Nuevo Amanecer: Promoting the Psychosocial Health of Latinas (NuevoAmanecer)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
California Breast Cancer Research Program
Circulo de Vida Cancer Support and Resource Center
Information provided by (Responsible Party):
Anna Napoles, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01383174
First received: June 3, 2011
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Breast Neoplasms
Psychology, Social
Behavioral: Peer Support Program

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 170
Study Start Date: February 2011
Estimated Study Completion Date: May 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • Work with a trained counselor who is a breast cancer survivor
  • Meet 8 times in-person over the 8 week program with the counselor
  • Counselor helps participant develop a personalized support program to help her improve her quality of life
  • Receives information on breast cancer, its treatments, and stress management
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.

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383174

Locations
United States, California
Alameda,Contra Costa,San Mateo,SF,Santa Clara counties, California, United States
Sponsors and Collaborators
University of California, San Francisco
California Breast Cancer Research Program
Circulo de Vida Cancer Support and Resource Center
Investigators
Principal Investigator: Anna M Napoles, PhD University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anna Napoles, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01383174     History of Changes
Other Study ID Numbers: 15BB-1300, 15BB-1301
Study First Received: June 3, 2011
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Breast cancer
Latinas
Peer support counselor
Spanish speaking
Community based

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014