A Randomized Controlled Trial of mHealth Mindfulness Intervention for Cancer Patients and Informal Cancer Caregivers: A Feasibility Study Within an Integrated Health Care Delivery System

Abstract

To assess feasibility and preliminary efficacy of a mobile/online-based (mHealth) mindfulness intervention for cancer patients and their caregivers to reduce distress and improve quality of life (QoL). Material and Methods: Twoarm randomized controlled trial within Kaiser Permanente Northern California targeting cancer patients who received chemotherapy and their informal caregivers. The intervention group received a commercially available mindfulness program for 8 weeks. The wait-list control group received usual care. We assessed feasibility using retention and adherence rates and obtained participant-reported data on distress, QoL, sleep, mindfulness, and posttraumatic growth before and immediately after the intervention. Results: Ninety-seven patients (median age 59 years; female 69%; 65% whites) and 31 caregivers (median age 63 years; female 58%; 77% whites) were randomized. Among randomized participants, 74% of the patients and 84% of the caregivers completed the study. Among those in the intervention arm who initiated the mindfulness program, 65% practiced at least 50% of the days during the intervention period. We observed significantly greater improvement in QoL among patients in the intervention arm compared with controls. Caregivers in the intervention group experienced increased mindfulness compared with controls. Participants appreciated the convenience of the intervention and the mindfulness skills they obtained from the program. Conclusion: We demonstrated the feasibility of conducting a randomized trial of an mHealth mindfulness intervention for cancer patients and their informal caregivers. Results from fully powered efficacy trials would inform the potential for clinicians to use this scalable intervention to help improve QoL of those affected by cancer and their caregivers.

Can mHealth interventions improve quality of life of cancer patients? A systematic review and meta-analysis

“…We identified 17 RCTs ( Willems et al, 2017 ; Mendoza et al, 2017 ; Graetz et al, 2018 ; Ferrante et al, 2018 ; Admiraal et al, 2017 ; Compen et al, 2018 ; Frensham et al, 2018 ; Galiano-Castillo et al, 2016 ; Greer et al, 2019 ; Ham et al, 2019 ; Ji et al, 2019 ; Kubo et al, 2019 ; Rosen et al, 2018 ; Uhm et al, 2017 ; Urech et al, 2018 ; Yang et al, 2019 ; Zhu et al, 2018 ) and 8 pre-post design studies ( Børøsund et al, 2019 ; Cheong et al, 2018 ; Lozano-Lozano et al, 2019 ; McCarroll et al, 2015 ; Pappot et al, 2019 ; Park et al, 2019 ; Pope et al, 2019 ; Trinh et al, 2018 ). Nine studies (5 RCTs and 4 pre-post designs) tested physical activity / rehab / fitness interventions ( Mendoza et al, 2017 ; Frensham et al, 2018 ; Galiano-Castillo et al, 2016 ; Ji et al, 2019 ; Uhm et al, 2017 ; Cheong et al, 2018 ; Lozano-Lozano et al, 2019 ; Park et al, 2019 ; Trinh et al, 2018 ), six studies – CBT interventions (4 RCTs and 2 pre-post designs) ( McCarthy et al, 2018 ; Willems et al, 2017 ; Compen et al, 2018 ; Greer et al, 2019 ; Greer et al, 2019 ; Ham et al, 2019 ; Børøsund et al, 2019 ), three studies - mindfulness/stress management interventions (3 RCTs) ( Kubo et al, 2019 ; Rosen et al, 2018 ; Urech et al, 2018 ), two studies - social support (1 RCT and 1 pre-post design) ( Zhu et al, 2018 ; Pappot et al, 2019 ), two studies - information/psychoeducation (2 RCTs) ( Graetz et al, 2018 ; Admiraal et al, 2017 ), two studies – weight management (1 RCT and 1 pre-post design) ( Ferrante et al, 2018 ;…”

“…The majority of studies (15 RCTs and 7 pre-post designs) found that mHealth interventions were associated with improvement in at least one domain of HRQoL of cancer patients ( Willems et al, 2017 ; Graetz et al, 2018 ; Ferrante et al, 2018 ; Compen et al, 2018 ; Frensham et al, 2018 ; Galiano-Castillo et al, 2016 ; Greer et al, 2019 ; Greer et al, 2019 ; Ji et al, 2019 ; Kubo et al, 2019 ; Rosen et al, 2018 ; Uhm et al, 2017 ; Urech et al, 2018 ; Yang et al, 2019 ; Zhu et al, 2018 ; Børøsund et al, 2019 ; Cheong et al, 2018 ; Lozano-Lozano et al, 2019 ; McCarroll et al, 2015 ; Pappot et al, 2019 ; Park et al, 2019 ; Trinh et al, 2018 ).…”

Rapid deployment of virtual mind-body interventions during the COVID-19 outbreak: feasibility, acceptability, and implications for future care

“…However, numerous barriers to in-person participation exist in the normal course of cancer care including travel burden, institutional resources (e.g., space), symptom burden, demanding treatment schedules, and susceptibility to infection in immune-compromised patients [ 10 ]. Prior research on virtual delivery of mind-body programs supports the feasibility and benefits of these services but has focused on mindfulness interventions delivered individually through a website or app [ 11 – 13 ]. Our virtual classes overcome barriers to in-person delivery while providing a range of services (e.g., fitness, music).…”

Technology-based Health Solutions for Cancer Caregivers to Better Shoulder the Impact of COVID-19: A Systematic Review Protocol

“…Studies have shown that technologies (e.g., telehealth) may be particularly useful to address issues cancer caregivers experienced during COVID-19; with some research identifying the potential improvement to health and well-being [ 23 – 25 ]. Technology-based interventions can offer greater accessibility to care for cancer caregivers that can be: (1) delivered remotely without physical contacts between interventionists and the caregivers [ 26 , 27 ], (2) received cost-effectively without the need for transportation [ 24 ], and accessed conveniently with self-paced learning [ 28 , 29 ] of tailored content [ 30 , 31 ]. In addressing the unique challenges cancer caregivers face amidst COVID-19, no research has identified technology-based health solutions for cancer patients that can address these needs, such as care needs, general healthcare needs, information and communication needs, and social support needs (see Table 1 ).…”