Facilitating Adjustment in Low Income Black Women With Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:4/21/2016
Start Date:December 2008
End Date:May 2015

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The main goal of the proposed study is to test whether a successful stress management
intervention can be effectively implemented in natural settings in the community and will be
acceptable to a community dwelling, low income population of African American women with
breast cancer.

Hypothesis 1: There will be no differences between women randomized to either the Cognitive
Behavioral Stress Management (CBSM) or the Cancer Wellness and Education condition (CW) on
ratings of acceptability of the program.

Hypothesis 2: Women randomized to the CBSM condition will show greater decreases over time
in cancer-specific distress and greater increases over time in quality of life as compared
to women in the CW condition over the course of the study from baseline to six month
follow-up.

Hypothesis 3: Women randomized to the CBSM condition will show greater improvement in pain
levels, sleep disturbance and fatigue as compared to women in the CW condition over the
course of the study from baseline to six month follow-up.

Hypothesis 4: Women randomized to the CBSM condition will report fewer sick days, earlier
return to work, fewer unanticipated health care visits, fewer visits to the Emergency
Department and better follow-up with oncologists as compared to women in the CW condition
over the course of the study from baseline to six month follow-up.

Hypothesis 5: Women randomized to the CBSM condition will show more normalized patterns of
diurnal cortisol (e.g., greater increase in negative AM-PM slope) as compared to women in
the CW condition over the course of the study from baseline to six month follow-up.

Hypothesis 6: Women randomized to the CBSM condition will show more less normalized patterns
of heart rate variability (e.g., more variation) as compared to women in the CW condition
over the course of the study from baseline to six month follow-up.

Minority women are grossly underserved and suffer poorer quality of life during and after
treatment for breast cancer. Despite this greater need, interventions designed to foster
adaptation to disease among such women are scarce. Our recent randomized trial tested the
efficacy of a 10-week multi-modal, group-based, cognitive behavioral stress management
(CBSM) intervention delivered in a university setting among women with breast cancer who
recently completed adjuvant treatment. Using a panel of psychological, physiological, and
physical indicators of adaptation, the investigators examined whether the intervention
facilitated "recovery" or adaptation after adjuvant therapy for breast cancer had been
completed. CBSM intervention participants showed improvements in multiple indicators of
psychosocial adaptation (fewer intrusive thoughts, lower anxiety, less social disruption,
less negative affect, more positive affect, greater benefit finding, and higher levels of
positive states of mind), physiological adaptation (decreased cortisol and increased
cellular immune function and Th1 cytokine production) and physical adaptation to disease
(less fatigue and improved sleep quality). Many of these findings held at 3 and 9 month
follow-ups. As with most psychosocial oncology research, participants in the randomized
trial were mostly non-Hispanic White women. Whether or not the results of that trial are
generalizable to the larger population that includes minority women needs to be tested.

The proposed research aims to translate this University-based, CBSM intervention into a
format that will be acceptable and effective in a community setting. The investigators will
target our efforts toward low-income African American women, (n=120 after attrition)
diagnosed with breast cancer (all stages of disease). Participants will be randomized to
10-week CBSM intervention or an attention time-matched Enhanced Breast Cancer Wellness and
Education (CW) active comparison-control condition and monitored for 6 months afterward.
Outcomes include: (a) acceptability of the intervention, (b) psychosocial adaptation, (c)
physical symptom clusters, (d) economic implications and (e) an objective indicator of
stress (diurnal salivary cortisol). The main goal is to test whether a successful
stress-management intervention can be effectively implemented in natural settings in the
community and will be acceptable to a community-dwelling, low-income population of African
American women with breast cancer.

Specific Aim 1: To examine the acceptability of an empirically-validated stress management
intervention in community-dwelling low-income African American women with breast cancer.

Specific Aim 2: To test the prediction that participants randomized to CBSM intervention
show significant improvements in indices of psychosocial adaptation (i.e., cancer-specific
distress, quality of life) relative to women randomized to a CW attention control condition
across the study period.

Specific Aim 3: To test the prediction that participants randomized to CBSM intervention
show significant improvements in indices of physical symptom clusters relative to women
randomized to a CW attention control condition across the study period (physical symptom
clusters include pain, sleep, fatigue).

Specific Aim 4: To test the prediction that women randomized to a CBSM intervention versus
CW attention control condition have better economic outcomes across the study period (as
measured by faster return to work, fewer sick days, fewer health care visits).

Specific Aim 5: To test the prediction that participants randomized to CBSM intervention
show significant improvements in indices of physiological adaptation relative to women
randomized to a CW attention control condition across the study period by examining diurnal
salivary cortisol as objective measure of stress.

Inclusion Criteria:

- Women who self-identify as Black;

- No prior history of cancer;

- Age 21 or older;

- Life expectancy of >= 12 months;

- No history of prior inpatient psychiatric treatment for severe mental illness within
1 year (e.g., psychosis)

- No active suicidality;

- No substance dependence within the past year;

- Fluent in English;

- Available for follow-up over the course of the study;

- Endorse moderate stress or distress as measured by a score of 4 or above on the a
distress thermometer and an adapted thermometer of stress;

- Completed treatment for breast cancer (except hormonal therapies) within 12 months.

Exclusion Criteria:

- Women who do not self-identify as Black;

- Prior history of cancer (other than skin cancer);

- Under age 21;

- A life expectancy of less than 12 months;

- History of prior inpatient psychiatric treatment for severe mental illness within the
past year (e.g., psychosis),

- Active suicidality;

- Substance dependence within the past year;

- Low English fluency;

- Not available for follow-up over the course of the study;

- Score below 4 on a distress thermometer and an adapted thermometer of stress;

- Are not within 12 months of completing treatment for breast cancer (except hormonal
therapies) at the time of recruitment;

- Males will be excluded.
We found this trial at
2
sites
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, Florida 33176
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