Received: 8 July 2020

DOI: 10.1002/pon.5557

PAPER
- -Revised: 3 September 2020 Accepted: 21 September 2020

Pilot pragmatic randomized trial of mHealth

mindfulness‐based intervention for advanced cancer
patients and their informal caregivers

Ai Kubo1 | Elaine Kurtovich1 | MegAnn McGinnis1 | Sara Aghaee1 |

Andrea Altschuler1 | Charles Quesenberry Jr.1 | Tatjana Kolevska2 |
Raymond Liu1,3 | Natalya Greyz‐Yusupov4 | Andrew Avins1,5

1
Kaiser Permanente Division of Research,
Oakland, California, USA Abstract
2
Kaiser Permanente Napa/Solano Medical Objective: Assess the feasibility of conducting a cluster randomized controlled trial
Center, Vallejo, California, USA
(RCT) comparing technology‐delivered mindfulness‐based intervention (MBI) pro-
3
Kaiser Permanente San Francisco Medical
Center, San Francisco, California, USA
grams against a waitlist control arm targeting advanced cancer patients and their
4
Kaiser Permanente San Rafael Medical informal caregivers.
Center, San Rafael, California, USA Methods: Two‐arm cluster RCT within Kaiser Permanente Northern California. We
5
School of Medicine, University of California, recruited patients with metastatic solid malignancies or hematological cancers and
San Francisco, California, USA
their informal caregivers. Intervention‐group participants chose to use either a
Correspondence commercially available mindfulness app (10–20 min/day) or a webinar‐based
Ai Kubo, Kaiser Permanente Division of
mindfulness course for 6 weeks. The waitlist control group received usual care. We
Research, 2000 Broadway, Oakland, CA
94612, USA. assessed feasibility measures and obtained participant‐reported data on quality of
Email: ai.kubo@kp.org
life (QoL; primary outcome) and distress outcomes (secondary) pre‐ and
Funding information postintervention.
The Permanente Medical Group (TPMG) Results: A hundred and three patients (median age 67 years; 70% female; 81%
Delivery Science Research Program
White) and 39 caregivers (median age 66 years; 79% female; 69% White) were
enrolled. Nearly all participants chose the mindfulness app over the webinar‐based
program. Among the participants in the intervention arm who chose the mobile‐app
program and completed the postintervention (6‐week) survey, 21 (68%) patients
and 7 (47%) caregivers practiced mindfulness at least 50% of the days during the
6‐week study period. Seventy‐four percent of intervention participants were “very”
or “extremely” satisfied with the mindfulness program. We observed improvements
in anxiety, QoL, and mindfulness among patients in the intervention arm compared
to those in the control group.
Conclusions: We demonstrated the feasibility of conducting a cluster RCT of
mHealth MBI for advanced cancer patients and their caregivers. Such remote in-
terventions can be helpful particularly during the COVID‐19 pandemic.

KEYWORDS
cancer, caregivers, chemotherapy, clinical trial, distress, intervention, mindfulness, oncology,
psycho‐oncology, quality of life

Psycho‐Oncology. 2024;e5557. wileyonlinelibrary.com/journal/pon © 2020 John Wiley & Sons Ltd. 1 of 11

https://doi.org/10.1002/pon.5557
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1 | BACKGROUND 2 | METHODS

Advanced cancer patients, their families, and friends face emotional 2.1 | Setting
upheaval and persistent concerns. As an estimated 35% of cancer
patients experience psychological distress,1 clinicians face frequent The study was conducted within Kaiser Permanente Northern Cali-
challenges in assisting patients and family caregivers. Screening for fornia (KPNC), an integrated health‐care delivery system that
psychosocial distress became a Commission on Cancer (CoC) provides comprehensive health care to a large, diverse population of
accreditation requirement in 2015.2 To fulfill the intent of this over 4.4 million individuals. KPNC members are representative of the
requirement, providers need efficient strategies for offering sup- area's population with regard to ethnicity (21% Asians, 25% His-
port. Research indicates that distress not only affects quality of life panics, and 7% African Americans), education,16 and cancer incidence
(QoL) but also survival and prognosis among cancer patients. 3
and survival rates.17 KPNC has a high‐quality cancer registry that
Furthermore, the effect of the COVID‐19 pandemic on cancer reports to the California Cancer Registry and the National Cancer
patients highlights their vulnerability to distress and poor QoL, Institute Surveillance, Epidemiology, and End Results program, cap-
while access to effective mental health care has drastically tures the same data elements, and uses the same quality control
diminished.4,5 protocols.
Traditional mindfulness‐based interventions (MBIs), such as
mindfulness‐based stress reduction (MBSR),6 have shown efficacy
in reducing psychological distress and improving QoL among 2.2 | Participants
7
cancer patients. Monitor and Acceptance Theory posits that
MBI improves stress‐related health and psychological outcomes via We targeted patients with metastatic solid malignancies or hema-
the skills of attention monitoring and acceptance.8 However, tological cancers. Primary informal caregivers of the patients were
standard MBIs require 30þ h of in‐person class sessions plus 45 also eligible and invited to participate. The inclusion criteria for both
min/day of daily homework. These programs are frequently too patients and caregivers included age ≥18 ears; owning a smartphone,
burdensome for sick patients on active treatment and their busy tablet, or computer with Internet access; and understanding English.
caregivers. Previous MBI studies mainly used early stage breast
cancer patients who completed treatment,7 and few focused on
advanced cancer patients.9,10 Furthermore, with the current 2.3 | Procedures
COVID‐19 pandemic, remote delivery of MBI interventions is
critical. This study was conducted between October 2018 and April 2020.
In addition, despite the tremendous burden they experience, Participants completed an online informed consent form, and study
informal caregivers of cancer patients rarely receive any inter- protocols and procedures were approved by the KPNC Institutional
vention to reduce their distress. Caregivers may have chronic Review Board. The study was registered on clinicaltrials.gov
health conditions of their own, and their health status can (NCT03751995).
be worsened by the stress and demands of caregiving.11 The
negative effects of caregiving, including a higher mortality rate,12
are found to be greater among caregivers of patients with 2.3.1 | Recruitment
advanced cancer, particularly when patients are receiving treat-
ments such as palliative chemotherapy.13 However, cancer care- Eligible patients were identified using the KPNC electronic health
givers' emotional, spiritual, and physical needs are often not record system. Patients were recruited using several strategies,
supported. Thus, research is needed to test methods of remote including referrals from oncology clinicians; brochures at each clinic;
MBI delivery that meet the needs of sicker patients and burdened and invitation emails, followed up with phone calls. Caregivers were
caregivers. recruited by referral of a patient‐participant. Patients could partici-
We conducted a two‐arm pilot cluster randomized controlled pate with or without caregiver participation, and caregivers could
trial (RCT) comparing technology‐delivered MBI programs against a also participate without an enrolled patient. Participants who
waitlist control arm targeting advanced cancer patients and their completed the study received a $25 gift card and a year's subscrip-
caregivers within a large health‐care delivery system. For the tion to the mindfulness app used for this trial.
intervention arm, we offered two options for MBI: self‐paced app
or instructor‐led webinar‐based program. In our previous feasibility
studies using a mobile‐app MBI,14,15 some participants expressed 2.3.2 | Randomization
desire for a more interactive program using a webinar format. We
aimed to assess patient preferences on the delivery of these two We randomized the 16 participating clinics into two arms (eight
types of MBI. intervention and eight control clinics) with stratification on clinic
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KUBO ET AL.
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size: small (<160 expected eligible patients), medium (160–300), 2.4 | Outcome measures
and large (>300). The nature of the group assignment and inter-
vention did not allow for masking of participants or clinicians. 2.4.1 | Retention
Research tasks were assigned to separate members of the team to
ensure that primary investigators remained blinded to participant Retention rates were calculated separately as the proportion of
status. enrolled participants who completed the 6‐week and 12‐week
follow‐up surveys.

2.3.3 | Intervention
2.4.2 | Adherence
Participants from clinics assigned to the intervention arm were
given two options: 6‐week mobile‐based mindfulness program The HeadspaceTM program automatically collected adherence data,
TM
using Headspace or 6‐week webinar‐based mindfulness including date, time, length, and name of session to which partici-
program, eMindful (detailed descriptions below). Research staff pants listened, identified by a study ID, and transferred the data to
explained the differences between these options to participants the researchers on a weekly basis. We calculated the proportion of
randomized to the intervention arm, and staff provided specific days during the 6‐week intervention period that each participant
instructions to access the participants' chosen program. Research used the program.
staff checked in with participants after a few days and provided
support for setting up HeadspaceTM or eMindful over the phone, if
needed. 2.4.3 | Participant‐reported measures

HeadspaceTM We collected outcome data using self‐administered online surveys

TM
Headspace is a self‐paced program that provides guided using DatStat software (DatStat Ilume, version 6.1.18.19) at the time
mindfulness meditation instruction via a website or mobile appli- of consent, immediately postintervention, and 6 weeks post-
cation (iOS and Android). Participants who chose HeadspaceTM intervention using instruments described below.
were asked to use the app daily for 6 weeks. They were encour-
aged to first complete the 30‐day “Basics” course, which teaches Quality of life (primary outcome)
users the basics of mindfulness meditation, then the cancer pack, We used the 46‐item Functional Assessment of Chronic Illness
which was designed specifically for individuals affected by cancer. Therapy—Palliative Care (FACIT‐Pal) to assess QoL in patients over
HeadspaceTM courses teach mindfulness using various techniques the past 7 days. FACIT‐Pal asks respondents to rate their QoL in four
in 10–20 min sessions, including breathing exercises, body scan, domains (physical, social/family, emotional, and functional well‐being)
noting (awareness of emotions arising at the moment), and visu- and also includes questions regarding additional concerns related to
alization. The HeadspaceTM app can send reminders using push palliative care.19 Caregiver QoL was determined using the Caregiver
notifications, and study staff made phone calls if an intervention Quality of Life Index—Cancer (CQOLC) scale.20 The CQOLC gauges
participant completed fewer than three HeadspaceTM sessions in a the daily and overall impact caregiving had on respondents' QoL in
week. the past week. Higher scores indicate better QoL on both scales.

eMindful Distress
eMindful offers an online virtual classroom in which patients and The National Comprehensive Cancer Network Distress Thermom-
caregivers could participate in online, synchronous, 2‐h weekly eter was used to assess current distress level.21 Respondents were
mindfulness courses for 6 consecutive weeks. Participants could asked to rate their level of distress during the past week by choosing
choose from either the "Stress Less, Live More" class, modeled after a number, with 0 indicating no distress and 10 extreme distress.
the MBSR program,6 or a Mindfulness‐based Cancer Recovery
course.18 Recorded versions of the classes and online manual were Anxiety and depression
available for missed live sessions. We used the 14‐item Hospital Anxiety and Depression Scale (HADS)
to assess anxiety and depressive symptoms that had occurred
through the prior week.22 A score of 0–7 is considered normal, 8–10
2.3.4 | Waitlist control arm represent “Borderline abnormal,” and 11–21 represent “Abnormal.”

Participants from the clinics randomized to the waitlist control arm Mindfulness
received usual care. Upon completion of the study, the participants The 24‐item Five Facet Mindfulness Questionnaire (FFMQ‐SF) mea-
TM
were provided with a 1‐year subscription to Headspace . sures five factors representing elements of mindfulness: observing,
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describing, acting with awareness, nonjudging of inner experience, and 60%; control n ¼ 42, 82%) and 27 caregivers (intervention n ¼ 14,
23
nonreactivity to inner experience, experienced over the past month. 64%; control n ¼ 13, 76%) completed the 12‐week survey.

2.5 | Postintervention interview 3.1.2 | Adherence

We conducted brief phone interviews with intervention participants Among the participants in the intervention arm who chose the
after they completed the intervention to obtain feedback regarding HeadspaceTM program and completed the postintervention survey,
the study using closed‐ and open‐ended questions. 21 (68%) patients and 7 (47%) caregivers used the app at least 50%
of the days during the 6‐week study period, and 16 (52%) patients
and 4 (27%) caregivers practiced at least 70% of the days. Six (19%)
2.6 | Data analyses patients and three (20%) caregivers did not initiate the HeadspaceTM
program. Of the 25 patients who completed at least one Head-
Data from patient and caregiver participants were analyzed sepa- spaceTM session, 21 (84%) and 16 (64%) used the app at least 50%
rately. To obtain preliminary efficacy results, we used mixed effects and at least 70% of the days during the 6‐week study period
regression to model change in outcome measures using baseline, respectively. Of the 12 caregivers who actively used HeadspaceTM, 7
postintervention, and follow‐up scores between intervention and (58%) completed at least 50% and 4 (33%) completed at least 70% of
control arms. We also modeled change in outcome scores between the days. In addition, approximately 96% of patients and 83% of
baseline and 12 weeks and compared models including and excluding caregivers continued to use the program at least once after
postintervention (6‐week) mindfulness score change in order to completion of the study.
determine if mindfulness had a mediating effect on other QoL out-
comes. All models controlled for race/ethnicity, gender, age at
baseline, and baseline score. Because only 3 intervention participants 3.2 | Participant‐reported outcomes
who chose eMindful completed the study, we determined that this
intervention was not sufficiently acceptable for a future trial and, Preliminary efficacy analyses were conducted on an intent‐to‐treat
therefore, we report only outcomes for intervention participants who basis.
TM
used Headspace . Analyses were conducted with SAS version 9.4
(SAS Institute).
3.2.1 | Patients

3 | RESULTS Table 2 presents change in scores between baseline and 6 and 12

weeks for the outcome measures by study arm. After adjusting for
3.1 | Participant characteristics, enrollment, age, gender, race/ethnicity, and baseline score, patients in the
and flow intervention arm experienced significantly greater improvements in
the HADS anxiety (p ¼ 0.01), FACIT‐Pal physical (p ¼ 0.03) and
Baseline characteristics of the patients and caregivers who partici- overall (p ¼ 0.04) well‐being, total FACIT‐Pal score (p ¼ 0.04), and
pated in the study are described in Table 1. Figure 1 shows the mindfulness (FFMQ total score [p ¼ 0.02]) compared to controls
overall flow of participants through the study, including common (Figure 2).
reasons for ineligibility and non‐participation. Fifty‐two (50%) pa-
tients identified a potential caregiver to participate in the study. In
addition, six caregivers self‐referred after seeing a study brochure. 3.2.2 | Caregivers
Three of the caregivers approached declined participation in the
study; the most common reason was lack of interest in participating. Caregivers in the intervention arm experienced significant improve-
Sixteen of the identified caregivers could not be reached. Nine ments in distress (p ¼ 0.03) and mindfulness (p ¼ 0.03) from baseline
caregivers participated in the study without a patient participant. to 6 weeks. However, comparing intervention and control arms, there
were no statistically significant differences (data not shown).

3.1.1 | Retention rate

3.2.3 | Exploratory mediation analyses
A total of 104 patients and 39 caregivers enrolled in the study. Eighty
patients (intervention n ¼ 33, 62%; control n ¼ 47, 92%) and 33 Controlling for postintervention change in mindfulness at 6 weeks,
caregivers (intervention n ¼ 17, 77%; control n ¼ 16, 94%) completed we observed substantial attenuation in the effect estimate on anxiety
the 6‐week survey. Seventy‐four (74) patients (intervention n ¼ 32, (between baseline and 12 weeks, data not shown).
 10991611, 2024, 2, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/pon.5557 by UNIVERSIDADE NOVE DE JULHO, Wiley Online Library on [25/06/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
KUBO ET AL.
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TABLE 1 Baseline demographic and clinical characteristics of participants

Patients Caregivers

Intervention arm Control arm Intervention arm Control arm

n ¼ 52 n ¼ 51 n ¼ 22 n ¼ 17

Age, mean (SD) 65.8 (8.8) 67.1 (10.4) 60.7 (16.5) 64.6 (7.9)

Female, n (%) 38 (73.1) 34 (66.7) 18 (81.8) 13 (76.5)

Marital status, n (%)

Married 37 (71.2) 34 (66.7) 19 (86.4)a 14 (82.4)

Living as married/domestic partner 2 (3.8) 4 (7.8) 0 (0.0) 0 (0.0)

Widowed 2 (3.8) 4 (7.8) 0 (0.0) 0 (0.0)

Divorced 7 (13.5) 6 (11.8) 0 (0.0) 3 (17.6)

Never married 4 (7.7) 3 (5.9) 3 (13.6) 0 (0.0)

Race, n (%)

White 44 (84.6) 39 (76.5) 16 (72.7) 11 (64.7)

AfricanAmerican 0 (0.0) 6 (11.8) 0 (0.0) 3 (17.6)

Hispanic 4 (7.7) 4 (7.8) 1 (4.5) 1 (5.9)

Asian/Pacific islander 1 (1.9) 2 (3.9) 2 (9.1) 1 (5.9)

Other/Unknown 3 (5.8) 0 (0.0) 3 (13.6) 1 (5.9)

Education, n (%)

Some college or less 25 (48.1) 26 (51) 7 (31.8) 9 (52.9)

College graduate 9 (17.3) 18 (35.3) 8 (36.4) 3 (17.6)

Postgraduate degree 18 (34.6) 7 (13.7) 7 (31.8) 5 (29.4)

Income, n (%)

Less than $75,000 14 (31.1) 19 (41.3) 5 (27.8) 4 (28.6)

$75,000 to $99,999 9 (20.0) 7 (15.2) 4 (22.2) 3 (21.4)

$100, 000 to $149,999 10 (22.2) 14 (30.4) 5 (27.8) 5 (35.7)

$150,000 or more 12 (26.7) 6 (13.0) 4 (22.2) 2 (14.3)

Primary delivery of the mindfulness program, n (%)

iOS (iPad or iPhone) 14 (56.0) ‐ 6 (50.0) ‐

Android 3 (12.0) ‐ 2 (16.7) ‐

Computer with Internet 8 (32.0) ‐ 4 (33.3) ‐

Cancer type, n (%)

Breast 16 (30.8) 25 (49.0) ‐ ‐

Hematologic 13 (25.0) 4 (7.8) ‐ ‐

Gastrointestinal 9 (17.3) 4 (7.8) ‐ ‐

Lung 4 (7.7) 8 (15.7) ‐ ‐

Urologic 6 (11.5) 5 (9.8) ‐ ‐

Gynecological 2 (3.8) 2 (3.9) ‐ ‐

Skin 1 (1.9) 2 (3.9) ‐ ‐

Other 1 (1.9) 1 (2.0) ‐ ‐

(Continues)
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TABLE 1 (Continued)

Patients Caregivers

Intervention arm Control arm Intervention arm Control arm

n ¼ 52 n ¼ 51 n ¼ 22 n ¼ 17

Caregiver relationship to the patient

Spouse/partner ‐ ‐ 10 (62.5) 12 (85.7)

Child ‐ ‐ 0 (0.0) 1 (7.1)

Other relative ‐ ‐ 5 (31.3) 0 (0.0)

Friend ‐ ‐ 1 (6.3) 1 (7.1)

a
Bolded values indicate statistically significant differences (p < 0.05) between intervention and control arms.

3.3 | Postintervention interview webinar‐style formats to address accessibility challenges in previous

MBI research. Several recent small RCTs demonstrated that,
Of the 37 participants who participated in the interviews, the most compared with a usual‐care control group, cancer patients in online
common reasons for joining the study were an interest in mind- webinar MBI arms experienced significant improvements in
fulness (78%), managing anxiety (57%), and reducing stress (46%). distress,27 QoL,27 and mindfulness.27,28 Although webinar‐based
Seven of nine caregivers interviewed enrolled to support their programs more closely represent traditional MBIs and offer conve-
friend/family member with cancer. The most commonly reported nience, they still lack flexibility in scheduling, are time‐demanding,
benefits of the mindfulness practice were increased skills to be in and can be expensive. Given the burdened circumstances of
the present moment (65%) and having a tool for managing stress/ advanced cancer patients and their busy families, we hypothesized
anxiety (62%). More than half (54%) said it was not difficult to that convenient, frequent, low‐dosage MBI that can be accessed from
meditate daily, while 27% reported that time was a barrier. Most anywhere would be more feasible and preferred by the patients and
participants (74%) were “very” or “extremely” satisfied with the their caregivers, than the traditional, lengthy, in‐person versions: our
mindfulness program and 86% planned to continue meditating after data supported this hypothesis.
the end of the study. Health‐care systems often have limited resources for psychoso-
cial services for oncology patients. Now that screening for psycho-
social distress has become a CoC accreditation requirement,2
4 | DISCUSSION clinicians need efficient strategies to offer psychosocial support to
those who are found to be distressed. Scalable and low‐cost in-
This is one of the first pilot cluster RCTs to test the feasibility of terventions such as mHealth MBI may help address this challenge. Of
offering a technology‐based MBI to metastatic cancer patients and note, KPNC recently began offering free subscriptions to a mobile‐
their informal caregivers. The mHealth MBI was well‐accepted and based mindfulness app to all members given the stressful situation of
appreciated by the participants. Although this study was not the COVID‐19 pandemic. Results from such system‐wide imple-
designed as an efficacy trial, the preliminary results suggested mentation of a self‐paced MBI app would provide important evidence
improvement in QoL, anxiety, and mindfulness among the patients that could help other health‐care systems and individuals affected by
in the intervention arm. This type of remote intervention that cancer.
requires no in‐person contact is particularly important given the Lastly, although we did not find significant improvement in the
current COVID‐19 pandemic where patients tend to avoid going to outcomes of caregivers in the present study, likely due to the
clinics in person, and levels of distress are even higher than smaller sample size, we observed a reduction in distress and
24
usual. improvement in mindfulness within the intervention arm. A growing
Our study addressed limitations in the previous MBI studies by body of literature suggests that distress is interdependent and
testing the feasibility and acceptability of offering self‐paced, reciprocal in families coping with cancer.29 Thus, a dyadic inter-
smaller‐dose MBI. Despite its known efficacy, traditional mindfulness vention involving both patients and families might result in maxi-
programs are often time‐consuming and demanding, often not prac- mizing the benefit. Furthermore, corroborating previous oncology
tical or feasible for advanced cancer patients or those who take care mindfulness studies, participants were predominantly female and
of them. Recent studies report that many Americans suffering from White (patients and caregivers). Future studies that focus on male
depression, stress, or anxiety prefer online mindfulness training over patients and minority populations may help reduce the current gap
in‐person sessions.25,26 Oncology studies have begun to incorporate in knowledge.
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Overall flow of participants through the study

FIGURE 1
ET AL.
KUBO
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TABLE 2 Patient outcome measures

Intervention arm (n ¼ 31) Waitlist control arm (n ¼ 46) Intervention effect

Change at Change at Change at Change at

Possible
6 weeks 12 weeks 6 weeks 12 weeks
score Difference 95% confidence
range N Mean (SD) N Mean (SD) N Mean (SD) N Mean (SD) in meansa interval p‐value

DT 0–10 31 0.81 (2.2) 30 1.23 (2.69) 46 0.48 (2.69) 41 0.17 (3.02) ¡0.78 2.01, 0.46 0.20
b
HADS

Depression 0–21 30 1.1 (3.48) 29 1.59 (3.81) 45 0.04 (2.01) 40 0.5 (2.52) ¡1.16 2.34, 0.03 0.06

Anxiety 0–21 30 1.23 (2.18) 28 1.75 (3.18) 42 0.31 (2.07) 38 0.71 (3.18) ¡1.39 2.45, 0.33 0.01

FACIT‐PAL
(QoL)b

Physical 0–28 31 1.78 (4.57) 30 2.03 (5.25) 46 0.72 (3.59) 41 0.36 (3.53) 2.44 0.28, 4.6 0.03
well‐being

Social/family 0–28 31 0.44 (2.48) 30 0.68 (3.06) 46 0.19 (3.65) 40 0.23 (3.45) ¡0.14 1.51, 1.22 0.83
well‐being

Emotional 0–24 31 1.07 (3.37) 30 1.75 (4.23) 46 0.07 (3.54) 41 0.2 (4.12) 0.99 0.63, 2.61 0.23
well‐being

Functional 0–28 31 1.25 (4.09) 30 1.49 (5.82) 46 0.05 (2.83) 41 0.53 (3.6) 0.96 1.09, 3.01 0.32
well‐being

Overall 0–108 31 4.54 (11.23) 30 5.95 (14.44) 46 0.94 (7.77) 39 1.08 (10.96) 4.80 0.15, 9.45 0.04
well‐being

Palliative care 0–76 31 3.02 (6.48) 30 3.51 (9.31) 46 0.5 (4.79) 41 0.5 (7.18) 2.45 0.38, 5.28 0.09
subscale

Total FACIT‐ 0–184 31 7.56 (16.46) 30 9.46 (23.13) 46 1.44 (10.78) 39 1.81 (16.98) 7.28 0.53, 14.04 0.04
PAL score

FFMQb

Total 24–120 26 4.35 (8.1) 27 5.44 (7.9) 34 1.79 (6.2) 30 1.2 (8.76) 4.34 0.75, 7.94 0.02

Abbreviations: DT, Distress Thermometer; FACIT‐PAL, Functional Assessment of Chronic Illness Therapy—Palliative Care scale; FFMQ, Five Facet
Mindfulness Questionnaire; HADS, Hospital Anxiety and Depression Scale; QoL, quality of life.
a
Adjusted for age, gender, race/ethnicity, and baseline score.
b
Higher scores indicate greater anxiety, depression, QoL, and mindfulness.
The bold text represent statistically significant results.

4.1 | Study limitations are now numerous language options available; future studies that
target individuals who speak different languages would provide more
Several limitations of the present study should be considered. First, generalizable results and potentially narrow the disparities in
because this study was conducted within a large health‐care system, oncology care.
the rate of access to technology may be higher than in the general
population. However, mobile devices and the Internet are increas-
ingly used by all segments of the population, including those in lower 4.2 | Clinical research implications and conclusions
30
socioeconomic status and those who live in remote areas. Second,
we used a usual‐care control group instead of an active control Despite limitations, our study provides encouraging preliminary evi-
group. Many active control group options are not appropriate for dence regarding the feasibility of conducting a cluster RCT using an
mind‐body research because there are rarely obvious placebo or mHealth MBI for metastatic cancer patients and their caregivers.
31
“sham” interventions that mimic mindfulness. Even when a satis- Rigorous examination of the effect of the recent system‐wide imple-
factory placebo exists, employing usual‐care controls would be of mentation of an mHealth mindfulness app would provide important
great value for pragmatic trials evaluating treatments to improve evidence regarding the effectiveness of a safe, low‐cost intervention
clinical care.32 Finally, we had to exclude patients whose primary for advanced cancer patients and their caregivers in improving QoL
language was not English because at the time of this study there was and distress. This type of intervention could also be cost saving for
no other language options offered by HeadspaceTM. However, there health‐care systems that have limited resources to offer mental health
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F I G U R E 2 Statistically significant differences in change in patient outcome measures between treatment arms. FACIT‐PAL, Functional
Assessment of Chronic Illness Therapy—Palliative Care scale; FFMQ, Five Facet Mindfulness Questionnaire; HADS, Hospital Anxiety and
-

Depression Scale
ET AL.
KUBO
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This project was supported by The Permanente Medical Group effect of mindfulness‐based stress reduction on psychological status,
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The quantitative data that support the findings of this study are trial of mhealth mindfulness intervention for cancer patients and
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Elaine Kurtovich https://orcid.org/0000-0002-9124-3504 projects/memberhealthsurvey/SiteCollectionDocuments/chis_non_
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