Project CARE is a 5-year, 3 million dollar R01 grant funded by the NIH/NCI. The study employs a randomized clinical trial design (2 active conditions measured over the course of baseline, post-intervention and 6-month follow up). Enrollment is limited to women who self-identify as African American or black (without limitations on cultural background) and:
- Have completed treatment for breast cancer within 12 months of recruitment (defined as surgery, chemotherapy and radiation therapy)
- Are fluent in English (minimum 6th grade reading level)
- Have no prior history of cancer of any type except skin cancers
- Are 21 years or older
- Have a life expectancy greater than 12 months
- No history of psychiatric hospitalizations, suicidality, psychosis or substance dependence within the past year
- Are willing to commit to attend all ten group sessions
- Currently experiencing distress or stress in relation to breast cancer.
Both group-based interventions are designed to enhance well-being and are held in a group setting where patients interact and learn from the experiences of other survivors. Endpoints include acceptability of the program, psychosocial adjustment (e.g., quality of life, distress), economic considerations (e.g., return to work), endocrine functioning (e.g., salivary cortisol), and immune system functioning (e.g., Th1, Th2 and pro-inflammatory cytokine production). Although the current trial is not funded to conduct long-term follow-up past a 6-month post-intervention window, we intend to follow participants into long-term survivorship to track recurrence.
This research does not employ a no-treatment control group for ethical reasons, per NCI standards. All participants will receive either skill or knowledge enhancement.
This study was approved by the Cancer Protocol Review Committee and Human Subject Research Office of the Institutional Review Board at the University of Miami. While the investigative team is affiliated with University of Miami Miller School of Medicine and the Sylvester Comprehensive Cancer Center, under no circumstances will we recommend that patients seek care at Sylvester. All research activities are held off-site in participants’ homes and community centers.
How You Can Help
We need your help to make this study a success. Please assist us with the following:
- Speak with your eligible patients about Project CARE and its potential impact on their lives and the future quality of care for breast cancer patients
- Spread the word of this ground-breaking study among medical colleagues and other community organizations to which you may belong
- Request and display Project CARE brochures in your office or convenient location for patients
Should you have any questions, comments, or suggestions contact the Project CARE office at 305-243-2440 or Suzanne Lechner, Ph.D. at 305-243-1645 or email at email@example.com.