Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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

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

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

Group Sessions

Suzanne C Lechner, PhD

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.

Facilitating Adjustment in Low Income Black Women With Breast Cancer

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).

National Cancer Institute (NCI)

University of Miami

Research Associate Professor

Heart and Blood Diseases

Heart Diseases

Each participant will have an individualized assessment with plan and goals set at the program intake visit. Program components will include: Physical Activity, Nutrition, Emotional Well-being, Cardiovascular Risk, Survivorship, and other items individualized to the participant as needed (e.g., tobacco cessation). The 12-week program will alternate between group and individual sessions each week. Individualized plans will be reviewed every two weeks at the participant individual sessions.

Each of the program components will have an individualized assessment with plan and goals set at the program intake visit.

Intake Session

Individual sessions will occur in person or virtual every other week during the 12-week intervention with a health promotion specialist (nurse or exercise physiologist). These sessions will include review of progress towards goals, update exercise prescription, make plan for the next two weeks.

Individual Sessions

Group sessions for wellness and education will be delivered by medical multi-disciplinary staff in person or virtual every other week during the 12-week intervention.

At the conclusion of the 12-week intervention, there will be a graduation session to honor the participant's achievement and establish a plan for maintenance after the intervention

Graduation

Participants will exercise as part of individual and group sessions. Participants will also be asked to exercise on their own, with a goal of working up to meeting US Physical Activity guidelines (150 minutes per week of moderate to vigorous exercise + 2 episodes of strength training).

Exercise

Ivan Leung@ucsf.edu

Ivan Leung

Alexis Beatty, MD, MAS

This is a pilot study testing multi-disciplinary health behavior intervention in breast cancer survivors who have been treated at Zuckerberg San Francisco General (ZSFG).

OBJECTIVES:

1. Evaluating feasibility and acceptability of the program.
2. Evaluating the effects of the program on health outcomes including change in exercise capacity, change in quality of life, change in risk factors, and adverse events.
3. Evaluating changes in patient-reported measures.

OUTLINE:

Participants with a history of breast cancer who receive care at Zuckerberg San Francisco General Hospital (ZSFG) will receive the intervention which is comprised of a 12-week multi-disciplinary health behavior program. Each participant will have an individualized assessment, goal and plan for each component of the program. Follow-up for outcomes will occur at 3 months, 6 months, and 12 months.

Heart Health After Cancer Treatment (HEART-ACT)

The Heart Health After Cancer Treatment (HEART-ACT): A Pilot Study of a Multi-disciplinary Health Behavior Intervention in People With a History of Breast Cancer to Reduce Heart Disease Risk After Cancer Treatment.

Analytic and community advisory board members will be provided with de-identified study data.

6MWD measures the distance walked over 6 minutes. The farther a person can walk indicates better exercise tolerance and mobility. The changes in distance will be compared at baseline and 12 months. We will measure the proportion of participants with analyzable 6MWD data.

The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The mental health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better mental health. We will calculate the change in the score between baseline and 12 months. The proportion of participants who can have a score measured will be calculated.

The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health. We will calculate the change in the score between baseline and 12 months.

The Net Promoter Score asks the participant to report how likely they are to recommend this health behavior program to another breast cancer survivor on a scale of 1 (Very Unlikely) to 10 (Very Likely). The Score is calculated as the percent of respondents who are "promoters" reporting a 9 or 10 minus the percent of responders who are "detractors" reporting a 1-6. The score can range from -100 to 100, with 100 being the best score.

6MWD measures the distance walked over 6 minutes. The farther a person can walk indicates better exercise tolerance and mobility. The changes in distance will be compared at baseline and 12 months.

6MWD measures the distance walked over 6 minutes. The farther a person can walk indicates better exercise tolerance and mobility. The changes in distance will be compared at baseline and 6 months.

6MWD measures the distance walked over 6 minutes. The farther a person can walk indicates better exercise tolerance and mobility. The changes in distance will be compared at baseline and 3 months.

The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The mental health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better mental health. We will calculate the change in the score between baseline and 12 months.

The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The mental health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better mental health. We will calculate the change in the score between baseline and 6 months.

The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The mental health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better mental health. We will calculate the change in the score between baseline and 3 months.

The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health. We will calculate the change in the score between baseline and 6 months.

The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health. We will calculate the change in the score between baseline and 3 months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Facilitating Adjustment in Low Income Black Women With Breast Cancer	NCT02272335	Breast Cancer	Group Sessions	21 Years -	University of Miami
Heart Health After Cancer Treatment (HEART-ACT)	NCT06055803	Breast Cancer	Intake Session Individual Sess... Group Sessions Graduation Exercise	18 Years -	University of California, San Francisco
Heart Health After Cancer Treatment (HEART-ACT)	NCT06055803	Breast Cancer	Intake Session Individual Sess... Group Sessions Graduation Exercise	18 Years -	University of California, San Francisco
Facilitating Adjustment in Low Income Black Women With Breast Cancer	NCT02272335	Breast Cancer	Group Sessions	21 Years -	University of Miami

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