Facilitating Adjustment in Low Income Black Women With Breast Cancer

NCT02272335 | Completed

• 2 other identifiers: 20081005R01CA131451
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Health Disparities; Psychosocial Intervention; Cancer Survivors

Outcome Measures

Primary Outcomes (1)

• Acceptability ratings of the program

  Acceptability is measured using a participant self-report scale that was created specifically for this project. This 16-item questionnaire assesses perceived satisfaction with the program, perceived comprehension of the material, comfort with group sessions, perceived competence of the interventionist, satisfaction with project staff, and ratings of project materials on a 4-point Likert scale (completely agree-completely disagree).

  12 months

Study Arms (2)

CB Stress Management

EXPERIMENTAL

The Cognitive-Behavioral Stress Management (CBSM) intervention arm is a closed, structured group intervention that offers 10 consecutive weekly sessions (and consists of a roughly 30-minute relaxation component, 45-minute cognitive-behavioral stress management component, and a 15-minute break). Groups include an average of 4-9 women and a female African American interventionist. Participants in CBSM receive a workbook that summarizes the rationale for each module, techniques learned within each module, a short out-of-session exercise to practice and the content of the Cancer Wellness and Education (CW) condition as well. i.e. Group Sessions

Behavioral: Group Sessions

Cancer Wellness (CW)

ACTIVE COMPARATOR

Enhanced Breast Cancer Wellness and Education (CW). The CW condition consists of 10 weekly sessions that are roughly 90 minutes in duration. Each session focuses on an important aspect of recovery from breast cancer. Modules were derived from products in the public domain (e.g., National Cancer Institute, Susan G. Komen Foundation, American Cancer Society).i.e. Group Sessions

Behavioral: Group Sessions

Interventions

Group Sessions BEHAVIORAL

10 weekly sessions: * CBSM - 10 consecutive weekly sessions (and consists of a roughly 30-minute relaxation component, 45-minute cognitive-behavioral stress management component, and a 15-minute break). Groups include an average of 4-9 women and a female African American interventionist. Participants in CBSM receive a workbook that summarizes the rationale for each module, techniques learned within each module, a short out-of-session exercise to practice and the content of the CW condition as well. * CW/EE - roughly 90 minutes in duration. Each session focuses on an important aspect of recovery from breast cancer. Modules were derived from products in the public domain

Also known as: CB Stress Management, CW Cancer Wellness

CB Stress Management; Cancer Wellness (CW)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Miami: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Jackson Health System

Miami, Florida, 33136, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Suzanne C Lechner, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 22, 2014
• Study Start: December 1, 2008
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

US (2)