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RESEARCH AND PRACTICE
Nuevo Amanecer: Results of a Randomized Controlled
Trial of a Community-Based, Peer-Delivered Stress
Management Intervention to Improve Quality of Life in
Latinas With Breast Cancer
Anna María Nápoles, PhD, MPH, Carmen Ortíz, PhD, Jasmine Santoyo-Olsson, MS, Anita L. Stewart, PhD, Steven Gregorich, PhD, Howard E. Lee,
MD, MPH, Ysabel Durón, BA, Peggy McGuire, MA, and Judith Luce, MD
Latinos are the fastest growing US racial/ethnic
group. With a population growth rate 4 times
that of the total US population (24.3% vs
6.1%), they accounted for half of the nation’s
growth between 2000 and 2006.1 Breast
cancer is the most frequently occurring cancer
and leading cause of cancer death among
Latinas.2 Latinas experience worse breast-cancerrecurrence-free survival than White women.3
Latinas are at higher risk for psychosocial and
physical sequelae of breast cancer than White
women and report higher rates of anxiety,
depression, fear of recurrence, fatigue, and
pain and worse health-related quality of life
(HRQOL).4—9 Limited English proficiency, employment, and insurance coverage; lack of
transportation; and problems paying for treatment increase their risk of distress.6 Anxiety
among Spanish-speaking patients is common
because they often do not understand the
diagnosis or treatment and are less involved in
patient-centered decision-making.10
These factors can chronically elevate stress
levels among Latinas after breast cancer. In fact,
disparities in HRQOL between Latinas and nonLatinas with breast cancer have been partially
explained by higher stress levels.5 Higher levels of
chronic stress and fatigue can cause hypothalamic–pituitary—adrenal axis dysregulation and inflammatory responses.3,11,12
Among breast cancer survivors, stress management interventions improve HRQOL, including increased positive affect and lifestyle
changes; decreased anxiety, stress, emotional
distress, and thought intrusion13—18; and improved sleep quality.14,19 These interventions
may also produce beneficial changes in biomarkers of the hypothalamic—pituitary—adrenal
axis14 and immune functioning.18 However,
Objectives. We evaluated a community-based, translational stress management program to improve health-related quality of life in Spanish-speaking
Latinas with breast cancer.
Methods. We adapted a cognitive–behavioral stress management program
integrating evidence-based and community best practices to address the needs
of Latinas with breast cancer. Spanish-speaking Latinas with breast cancer were
randomly assigned to an intervention or usual-care control group. Trained peers
delivered the 8-week intervention between February 2011 and February 2014.
Primary outcomes were breast cancer–specific quality of life and distress, and
general symptoms of distress.
Results. Of 151 participants, 95% were retained at 6 months (between May
2011 and May 2014). Improvements in quality of life from baseline to 6 months
were greater for the intervention than the control group on physical well-being,
emotional well-being, breast cancer concerns, and overall quality of life. Decreases from baseline to 6 months were greater for the intervention group on
depression and somatization.
Conclusions. Results suggest that translation of evidence-based programs
can reduce psychosocial health disparities in Latinas with breast cancer.
Integration of this program into community-based organizations enhances its
dissemination potential. (Am J Public Health. 2015;105:e55–e63. doi:10.2105/
AJPH.2015.302598)
such studies are lacking among Latinas with
breast cancer. Translation of evidence-based
Cancer Support and Resource Center; and
a coalition of community-based organizations
stress management interventions could help
and clinical partners.21,22
address this gap and reduce ethnic disparities
in psychosocial health of Latinas with breast
METHODS
cancer.
We present results of a randomized controlled trial of a peer-delivered cognitive—
In this 6-month randomized controlled trial,
we compared the Nuevo Amanecer intervention
behavioral stress management (CBSM) program called Nuevo Amanecer (“a new dawn”)
with a usual-care control group (control group
for Spanish-speaking Latinas with breast
trial). We examined the program’s effectiveness
cancer. The program was developed using
community-based participatory research
in improving several dimensions of HRQOL
participants were offered the program after the
and distress at 3 months and 6 months. We
methods for translating evidence-based inter-
selected the 3-month interval because benefits
ventions for underserved populations20
through a collaboration between the University
from these types of interventions in women
of California, San Francisco; Círculo de Vida
after 6 to 12 weeks.23—25
Supplement 3, 2015, Vol 105, No. S3 | American Journal of Public Health
with breast cancer have been demonstrated
Nápoles et al. | Peer Reviewed | Research and Practice | e55
RESEARCH AND PRACTICE
Assessed for study eligibility (n = 195)
Excluded (n = 44)
Not meeting inclusion criteria (n = 22)
Declined to participate (n = 22)
Randomized (n = 151)
76 Randomized to intervention group
75 Randomized to control group
70 Completed 3-month follow-up
4 Refused
2 Lost to follow-up
74 Completed 3-month follow-up
1 Deceased
71 Completed 6-month follow-up
4 Refused
1 Lost to follow-up
1 Returned to study
73 Completed 6-month follow-up
1 Lost to follow-up
76 Included in analysis
75 Included in analysis
FIGURE 1—Flow of participants from screening to completion of final follow-up assessment: Nuevo Amanecer study; San Francisco Bay Area, CA;
February 2011–May 2014.
Participants
The study population consisted of Spanishspeaking Latinas with breast cancer residing in
5 Northern California counties. Inclusion criteria were (1) 1 year or less since diagnosis with
stage 0 to stage IIIC primary breast cancer; (2)
living in Alameda, Contra Costa, San Francisco,
San Mateo, or Santa Clara County; (3) primarily
Spanish speaking or Spanish monolingual; and
(4) self-identifying as Latina. Exclusion criteria
were (1) previous cancer diagnosis except for
nonmelanoma skin cancer, (2) terminal illness,
or (3) stage IV breast cancer (distant metastasis). We excluded women with metastatic cancer because their survival rates decline dramatically compared with those of women
diagnosed at earlier stages, suggesting that their
psychosocial concerns differ (greater emphasis
on symptomatic relief, existential matters).26
Recruitment was conducted by trained
bilingual Latinas employed by the communitybased organization partners on the project.21
Nuevo Amanecer Intervention
The Nuevo Amanecer program and its
development are described in detail elsewhere.21,22 Program development emphasized
appropriate methods for translating evidencebased interventions for underserved populations20 to address known determinants of
HRQOL disparities in Latinas with breast cancer. Nuevo Amanecer integrates an evidencebased CBSM program,23 a community bestpractices intervention offered at Círculo de
Vida for Latinas, literature, and formative research. Our formative work identified several
unique needs of Latinas with breast cancer
(e.g., the intervention needs to address lack of
comprehensible cancer information, feelings of
powerlessness and fear of death) and optimal
e56 | Research and Practice | Peer Reviewed | Nápoles et al.
delivery mechanisms (e.g., culturally competent
peer support).22
Adaptations to address known determinants
and Latinas’ needs included translation into
low-literacy (sixth-grade-level) Spanish with
images, integration of culturally appropriate
content, delivery by trained Latina breast
cancer survivors rather than professionals,
emotional support, and simple information on
cancer and its treatment. Adaptations were
guided by our community advisory board,
Círculo de Vida staff, and the author of the
evidence-based program.
Social-cognitive theory served as the conceptual framework for the intervention.27 The
program emphasized cognitive—behavioral
coping skills training, coaching, and modeling
to actively manage stress and emotions. Because vulnerable populations typically reside
in high-stress environments and perceive
American Journal of Public Health | Supplement 3, 2015, Vol 105, No. S3
RESEARCH AND PRACTICE
TABLE 1—Baseline Characteristics of Spanish-Speaking Latina Participants With
Breast Cancer: Nuevo Amanecer Study; San Francisco Bay Area, CA; February 2011–
May 2014
Intervention
Group
(n = 76),
Mean 6SD or
No. (%)
Control
Group (n = 75),
Mean 6SD or
No. (%)
Pa
Total Sample
(n = 151),
Mean 6SD or
No. (%)
Age, y
50.8 611.9
50.2 69.9
.76
50.5 610.9
Acculturation (scale 1–5)b
1.4 60.6
1.3 60.5
.31
1.3 60.6
.78
100 (66)
Characteristics
Educational attainment
< sixth grade
50 (66)
50 (67)
Sixth grade to < high school
15 (20)
12 (16)
27 (18)
High school graduate
11 (14)
13 (17)
24 (16)
Health insurancec
Any private
11 (14)
10 (15)
Public insurance only
62 (82)
56 (82)
None
Employed full or part time
Any financial hardship in past y
.95
21 (15)
118 (82)
3 (4)
2 (3)
12 (16)
59 (79)
14 (19)
56 (77)
.64
.78
26 (17)
115 (78)
5 (3)
.6
102 (68)
Ethnicity
Mexican
50 (66)
52 (69)
Central American
20 (26)
15 (20)
South American
6 (8)
8 (11)
35 (46)
45 (60)
51 (67)
45 (62)
Married or living with a partner
Poor or fair self-rated health
Presence of chronic medical condition
37 (49)
40 (53)
Clinical and treatment characteristics
35 (23)
14 (9)
.09
80 (53)
.49
96 (64)
.57
77 (51)
Type of breast cancer
DCIS
20 (26)
20 (27)
Invasive
56 (74)
55 (73)
.96
40 (26)
0
20 (26)
20 (27)
1
12 (16)
11 (15)
23 (15)
2
3
31 (41)
13 (17)
26 (35)
18 (24)
57 (38)
31 (21)
Breast conserving
43 (57)
41 (55)
Mastectomy
33 (43)
34 (45)
33 (43)
27 (36)
111 (74)
Stage
.73
40 (26)
Surgery
.81
84 (56)
Data Collection
67 (44)
Adjuvant treatment
Both chemotherapy and radiation
.58
60 (40)
Only radiation
18 (24)
24 (32)
42 (28)
Only chemotherapy
No treatment
14 (18)
11 (15)
11 (15)
13 (17)
25 (17)
24 (16)
Physical well-being (scale 0–24)
Breast cancer-specific quality of lifed
15.29 65.78
16.76 65.02
.1
16.0 65.5
Social/family well-being (scale 0–20)
13.67 64.42
.15
13.2 64.4
12.66 64.25
Emotional well-being (scale 0–20)
12.07 64.91
12.86 65.14
.33
12.5 65.0
Breast cancer concerns (scale 0–28)
16.52 65.43
17.33 65.08
.34
16.9 65.3
Enjoyment of life (scale 0–16)
8.92 63.80
9.22 63.43
.61
9.1 63.6
Continued
Supplement 3, 2015, Vol 105, No. S3 | American Journal of Public Health
a limited sense of control, acquisition of stress
management skills constitutes a critical, practical intervention to enhance their abilities to
cope with stressful situations. Thus, program
components aimed to increase self-efficacy for
cancer coping, use of coping skills, and perceived social support, which could improve
HRQOL and reduce distress. Eight weekly
modules covered managing the initial impact of
cancer, finding cancer information, getting
support, identifying helpful and unhelpful
thoughts, managing thoughts and mood, stress
management techniques, managing activities
that affect mood, and goal setting.21 Modules
addressed 3 social-cognitive theory components: self-efficacy (e.g., accessing information,
managing thoughts and activities affecting
mood), outcome expectations (e.g., recognizing
and restructuring unhelpful thoughts about
cancer and the future), and self-regulation (e.g.,
self-monitoring and adapting behaviors and
cognitions until goals were met).
The program was delivered by trained
compañeras (companions). Compañeras were
bilingual or Spanish-monolingual Latina breast
cancer survivors who had completed active
treatment and were at least 3 years postdiagnosis with no recurrence. Compañeras participated in 3 consecutive 8-hour training sessions
conducted by academic and community partners.21 The Nuevo Amanecer program was delivered face to face in participants’ homes for 8
weeks. Each week, one 90-minute module was
presented using visuals and hands-on exercises
to teach and reinforce concepts and skills.
Control group participants received usual care
until after the 6-month assessment, at which
time they were offered the intervention.
Baseline, 3-month, and 6-month assessments corresponded with our aims of evaluating the 8-week intervention soon after completion and retention of benefits after program
termination. Recruiters conducted 60-minute
baseline assessments in person.
An experienced, bilingual research associate
blinded to participants’ group assignment conducted the 3- and 6-month 30-minute telephone surveys. Data were collected and managed using a secure Web-based tool, Research
Electronic Data Capture (Harvard Catalyst,
Boston, MA).28 Participants were compensated
Nápoles et al. | Peer Reviewed | Research and Practice | e57
RESEARCH AND PRACTICE
TABLE 1—Continued
Overall quality of life (scale 0–108)
66.46 616.92
68.83 615.33
.37
67.6 616.1
General symptoms of distresse
Anxiety (scale 0–4)
0.93 60.84
1.01 60.88
.58
0.97 60.86
Depression (scale 0–4)
0.93 60.84
0.75 60.76
.16
0.84 60.80
Somatization (scale 0–4)
0.93 60.78
0.75 60.59
.1
0.84 60.70
Intrusive thoughts scale (scale 0–35)
Breast cancer-specific distressf
7.96 68.46
8.65 68.91
.63
8.30 68.66
Note. DCIS = ductal carcinoma in situ.
a
Compares differences between intervention and control group at baseline.
b
Marin language scale; higher score indicates greater acculturation to English.
c
Totals do not add up because of missing data (n = 7).
d
Functional Assessment of Cancer Therapy–Breast scores, modified; higher scores indicate better quality of life.
e
Brief Symptom Inventory; higher scores indicate more distress.
f
Intrusive Thoughts Scale; higher score indicates more distress.
published scoring algorithm, we summed items
after recoding responses to 0, 1, 3, and 5
(possible range = 0---35); higher scores indicate
greater distress. Internal consistency reliability
was 0.89.
Other variables. Descriptive characteristics
included self-reported age, language acculturation (Marin short version32), education, health
insurance, employment status, financial hardship, ethnicity, national origin, US-born or
foreign-born, marital status, self-rated health,
and presence of other chronic medical conditions. Breast cancer characteristics verified
through medical records review included cancer type, stage at diagnosis, and type of surgery
and adjuvant treatment.
Randomization
$30 per assessment; all assessments were
completed in Spanish.
Measures
Using baseline data, we examined the psychometric properties of our primary outcome
measures.
Breast cancer---specific quality of life. The
Functional Assessment of Cancer Therapy--Breast (FACT-B) was our breast cancer---specific
quality-of-life outcome measure29; it has been
translated into Spanish.30 The FACT-B consists
of 5 subscale scores pertaining to 4 well-being
dimensions (physical, social---family, emotional,
functional) and additional breast cancer concerns. A total overall score is the sum of all
subscales. Women were asked the extent to
which statements applied to them during the
previous 7 days (response options: 0 = not at
all, 1 = a little bit, 2 = somewhat, 3 = quite a bit,
and 4 = very much).
Our psychometric analysis resulted in some
modifications; of 37 items, 8 were dropped
because of 1 or more problems: (1) low itemscale correlations (< 0.30 with other items in
the scale corrected for overlap), (2) being
conditional on having a partner and thus
having a large amount of missing data, and (3)
being conceptually different from other items
on that scale. Subscales were scored by summing items after reversing some items; higher
scores indicated greater well-being. Possible
score ranges are as follows: physical well-being,
0---24; social---family well-being, 0---20; emotional well-being, 0---20; breast cancer
concerns, 0---28; and enjoyment of life, 0---16.
The total FACT-B score was the sum of the 5
modified subscales (range = 0---108). In our
sample, internal consistency reliabilities ranged
from 0.69 to 0.84 for the subscales.
General distress symptoms. We used 3 scales
from the Brief Symptom Inventory31: anxiety
(e.g., feeling nervous, fearful), depression (e.g.,
feeling lonely, worthless), and somatization
(e.g., dizziness, feeling weak). Women were asked
how much each symptom had bothered them
during the previous 7 days (response options:
0 = not at all, 1= a little bit, 2 = moderately,
3 = quite a bit, or 4 = extremely). Scores were
the mean of nonmissing items (possible
range = 0---4); higher scores indicate more distress. In our sample, internal consistency reliabilities were 0.85 for anxiety, 0.83 for depression, and 0.76 for somatization.
Breast cancer---specific distress. We measured
breast cancer distress with the 7-item Intrusive
Thoughts Scale, a subscale of the revised
Impact of Event Scale that is sensitive to change
in women with breast cancer who are receiving
a cognitive---behavioral intervention.13 Items
were anchored to the breast cancer experience
(as intended by the authors of the scale) and
asked about ruminations related to their breast
cancer, such as: “I had trouble falling asleep or
staying asleep because of pictures or thoughts
about my breast cancer that came into my
mind.” Women were asked how often each
symptom had applied to them in the past 7
days (response options: 0 = not at all, 1= rarely,
2 = sometimes, and 3 = often). Using the
e58 | Research and Practice | Peer Reviewed | Nápoles et al.
The individual was the unit of randomization
with 1:1 allocation to experimental groups. Randomization was stratified by recruitment site.
Before initiating recruitment, stratumspecific sequential identification numbers were
generated and randomly preassigned in blocks
of random sizes. After the baseline assessment,
each participant was handed a sealed opaque
envelope preprinted with the next sequential
identification number from her stratum that
revealed her group assignment.
Statistical Analysis
Using intention-to-treat analyses, we used
repeated-measures linear regression models to
estimate the intervention effects on study outcomes across the baseline, 3-month, and
6-month assessments. Likelihood-based model
estimation assumed outcome responses were
missing at random.33 Explanatory variables
included an intervention group indicator, a categorical time indicator, and a group · time
interaction variable.
Custom contrasts estimated differences between treatment groups at each assessment
as well as 2 group · linear time interactions:
1 examining the change from baseline to
3-month assessment (immediately after intervention) and 1 examining the change from
baseline to 6 months. We compared experimental groups on primary outcomes of breast
cancer---specific quality of life, general distress
symptoms (anxiety, depression, somatization),
and breast cancer---specific distress (intrusive
thoughts).
American Journal of Public Health | Supplement 3, 2015, Vol 105, No. S3
RESEARCH AND PRACTICE
RESULTS
TABLE 2—Quality of Life and Symptoms of Distress Among Spanish-Speaking Latinas With
Breast Cancer, by Treatment Group at Baseline, 3 Months, and 6 Months: Nuevo Amanecer
Study; San Francisco Bay Area, CA; February 2011–May 2014
Intervention, Mean (SD)
Control, Mean (SD)
Pa
Breast cancer-specific quality of lifeb
Physical well-being (scale 0–24)
Baseline
15.29 (5.78)
16.76 (5.02)
.098
3 mo
6 mo
18.13 (4.81)
19.44 (4.26)
18.01 (4.44)
18.44 (4.58)
.923
.212
Treatment · time interaction (0–3 mo)
.151
Treatment · time interaction (0–6 mo)
.015
Social/family well-being (scale 0–20)
Baseline
13.67 (4.42)
12.66 (4.25)
.154
3 mo
13.57 (4.65)
13.74 (4.24)
.732
6 mo
13.72 (4.81)
14.47 (3.81)
.293
Treatment · time interaction (0–3 mo)
Treatment · time interaction (0–6 mo)
.071
.025
Emotional well-being (scale 0–20)
Baseline
12.07 (4.91)
12.86 (5.14)
.333
3 mo
15.93 (3.52)
14.73 (4.33)
.081
6 mo
16.39 (3.30)
14.89 (3.95)
.018
Treatment · time interaction (0–3 mo)
.018
Treatment · time interaction (0–6 mo)
.004
Breast cancer concerns (scale 0–28)
Baseline
16.52 (5.43)
17.33 (5.08)
.344
3 mo
19.91 (4.69)
19.20 (4.69)
.396
6 mo
21.31 (3.83)
19.92 (5.22)
.083
Treatment · time interaction (0–3 mo)
.08
Treatment · time interaction (0–6 mo)
.013
Enjoyment of life (scale 0–16)
Baseline
8.92 (3.80)
9.22 (3.43)
.61
3 mo
6 mo
9.70 (3.59)
9.79 (3.39)
8.72 (3.28)
9.30 (3.06)
.103
.41
Treatment · time interaction (0–3 mo)
.048
Treatment · time interaction (0–6 mo)
.267
Overall quality of life (scale 0–108)
Baseline
66.46 (16.92)
68.83 (15.33)
.37
3 mo
77.24 (15.13)
74.39 (15.34)
.37
6 mo
80.64 (13.64)
77.02 (15.62)
.174
Treatment · time interaction (0–3 mo)
Treatment · time interaction (0–6 mo)
.061
.03
General symptoms of distressc
Anxiety (scale 0–4)
Baseline
0.93 (0.84)
1.01 (0.88)
.577
3 mo
0.48 (0.66)
0.60 (0.73)
.32
6 mo
0.39 (0.53)
0.58 (0.76)
.09
Treatment · time interaction (0–3 mo)
.808
Treatment · time interaction (0–6 mo)
.465
Continued
Supplement 3, 2015, Vol 105, No. S3 | American Journal of Public Health
We invited 195 women to the study; 22
were ineligible, and 22 refused to participate.
We randomly assigned 151 women (77%) to
the intervention (n = 76) or to the control
group (n = 75) between February 2011 and
November 2013; follow-up assessments occurred from May 2011 through May 2014
(Figure 1). More than 80% were enrolled
within 6 months of diagnosis; almost half
(47%) were enrolled within 3 months.
The sample had a mean age of 50 years
(SD = 11), low levels of acculturation to English, low levels of educational attainment, and
mostly public health insurance and was mostly
unemployed; the majority had experienced
financial hardship in the previous year (Table 1).
All but 1 were immigrants; the majority were
of Mexican origin (68%), followed by Central
American (23%). About a third reported being
in poor or fair health, and about half reported
a comorbid chronic condition.
About three fourths of the women were
diagnosed with invasive breast cancer, and the
rest with ductal carcinoma in situ. The majority
had breast-conserving surgery; 44% had
a mastectomy. Almost 60% had chemotherapy, mostly followed by radiation therapy.
Only 28% had radiation only, and 16% had no
adjuvant treatment.
Baseline levels of breast cancer---specific
quality of life were low, indicating poor quality
of life. In general, symptoms of anxiety, depression, somatization, and intrusive thoughts
were also low, indicating low levels of general
distress (Table 1). We found no significant
differences between intervention and control
groups at baseline on demographics, clinical
characteristics, quality of life, or distress outcomes (Table 1), indicating that balance between treatment groups was achieved with
randomization.
Approximately 82% of intervention group
participants were minimally compliant, completing at least 6 of 8 weekly sessions. Sixmonth study retention was excellent: 71 (93%)
of the intervention group and 73 (97%) of the
control group.
From baseline to 3-month follow-up, there
were statistically significant treatment · time
interaction effects for emotional well-being
Nápoles et al. | Peer Reviewed | Research and Practice | e59
RESEARCH AND PRACTICE
intervention group than the control group,
indicating less distress (3.87 vs 6.27; P = .046).
TABLE 2—Continued
Depression (scale 0–4)
Baseline
0.93 (0.84)
0.75 (0.76)
.164
3 mo
0.46 (0.59)
0.52 (0.63)
.531
6 mo
0.38 (0.48)
0.46 (0.62)
.355
Treatment · time interaction (0–3 mo)
.06
Treatment · time interaction (0–6 mo)
Somatization (scale 0–4)
.045
Baseline
0.93 (0.78)
0.75 (0.59)
.104
3 mo
0.67 (0.65)
0.74 (0.63)
.558
6 mo
0.52 (0.51)
0.66 (0.60)
.162
Treatment · time interaction (0–3 mo)
.038
Treatment · time interaction (0–6 mo)
.005
Breast cancer-specific distressd
Intrusive thoughts scale (scale 0–35)
Baseline
7.96 (8.46)
8.65 (8.91)
.625
3 mo
5.46 (7.52)
7.04 (8.00)
.232
6 mo
3.87 (5.79)
6.27 (8.42)
.046
Treatment · time interaction (0–3 mo)
.589
Treatment · time interaction (0–6 mo)
.226
Group means were compared at each assessment. Treatment · time interaction from baseline to 3-month assessment is
shortly after completing the intervention; treatment · time interaction from baseline to 6-month assessment is 3 months
after intervention.
b
Functional Assessment of Cancer Therapy–Breast scores, modified; higher scores indicate better quality of life.
c
Brief Symptom Inventory; higher scores indicate more distress.
d
Intrusive Thoughts Scale; higher score indicates more distress.
a
(P = .018), enjoyment of life (P = .048), and
somatization (P = .038) and trends toward
significance for breast cancer concerns
(P = .08), the total score (overall quality of life;
P = .061), and depression (P = .06; Table 2).
From baseline to 3 months, the intervention
group improved significantly more than the
control group on quality of life and distress:
emotional well-being, +3.86 versus +1.87
points (range = 0---20; Figure 2); enjoyment
of life, +0.78 points vs –0.50 points (range =
0---16); and somatization, –0.26 vs –0.01
points (range = 0---4).
From baseline to 6-month follow-up (3
months after intervention), we found significant
treatment · time interaction effects for physical
well-being (P = .015), social---family well-being
(P = .025), emotional well-being (P = .004),
breast cancer concerns (P = .013), overall
quality of life (P = .03), depression (P = .045),
and somatization (P = .005). From baseline to
6 months, the intervention group improved
significantly more than the control group on quality
of life and distress: physical well-being, +4.15
versus +1.68 points (range = 0---24; Figure 2);
emotional well-being, +4.32 versus +2.03
points (range = 0---20; Figure 2); breast cancer
concerns, +4.79 points versus +2.59 points
(range = 0---28); overall quality of life, +14.18
versus +8.19 points (range = 0---108); depression, –0.55 versus –0.29 points (range = 0---4);
and somatization, –0.41 versus –0.09 points
(range = 0---4). All significant interaction effects
were in the hypothesized direction of better
quality-of-life improvements in the intervention than in the control group, except for
social---family well-being. From baseline to 6
months, the control group improved significantly more than the intervention group on
social---family well-being (+0.05 vs +1.81
points; range = 0---20).
Regarding group main effects, at 6 months
the group mean for emotional well-being was
significantly higher for the intervention than
the control group, indicating better quality of
life (16.39 vs 14.89; P = .018). Although we
observed no significant treatment · time interaction effects for anxiety or intrusive
thoughts, the group mean on intrusive thoughts
at 6 months was significantly lower for the
e60 | Research and Practice | Peer Reviewed | Nápoles et al.
DISCUSSION
In this community-based peer-delivered
translational trial of a CBSM intervention for
Spanish-speaking Latinas with breast cancer,
we achieved excellent study retention and
program participation and clinically significant
improvements in several HRQOL dimensions.
Compared with the usual-care control group,
women who received the intervention reported
significant improvements at 6 months in breast
cancer---specific physical well-being, emotional
well-being, breast cancer concerns, and overall
quality of life as well as significant reductions in
general symptoms of depression and somatization.
Minimally important differences for the
FACT-B measures of breast cancer---specific
quality of life, that is, differences that are
important to patients, have been estimated on
the basis of 2 studies of White women with
metastatic breast cancer.34 These estimates
suggest that improvements of 2 to 3 points on
breast cancer concerns and of 7 to 8 points on
FACT-B total scores are minimally important
differences. Differences in improvements from
baseline to 6 months between intervention and
control group women in our study were about
this magnitude, suggesting that minimally important differences were achieved if one can
extrapolate from these previous studies conducted in different ethnic and clinical populations.34 However, it would be preferable to
identify minimally important differences specifically for Latinas with breast cancer.
It is interesting that some of the greatest
improvements occurred in somatization. This is
an important outcome for Latinas because
somatization may be a more culturally acceptable way to express psychological distress
because of the stigma associated with mental
health issues. For example, a validation study of
the Patient Health Questionnaire-15, which
assesses somatic complaints in primary care,
found that among Latinos, the questionnaire
captured mostly psychiatric distress, whereas
among non-Latinos it was equally associated with
psychiatric distress and a history of medically
unexplained symptoms.35 Thus, for Latinos,
somatization measures may be especially sensitive
American Journal of Public Health | Supplement 3, 2015, Vol 105, No. S3
RESEARCH AND PRACTICE
a
20
Physical Well-Being Mean Score
19.4
18.0
18
18.4
16.8
18.0
16
15.3
14
12
10
Control
Nuevo Amanecer
0
Baseline
3 months
6 months
Time
b
Emotional Well-Being Mean Score
20
18
15.9
16
14.8
14
16.4
15.0
12.9
12
12.1
10
Control
Nuevo Amanecer
0
Baseline
3 months
6 months
Time
FIGURE 2—Mean differences between Nuevo Amanecer and control groups in (a) physical
well-being and (b) emotional well-being: San Francisco Bay Area, CA; February 2011–May
2014.
outcomes to include in intervention trials that aim
to improve quality of life and psychosocial health.
We found no significant differences between
treatment groups in changes over time in
intrusive thoughts about breast cancer; however, at 6 months, the treatment group
reported significantly less distress than the
control group. The lack of a significant interaction effect is counter to previous psychosocial intervention trials, including similar types
of cognitive---behavioral interventions conducted with samples of predominantly White
women with breast cancer, which found significant improvements on this outcome over
time.13,36 Cultural factors might help explain
why we did not observe such changes in our
Latina sample. It is well documented that
traditional Latinos have a strong tendency to
equate cancer with death.37,38 Fatalistic beliefs
may be so embedded among Latina women
Supplement 3, 2015, Vol 105, No. S3 | American Journal of Public Health
that stress management interventions are insufficient to achieve significant reductions in
intrusive thoughts over time without special
emphasis on managing fears of recurrence and
death. In fact, when we shared our results with
Latina breast cancer survivors, they stated that
this fear of death never goes away and manifests as ongoing fears of recurrence.
The intervention group unexpectedly demonstrated worse social---family well-being than the
control group. A potential explanation is that
women who were in the intervention group
became more confident in expressing their needs
and asking for help from partners, family members, and friends. The program included instruction in communicating with family and friends
about cancer, how to ask for help, and expressing
feelings and needs because our formative work
indicated the need to teach traditional Latinas to
be more assertive because they may defer to their
partners and hide their needs to protect their
families.22 If Latina women were more expressive
of their needs as a result of the intervention, this
may have disrupted customary social interactions
and might explain the lower ratings of social and
family well-being. Interventions that target the
family unit may perhaps help prevent these lower
ratings.
Using community-based participatory research methods and social-cognitive theory, we
designed the Nuevo Amanecer program to
enhance its cultural relevance for Spanishspeaking Latinas with breast cancer who suffer
disparities in HRQOL and psychosocial health
compared with White women. Nuevo Amanecer
is the only community-based translation of
a CBSM program for Spanish-speaking Latinas
with breast cancer, and it thus makes a substantial contribution to efforts to address these
disparities. Another study among 52 Latinas
with breast cancer tested a psychoeducational
intervention to facilitate posttreatment survivorship, but the investigators did not differentiate between English- and Spanish-speaking
Latinas and did not find significant improvements in quality-of-life outcomes.39 The
greater improvements in our study could be
the result of intervening earlier in the survivorship continuum of care, training in cognitive---behavioral stress management skills that
can be applied across quality-of-life domains,
intervention delive
