringing non-judgmental attention or awareness to one’s moment-to-moment experience [12]. Mindfulness meditation is the setting aside of time to specifically engage in what is often a seated meditation practice where participants are instructed to close their eyes and are guided through a breathing and focused attention process [13].

The practice of mindfulness with the goal of improving well-being has been described as a universal human capacity that does not involve a particular cultural or religious belief system [11, 12]. In the recent decades, mindfulness has gained popularity in the mainstream United States and has been found to have numerous psychological and physical benefits, with a growing body of research on clinical applications of mindfulness to treat various conditions [2, 11, 14–17–20]. Mindfulness has been studied as a therapy to reduce symptoms of depression and anxiety [2], improve outcomes for chronic pain [14], reduce stress and improve attention [15], improve brain function and connectivity [16], and improve immune function [17].

The practice of mindfulness has been shown to improve quality of life and be related to more positive mental health in cancer survivors [18]. Recent studies indicate that mindfulness-based interventions have a positive impact on depression, anxiety, and quality of life in ovarian cancer patients [2], men living with cancer [19], and metastatic non-small cell lung cancer patients and their caregivers [20], just to name a few.

Online behavioral therapy for anxiety and cancer-related neuropathy

While mindfulness is gaining a larger evidence base for applications in the clinical setting, lack of trained personnel, time constraints, reimbursement issues, and patient and provider availability are barriers to delivery and participation in a traditional, face-to-face mindfulness course [21]. Researchers in a recent face-to-face mindfulness-based stress reduction (MBSR) intervention for young adult cancer survivors identified barriers to participation reported by eligible patients who declined to participate in the intervention [22]. Out of the 446 eligible people who declined to participate, the majority reported distance to the intervention site as the main factor (41.5%), followed by time constraints (21.7%). A subset of individuals who declined were asked if they would participate in the course if it were offered in a different location or format. Of those asked, 73.8% stated that they would enroll in a MBSR course offered closer to their home, and 70.8% stated that they would enroll in an online MBSR course. Of the individuals who stated interest in an online MBSR course, 70.9% stated that they would enroll in a self-directed course delivered through educational modules [22]. These barriers to face-to-face mindfulness interventions limit access to care, and therefore make face-to-face interventions less likely to be a realistic treatment model [21], but online interventions for mindfulness provide a potential avenue to overcome these barriers and increase accessibility to effective mindfulness interventions.

Advances in technology have allowed for delivery of effective online interventions in the patient’s home through a mobile app [23]. When used to effectively disseminate evidence-based interventions, apps have the potential to increase access to evidence-based healthcare and use of evidence-based practices by the general population [21, 23]. Previous studies have shown that online mindfulness-based interventions involving guided meditation audios are feasible and acceptable for cancer survivors [24], who may be too ill or lack the resources to travel to a face-to-face mindfulness intervention. A recent study using the Calm mobile app for mindfulness meditation found that use of the app for 10 minutes daily for four weeks was significantly effective in reducing symptoms of depression and anxiety in patients with myeloproliferative neoplasm, but did not significantly impact sleep disturbance [25].

The current American Society of Clinical Oncology clinical practice guideline does not recommend any pharmacologic agents in preventing CIPN, and there is limited evidence for treatment of existing CIPN with pharmacologic agents, with a moderate recommendation for the use of duloxetine [26]. Previous studies suggest that online interventions may have the potential to improve conditions involving chronic pain. A study involving an online, self-guided cognitive and behaviorally-based pain management intervention for cancer survivors experiencing CIPN had significantly greater improvements in "worst pain" compared with individuals receiving usual care [27].

Mindfulness Coach, an iOS- and Android-based mobile app, is designed to deliver a mobile mindfulness training course designed by researchers from the U.S. Department of Veterans Affairs (VA) [21, 28]. The senior author on this paper, Dr. Erin Bantum, was part of the team that developed the most recent version of the app. Initially developed among other mobile apps in collaboration with the U.S. Department of Defense [28], Mindfulness Coach is freely available to the general public for both iOS and Android operating systems. A recent study exploring the effects of the app among the general population found that use of the Mindfulness Coach app was feasible, and increased use was strongly correlated with an increase in scores measuring mindfulness characteristics including observing, describing, acting with awareness, nonreactivity to inner experience, and non judging of inner experience, as measured by the Five-Facet Mindfulness Questionnaire Short Form (FFMQ-SF) [21, 29].

With the larger goal of decreasing anxiety and cancer related neuropathy for cancer survivors, the Online Mobile Mindfulness (OMM) study is underway to test the impact of 8 weeks of use of the Mindfulness Coach mobile app for cancer survivors. The study contains the following primary aims: Evaluate the impact of mobile mindfulness on anxiety or cancer related neuropathy (depending on the arm selected), other pain, fatigue, trauma, and sleep, and to evaluate the satisfaction with the Mindfulness Coach mobile app.

Study design

The study is being conducted as a randomized wait-list control design, such that participants are randomized through Qualtrics to either begin the intervention immediately or after 8 weeks. For both the anxiety and cancer related neuropathy arms, participants are randomized into one of the two treatment conditions. The goal is to have 200 people complete the 8 week survey measures in each arm.

Procedure

Recruitment

The study is currently open for recruitment. The University of Hawai’i (UH) Cancer Center is recognized by the National Cancer Institute (NCI) as an NCI-designated cancer center. The Hawai’i Cancer Consortium, in which all major medical centers on Oahu belong, is led by the UH Cancer Center. Clinic-based, community based, and online recruitments are underway [30].

Participants

Cancer survivors experiencing anxiety or cancer related neuropathy and who have finished primary treatment for cancer are invited to participate in the study. Inclusion criteria are the same for both arms, aside from the different scales used to measure levels of anxiety or neuropathy. Inclusion criteria for both arms include a previous diagnosis of cancer, other than non-melanoma skin cancer; completion of primary treatment for cancer; not currently practicing meditation for more than one hour per week; age over 21 years; comfortable reading and writing in English; routine access to the internet; and own a smartphone or tablet. There are no exclusion criteria.

For the anxiety arm, participants must be experiencing cancer related anxiety, per self-report, as indicated by a score of 22 or higher on the PROMIS Anxiety Short Form measure [31]. For the neuropathy arm, participants must be experiencing CIPN, per self-report, as indicated by a score of 22 points or higher on the FACT-GOG-Ntx CIPN items [32]. The study is powered to examine differences between groups with 200 people in each arm.

Baseline and follow-up assessments

Figure 1 summarizes the overall timeline for baseline and follow-up data collection. For both the anxiety and neuropathy arms, data on demographics and medical history are collected at baseline. Baseline data collected include: Cancer status and treatment, past medical conditions, gender, ethnicity, and previous experience with mindfulness. For both the anxiety and neuropathy arms, all three surveys include questions about quality of life: physical well-being, social/family well-being, emotional well-being, and functional well-being; anxiety: symptoms of anxiety and whether help was needed due to anxiety symptoms; fatigue: severity of fatigue and the impact of fatigue on daily functioning; pain: sensory, affective/emotional impact, and cognitive evaluation of pain; and mood: anxiety. The anxiety arm includes additional assessment questions: depression, mindfulness, and PTSD. The neuropathy arm includes questions about neuropathy: severity and impact of CIPN. Specific measures are listed below for each arm.

Anxiety arm

Potential participants are screened with the PROMIS Anxiety Short Form measure, an eight-item measure assessing anxiety on a Likert-type scale, with options ranging from “never” to “always” [31]. Pain is measured with the PEG-3, a three-item measure assessing pain intensity, interference with general activity, and interference with enjoyment of life, with response options ranging from a 0–10 scale, with 0 being “no pain” or “does not interfere” and 10 being “pain as bad as you can imagine” or “completely interferes” [33]. Sleep related impairment is measured using the PROMIS Sleep Related Impairment Short Form, an eight-item measure assessing sleep disturbance and sleep related impairment [34]. Fatigue is measured with the Brief Fatigue Inventory (BFI), a nine-item measure to rate fatigue on a 0–10 scale, with 0 being “no fatigue” or “does not interfere” and 10 being “as bad as you can imagine” or “completely interferes.” [35]. Anxiety is measured with the GAD-7, a seven-item measure of anxiety on a five-point Likert-type scale [36]. Depression is measured with the PHQ-9, a nine-item measure utilizing four response options to assess depressive symptoms and behaviors [37]. Post traumatic stress disorder (PTSD) is measured using the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5), a 20-item measure that assesses the 20 DSM-5 symptoms of PTSD [38]. Mindfulness is measured with the Five Facet Mindfulness Questionnaire (FFMQ), a 39-item measure of the five facets of mindfulness (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience), with answer options on a 1–5 scale ranging from “never or rarely true” to “very often or always true” [29]. For the follow-up assessments, the demographic questions are removed. A question regarding how much they have been practicing mindfulness (all groups), and a question about satisfaction with the intervention (for the intervention groups) are added.

Neuropathy arm

Potential participants are screened with the 11-item CIPN measure included in the FACT-GOG-Ntx [32]. The Functional Assessment of Cancer Treatment (FACT) scale is a well-validated quality of life measure with 27 items measuring physical, social/family, emotional, and functional well being, with the FACT-GOC-Ntx scale including 11 additional items to measure the severity and impact of CIPN [32]. The 11-item FACT-GOG-Ntx data serves as both a screening tool and baseline measure of CIPN. The rest of the FACT items (27 questions) are included in the baseline questionnaire, with the total measure being included at the 8 and 16 week assessment time points. At each assessment time point, participants are asked about any additional support services (such as support groups) or clinical trials that they have been enrolled in, to include anything they have done to treat CIPN. In order to assess anxiety, the eight-item PROMIS Anxiety Short Form measure is used [31]. Fatigue is measured using the Brief Fatigue Inventory (BFI) [35]. The Short-form McGill Pain Questionnaire (SFMPQ) is used as a brief measure of pain [39]. The McGill Pain Questionnaire (MPQ) is a self-report questionnaire, consisting of three major classes of word descriptors of pain—sensory, affective/emotional impact, and cognitive evaluation of pain. The SFMPQ was developed to provide an instrument that could be completed in less time than the MPQ but would still reflect both the sensory and affective dimensions of pain and has been shown to have high correlations with the original MPQ [39]. For the follow-up assessments, the demographic questions are removed. For the follow-up assessments, a question regarding how much they have been practicing mindfulness (all groups), and a question about satisfaction with the intervention (for the intervention groups) are added.

Intervention

Mindfulness Coach provides simple written instructions and a brief tutorial that introduces the major features, including a training plan, practice exercises, learning topics, and tracking via the app. Mindfulness exercises are delivered via brief, guided audio mindfulness exercises. This information has been arranged in such an order to where it is helpful to have learned the material prior to any given session, although not necessary. The core meditation centers around the seated mindfulness practice, and as the sessions go on, users are asked to sit for longer periods of time, building physical and mental capabilities for meditation. Through this process, participants are instructed to bring non-judgmental awareness to what they are experiencing in a basic sensorial way (e.g., what they are feeling on their skin, hearing in the environment, and experiencing inside their body in regards to physical or emotional sensations or thoughts), with a primary aspect of this involving paying attention to and deepening one’s breathing. The app delivers 14 sessions (levels) that each include a pre-recorded guided audio meditation exercise. The app also provides a mindfulness self-assessment tool through the FFMQ-SF [29], which users are reminded, but not required, to complete at levels 1, 7, and 14. Assessment feedback “quick tips” are provided based on the results of the FFMQ-SF.

The intervention includes 8 weeks of Mindfulness Coach. (See Fig. 2 for examples of features included in Mindfulness Coach). This practice is encouraged daily through the app and participants are asked to build the amount of time they are spending daily. There are many other audio recordings that are placed throughout the sessions, to include meditations around scanning the body for sensations, awareness and processing of difficult emotions, eating mindfully, and loving kindness. Participants are asked to use Mindfulness Coach for 8 weeks, either immediately (treatment group) or 8 weeks after the baseline assessment (wait-list control group).

Retention and incentive plan

Participants receive a $20 gift card after completing each of the three surveys, with total incentives of $60 for completing all three surveys. Reminder emails are sent to participants by a member of the study team.

Planned Analyses

This randomized controlled trial will be evaluated using an intent-to-treat (ITT) mixed (within-subjects and between-subjects variables) analysis of variance (ANOVA) model. Time is a three-level (baseline, 8 week follow-up, and 16 week follow-up) within-subjects variable and treatment condition is a two-level (Mobile Mindfulness Meditation via the Mindfulness Coach App, wait-list control) between-subjects variable. Subsequent tests will compare the control condition against the app condition. Separate models will be run for each outcome in each arm of the study. Model assumptions will be assessed and analyses will be modified as needed (e.g., transformations, nonparametric tests, etc.). In an ITT analysis, all participants randomized to the treatment conditions are included, even if they do not complete their assigned treatments. We will examine if missing values are random, and if necessary, we will impute values using multiple imputation procedures.

What we’ve learned so far

We hope that this study will result in findings that are useful to improving the well-being of cancer survivors experiencing anxiety and cancer-related neuropathy. If the study shows improvement in symptoms of anxiety or neuropathy in cancer survivors, it will allow for greater accessibility to mindfulness meditation via Mindfulness Coach, which is free, publicly available, and easily accessible through a mobile app. This will allow cancer patients to access guided mindfulness meditation exercises in the comfort of their own home and on their own time. This can be helpful for patients who may be too ill, lack the resources, or live in a rural area where accessing a face-to-face mindfulness meditation intervention would be difficult or inaccessible. Results of the study may also be useful for clinicians working alongside cancer patients or survivors for evidence-based, non-pharmacologic interventions to improve anxiety or neuropathy, with mindfulness meditation used alone or along with pharmacologic interventions.

Non-pharmacologic interventions, including exercise, yoga, and mindfulness meditation have been studied for treatment of psychological disorders, including anxiety, as a monotherapy or adjunctive therapy [40]. Current evidence supports the use of mindfulness meditation as an adjunctive therapy for people with an anxiety disorder, as there is limited evidence for mindfulness being used as a monotherapy for anxiety [40]. The general health benefits and low risk for harm justify use of mindfulness as adjunctive therapy for patients with anxiety disorders and other mental health conditions such as depression [40]. Poor recognition of anxiety and depression are associated with decreased quality of life and survival in cancer patients [4], and cultivation of mindfulness has sustainable long-term health effects by helping an individual develop self-efficacy skills that support mechanisms to cope with negative feelings, including self-awareness, emotional self-regulation, less worry and rumination, and meta-cognition [41]. No existing literature could be found on the effectiveness of a mindfulness based intervention compared to a pharmacologic intervention to treat anxiety.

At the current time, pharmacologic interventions for neuropathy are not highly effective and are not well tolerated by many patients due to various side effects [42]. First-line drugs used to treat neuropathy include antidepressants and anticonvulsants acting at voltage-gated calcium channels, which can have side effects including risk for cardiotoxicity, orthostatic hypotension, dry mouth, nausea, and confusion, among others [43]. In a randomized controlled trial involving 402 patients with neuropathy, four drugs commonly used for neuropathy of different drug classes (pregabalin, duloxetine, nortriptyline, and mexiletine) were tested for tolerance and treatment of neuropathic pain. Results of the study found that none of the drugs tested was clearly superior in performance or highly effective for treating neuropathic pain [42]. The most effective treatment for neuropathy was nortriptyline, with 25% of patients reporting at least 50% improvement in discomfort. The least effective treatment was pregabalin, with only 15% of patients reporting at least 50% improvement [42]. If results from this study show potential for mindfulness to be used as an alternative intervention to treat neuropathy, a larger number of people, including cancer survivors affected by CIPN, can access effective treatment without the side effects associated with medications commonly used to treat neuropathy.

Mindfulness meditation is becoming more commonly known and used for a breadth of health purposes. Cancer survivors are a group that could particularly benefit from these interventions, given high rates of anxiety and pain— two effects of treatment found to be positively impacted through the practice of mindfulness meditation. Mobile apps have large dissemination potential and identifying apps that are found to be related to outcomes of interest is important given the ubiquitous nature of apps. Without identifying apps that are effective, apps that are available yet not effective can easily be reached for. Findings from the currently described study will be published as soon as available.

Ethics approval and consent to participate: The study was approved through the Western Internal Review Board (WIRB). Informed consent was obtained from all participants included in the study.

Consent for publication: Not applicable – no identifying information about participants is included in this article.

Availability of data and materials: The datasets generated during and/or analyzed during the current study are not publicly available due to the ongoing study. Findings from the currently described study will be published as soon as available.

Competing interests: The authors have no relevant financial or non-financial interests related to the content of this article to disclose.

Funding: The study is funded by a donation to the University of Hawai’i Cancer Center from the Women's Veterans Fund and through seed funding through a Strategic Investment in Translational Science from the University of Hawai’i Cancer Center. The first author is supported in part by a grant from the National Cancer Institute (R25 CA244073), an endowment from the Meiji Yasuda Life Insurance Company, donations from The Friends of the University of Hawai’i Cancer Center, and support from the University of Hawai’i Cancer Center.

Author contributions: Erin Bantum created the design for the study and wrote the proposal to receive funding for the project. Ariel Orasud and Erin Bantum conducted the literature review and wrote the main manuscript text. Mai Smith edited the manuscript. All authors are team members involved in the research study and reviewed the manuscript.

Acknowledgements: We would like to thank all of the participants who have consented and participated in this study. We would also like to thank everyone who has helped inform potential participants of the study, and we would like to thank Dr. Jami Fukui, Dr. Ian Pagano, Celine Arnobit, and Dr. Jason Owen for their help with the study, as well.

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No competing interests reported.

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OMM: Online Mobile Mindfulness to Improve the Well-Being of Cancer Survivors

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Abstract

Figures

Background

Mindfulness meditation

Online behavioral therapy for anxiety and cancer-related neuropathy

Methods

Study design

Procedure

Recruitment

Participants

Baseline and follow-up assessments

Anxiety arm

Neuropathy arm

Intervention

Retention and incentive plan

Planned Analyses

Conclusion

What we’ve learned so far

Declarations

References

Additional Declarations

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