Katherine-Ann Laura Piedalue

PURPOSE: Sleep, fatigue, and pain are common symptoms in cancer survivors. Mindfulness-based cancer recovery (MBCR) and Tai Chi/Qigong (TCQ) are beneficial for these conditions, but have not been studied together. The Mindfulness and Tai Chi for Cancer Health (MATCH) study was designed to incorporate innovative design features, including patient choice, while evaluating two interventions for distressed cancer survivors with predefined secondary outcomes, including sleep, fatigue, and pain. METHODS: Participants chose one of the two interventions or chose to be randomly assigned into either intervention, then were further randomly assigned into immediate intervention or waitlist groups. We evaluated the efficacy of MBCR and TCQ, whether participants' choices affected intervention effects, and correlations among changes in sleep, fatigue, and pain. RESULTS: Participants (N = 587) were on average 60.7 years, with multiple types and stages of cancer. At postintervention, compared with waitlist controls, the TCQ group had an average improvement of 1.9 points on the sleep quality scale, which remained statistically significant compared with controls after adjustment for age, sex, cancer stage, and preference ( P = .004). Compared with waitlist controls, both MBCR and TCQ groups had significantly improved fatigue with mean improvements of 3.66 and 3.42 points, respectively (MBCR: P = .036. TCQ: P = .043) and over 1 point of change on pain interference (MBCR: P = .029. TCQ: P = .002). MBCR and TCQ did not differ from one another. Preference status did not affect outcomes. Significant correlations were observed among changes in sleep, fatigue, and pain interference, suggesting mild to moderate associations. CONCLUSION: Compared with waitlist controls, MBCR and TCQ both improved fatigue and pain interference at post-intervention, and TCQ also improved sleep quality. Correlations across outcomes highlight the importance of addressing clusters of cancer symptoms within a whole-person health framework.

Background: Insomnia affects the quality of life and health outcomes of cancer survivors. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia among cancer survivors, but it is not readily accessible due to the limited number of trained providers and the difficulties in providing care across wide geographical areas. Mobile health (mHealth) technologies represent a promising solution; however, these technologies are not tailored to the unique needs of cancer survivors. Objective: This study aimed to understand the needs and preferences of cancer survivors and test the usability of an evidence-based CBT-I smartphone app called iCANSleep that will be tailored and accessible to cancer survivors. Methods: A user-centered design (UCD) approach was applied, and cancer survivors were actively engaged in the app’s design, usability testing, and prototype refinement. In phase 1, semistructured interviews were conducted with a purposive sample of cancer survivors (n=20) to inform the design of the app and its content. In phase 2, iterative low- (n=8) and high-fidelity (n=7) usability testing was conducted with participants until no further recommendations for change were suggested. Results: Users suggested several defining characteristics, features, and desired functionalities, including a user-friendly and evidence-based design. They saw increased accessibility and simplicity as advantages of a mobile app but expressed some concerns about data security and losing the accountability that comes with in-person treatment. User testing highlighted the preference for images of real people and diverse stories over graphics and animated videos, and offered suggestions for enhanced navigation. The first iteration of the app was developed using the information gained during the needs assessment and usability testing. Feedback was integrated into the final prototype of the iCANSleep app, which will be tested for feasibility, acceptability, and efficacy. Conclusions: Cancer survivors desire an insomnia treatment app that is simple, user-friendly, evidence-based, convenient, and secure. The iCANSleep app represents the merging of mHealth principles and best practices with evidence-based insomnia care, allowing for an intervention with minimal access barriers related to cost, geography, and provider availability. Feasibility, acceptability, and efficacy of the intervention will be maximized by following a UCD framework involving the engagement of end users at every design stage.

PURPOSE: Many cancer survivors have high levels of distress and psychosocial symptoms. Two mind-body interventions for treating these problems are Mindfulness-Based Cancer Recovery (MBCR) and Tai Chi/Qigong (TCQ). However, while both interventions show efficacy compared with usual care, they have never been studied together. This trial was the first, to our knowledge, to incorporate innovative design features including patient choice while evaluating two interventions to treat distressed cancer survivors. METHODS: A preference-based multisite randomized comparative effectiveness trial design with broad pragmatic inclusion criteria was used. Participants with a preference for either MBCR or TCQ received their preferred intervention, while those without a preference were randomly assigned 1:1 into either intervention. Furthermore, participants were all randomly assigned 2:1 into immediate intervention or waitlist control. Total mood disturbance (TMD) on the Profile of Mood States after intervention was the primary outcome. RESULTS: Five hundred eighty-seven participants provided baseline data, 75% were female, with an average age of 60.7 years. Of 12 cancer types, the most prevalent were breast (40.7%), prostate (11.2%), and GI (9.7%) cancers. Most had stage 0-II (50.1%) diagnoses, with 17% having more advanced disease. Approximately two thirds had a preference, with 57% of those choosing TCQ and 43% choosing MBCR. The remaining 36% were equally randomly assigned. Choosing a specific program or choosing to be randomly assigned had no significant effect on outcomes. Both the combined random assignment and preference MBCR and TCQ groups improved more than their respective waitlists on TMD scores with small to medium effects. The largest improvements occurred for MBCR on subscales of tension, anger, and vigor and in TCQ on anger, depression, and vigor. CONCLUSION: This large, pragmatic trial demonstrated both mindfulness and TCQ interventions improved mood in distressed cancer survivors, whether they chose a program or chose to be randomly assigned.

Objective: To examine the factors associated with loss to follow-up (LTFU) in an ongoing preference-based randomized waitlist controlled trial of mindfulness-based cancer recovery (MBCR) and Taichi/Qigong (TCQ) for cancer survivors (the MATCH Study). Hierarchical logistic regression was used to determine the factors associated with LTFU. Predictors included adherence to treatment, preference vs. randomized, type of intervention (MBCR vs. TCQ) and program timing (immediate {IM} vs. waitlist control {WLC} group). Results: Data indicated that randomization to the WLC group and, once in the intervention, low adherence were the main predictors of LTFU. Participants in the WLC group were 4 times more likely to be LTFU post-randomization [OR 3.96, 95% CI 2.08–7.56, p < 0.005] than those in the IM group. Participants showing low adherence to treatment were 6 times more likely for LTFU post-intervention [5.87 (2.57–13.400; p < 0.005] and 4 times more likely for LTFU 6 months post-intervention [OR 3.93, 95% CI 1.53–10.02, p = 0.01].

Background: Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Mindfulness-based interventions (MBIs) are effective for treating these symptoms; however, cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as work and family commitments, treatment-related side-effects, scheduling conflicts, and geography. Smartphone app–based MBIs are an innovative way to deliver psychosocial cancer care and can overcome several such difficulties, since patients can participate at their own convenience. Objective: The SEAMLESS (Smartphone App–Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship—MBCS—Journey) for treating (1) symptoms of stress (primary outcome), as well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes). This is the first Canadian efficacy trial of a tailored mindfulness app intervention in cancer survivors. Methods: This is a randomized waitlist-controlled trial, which will evaluate the effectiveness of Am MBCS for impacting the primary and secondary outcomes in cancer survivors who have completed all their cancer treatments. Outcomes will be assessed using web-based surveys with validated psychometric instruments at (1) baseline, (2) mid-intervention (2 weeks later), (3) immediately postintervention (4 weeks), (4) 3 months postbaseline, (5) 6 months postbaseline, and (6) 12 months postbaseline. The waitlist group will complete all assessments and will cross over to the intervention condition after the 3-month assessment. In addition, data will be obtained by the smartphone app itself, which includes users’ engagement with the app-based intervention, their emotional state (eg, angry and elated) from a user-inputted digital emotion-mapping board, and psychobiometric data using photoplethysmography technology. Results: The study received ethics approval in September 2018 and recruitment commenced in January 2019. Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors, although some survivors of other cancer are also present. Data collection for analysis of the primary outcome time-point will be complete by September 2019, and the follow-up data will be collected and analyzed by September 2020. Data will be analyzed to determine group differences using linear mixed modelling statistical techniques. Conclusions: Cancer care providers are uncertain about the efficacy of app-based mindfulness interventions for patients, which are available in great supply in today’s digital world. This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, could be made available for psychosocial care at cancer centers worldwide. Trial Registration: ClinicalTrials.gov NCT03484000; https://clinicaltrials.gov/ct2/show/NCT03484000 International Registered Report Identifier (IRRID): DERR1-10.2196/15178

Background. A service delivery model using group acupuncture (AP) may be more cost‐effective than individual AP in general, but there is little evidence to assess whether group AP is a comparable treatment in terms of efficacy to standard individual AP. The study aimed to compare the group to individual delivery of 6‐week AP among cancer patients with pain. Methods. The study design was a randomized noninferiority trial of the individual (gold standard treatment) vs. group AP for cancer pain. The primary outcome was pain interference and severity, measured through the Brief Pain Inventory (BPI). Secondary outcomes included measures of mood, sleep, fatigue, and social support. Changes in outcomes from pre‐ to postintervention were examined using linear mixed effects modeling and noninferiority was inferred using a noninferiority margin, a difference of change between the two arms and 95% CIs. Pain interference was tested with a noninferiority margin of 1 on the BPI, while pain severity and secondary outcomes were compared using conventional statistical methods. Results. The trial included 74 participants randomly allocated to group (35) or individual (39) AP. The noninferiority hypothesis was supported for pain interference [Ө − 1, Δ 1.03, 95% CI: 0.15–2.20] and severity [Ө − 0.81, Δ 0.52, 95% CI:.33–1.38] as well as for mood [Ө − 7.52, Δ 9.86, 95% CI: 0.85–18.86], sleep [Ө − 1.65, Δ 2.60, 95% CI: 0.33–4.88], fatigue [Ө 8.54, Δ − 15.57, 95% CI: 25.60–5.54], and social support [Ө.26, Δ − 0.15, 95% CI: − 0.42–0.13], meaning that group AP was not inferior to individual AP treatment. Both arms evidenced statistically significant improvements across all symptoms before and after the intervention. Effect sizes for the group vs. individual AP on outcomes of pain, sleep, mood, and social support ranged from small to very large and were consistently larger in the group condition. The total average cost‐per‐person for group AP ($221.25) was almost half that of individual AP ($420). Conclusions. This is the first study to examine the noninferiority of group AP with the gold standard individual AP. Group AP was noninferior to individual AP for treating cancer pain and was superior in many health outcomes. Group AP is more cost‐effective for alleviating cancer pain and should be considered for implementation trials.

BACKGROUND Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Mindfulness-based interventions (MBIs) are effective for treating these symptoms; however, cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as work and family commitments, treatment-related side-effects, scheduling conflicts, and geography. Smartphone app–based MBIs are an innovative way to deliver psychosocial cancer care and can overcome several such difficulties, since patients can participate at their own convenience. OBJECTIVE The SEAMLESS (Smartphone App–Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship—MBCS—Journey) for treating (1) symptoms of stress (primary outcome), as well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes). This is the first Canadian efficacy trial of a tailored mindfulness app intervention in cancer survivors. METHODS This is a randomized waitlist-controlled trial, which will evaluate the effectiveness of Am MBCS for impacting the primary and secondary outcomes in cancer survivors who have completed all their cancer treatments. Outcomes will be assessed using web-based surveys with validated psychometric instruments at (1) baseline, (2) mid-intervention (2 weeks later), (3) immediately postintervention (4 weeks), (4) 3 months postbaseline, (5) 6 months postbaseline, and (6) 12 months postbaseline. The waitlist group will complete all assessments and will cross over to the intervention condition after the 3-month assessment. In addition, data will be obtained by the smartphone app itself, which includes users’ engagement with the app-based intervention, their emotional state (eg, angry and elated) from a user-inputted digital emotion-mapping board, and psychobiometric data using photoplethysmography technology. RESULTS The study received ethics approval in September 2018 and recruitment commenced in January 2019. Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors, although some survivors of other cancer are also present. Data collection for analysis of the primary outcome time-point will be complete by September 2019, and the follow-up data will be collected and analyzed by September 2020. Data will be analyzed to determine group differences using linear mixed modelling statistical techniques. CONCLUSIONS Cancer care providers are uncertain about the efficacy of app-based mindfulness interventions for patients, which are available in great supply in today’s digital world. This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, could be made available for psychosocial care at cancer centers worldwide. CLINICALTRIAL ClinicalTrials.gov NCT03484000; https://clinicaltrials.gov/ct2/show/NCT03484000 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15178