Original Article

Dyadic Psychosocial Intervention for Advanced Lung Cancer

Patients and Their Family Caregivers: Results of a
Randomized Pilot Trial
Hoda Badr, PhD1; Cardinale B. Smith, MD, MSCR2,3; Nathan E. Goldstein, MD3,4; Jorge E. Gomez, MD3;
and William H. Redd, PhD1

BACKGROUND: Advanced lung cancer (LC) patients and their families have reported low self-efficacy for self-care/caregiving and high
rates of distress, yet few programs exist to address their supportive care needs during treatment. This pilot study examined the feasibil-
ity, acceptability, and preliminary efficacy of a 6-session, telephone-based dyadic psychosocial intervention that was developed for
advanced LC patients and their caregivers. The program was grounded in self-determination theory (SDT), which emphasizes the impor-
tance of competence (self-efficacy), autonomy (sense of choice/volition), and relatedness (sense of belonging/connection) for psycho-
logical functioning. The primary outcomes were patient and caregiver psychological functioning (depression/anxiety) and caregiver
burden. The secondary outcomes were the SDT constructs of competence, autonomy, and relatedness. METHODS: Thirty-nine advanced
LC patients who were within 1 month of treatment initiation (baseline) and their caregivers (51% spouses/partners) completed surveys
and were randomized to the intervention or usual medical care. Eight weeks after baseline, they completed follow-up surveys.
RESULTS: Solid recruitment (60%) and low attrition rates demonstrated feasibility. Strong program evaluations (mean, 8.6/10) and
homework completion rates (88%) supported acceptability. Participants receiving the intervention evidenced significant improve-
ments (P <.0001) in depression, anxiety, and caregiver burden in comparison with usual medical care. Large effect sizes (d  1.2)
favoring the intervention were also found for patient and caregiver competence and relatedness and for caregiver autonomous moti-
vation for providing care. CONCLUSION: These findings support intervention feasibility, acceptability, and preliminary efficacy. By
empowering families with the skills to coordinate care and meet the challenges of LC together, this intervention holds great promise
for improving palliative/supportive care services in cancer. Cancer 2015;121:150-8. V
C 2014 American Cancer Society.

KEYWORDS: caregivers, couples, lung cancer, palliative care, psychological distress, psychosocial intervention, supportive care.

INTRODUCTION
Lung cancer (LC) is the second most common cancer and the leading cause of cancer death in the United States.1 Non–
small cell LC is the most common type and often presents at an advanced stage (III or IV).2 Likewise, 70% of small cell
LC cases are diagnosed at an advanced/extensive stage. Unfortunately, the prognosis is extremely poor. The median sur-
vival is approximately 12 months for advanced LC.3 In addition, patients with advanced LC experience higher rates of
physical and emotional distress in comparison with patients with other cancers.4,5 This contributes not only to their suffer-
ing but also to the suffering of their families, who play a key role in providing care and emotional support.6 Now that the
early integration of palliative care into standard oncologic care has been shown to improve the quality of life and possibly
survival of advanced LC patients,7 practice guidelines have been changed to advocate the idea that patients receive concur-
rent palliative and standard oncologic care from the point of diagnosis.8,9 Although support for the family is deeply
ingrained in the philosophy of palliative care,10 the reality is that the support provided to families is often suboptimal.11
Despite outpatient palliative care services, the families of LC patients are often unprepared for caregiving,12 have low self-
efficacy for managing patient symptoms at home,13 report high rates of psychological distress,14 and have a number of
unmet supportive care needs.12 LC also adversely affects family relationships. Both patients and caregivers have reported
decreased closeness15 and increased conflict regarding symptom management after the diagnosis.16 To date, only a hand-
ful of randomized controlled trials of psychosocial interventions for advanced cancer patients and/or their family members

Correspondence to: Hoda Badr, PhD, Department of Oncological Sciences, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1130, New
York, NY 10029; Fax: (212) 849-2564; hoda.badr@mssm.edu
1
Department of Oncological Sciences, Icahn School of Medicine at Mount Sinai, New York, New York; 2Division of Hematology and Medical Oncology, Depart-
ment of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York; 3Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at
Mount Sinai, New York, New York; 4Geriatric Research Education and Clinical Care Unit, James J. Peters VA Medical Center, Bronx, New York.

The views represented in this article are those of the authors and do not represent those of the National Institutes of Health, the National Institute on Aging, or
the Department of Veterans Affairs.

DOI: 10.1002/cncr.29009, Received: May 22, 2014; Revised: July 18, 2014; Accepted: July 24, 2014, Published online September 10, 2014 in Wiley Online
Library (wileyonlinelibrary.com)

150 Cancer January 1, 2015


have been conducted.17-21 Most have targeted families in
hospice (with patients not undergoing cancer-directed
treatment) and have not addressed the specific challenges
of LC. Programs that address these gaps may improve not
only patient and caregiver quality of life but also the qual-
ity of palliative and supportive care services that are
offered in the setting of cancer.
We have developed a dyadic psychosocial intervention
designed to improve the quality of life of advanced LC
patients and their caregivers. The program is telephone-
based to reduce its burden and is grounded in self-
determination theory (SDT).22 Because SDT emphasizes
the need for individuals to develop a sense of competence
(self-efficacy), autonomy (a sense of choice and volition),
and relatedness (a sense of belonging and connection) for
psychological functioning, the intervention (1) teaches skills
to enhance patient and caregiver competence for self-care,
coping with cancer, and managing symptoms at home; (2)
supports patient/caregiver autonomy by providing a clear
rationale for recommendations and a variety of options to
encourage choice and elaboration; and (3) seeks to improve
interpersonal connections or the sense of relatedness by
teaching patients and caregivers strategies for solving prob-
lems, effectively communicating, and mobilizing support/
maintaining supportive relationships.
This study tested the feasibility, acceptability, and
preliminary efficacy of the dyadic intervention that we
developed. We expected that it would be feasible as assessed
through adequate recruitment, retention, and completion
of sessions. We also expected that it would be acceptable as
assessed through participant evaluations. With respect to
preliminary efficacy, we hypothesized that in comparison
with patients and caregivers receiving usual medical care
(UMC), those receiving the intervention would show
greater improvements on the primary outcomes of psycho-
logical functioning (ie, depression and anxiety) and care-
giver burden. Finally, we hypothesized that patients and
caregivers receiving the intervention would report greater
improvements on the secondary outcomes (SDT con-
structs) of autonomy, competence, and relatedness relative
to those those receiving UMC.
MATERIALS AND METHODS
Participants
Patients were eligible if they (1) had advanced LC and
were within 1 month of treatment initiation (any line of
therapy); (2) were spending more than 50% of their time
out of bed on a daily basis, as measured by an Eastern Co-
operative Oncology Group performance status  2; and,
Cancer January 1, 2015
Lung Cancer Dyadic Intervention/Badr et al
(3) had a spouse/partner or other close family member
whom they identified as their primary caregiver. In addi-
tion, both patients and caregivers had to (1) be 18 years
old; (2) have the ability to read and understand English;
and, (3) be able to provide informed consent.
Procedures
The study was reviewed and approved by the Mount Sinai
institutional review board. Patients were identified through
medical chart review and were approached to participate
during chemotherapy infusion. If caregivers were not pres-
ent, permission was obtained to contact them by phone.
Interested dyads provided informed consent, independently
completed baseline paper-and-pencil surveys, and were ran-
domly assigned to either the 6-week intervention or UMC.
Participants in both groups completed follow-up paper-and-
pencil surveys 8 weeks after baseline and received $20 gift
cards upon the return of each completed survey.
Measures
Primary outcomes
Psychological functioning. The 6-item Patient Reported
Outcomes Measurement Information System (PROMIS)
short-form depression measure assesses negative mood and
views of the self.23 The 6-item PROMIS short-form anxiety
measure assesses fear, anxious misery (eg, worry), and hyperar-
ousal.23 For both measures, the time frame is the past 7 days;
responses range from 1 (never) to 5 (always) and are summed
to form a raw score that can then be rescaled into a T-score
(standardized) with a mean of 50 and a standard deviation
(SD) of 10 through the use of tables available through the
PROMIS Web site. Thus, a T-score of 60 is 1 SD above the
mean, and a T-score of 40 is 1 SD below the mean. In this
study, the internal consistency reliability (Cronbach’s a) for
depression was apatients 5 .96 and acaregivers 5 .97; for anxiety,
a was .93 for both patients and caregivers.
Caregiver burden. The 12-item short form of the Zarit
Burden Interview24 taps the constructs of personal and
role strain. Items are rated on a 5-point Likert-type scale
from 0 (never) to 4 (nearly always). Cronbach’s a was .87.
Secondary outcomes
Autonomy. Five items developed by Pierce et al25 were
used to assess caregivers’ autonomous motivation for
tending to patient needs and providing care on a scale of 0
(not at all) to 4 (extremely). Cronbach’s a was .78. Six
items from the Treatment Self-Regulation Question-
naire26 were used to assess patient autonomy for engaging
in self-care on a 7-point Likert-type scale; higher scores
indicated greater endorsement.26 Cronbach’s a was .80.
151
Original Article
Competence. We developed 38 items based on the work
27
of Lorig et al ; patients and caregivers rated on a scale of
0 (not at all confident) to 10 (totally confident) their self-
efficacy for seeking and understanding medical
information, managing stress, regulating affect, managing
physical symptoms, seeking support, and working to-
gether as a team. In this study, apatients was .98, and
acaregivers was .93.
Relatedness. Relatedness was assessed with a 4-item mea-
sure that assesses the quality of the caregiver-care recipient
relationship.28 The items assess closeness, the ability to
communicate, the similarity of views, and the degree to
which family members get along on a scale from 1 (not at
all close/similar/well) to 4 (very close/similar/well). Cron-
bach’s a was .85 for patients and caregivers.
Feasibility, acceptability, and treatment fidelity
Feasibility was assessed through rates of study enrollment
and participation. Acceptability was measured through
reports of the number of homework assignments com-
pleted and posttreatment ratings of the overall ease of par-
ticipation, helpfulness of the program, and relevance of
the information provided (from 0 [not easy/helpful/rele-
vant] to 10 [extremely easy/helpful/relevant]). Partici-
pants also rated their liking of the dyadic format,
telephone-based delivery, study materials, homework
assignments, and the interventionist on a scale of 1 to 10,
with higher ratings indicating greater endorsement.
Finally, an open-ended question asked about suggestions
for improvement.
A fidelity checklist was created that comprised the
session topics covered, whether in-session exercises were
conducted, and whether home assignments were given.
The fidelity score consisted of the number of topics di-
vided by the total number of fidelity criteria.
Study Conditions
UMC Group
At Mount Sinai, UMC consists of standard oncologic care
and primary palliative care for the patient from the point of
the diagnosis of advanced LC. Primary palliative care is pro-
vided by the patient’s medical oncologist and includes the
basic management of pain and other symptoms, including
depression and anxiety, as well as basic discussions about
the prognosis and goals of treatment. In addition, patients
may be referred to the outpatient supportive oncology prac-
tice for a specialty palliative care consultation according to
need as determined by the treating oncologist. This consult
follows the National Consensus Project for Quality Pallia-
152
tive Care guidelines.29 Caregivers are welcome to attend/
participate but are not required to do so. The supportive
oncology practice provides assistance as needed in the man-
agement of pain and other symptoms, existential distress,
and goals of care. Psychiatry, social work, and home-based
visiting nurse association services are available for patients
on referral. Chaplaincy and other integrative services (eg,
massage/art therapy) are also available and require referral
from the primary medical oncologist.
Intervention Group
We created separate standardized, tailored manuals for
patients and caregivers. The manuals were divided into 6
sections. The topics were self-care, stress and coping, symp-
tom management, effective communication, problem solv-
ing, and maintaining and enhancing relationships. For
each topic, approximately half the content was the same for
patients and caregivers, and half was tailored to the person’s
role (patient or caregiver). For example, shared content
included information about self-care and symptom man-
agement, strategies for coping as a team (eg, joint problem
solving), relationship maintenance strategies, and
cognitive-behavioral strategies for managing depression
and anxiety symptoms (eg, cognitive reframing and relaxa-
tion). Tailored content for patients included strategies for
balancing autonomy with soliciting/accepting support, dis-
closing care/support needs, and supporting/acknowledging
the caregiver. Tailored content for caregivers included strat-
egies for minimizing overprotection and negative interac-
tion patterns (eg, nagging and criticizing) and for
supporting the patient’s self-care goals.
In addition to UMC, patients and caregivers in the
intervention group each received their own tailored man-
uals and participated together in 6 weekly 60-minute tele-
phone counseling sessions with a trained interventionist
who had a master’s degree in mental health counseling.
During sessions, the interventionist reviewed homework
and manual content for that week, guided participants
through in-session activities, and assigned the next week’s
homework to reinforce the practice of skills taught.
Data Analysis
Descriptive analyses examined recruitment rates, baseline
(T0) and follow-up (T1) means for the 2 conditions, and
feasibility and acceptability measures. Baseline compari-
sons (v2 and t tests) examined differences between the
intervention and UMC groups (for patients and caregivers
separately). Possible sex differences were examined, as well
as Pearson correlations among the outcome variables and
partial correlations between patients and caregivers.
Cancer January 1, 2015

Figure 1.
To test the preliminary efficacy of the intervention,
we performed analyses of covariance with T0 scores as cova-
riates and follow-up T1 outcome scores as dependent varia-
bles. The main effects tested were for treatment group
(intervention or UMC) and role (patient or caregiver). We
also examined the treatment group 3 role interaction. Sex
was not included in the model because there were no signif-
icant differences between men and women on the study
outcomes. Effect sizes (Cohen’s d) were calculated for sig-
nificant findings at T1 with the following for-
mula:[d 5  x INT 2
x UMC =s] where 
x INT is the mean for the
intervention group at T1, X UMC is the mean for the control
group at T1, and s is the pooled SD for the 2 groups.30
To gauge the clinical significance of the treatment
effects, we identified patients and caregivers in the inter-
vention and UMC groups who had high levels of depres-
sion and anxiety (T-scores > 60 or 1 SD on the PROMIS
measures). The proportion of participants scoring higher
than 1 SD in the intervention and UMC groups who
improved (ie, their T-score moved from 1 SD to <1
SD) versus those who remained stable or got worse from
T0 to T1 was then examined with v2 analyses.
RESULTS
Feasibility and Acceptability
Study enrollment and participation
As Figure 1 shows, 76 patient-caregiver dyads were
screened, and 9 were excluded because one of the dyad
members was not eligible. Forty of the remaining 67
Cancer January 1, 2015
Lung Cancer Dyadic Intervention/Badr et al
eligible dyads (60%) consented. There were no significant
differences between participants and refusers with regard
to either demographic or medical characteristics. The pri-
mary reasons for refusal were that the patient, caregiver, or
both were not interested or that they had too much going
on. One dyad dropped out before the baseline survey was
returned; the patient did not feel well enough to partici-
pate. Twenty of the remaining 39 dyads were randomized
to the intervention, and 19 were randomized to UMC.
Telephone session attendance was high: in 90% of cases,
both the patient and the caregiver participated on the call
together; in 10% of cases, one of the dyad members missed
the call and a make-up call was scheduled with that individ-
ual before the next session. In all cases, missed sessions were
due to scheduling conflicts, and make-ups were completed.
All the patients and the caregivers in the intervention group
completed the follow-up, as did all patients and 95% of the
caregivers in the UMC group. Sessions generally occurred
weekly; the total duration averaged 6.5 weeks (SD, 0.20
weeks). Dyads completed an average of 4.4 out of 5 home-
work assignments (SD, 0.20; range, 2-5).
Treatment fidelity and program evaluation
All sessions were digitally recorded, and fidelity was rated
for 25% of the sessions. The average fidelity rating was
86%. Participants rated the program favorably in terms of
convenience, helpfulness, and relevance (see Table 1).
They also rated the interventionist highly. Although most
patients and caregivers said that they had enjoyed
153
Original Article

TABLE 1. Treatment Evaluations (20 Patients and TABLE 2. Description of the Study Sample
18 Caregivers)a (39 Patient-Caregiver Dyads)

Patients Caregivers Patients Caregivers

How interesting were the sessions? 8.1 (1.5) 8.5 (1.5) Sex, n (%)
How helpful were the sessions? 7.7 (1.3) 8.1 (1.6) Male 10 (26) 12 (31)
How useful was the manual? 9.6 (0.3) 9.1 (0.7) Female 29 (74) 27 (69)
How relevant was the covered material to 8.9 (1.4) 9.3 (0.7) Age (y)
what you are experiencing? Mean 68.17 51.10
How helpful was the interventionist? 8.8 (0.9) 8.5 (1.4) SD 10.30 10.24
How likely is it that you would recommend 8.8 (1.1) 8.2 (1.3) Range 38-87 35-70
the program to another patient/caregiver? Race, white (non-Hispanic), n (%)a 33 (85)
How convenient was it to participate 9.1 (0.8) 9.5 (0.8) Employment status, n (%)
by telephone? Employed full-time 6 (15) 14 (36)
How helpful were the homework 8.4 (1.1) 8.4 (1.0) Employed part-time 9 (23) 16 (41)
assignments? Unemployed/retired 24 (62) 9 (23)
How much did you enjoy participating in this 9.4 (0.6) 9.0 (1.0) Education, n (%)
program with your patient/caregiver? High school diploma or less 5 (14) 2 (5)
How much did you like the telephone 7.9 (1.5) 9.2 (0.6) At least some college 15 (38) 13 (33)
delivery format? College degree 19 (48) 24 (62)
How much did you enjoy the dyadic format 6.1 (2.9) 5.7 (2.4) Caregiver relationship to
(ie, the patient and the caregiver the patient, n (%)
participate in Spouse/partner 20 (51)
all sessions together)? Son/daughter 12 (31)
Overall, how satisfied are you 8.5 (1.0) 8.6 (1.0) Other family member (ie, sibling, 7 (18)
with the program? cousin, or parent)
Married, n (%) 23 (59)
a Length of marriage (y)
The data are presented as means (with standard deviations in parenthe-
ses). All ratings were on a 0 to 10 scale, with higher scores indicating Mean 36.20
greater endorsement. SD 8.70
Range 18-51
Type of lung cancer, n (%)
participating in the program together, they also noted that SCLC 6 (16)
they would have preferred some joint/dyadic sessions and NSCLC 33 (84)
Stage of cancer, n (%)
some one-on-one sessions with the interventionist. The Stage 3 NSCLC 10 (26)
reasons included (1) discussing topics that they were Stage 4 NSCLC 23 (58)
Extensive-stage SCLC 6 (16)
uncomfortable discussing in front of their loved one; (2)
gaining more skill practice by working individually with Abbreviations: NSCLC, non–small cell lung cancer; SCLC, small cell lung
cancer.
the interventionist; and, (3) scheduling convenience. a
The race of the caregiver was not assessed.

Participant Characteristics
Baseline demographic and medical data are presented in
Table 2. Patients were mostly female (74%), white
(85%), educated with at least some college credits (86%),
elderly (mean, 68.17 years; SD, 10.30 years), and unem-
ployed/retired (62%); 84% had non–small cell LC. Care-
givers were also mostly female (69%), educated with at
least some college credits (95%), middle-aged (mean,
51.10 years; SD, 10.24 years), and employed at least part-
time (77%); 51% were spouses/partners, and the rest were
either siblings or adult sons/daughters of the patients. No
significant baseline differences in medical or outcome var-
iables were found for patients randomized to the interven-
tion and UMC groups (P  .11).
At baseline, 33% of patients and 60% of caregivers
had PROMIS depression T-scores > 60 (11 SD), indi-
cating high levels of depression. In 23% of dyads, both
the patient and caregiver scored higher than 60. Also at
baseline, 46% of patients and 69% of caregivers had
PROMIS anxiety T-scores > 60, indicating high levels of
anxiety. In 33% of dyads, both the patient and caregiver
scored higher than 60. As Table 3 shows, all correlations
were in the expected directions. The partial correlations
for patient and caregiver depression and anxiety were not
significant.
Preliminary Efficacy
Means for the primary and secondary outcomes at T0 and
T1 are presented in Table 4.
Primary outcomes
Depression. At T1, there was a significant difference in
depression (P < .0001), with the intervention group hav-
ing lower mean scores (less depressive symptomatology)
than the UMC group. The effect size for this difference
was d 5 21.8, which is a large effect.31 There was also a
significant main effect for role [F(1,73) 5 4.55, P 5 .04],

154 Cancer January 1, 2015

 Lung Cancer Dyadic Intervention/Badr et al

TABLE 3. Baseline Correlations (39 Patients and 39 Caregivers)a

1 2 3 4 5 6

1. Depression .30b .69c — 2.47c 2.60c 2.24

2. Anxiety .75c .21 — 2.39d 2.59c 2.19
3. Caregiver burden .47c .35d — — — —
4. Autonomye 2.40d .33d 2.20 — .66c .34d
5. Competence 2.38d 2.37d 2.35d .26b .46c .21
6. Relatedness 2.12 2.19 2.27b 2.01 .20 .66c

a
Partial correlations between patients and caregivers are bolded and form a diagonal. Correlations for patients are above the diagonal. Correlations for care-
givers are below the diagonal.
b
P <.10.
c
P <.01
d
P <.05.
e
Patient autonomy and caregiver autonomy were assessed with 2 different measures, so partial correlations were not calculated.

TABLE 4. Baseline and Follow-Up Means and Standard Deviations for the Study Outcomes of Patients and
Caregivers in the Intervention and UMC Groupsa

Patients Caregivers

Intervention Group UMC Group Intervention Group UMC Group

Baseline Follow-Up Baseline Follow-Up Baseline Follow-Up Baseline Follow-Up

Depressionb 14.75 (3.60) 11.65 (3.77) 14.74 (4.69) 16.00 (5.69) 16.45 (4.03) 11.50 (3.20) 16.26 (5.50) 16.53 (5.47)
Anxietyb 14.95 (4.96) 12.35 (4.46) 14.79 (4.54) 14.84 (4.96) 17.40 (4.36) 12.10 (3.60) 17.42 (5.63) 17.16 (5.41)
Caregiver burdenc — — — — 27.65 (5.46) 24.70 (4.96) 27.32 (6.28) 28.16 (6.53)
Autonomyd 4.11 (1.29) 4.83 (1.49) 4.06 (1.42) 4.35 (1.48) 2.04 (0.67) 2.63 (0.65) 2.23 (0.60) 2.10 (0.62)
Competencee 4.75 (1.83) 7.16 (1.42) 4.68 (2.01) 4.78 (1.95) 4.68 (1.36) 7.05 (0.98) 4.50 (0.81) 4.30 (0.69)
Relatednesse 11.00 (1.45) 12.60 (1.39) 11.26 (1.91) 11.00 (2.08) 11.10 (1.77) 12.65 (1.69) 11.21 (2.37) 10.42 (2.39)

Abbreviations: PROMIS, Patient Reported Outcomes Measurement Information System; UMC, usual medical care.
a
The data are presented as means (with standard deviations in parentheses).
b
Raw scores for the PROMIS depression and anxiety measures are presented. Scores can range from 6 to 30; higher scores indicate greater anxiety/
depression.
c
For the 12-item Zarit Caregiver Burden measure, scores can range from 0 to 48; higher scores indicate a greater burden.
d
Patient autonomous motivation for self-care was assessed on a 1 to 7 scale; caregiver autonomous motivation was assessed on a 0 to 4 scale. Higher
scores indicate greater autonomous motivation.
Competence scores can range from 0 to 10; higher scores indicate greater competence.
e
Relatedness scores can range from 4 to 16; higher scores indicate greater relationship quality.

with caregivers reporting lower levels of depression at T1
than patients.
Anxiety. At T1, there was a significant difference in anxi-
ety (P < .0001), with the intervention group having lower
mean scores (less anxiety) than the UMC group. The
effect size was d 5 21.3.
Specifically, caregivers receiving the intervention had signif-
icantly higher scores for autonomy at T1 compared with
caregivers receiving UMC (d 5 1.2). Likewise, patients and
caregivers receiving the intervention had significantly
higher scores for competence (d 5 2.6) and relatedness
(d 5 2.2) at T1 compared with those receiving UMC.

Caregiver burden. At T1, there was a significant difference Clinical significance

in caregiver burden (P < .0001), with the intervention
group having lower mean scores (less caregiver burden)
than the UMC group. The effect size was d 5 22.5.
Secondary outcomes
As Table 5 shows, with the exception of patient
autonomy, significant main effects for treatment group
were found for all of the secondary outcomes at T1.
For caregivers with high depression levels (n 5 23), 2 of
the 11 (18%) who received UMC improved (ie, their T-
score moved from 1 SD to <1 SD), and 10 of the 12
(83%) who received the intervention improved
(v2 5 9.91, P 5 .01). For patients with high depression
levels (n 5 13), 2 of the 6 (33%) who received UMC
improved, whereas 5 of the 7 (71%) who received the
intervention improved (v2 5 1.89, P 5 .39). For

Cancer January 1, 2015 155

Original Article

TABLE 5. Results of Analyses of Covariance for the Study Outcomes at Baseline and Follow-Up

Group 3 Role
Treatment Group Role Interaction

Measure at Baseline F P F P F P Least Square Means

Depression 72.13 <.0001 4.55 .04 NS NS UMC, 16.31; Intervention, 11.53;

Patients, 14.53; Caregivers, 13.31
Anxiety 34.34 <.0001 NS NS 3.46 .07 UMC, 16.03; Intervention, 12.20;
UMCpatients, 15.85; UMCcaregivers,
16.20; Interventionpatients, 13.24;
Interventioncaregivers, 11.16
Caregiver burdena 21.46 <.0001 — — — — UMC, 28.32; Intervention, 24.55
Patient autonomya,b 3.13 .09 — — — — UMC, 4.37; Intervention, 4.81
Caregiver autonomya,b 21.46 <.0001 — — — — UMC, 2.03; Intervention, 2.70
Competence 132.34 <.0001 NS NS NS NS UMC, 4.58; Intervention, 7.07
Relatedness 63.66 <.0001 NS NS NS NS UMC, 10.63; Intervention, 12.71

Abbreviations: NS, not significant; UMC, usual medical care.

a
An analysis was not performed because only 1 partner (the caregiver only or the patient only) completed this measure.
b
Two different measures of autonomy were used for patients and caregivers. Specifically, we assessed patient autonomous motivation for self-care and care-
giver autonomous motivation for providing care.

caregivers with high anxiety levels (n 5 27), 2 of the 12
(17%) who received UMC improved, whereas 10 of the
15 (67%) who received the intervention improved
(v2 5 8.44, P 5 .02). Finally, for patients with high anxi-
ety levels (n 5 18), 2 of the 10 (20%) who received UMC
improved, whereas 3 of the 8 (38%) who received the
intervention improved (v2 5 1.80, P 5 .41).
DISCUSSION
This study supports the feasibility, acceptability, and
preliminary efficacy of a 6-session, telephone-based
dyadic psychosocial intervention that we developed for
advanced LC patients and their caregivers. Our recruit-
ment rate was 60%, which is comparable to rates
reported by other telephone-based dyadic interventions
in cancer32 and supports the feasibility of recruiting
advanced LC patients on active treatment and their
caregivers for this trial. Participants rated the interven-
tion as relevant, convenient, and helpful. Retention was
excellent, and patients and caregivers completed the ma-
jority (88%) of the homework assignments; this suggests
that the intervention was highly acceptable. Large effect
sizes were found for the impact of the intervention com-
pared with UMC on the primary outcomes of patient
and caregiver depression (d 5 21.8), anxiety
(d 5 21.3), and caregiver burden (d 5 22.5). Large
effect sizes (d  1.2) for the impact of the intervention
were also found for the secondary outcomes of patient
and caregiver competence and relatedness and for
caregiver autonomous motivation for providing
care. Finally, the proportion of highly depressed and
anxious caregivers who experienced improvements in
psychological functioning was significantly greater in
the intervention group versus the UMC group.
Although effect sizes for most of the outcomes were
large, there is room for improvement. Patient autonomy
increased as a result of receiving the intervention, but the
effect was not statistically significant. Likewise, a greater
number of the most distressed patients improved in the
intervention group versus the UMC group, but the differ-
ence was not significant. One explanation is that the small
sample size and the lack of extended follow-up limited
our ability to detect differences. At the same time, many
participants said that they would have preferred not to
have had all the telephone sessions together with their
loved one. Thus, some patients may have held back con-
cerns because their caregiver was present, and this may
have prevented them from fully benefiting from the inter-
vention. Although the cancer literature shows that
patients and caregivers have both individual and shared
needs and concerns, the vast majority of dyadic interven-
tions in cancer have been delivered to patients and caregiv-
ers together, and this is more consistent with a couples
therapy approach.32 Because acknowledging and address-
ing individuals’ unique and shared needs may enhance
dyadic coping, it may not be sufficient solely to tailor
intervention materials according to role. Thus, the next
step in this research program will be to conduct a large-
scale randomized control trial in which half of the sessions
will be delivered to patients and caregivers together and
half will be delivered separately. This should allow (1)
more in-depth coverage of tailored materials; (2) more
time with the interventionist to address individual needs/

156 Cancer January 1, 2015


concerns; and, (3) more time to practice skills and receive
feedback, which may enhance program satisfaction and
outcomes.
In terms of limitations, our sample was primarily
white and was relatively well educated. The ability to gen-
eralize findings to other populations is limited. We also
did not collect data on the number of patients in both
groups who were referred to the specialist palliative care
team. We intend to address these issues in our future
research and will continue to work to refine and shorten
our 38-item measure of competence to reduce possible
redundancies and participant burden. Because initial sup-
port has now been obtained for our dyadic intervention, it
is important to replicate findings with a larger sample size.
A larger trial would make it possible to examine whether
certain subgroups are more likely to benefit and whether
sociodemographic, medical, or relationship factors (eg,
whether the caregiver is a spouse/partner or other family
member) moderate the effects of the intervention on study
outcomes. Longer follow-up would allow us to examine
the maintenance of effects after patients have undergone
the first few rounds of treatment and have had more time
to access and use existing palliative and supportive care
services. Longer follow-up is also needed because it is pos-
sible that the clinically meaningful improvements seen in
caregivers may precede and lead to improvements for
patients over time. Because of the dyadic nature of the
study and the poor prognosis and fragility of this patient
population, retention over an extended follow-up is likely
to be challenging; however, because of the rapid func-
tional decline in advanced LC, it is important to deter-
mine how long intervention effects last, whether booster
sessions are needed, and whether receiving the interven-
tion results in decreased health care utilization such as
unnecessary hospital admissions (ie, due to poor symptom
control at home). It may also be useful to extend follow-
up after the patient’s death to determine whether receiving
the intervention results in less complicated bereavement
for caregivers. Finally, in the future, it will be important
to explore what it is about the intervention that is benefi-
cial and whether the active ingredients are the same for
patients and caregivers.
Because we chose to compare the intervention to
UMC instead of an attention control condition, it is pos-
sible that the improvements found were due to nonspe-
cific effects. At the same time, if the aim of a trial is to
determine whether an intervention is superior to existing
practices (in this case, UMC), then it needs to be com-
pared with those practices.33 Because the paramount con-
sideration in choosing a control condition is how well it
Cancer January 1, 2015
Lung Cancer Dyadic Intervention/Badr et al
fits the purpose of the trial34 and the goal of this prelimi-
nary efficacy trial was to push the envelope of efficacy to
achieve better outcomes for patients and caregivers (not to
differentiate between specific and nonspecific ingredients
of the intervention), we believe that UMC was a reasona-
ble and appropriate comparison condition. In the future,
we would like to examine whether comparable outcomes
can be achieved with a less expensive or intensive interven-
tion such as the kind that might be employed in an atten-
tion control. That, however, is a comparative effectiveness
question, and there will be no need for it unless this inter-
vention is first shown to be superior to UMC in a large,
full-scale efficacy trial.
In conclusion, our findings provide evidence that a
dyadic psychosocial intervention can be beneficial to the
advanced LC population and result in improvements in
both patient and caregiver psychological functioning.
They also suggest that such interventions have the poten-
tial to improve patient and caregiver self-efficacy for man-
aging symptoms and working together as a team. Finally,
our findings suggest that interventions simultaneously tar-
geting the patient and the caregiver as individuals and as a
dyad can result in improvements on both individual (ie,
psychological functioning and self-efficacy) and dyadic
levels (ie, patient and caregiver sense of relatedness).
Because of this and because attending to the needs/con-
cerns of patients and their family caregivers is an impor-
tant component of quality end-of-life care, more research
on ways to integrate dyadic and other family-based psy-
chosocial interventions into oncology palliative and sup-
portive care programs is warranted.
FUNDING SUPPORT
This work was supported by a pilot grant awarded to Hoda Badr
under P30 AG028741 (Albert Siu, MD, principal investigator).
CONFLICT OF INTEREST DISCLOSURES
The authors made no disclosures.
REFERENCES
1. American Cancer Society. Cancer Facts & Figures 2014. http://
www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2014/.
Accessed July 2014.
2. Mountain CF. Revisions in the international system for staging lung
cancer. Chest. 1997;111:1710-1717.
3. Alberti W, Anderson G, Bartolucci A, et al. Chemotherapy in non-
small cell lung cancer: a meta-analysis using updated data on indi-
vidual patients from 52 randomised clinical trials. BMJ. 1995;311:
899-909.
4. Degner LF, Sloan JA. Symptom distress in newly diagnosed ambula-
tory cancer patients and as a predictor of survival in lung cancer.
J Pain Symptom Manage. 1995;10:423-431.
157
Original Article
5. Zabora J, Brintzenhofeszoc K, Curbow B, Hooker C, Piantadosi S.
The prevalence of psychological distress by cancer site. Psychooncol-
ogy. 2001;10:19-28.
6. Bee PE, Barnes P, Luker KA. A systematic review of informal care-
givers’ needs in providing home-based end-of-life care to people
with cancer. J Clin Nurs. 2009;18:1379-1393.
7. Temel JS, Greer JA, Muzikansky A, et al. Early palliative care for
patients with metastatic non–small-cell lung cancer. N Engl J Med.
2010;363:733-742.
8. Smith TJ, Temin S, Alesi ER, et al. American Society of Clinical
Oncology provisional clinical opinion: the integration of palliative
care into standard oncology care. J Clin Oncol. 2012;30:880-887.
9. Ford DW, Koch KA, Ray DE, Selecky PA. Palliative and end-of-life
care in lung cancer: diagnosis and management of lung cancer, 3rd
ed: American College of Chest Physicians evidence-based clinical
practice guidelines. Chest. 2013;143:e498S-e512S.
10. Davies B, Reimer JC, Martens N. Family functioning and its impli-
cations for palliative care. J Palliat Med. 1994;10:29-36.
11. Hudson P, Remedios C, Zordan R, et al. Guidelines for the psycho-
social and bereavement support of family caregivers of palliative care
patients. J Palliat Med. 2012;15:696-702.
12. Bakas T, Lewis RR, Parsons JE. Caregiving tasks among family care-
givers of patients with lung cancer. Oncol Nurs Forum. 2001;28:847-
854.
13. Porter LS, Keefe FJ, Garst J, McBride CM, Baucom D. Self-efficacy
for managing pain, symptoms, and function in patients with lung
cancer and their informal caregivers: associations with symptoms &
distress. Pain. 2008;137:306-315.
14. Carmack Taylor CL, Badr H, Lee L, et al. Lung cancer patients and
their spouses: psychological and relationship functioning within 1
month of treatment initiation. Ann Behav Med. 2008;36:129-140.
15. Cooper ET. A pilot study on the effects of the diagnosis of lung
cancer on family relationships. Cancer Nurs. 1984: 301-308.
16. Badr H, Carmack Taylor C. Social constraints and spousal commu-
nication in lung cancer. Psychooncology. 2006;15:673-683.
17. Kissane D, McKenzie M, Bloch S, Moskowitz C, McKenzie D,
O’Neill I. Family focused grief therapy: a randomized, controlled
trial in palliative care and bereavement. Am J Psychiatry. 2006;163:
1208-1218.
18. McLean LM, Walton T, Rodin G, Esplen MJ, Jones JM. A couple-
based intervention for patients and caregivers facing end-stage cancer:
outcomes of a randomized controlled trial. Psychooncology. 2011;22:
28-38.
19. Keefe FJ, Ahles TA, Sutton L, et al. Partner-guided cancer pain
management at the end of life: a preliminary study. J Pain Symptom
Manage. 2005;29:263-272.
158
20. McMillan SC, Small BJ, Weitzner M, et al. Impact of coping skills
intervention with family caregivers of hospice patients with cancer: a
randomized clinical trial. Cancer. 2006;106:214-222.
21. Hudson PL, Aranda S, Hayman-White K. A psycho-educational
intervention for family caregivers of patients receiving palliative care:
a randomized controlled trial. J Pain Symptom Manage. 2005;30:
329-341.
22. Deci EL, Ryan RM. The "what" and "why" of goal pursuits: human
needs and the self-determination of behavior. Psychol Inq. 2000;11:
227-268.
23. Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D.
Item banks for measuring emotional distress from the Patient-
Reported Outcomes Measurement Information System (PROMISV R ):
depression, anxiety, and anger. Assessment. 2011;18:263-283.
24. Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O’Donnell
M. The Zarit Burden Interview: a new short version and screening
version. Gerontologist. 2001;41:652-657.
25. Pierce T, Lydon JE, Yang S. Enthusiasm and moral commitment:
what sustains family caregivers of those with dementia. Basic Appl
Soc Psychol. 2001;23:29-41.
26. Levesque C, Williams GC, Elliot D, Pickering MA, Bodenhamer B,
Finley PJ. Validating the theoretical structure of the Treatment Self-
Regulation Questionnaire (TSRQ) across three different health
behaviors. Health Educ Res. 2007;22:691-702.
27. Lorig K, Stewart A, Ritter P, Gonzalez V, Laurent D, Lynch J. Out-
come Measures for Health Education and Other Health Care Inter-
ventions. Thousand Oaks, CA: Sage; 1996.
28. Lawrence RH, Tennstedt SL, Assmann SF. Quality of the caregiver-
care recipient relationship: does it offset negative consequences of
caregiving for family caregivers? Psychol Aging. 1998;13:150-158.
29. National Consensus Project for Quality Palliative Care. Clinical
practice guidelines for quality palliative care. 3rd ed. http://www.
nationalconsensusproject.org/Guideline.pdf 2013. Accessed July
2014.
30. Rosnow RL, Rosenthal R. Computing contrasts, effect sizes, and
counternulls on other people’s published data: general procedures for
research consumers. Psychol Methods. 1996;1:331-340.
31. Cohen J. Statistical Power Analysis for the Behavioral Sciences. Mah-
wah, NJ: Lawrence Erlbaum Associates; 1988.
32. Badr H, Krebs P. A systematic review and meta-analysis of psychoso-
cial interventions for couples coping with cancer. Psychooncology.
2013;22:1688-1704.
33. Freedland KE, Mohr DC, Davidson KW, Schwartz JE. Usual and
unusual care: existing practice control groups in randomized con-
trolled trials of behavioral interventions. Psychosom Med. 2011;73:
323-335.
34. Wampold BE. The Great Psychotherapy Debate: Models, Methods,
and Findings. London, United Kingdom: Routledge; 2001.
Cancer January 1, 2015