ORIGINAL ARTICLE

Comparing dyadic cognitive behavioral therapy (CBT) with

dyadic integrative body-mind-spirit intervention (I-BMS) for
Chinese family caregivers of lung cancer patients: a
randomized controlled trial

Daiming Xiu​1 ​& ​Yat-Lui Fung​1 ​& ​Bobo Hi-Po Lau​2 ​& ​Daniel F. K. Wong​1 ​& ​Celia H. Y. Chan​1 ​& ​Rainbow T. H. Ho​1
& ​Tsz-Him So​3 ​& ​Tai-Chung Lam​3 ​& ​Victor Ho-Fun Lee​3 ​& ​Anne W. M. Lee​3 ​& ​Sau Fong Chow​4 ​& ​Fai Man Lim​4 ​&
Miu Wah Tsang​4 ​& ​Cecilia L. W. Chan​1 ​& ​Amy Y. M. Chow​1

Received: 14 March 2019 /Accepted: 28 June 2019 ©

Springer-Verlag GmbH Germany, part of Springer Nature
2019

Abstract ​Purpose ​The study adopted a randomized controlled trial to compare the effect of culturally compatible
psychosocial interven- tions on multiple aspects of quality of life (QoL) for family caregivers of lung cancer patients. ​Methods
157 Chinese informal caregivers of lung cancer patients were recruited together with the family members for whom they were
providing care, and randomly assigned to either integrative body-mind-spirit intervention (I-BMS) or cognitive behavioral
therapy (CBT). Patient-caregiver dyads attended the same arm of intervention in separate groups for 8 weeks. Assessments of
generic QoL, anxiety, depression, perceived stress, insomnia, and caregiving burden were measured before intervention (​T​0​),

within 1-week (​T​1​), 8-week (​T​2​), and 16-week (​T​3​) post-intervention. Results
​ ​Adopting the intention-to-treat analysis, family
caregivers in receipt of both I-BMS and CBT exhibited a statistically significant improvement in generic QoL immediately
following intervention and at follow-up assessments, with moderate effect size. Improvement of insomnia was found at ​T​1 ​for

both modes, which deteriorated at follow-up; both modes reduced anxiety and perceived
​ stress at follow-up. No intervention
effect was observed in depression and domains of caregiving burden. There was no significant interaction effect between
intervention type and time. No main or interaction effect between sample background variables and intervention type was
found to predict symptomatic changes at ​T​1 ​and T
​ 3​ ​. Conclusions
​ ​Culturally attuned I-BMS and CBT exhibited equivalent
effectiveness in improving psychological distress and generic QoL for family caregivers of lung cancer patients. To improve
the evaluation of outcomes, future study could benefit from incorporating a usual care control.

.​ .​ .​ .​ .​
Keywords ​Lung cancer ​ Family caregiver ​ Cognitive behavioral therapy ​ Mind-body intervention ​ Chinese ​ Quality of
life
Hong Kong for many years [​1​], as well as in other more and
less developed countries [​2​, ​3​]. The importance of family
Introduction caregivers (FCGs) is increasingly recognized in outpatient,
palliative care, and home-based care for lung cancer [​2​, ​4​].
Lung cancer has been the leading cause of cancer deaths in FCGs deliver intimate patient care and interventions at home,
which can improve patient access to supportive modalities and
potentially reduce the costs of care [​5​]. Meanwhile, the care-
giving burden may impair FCGs​’ ​quality of life (QoL) [​6​], and
give rise to clinical levels of anxiety, depression, sleep distur-
bances, and fatigue [​7​]. This may negatively impact FCGs​’
ability to provide quality care, and even exacerbate patient
distress [​8​]. FCGs have psychosocial needs that must be ad-
dressed so that they can maintain their own health and provide
the best care possible to the patients.
Thus far, the majority of psychosocial intervention
research with cancer caregivers have focused on coping with
localized
Supportive Care in Cancer
https://doi.org/10.1007/s00520-019-0497
4-z

* ​Amy Y. M. Chow
chowamy@hku.hk

1​
Department of Social Work and Social Administration, The
University of Hong Kong, Pokfulam, Hong Kong

2​
Department of Counselling and Psychology, Hong Kong Shue Yan
 University, North Point, Hong Kong (e.g., social interac- tion and familial relationship) [​19​]. To
demonstrate the benefit of cultural adaption in CBT, we
3​
Department of Clinical Oncology, The University of Hong Kong, adopted a culturally sensitive intervention, i.e., I-BMS as a
Pokfulam, Hong Kong comparative condition. I-BMS was developed based on
integrating insights from Daoism, traditional Chinese medicine
4​
Hong Kong Cancer Fund, Central, Hong Kong (TCM), and Western psycho- therapy models. Distinct from
breast or prostate cancer; few have focused on randomizedCBT, I-BMS aims to foster the well-being of clients by
controlled trials (RCT) for lung cancer (see reviews [​9​, ​10​]).restoring dynamic equilibrium between body, mind, and spirit
Several recent studies have addressed QoL issues for lung[​20​, ​21​]. I-BMS has been found efficacious in improving the
cancer FCGs. These studies involved both patients and theirmental health and func- tions in individuals with depression
caregiver simultaneously, and entailed intervention modes such[​20​] or insomnia [​22​], as well as enhancing QoL of different
as skill training grounded in cognitive behavioral therapycancer patient populations
(CBT) [​11​, ​12​], psycho-educational interventions [​13​, ​14​],
mind-body programs [​8​, ​15​], and a telephone-based interven-
tion focusing on psychosocial topics [​9​]. While the majority of
(breast, colorectal, mixed cancers) [​23​, ​24​]. However, no pre-
these studies showed significant efficacy for the patients, their
vious study has focused on FCGs, particularly for lung cancer.
effect on caregivers varied. Schellekens et al. speculated that a
The significance of improving multifaceted QoL for FCGs has
possible reason for this was that FCGs were more focused on
been emphasized from the integrative psychosocial per-
the patients​’ ​well-being than on their own [​15​]. Therefore,
spective [​6​]. Since both CBT and I-BMS were multi-compo-
interventions that employ a parallel patient-caregiver group
nent, we expected to see their intervention effect in both the
design (i.e., patients and caregivers receiving the same dose of
generic and multiple aspects of QoL for FCGs of lung cancer
intervention, but at separate venues and using homogenous
patients, including psychological distress (e.g., perceived stress,
groups) will allow therapeutic space for addressing role-
anxiety, and depression), physical health (e.g., sleep problem),
specific needs [​16​], and may work effectively for FCGs.
and psychosocial functions to caregiving burden. Moreover,
Moreover, evaluations of two dyadic programs (caregiver-
factors related to greater burden and higher risk of
assisted group training vs. telephone-delivered intervention on
psychological distress have been identified for spousal
dyads) that adhered to cognitive-behavioral principles in- dicate
caregivers, being a younger caregiver, caring for another sick
that CBT has the potential to alleviate FCG​’​s psycho- logical
family member, having lower educational attainment, and
distress, but its role to improve the QoL of FCGs of lung cancer
lower family cohesion and expressiveness [​7​, ​25​]. The effica-
patients needs further investigation [​11​, ​12​].
cy of psychosocial interventions has been found to vary ac-
The current study included an RCT comparing the cording to gender, age, and stage of patients​’ ​lung cancer [​12​,
efficacy of dyadic CBT with dyadic integrative 18​]. It was expected that both CBT and I-BMS could be ef-
body-mind-spirit (I- BMS), specifically for FCGs. Both are fective for different populations. We thus examined the asso-
active multi-compo- nent, culturally compatible psychosocial ciation between the intervention effects and the sample
interventions. CBT has been found to be effective in treating characteristics.
anxiety and depres- sion among Chinese populations
[​17​]​—​common complaints of FCGs​—​and hence it has been
considered as a preferential intervention for FCGs caring for Methods
cancer patients [​18​]. However, a meta-analysis revealed only
small effect sizes of CBT to improve the well-being of
Research design and participant
non-Chinese FCGs of can- cer patients [​18​]. To enhance the
recruitment
effect, the current study employed dyadic CBT with a
caregiver-patient parallel group design, in which patients and
their FCGs were assigned to separate groups in order to provideThis study included two active intervention arms. Owing to the
space to address their role-specific needs. Furthermore, theshort prognosis of most lung cancer cases [​26​], a waitlist
intervention content and approach manners were culturally control design is not viable. FCGs also need prompt supports,
attuned according to Chinese values (e.g., pragmatism, and given that FCGs experience severe burden and persistent psy-
respect for authority) and the specific needs of Chinese dyadschological distress over time [​27​].
 Participants were openly recruited in Hong Kongipants to socialize among themselves. No new intervention
between January 2016 and February 2018 through onlinematerials were introduced.
advertise- ments, public educational talks, local cancer patient In CBT, participants learned relaxation techniques,
support service centers, and social media. Chinese informalidenti- fied negative thoughts and dysfunctional coping
caregivers of lung cancer patients were recruited together withpatterns, used cognitive and behavioral strategies to manage
their pa- tients. The patients who have been diagnosed withanxious and depressive emotions, develop strategies to modify
lung cancer and have no marked functional disabilitytheir dys- functional attitudes, rules and values, and
nominated a primary FCG. FCGs were close family caregiversimplemented plans of pleasurable activities. In I-BMS,
(i.e., spouse, adult child, parents, or sibling) and aged over 21participants received psycho-education about holistic
years. Individuals who were suffering from severe healthwell-being, practiced mind- body exercises (e.g., acupressure
problems (e.g., cogni- tive impairment, severe cardiovascularand Qigoing) and mindfulness-based relaxation techniques, and
diseases, and psychot- ic illnesses) or participating in regularparticipated in life review exercises for reconstructing
psychosocial interven- tions were excluded. meanings out of their caregiving journey. In particular, to cater
After completing the baseline assessment, eligiblefor the Chinese con- text, both dyadic CBT and I-BMS were
dyads were randomized on a 1:1 ratio into either arm ofculturally attuned. For example, in order to address
interventions without stratification. Block randomization bypragmatism, both modes empha- sized the transmission of
gender was conducted for cancer patients. Caregivers and theirspecific knowledge and skills, while encouraging guided
patients were assigned to the same arm of interventions, butself-discovery; Wellness education and disease discussion were
attended groups in a different room at the same time and in thebased on Chinese philosophy such as acceptance then
same venue. Three follow-up assessments were conducted:transformation, and psychosocial resilience regarding an
within 1 week following the completion of the 8 intervention uncertain future. Both the CBT and I-BMS inter- ventions
emphasized the engagement of family members and explored
sessions (​T1​​ ), and at 8-week (​T2​ ​) and 16-week (​T3​ ​) post-inter-topics related to familial relationships and conflicts. Further
vention, respectively. The RCT received necessary ethics ap-details about the intervention content are available in the study
proval by the Human Research Ethics Committee of theprotocol [​19​].
University of Hong Kong (EA1502012) and registered with the
Hong Kong Clinical Trial Registry (HKCTR-1973). InformedMeasurements
consent from both patients and FCGs were provided prior to the
baseline assessment. The Chinese version of the ​Hospital Anxiety and Depression
Scale ​(HADS) [​28​] was adopted to measure FCGs​’ ​depression
Interventions Support Care Cancer

Both CBT and I-BMS intervention consisted of eight weeklyand anxiety symptoms. Half of its 14 items measure anxiety
3-h group sessions and two follow-up group sessions. Eachand the other half measure depression, with satisfactory reli-
group comprised 8​–​12 participants. The interventions wereabilities achieved in the Chinese-Cantonese version (Cronbach
facilitated by two or three trained facilitators with back-alpha = .82 and .77). FCGs also completed the 10-item
grounds in social work or health psychology. In the first sevenPerceived Stress Scale ​(PSS) [​29​], which demonstrat- ed
sessions, patients and FCGs attended parallel group sessions ingood reliability (Cronbach alpha = .83) in measuring per-
different rooms. The content of the patient and FCG ses- sionsceived stress among a sample of Hong Kong Chinese adults
was similar in the same mode, with slight adjustments[​30​]. Physical sleep problems were measured by the 7-item
according to their respective role, such as FCG-specific con-Insomnia Severity Index ​(ISI) [​31​]. This scale demonstrates
cerns on caregiving burden and anticipatory grief. Patients andsatisfactory reliability in samples of Hong Kong Chinese el-
FCGs attended the final session in the same venue, with ac-derly (Cronbach alpha = .81) [​32​].
tivities tailored to the dyads. The two bi-monthly follow-up The ​Caregiver Reaction Assessment ​(CRA) [​33​]
group sessions were held shortly before the ​T​2 ​assessments tomeasured the functional burden and consequence of being a
cancer care- giver. The CRA consists of 24 items, measuring
encourage retention and provide an opportunity for the partic-
positive and negative dimensions of caregiving, including
disrupted sched- ule, financial problems, lack of familyeffect (​Group​: CBT vs. I-BMS), one ordinal fixed effect
support, health prob- lems, and impact of caregiving on the(​Time​: pretreatment vs. post-treatment vs. 8-week fol- low-up
FCG​’​s self-esteem. This scale has been adapted for a sample ofvs. 16-week follow-up), and the ​Group × Time i​ nter- action.
Chinese FCGs of can- cer patients with adequate reliabilityPooled results of ​F t​ est by the fixed effect of ​Group × Time
(Cronbach alphas = .66 to .77) [​34​]. represented the difference of effects between the inter- vention
Caregiver Quality of Life Index​–C ​ ancer ​(CQOLC)modes.
[​35​] was adopted to assess the QoL of FCGs. The CQOLC is a Additionally, to examine whether intervention effects
35-item scale designed to assess multiple aspects of FCGs​’varied according to participants​’​sample characteristics,
QoL, including physical, emotional, family, and social func-regression anal- yses were conducted to estimate the main
tioning. The overall scale reliability was .87 in a sample ofeffects of background variables, and their interaction with
Taiwan Chinese FCGs [​36​]. intervention type. The imme- diate and long-term intervention
effects were represented by the standardized residual of
Statistical analysis post-intervention (​T​0 ​vs. ​T​1​) and follow- ​up changes (​T0​ ​vs. ​T​3​),

Before starting this project, the required sample size was de-respectively. In the light of previous research
​ findings [12, 24,
termined by power analysis in G Power 3.1.3 software [​37​].43], we focused on predictors of FCGs​’ ​age, gender,
We anticipated a moderate effect size of .3 based on previouseducational level, marital status, and relation- ship with the
studies [​9​]. Assuming 80% power and alpha of 0.05, 64 dyadspatients, and the staging of patients​’ ​cancer.
were required in each intervention arm to provide sufficient
power in the study.
To detect the intervention effects, we performed bothResults
intention-to-treat and completer analyses in IBM SPSS 24.0
software. Intention-to-treat analyses can analyze all partici-Participants
pants who meet the criteria and have been allocated at the
baseline, irrespective of the level of intervention received [​38​].In this RCT, 157 eligible dyads were assigned to either CBT or
First, multiple imputation by fully conditional specifica- tion
was used to address missing data. Since the proportion ofI-BMS. FCGs​’ ​demographic characteristics collected at ​T​0 ​are
missing data is 37.3% of the long-form dataset (rather than ashown in Table ​1​. A significant group difference was only
case-based calculation), 40 imputations (and 50 iterations) werefound in respect of gender (​p​< .05).
conducted [​39​]. Background variables (i.e., FCGs​’ ​age, gender, Figure ​1 ​illustrates a flow diagram of participants.
and education level, intervention type) and behavioral measuresSpecifically, 120 dyads were successfully enrolled in the in-
(i.e., anxiety, depression, perceived stress, insomnia, CRAs,terventions, and 59 dyads (27 in CBT and 32 in I-BMS group)
and CQOLC at all four time-points) were entered into thecompleted the interventions and all the four assessments. The
model estimating the missing data. Second, based on theattrition rates were 63.0% for CBT group, and 56.6% for I-
imputed database, we used paired ​t ​tests to compare the base-BMS group at 16-week follow-up. The reasons of attrition
line (​T0​​ ) with the post-intervention (​T1​ ​) and two follow-up (​T​2include time or location conflict after randomized assignment
(19.6% of the drop-outs in CBT vs. 11.6% in I-BMS), deteri-
and ​T​3​) assessments to assess the immediate, and follow-uporated health (29.4% in CBT vs. 20.9% in I-BMS) or death
intervention effects within each intervention group. The (5.9% in CBT vs. 7.0%) of the patients, and loss of contact
pooled means and standardized deviations were used to com-after intervention (43.1% in CBT vs. 55.8% in I-BMS).
pute the effect sizes of changes by Cohen​’​s ​d b​ etween the
conditions for repeated measures [​40​]. Below .33 is small sizeIntervention effects
in the group difference; between .33 and .55 is moderate; above
.55 is large [​41​]. Third, a linear mixed model was used to testIn the intention-to-treat analysis (​n=
​ 157), participants in both
the longitudinal intervention effect. The present model includedgroups exhibited a statistically significant improvement in
one categorical random effect (​Subject​), one categor- ical fixedCQOLC at post-intervention, 8-week and 16-week follow- up
assessments (see Table ​2​), with moderate effect sizes.
Participants in the CBT group showed a significant reduction at
their levels of anxiety and perceived stress at post- Discussion
Support Care Cancer

This RCT examined and compared the efficacy of two empir-

intervention, 8-week and 16-week follow-up assessments.ically based culturally compatible psychosocial interventions in
Similar effects were observed for the participants in the I- BMSimproving the multiple aspects of QoL for Chinese FCGs of
group only at the two follow-up assessments. Both groupslung cancer patients. In intention-to-treat analysis, regarding
showed significant immediate improvement in insom- nia atpsychological well-being, both dyadic CBT and I-BMS ap-
post-intervention, although these effects did not remain at thepeared to alleviate the severity of perceived stress and anxiety.
16-week follow-up assessment. Neither of the interven- tionThese effects were maintained with a moderate size at 16-
modes showed any effect on depression. Regarding theweek follow-up. The CBT and I-BMS interventions present
domains of CRA, an increase in the domain for the lack ofsimilar immediate and follow-up efficacy to alleviate FCGs​’
family support was observed in the I-BMS group at the 16-stress and anxiety, consistent with previous psychosocial
week follow-up, whereas no significant changes were shown in
other aspects for either group. Moreover, the ​Group × Time
effects for all the measures were statistically non-significant
​ .05), indicating there were no differences between CBT
(all ​p >
and I-BMS in their intervention effects.
For those who completed all four assessments (​n = ​ 59)
in Table ​3​, the I-BMS group exhibited a significant increase of
CQOLC at post-intervention and both follow-ups, and a sig-
nificant reduction in anxiety and perceived stress at follow-up.
​ ​2​, but
The insomnia showed significant improvement at T

​ ​3​. By contrast, the CBT group only

tended to deteriorate at T
showed a significant increase of CQOLC post-intervention.
Consistent with intention-to-treat analysis, the ​Group × Time
effects for all the measures were statistically non-significant
​ .05).
(all ​p >

Predictions to post-intervention and

follow-up changes

In Table ​4​, the immediate and long-term intervention effects of

significant outcomes (i.e., caregivers​’ ​quality of life, anxi- ety,
perceived stress, and insomnia) were estimated by the
post-intervention (​T0​ ​vs. ​T​1​) and 16-week follow-up (​T​0 ​vs. T
​ ​3​)

changes respectively, based on an imputed sample. However,

​
no statically significant main effect of FCGs​’ ​back- ground
variables (i.e., age, gender, educational level, reli- gious, and
relationship with the patients) or the staging of patients​’ ​cancer
were found to predict the changes (all ​p> ​.05). Likewise, their
interactions with intervention type were non-significant.
 everyday cancer-specific stressors were limited.
Support Care Cancer

interventions [​12​–​14​]. Regarding the physical aspect, CBT and

I-BMS tended to improve insomnia immediately post-
intervention, which may partially benefit from a reduction of
perceived stress. However, these effects relating to insomnia
were no longer observed at 16-week follow-up for either group, Because caregiving burdens are mostly related to uncontrol-
suggesting that continuous practice, and a long-term self-care lable, external circumstances (e.g., lack of family support de-
plan and prescription need to be established. The interventionpending on the availability of family members, disrupted
effect was not observed in the different domains of caregivingschedules depending on the progression of the disease of the
burden, indicating that their effects to facilitate coping withpatients) that are difficult for CBT or I-BMS to mitigate.
 Nevertheless, the interventions showed an effect on psycho-close association between caregiving burden and depression
logical reactions to the caregiving burden, i.e., reduction in[​42​]. It is thus speculated that in the current study the non-
perceived stress. Additionally, previous research revealed a
Table 1 ​Sample characteristics of family caregivers for lung cancer patients

​ 157) CBT group (​n​= 81) I-BMS group (​n​= 76) Group comparison (​t​/​χ2​ ​) a​
Characteristics Total sample (​n =

Age (SD) 53.9(12.18) 53.7(12.29) 54.1(12.15) ​−​.12 Gender [female] 82(52.2%) 50(61.7%) 32(42.1%) 6.05* Educational level
.46
Primary school and below 16(10.2%) 8(9.9%) 8(10.5%) Secondary school 73(46.5%) 40(49.4%) 33(43.4%) University or
above 67(42.7%) 33(40.7%) 34(44.7%) Missing data 1 1 Religious [yes] 80(51.0%) 40(49.4%) 40(52.6%) .06 Marital status
.68
Married 133 (84.7%) 66(81.5%) 67(88.2%) Single/divorce/widowhood 22(14.0%) 13 (16.0%) 9(11.8%) Missing data 2 (1.3%) 2
(2.5%) 0 FCG has chronic disease [yes] 39(24.7%) 22(27.2%) 17(22.4%) .55 Age of patient (mean [SD]) 60.0(9.54) 61.4(10.29)
58.6(8.48) 1.90 Gender of patient [female] 94 (59.9%) 43(53.1%) 51(67.1%) 3.21 Relationship with lung cancer patients 2.08
Spouse 109(69.4%) 52(64.2%) 57(75%) Children 27(17.2%) 14(17.3%) 13(17.1%) Parents 8(5.1%) 5(6.2%) 3(3.9%) Siblings
13(8.3%) 10(12.3%) 3(3.9%) Stage of lung cancer 1.86
I 4 (2.5%) 2(2.5%) 2(2.6%) II 10 (6.4%) 7(8.6%) 3(3.9%) III 31 (19.7%) 18(22.2%) 13(17.1%) IV 100
(63.7%) 50(61.7%) 50(65.8%) Unclear 12 (7.6%) 4(4.9%) 8(10.5%) Cancer treatment types that patients
received
Surgery 39(24.8%) 21(25.9%) 18(23.7%) Chemotherapy 68(43.3%) 37(45.7%) 31(40.8%) Radiation therapy 51(32.5%)
25(30.9%) 26(34.2%) Laser therapy 4(2.5%) 0 4(5.3%) Palliative care 4(2.5%) 2(2.5%) 2(2.6%) Traditional Chinese medicine
46 (29.3%) 24(29.6%) 22(28.9%) Treatment status for the patients at baseline .38
Completed treatment 23(14.6%) 13(16%) 10(13.2%) During treatment 119(75.8%) 61(75.3%)
58(76.3%) Waiting for treatment 15(9.6%) 7(8.6%) 8(10.5%)

a​
Group comparison for continuous variables used one-sample ​t ​test; for categories variables using ​χ2​ ​test. *​p​< .05
 signif- icant effect on improved psychological, interpersonal,
and physical well-being, but a non-significant effect size for
Fig. 1 ​Flowchart of participant
progress

robust changes in FCGs​’ ​depression could be linked to the

unresolved multi-dimensional burden from cancer caregiving.
Completer analyses confirmed the effectiveness of I-BMS,
giving similar results to the intention-to-treat analysis, with one
exception: the immediate effect on insomnia was non-generic QoL. By contrast, in both intention-to-treat and com-
significant at post-intervention. By contrast, the CBT group pleter analyses, the current study showed moderate effect size
yielded different results from the intention-to-treat analysis. for both CBT and I-BMS in psychological symptoms as well
Despite continuing medium effect sizes, significant effect was generic QoL. The salient promotion may benefit from the
no longer detected for anxiety and perceived stress. This culturally attuned procedure and parallel caregiver-patient
indicates that the drop-out had more of a salient impact on CBT group design, which provided a culturally adaptive means of
than on I-BMS.addressing role-specific needs. Moreover, the effects of both
modes in the study that remained at 8- and 16-week follow-up
A previous meta-analysis [​18​] analyzed 36 studies on
might also benefit from continuing support, i.e., the two
CBT for cancer caregivers, and revealed a small, statistically
follow-up group gatherings.
 I-BMS and CBT were equally efficacious in alleviat-explanation is that both modes involve similar therapeutic
ing perceived stress and anxiety of FCGs caring for lung cancerfactors/processes addressing
patients, and improving their generic QoL. One plausible
commons problems facing FCGs, such as psychosocial education in conjunction with specific skills, guided
self-discovery. Additionally, although the study exam- ined the intervention effect on multi-dimensional QoL, more
sensitive tools may be needed to measure some specific outcomes, e.g., the emotional regulation and cognitive
process in CBT, spiritual and physical do- mains for I-BMS. Despite their equivalent effect, CBT and I-BMS
involved distinguishing mechanisms how the changes occurred, as they have different therapeutic phi- losophies.
Future study could reveal the potential inter- vention difference through identifying their underlying mechanisms.
Support Care Cancer
​ 157)
Table 2 ​Mean, standard error (SE), and effect size for assessments by CBT and I-BMS groups for ITT data (​n=
a ​T​ [mean
T0​ [mean
​ (SE)]​ 1 ​
T​ [mean
(SE)]​a ​ 2​

​ ​ [mean
aT
(SE)]​ 3​

a Effect
​ size ​T​ to ​T​ Effect size ​T​ to ​T​ ​ ​ to​T​
Effect size T Group × Time
(SE)]​ 0​ 1​
(​d​)​b ​ 0​ 2​
(​d​)​b ​ 0​ 3​
(​d​)​b ​
effect (​F)​ c​
Caregiver quality of life-cancer (CQOLC) .54
CBT 77.9(2.03) 88.4(2.56) 88.1(2.53) 89.1(3.05) ​− ​.50*** ​− ​.49*** ​− ​.48** I-BMS 78.8(2.16) 90.1(2.37) 90.6(2.37) 92.5(2.63) ​− ​.57***
− ​.59*** ​− ​.65*** Depression .67
CBT 7.0(.4) 6(.49) 6.3(.52) 6.2(.6) .23 .16 .17 I-BMS 7.3(.49) 6.6(.54) 6.7(.57) 6.1(.56) .15 .13 .24 Anxiety .43
CBT 8.5(.39) 7.2(.48) 7(.51) 6.9(.55) .33* .38** .38* I-BMS 8.9(.54) 7.7(.49) 7.4(.54) 7.3(.54) .26 .32* .35* Perceived stress .84
CBT 21.1(.46) 19.7(.62) 18.9(.69) 19.6(.61) .28* .41** .31* I-BMS 21(.59) 20(.62) 18.7(.65) 18.9(.76) .19 .42** .35* Insomnia .96
CBT 9.4(.64) 7.8(.65) 8(.8) 8.2(.82) .28* .21 .18 I-BMS 8.9(.67) 7.3(.71) 6.6(.65) 7.4(.8) .27* .41** .23 CRA disrupted schedule 1.01
CBT 3.1(.08) 2.9(.11) 3.1(.1) 3.0(.14) .17 .01 .07 I-BMS 3.1(.09) 3.1(.09) 3.1(.11) 3.0(.13) .04 .04 .10 CRA lack of family support 1.75
CBT 2.2(.08) 2.1(.09) 2.2(.1) 2.3(.11) .07 ​− ​.02 ​− ​.14 I-BMS 2.1(.07) 2.3(.09) 2.3(.09) 2.4(.11) ​− ​.25 ​− ​.19 ​− ​.33* CRA health problem
.72
CBT 2.8(.08) 2.7(.09) 2.6(.09) 2.7(.11) .10 .17 .12 I-BMS 2.8(.08) 2.8(.09) 2.7(.1) 2.7(.11) .06 .09 .16 CRA self-esteem .73
CBT 4.0(.06) 4.0(.08) 4.0(.08) 4.0(.09) .01 ​− ​.02 ​− ​.05 I-BMS 4.1(.06) 4.1(.07) 4.1(.07) 4.1(.09) .02 ​− ​.07 .03 CRA financial problem .87
CBT 3.0(.10) 2.8(.14) 2.9(.14) 2.9(.16) .23 .17 .11 I-BMS 2.9(.12) 2.7(.12) 2.9(.14) 2.8(.16) .23 .06 .07

a​
For the ITT data, pooled Mean, pooled standard error (SE), and pooled ​F ​value are reported ​b​Effect size was estimated by pooled paired ​t

test, i.e., the mean difference was divided by pooled standard deviations with considering their correlation ​(​r​): Cohen​’​s ​d=
​ (​x1​​ −

x​2​)/SQRT((SD​1​2 ​+ SD​22​​ –​2*​r*​SD​1*SD​

​ 2​)/2*(1​− ​r​)), ​SD s
​ tandard deviation, ​x​1 and
​ ​x​2 are
​ the mean values ​c​The interaction of Group × Time

was estimated by the fixed effect in linear mixed models The

​ effect sizes with significance of changes were tested by paired ​t t​ est, *​p​<
​ .01, ***​p​< .001
.05, **​p<
Another important finding was that the immediate and follow-up intervention effects did not differ by sample back-
grounds, in contrast to previous findings [​12​, ​18​]. Since both current interventions are integrative in nature with
complex components, they may be thus effectively applied to different Chinese groups. Also, the lack of significant
results might be due to insufficient diversity in our samples, e.g., the large proportions of married FCGs and patients
with stage IV can- cer. Nevertheless, this study suggests that both CBT and I- BMS can apply to different Chinese
populations regardless of demographic and disease-related characteristics. However, it needs to be cautious when
generalizing the findings to an- other social-cultural contexts.
 This study has other limitations. A more rigorous study design could have included a waitlist non- intervention control
in addition to the two study condi- tions compared here. It is thus not possible to draw definitive conclusions about the impact
of these two interventions without a non-treatment or standard-care control condition. A second limitation was the high at-
trition rate, mainly because of the patients​’ ​declining health or death. Another large contributor to attrition was ​“​loss of contact.​”
Possibly, these participants are too occupied in the later stage of the disease by their heavy caring burdens, and may also want
to spend more time with their own close families. These groups may need other specific care and practical support. Third,
although this study proposed to investigate multiple as- pects of QoL, we did not examine its subscales of CQOLC due to the
inconsistent findings in its
Support Care Cancer
component structure [​33​, ​34​]. Instead, another validated scales were adopted to assess the severity of insomnia, psychological
stress, and caregiver burden in caregivers. It is of value to measure the potential positive effects such as spiritual and social
well-beings, and another aspects of physical health in future studies. Fourth, al- though FCGs reported their health condition at
baseline, information about caregivers​’ ​medication usage were not collected. This may impact their QoL and other out- comes,
which needs be considered in future studies. Moreover, in a parallel caregiver-patients study, changes of patients​’ ​conditions
could reciprocally influence the FCGs​’ ​condition. Although the current study presumed a direct intervention effect on FCGs,
the dyadic effect of interventions with the patients was neglected. Further longitudinal investigation should focus on reciprocal
changes.
Table 3 ​Mean, standard deviation (SD), and effect size for assessments by CBT and I-BMS groups for participants who completed all the four
assessments (n = 59)

T0​ ​[mean
(SD)]
 Effect size ​T​0 ​to ​T3​
(​d​)

Effect size ​T​0 ​to ​T3​

an (​d​)

Effect size ​T​0 ​to ​T3​

an (​d​)

Effect size ​T​0 ​to ​T3​

an (​d​)

Effect size ​T​0 ​to ​T3​

Effect size ​T​0 ​to ​T1​ ​(​d​) (​d​)
Group× Time
Effect size ​T​0 ​to ​T1​ ​(​d​)
effect (​F)​
Effect size ​T​0 ​to ​T1​ ​(​d​) Group× Time
effect (​F)​
Effect size ​T​0 ​to ​T1​ ​(​d​) Group× Time
Effect size ​T​0 ​to ​T​2 ​(​d​) effect (​F)​
Group× Time
Effect size ​T​0 ​to ​T​2 ​(​d​) effect (​F)​
Group× Time
Effect size ​T​0 ​to ​T​2 ​(​d​)
effect (​F)​
Effect size ​T​0 ​to ​T​2 ​(​d​) Group× Time
effect (​F)​
Effect size ​T​0 ​to ​T​2 ​(​d​) Group× Time
effect (​F)​
Effect size ​T​0 ​to ​T3​
(​d​)

Caregiver quality of life-cancer (CQOLC) 1.32

CBT 81.4(15.73) 87.8(15.22) 87.7(18.1) 88.4(16.95) ​− ​.42* ​− ​.35 ​− ​.41 I-BMS 79.1(18.37) 93.9(16.2) 91.4(17.25) 94.1(16.89) ​−
.85*** ​− ​.76*** ​− ​.86*** Depression .85
CBT 6.7(3.8) 6.1(3.29) 6.4(3) 6.7(3.51) .17 .07 ​− ​.01 I-BMS 7.4(4.61) 6.7(4.54) 6.5(4.38) 5.9(3.62) .20 .24 .35 Anxiety .27
CBT 8(3.08) 7.3(2.88) 7(3.11) 6.9(2.89) .24 .27 .34 I-BMS 8.8(4.74) 7.3(3.68) 7.2(4.26) 6.7(4.07) .34 .39 .47* Perceived stress 1.94
CBT 20.5(2.74) 19(4.86) 18.8(5.02) 20.2(4.55) .37 .37 .05 I-BMS 21.3(5.63) 20.3(5.58) 18.5(4.36) 18.3(4.04) .18 .64** .59** Insomnia
2.19
CBT 8.9(6.02) 8.1(4.29) 8.9(4.78) 8.8(4.92) .13 ​− ​.07 ​− ​.05 I-BMS 8(5.29) 6.3(4.49) 5.5(4.97) 6.9(4.4) .33 .45* .24 CRA disrupted
schedule 1.03
CBT 3(0.68) 3.0(0.74) 3.2(0.71) 3.1(0.65) .09 ​− ​.26 ​− ​.14 I-BMS 3(0.87) 3.1(0.79) 3.1(0.88) 2.9(0.83) ​− ​.05 ​− ​.09 .01 CRA lack of
family support 1.07
CBT 2.2(0.65) 2.1(0.72) 2.1(0.66) 2.3(0.71) .08 .06 ​−​.14 I-BMS 2.2(0.53) 2.4(0.62) 2.4(0.69) 2.4(0.67) −
​ ​.34 ​− ​.33 ​− ​.46 CRA health
problem .83
CBT 2.7(0.61) 2.8(0.6) 2.6(0.67) 2.8(0.59) ​− ​.11 .13 ​− ​.06 I-BMS 2.8(0.55) 2.7(0.54) 2.8(0.72) 2.6(0.61) .17 .06 .25 CRA self-esteem
1.87
CBT 3.9(0.49) 4.0(0.45) 4.0(0.57) 4.1(0.46) ​− ​.24 ​− ​.23 ​− ​.26 I-BMS 4.2(0.46) 4.2(0.57) 4.1(0.58) 4.1(0.66) .11 .14 .32 CRA financial
problem 1.39
CBT 2.9(0.81) 2.7(0.92) 2.7(0.92) 2.8(1) .17 .22 .07 I-BMS 3.0(1.15) 2.5(0.92) 2.8(1.05) 2.7(0.86) .35* .02 .21

The effect sizes with significance of changes were tested by paired ​t t​ est, *​p ​< .05, **​p<
​ .01, ***​p<
​ .001
 sample backgrounds. Nevertheless, the
Support Care Cancer

Conclusions

This study contributes evidence of the effectiveness of

psychosocial interventions for Chinese FCGs caring for
patients with lung cancer. Culturally attuned dyadic CBT and current study design that lacked a waitlist control weak- ened
I-BMS were found equally effective to improve thethe conclusions about the impact of these interven- tions. To
psychological distress and generic QoL of FGCs. These effectsimprove evaluation of outcomes, future study could benefit
were maintained at follow-up assessment points, regardless of from using three-group designs incorporat- ing a usual care
 control. Kong [grant number 17614515, 2015].

Funding ​This work was supported by the General Research Fund, Hong

Table 4 ​The main effect of predictive factors to the standardized residual of immediate (​T0​ ​vs. ​T1​ ​) and follow-up changes (​T0​ ​vs. ​T3​ ​), and their
interactions with intervention mode (Beta)

Variables Generic QoL Anxiety Perceived stress Insomnia

T0​ ​vs. ​T1​ ​T0​ ​vs. ​T3​ ​T​0 ​vs. ​T​1 ​T​0 ​vs. ​T​3 ​T​0 ​vs. ​T​1 ​T​0 ​vs. ​T​3 ​T0​ ​vs. ​T1​ ​T0​ ​vs. ​T3​

Main effects
Age ​− ​.008 ​− ​.01 ​− ​.008 ​− ​.001 ​− ​.02 < .001 .01 .006 Gender [male vs. female] .58 .59 ​− ​.37 ​− ​.18 .83 ​− ​.49 ​− ​.52 ​− ​.14 Educational level
Primary school and below = 1 .22 ​− ​.22 .36 .17 .52 ​− ​.36 .15 .63 Secondary school = 2 .10 .07 .06 .08 .18 .12 .11 .37 University or above = 3 0​a ​0​a
0​a ​0​a ​0​a ​0​a ​0​a ​0​a ​Marital status [others vs. married​a​] ​− ​.43 .002 .66 ​− ​.14 ​− ​.22 .59 .24 ​− ​.41 Relationship with the patients
Spouse = 1 ​− ​.54 ​− ​.38 .95 .14 .16 .62 ​− ​.32 ​− ​.28 Children = 2 ​− ​.42 ​−​.47 .74 .22 ​− ​.13 .69 .01 ​− ​.05 Parents = 3 ​− ​.31 ​− ​.38 .04 .18 .17 .13 ​− ​.41
.23 Siblings = 4 0​a ​0​a ​0​a ​0​a ​0​a ​0​a ​0​a ​0​a ​Stage of lung cancer

​ ​.26 ​− ​.03 .51 .24 .15 ​− ​.08 .40 .09 III = 3 .27 .02 ​− ​.09 ​− ​.09 ​− ​.20 .06 .14 ​− ​.08 IV = 4​a ​0​a
I = 1 .72 ​− ​.04 ​− ​.79 ​− ​.12 ​− ​.96 .48 ​− ​.73 ​− ​.20 II = 2 −
0​a ​0​a ​0​a ​0​a ​0​a ​0​a ​0​a ​Intervention mode [I-BMS vs. CBT​a​] −
​ ​.73 ​− ​.74 .89 1.59 ​− ​.10 .87 ​− ​.04 ​− ​.01 Interaction effects
Age × Intervention mode .004 .003 .01 ​− ​.01 .005 ​− ​.005 .01 < .001 Gender × Intervention mode .55 .38 ​− ​.55 ​− ​.15 ​− ​.22 ​− ​.36 ​− ​.05 ​− ​.35
Education × Intervention mode
Education = 1 × Intervention mode ​− ​.47 .42 .19 ​− ​.21 ​− ​.01 .64 .22 ​− ​.71 Education = 2 × Intervention mode ​− ​.06 .02 ​− ​.29 ​− ​.28 ​− ​.27 .04 ​−
.02 ​− ​.26 Marital status × Intervention mode 1.13 .27 ​− ​1.55 .18 .16 ​− ​.30 ​− ​.90 .20 Relationship × Intervention mode
Relationship = 1 × Intervention mode .43 .48 ​− ​.93 ​− ​.55 .01 ​− ​.61 .13 .28 Relationship = 2 × Intervention mode ​− ​.08 .56 ​− ​.12 ​− ​.79 .37 ​− ​.67
.47 .40 Relationship = 3 × Intervention mode ​− ​.22 .06 .07 ​− ​.68 .18 ​− ​.40 1.74 ​− ​.20 Cancer stage × Intervention mode
Stage = 1 × Intervention mode ​− ​.53 .434 .40 ​− ​.01 .55 .19 .09 .21 Stage = 2 × Intervention mode .87 .589 ​− ​1.07 ​− ​.07 .04 ​− ​.86 ​− ​1.24 ​− ​.14
Stage = 3 × Intervention mode ​− ​.004 .111 ​− ​.19 .59 .18 ​− ​.07 ​− ​.23 ​− ​.01

Set as 0 in the parameter estimations ​The ​t v​ alues for all above parameters are
a​

​ .05)
statistically non-significant (​p>
Compliance with ethical
standards
The RCT received necessary ethics approval by the Human Research
Ethics Committee of the University of Hong Kong (EA1502012) and
registered with the Hong Kong Clinical Trial Registry (HKCTR-1973).
Informed consent from both patients and FCGs were provided prior to the
baseline assessment.
Conflict of interest ​The authors declare that there is no conflict of
interests.
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