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Nuevo Amanecer: Promoting the Psychosocial Health of Latinas


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms, Psychology, Social

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Trial Information

Nuevo Amanecer: Promoting the Psychosocial Health of Latinas


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).


Inclusion Criteria:



- Self-identifies as Latina

- Diagnosed with Stage 0, I, II, or IIIC in the prior month

- Primarily Spanish-speaking, or Spanish monolingual

- Aged 18 or older

- Diagnosed in Alameda, Contra Costa, San Mateo, San Francisco or Santa Clara counties,
California.

Exclusion Criteria:

- Previous cancer diagnosis except for non-melanoma skin cancer

- Terminal illness

- Stage IV breast cancer (distant metastasis)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Health Related Quality of Life

Outcome Description:

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.

Outcome Time Frame:

Baseline, 3 months, and 6 months

Safety Issue:

No

Principal Investigator

Anna M Napoles, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Institutional Review Board

Study ID:

15BB-1300

NCT ID:

NCT01383174

Start Date:

February 2011

Completion Date:

November 2013

Related Keywords:

  • Breast Neoplasms
  • Psychology, Social
  • Breast cancer
  • Latinas
  • Peer support counselor
  • Spanish speaking
  • Community based
  • Breast Neoplasms
  • Neoplasms

Name

Location
Fountain Valley, California  92708