Nuevo Amanecer: Promoting the Psychosocial Health of Latinas

University of California San Francisco (UCSF)

Status: Completed

Conditions: Psychology, Social; Breast Neoplasms

Treatments: Behavioral: Peer Support Program

Study type: Interventional

Funder types: Other

Identifiers

NCT01383174

15BB-1300

15BB-1301 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 151 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Self-identifies as Latina
• Diagnosed with Stage 0, I, II, or III 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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151 participants in 2 patient groups

Peer Support Program

Experimental group

Description:

Nuevo Amanecer is the peer support program. Participants receive the peer support program as soon as possible after randomization.

Treatment:

Behavioral: Peer Support Program

Wait-list Control

No Intervention group

Description:

Waits six months, and at the end of the six months is offered the option of participating in the peer support program.