Facilitating Adjustment in Low Income Black Women With Breast Cancer

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02272335

Run by

University of Miami

People needed

114

Starts

2008-12-01

Expected to finish

2015-05-01

Last updated by the study team

2015-10-27

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Jackson Health System — Miami, Florida, United States
• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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