Nuevo Amanecer: Promoting the Psychosocial Health of Latinas (NuevoAmanecer)
The purpose of this study is to test whether a new program Nuevo Amanecer (A New Dawn), improves the quality of life of Latinas diagnosed with breast cancer. Trained Latina counselors who have had breast cancer provide support to recently diagnosed women. The investigators call these counselors peer support counselors.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
|Official Title:||Nuevo Amanecer: Promoting the Psychosocial Health of Latinas|
- Health Related Quality of Life [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]We will assess whether any differences between treatment and control groups on quality of life are mediated by changes in cancer coping skills. The Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B), which has five subscales: Physical, Social, Emotional, and Functional Well-Being, as well as Additional Concerns about Breast Cancer will be used to measure quality of life.
- Breast-cancer specific distress and anxiety [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]We will assess whether any differences between treatment and control groups on breast-cancer specific distress and anxiety are mediated by changes in cancer coping skills. These will be measured using the Revised Impact of Event Scale (RIES) (a measure of breast cancer-specific distress), and the 6-item Brief Symptom Inventory (BSI)-Anxiety Scale.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||May 2014|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Peer Support Program
Nuevo Amanecer is the peer support program. Participants receive the peer support program as soon as possible after randomization.
Behavioral: Peer Support Program
Other Name: Nuevo Amanecer (A New Dawn)
No Intervention: Wait-list Control
Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
This study will assess the effectiveness of a cognitive-behavioral stress management (CBSM) intervention for newly diagnosed Latina breast cancer patients. In our prior work, the investigators established the appropriate content of the intervention, the need for early intervention, and the value of culturally competent peer support. In this study the investigators will adapt an evidence-based CBSM intervention designed to meet these needs. This study will use a randomized controlled trial (RCT) design with a wait-listed usual care control group to adapt the intervention and test its effectiveness in improving breast cancer specific quality-of-life, and decreasing anxiety and breast cancer specific distress. The new, adapted intervention will be called "Nuevo Amanecer" (A New Dawn).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383174
|United States, California|
|Alameda,Contra Costa,San Mateo,SF,Santa Clara counties, California, United States|
|Principal Investigator:||Anna M Napoles, PhD||University of California, San Francisco|