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Summary

for females ages 18 years and up (full criteria)
healthy people welcome
at Tulare, Santa Cruz, Imperial Valley counties, California
study started
estimated completion:
Anna M Napoles

Description

Summary

The primary aim is to assess the effectiveness of the Nuevo Amanecer-II (NA-II) cognitive-behavioral stress management program through a 6-month RCT with 150 Spanish-speaking Latinas with breast cancer in three rural settings in terms of improving quality of lie (QoL) and reducing distress, compared to a usual care control group (that is offered the program at the end of the 6 months). We will test also the effects of the program on biomarkers of stress (hair and saliva cortisol) and aging (telomere length from saliva). Trained Latinas, called Compañeras (Companions), who have had breast cancer deliver the stress management program in-person to Spanish-speaking Latinas with breast cancer.

Official Title

Translating a Stress Management Program for Latinas

Details

The purpose of this study is to adapt Nuevo Amanecer (NA-I) for use in rural populations and test the effects of the new adapted program, NA-II, in a 6-month RCT among 150 rural, low literacy Latinas with non-metastatic breast cancer. Primary outcomes will consist of quality of life and distress. In an ancillary study, we will compare the intervention and wait-list control groups on biomarkers of stress (hair and saliva cortisol) and aging (telomere length from saliva). Finally, to facilitate statewide dissemination of Nuevo Amanecer-II (NA-II), we will develop a guide to implementation for community-based organizations.

We will adapt NA-I to be appropriate for rural and low-literacy Latinas with breast cancer. Needed program adaptations will be identified through a formative evaluation consisting of semi-structured interviews with key informants (e.g., rural Latina breast cancer survivors, advocates, health care providers) and iterative consultations with community representatives in three rural areas with large Latino populations. Results will be applied by our team and community advisors to adapt NA-I to create NA-II and create the implementation guide.

We will identify key individual, organizational, and community factors that facilitate implementation and support scalability and statewide dissemination through a process evaluation where we will track key implementation activities and debrief program participants, interventionists, and advocates. Products will include NA-II interventionist and participant manuals and a guide to implementation for organizations seeking to replicate the program.

Keywords

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

Eligibility

You can join if…

Open to females ages 18 years and up

  • Self-identifies as Latina
  • Diagnosed with Stage 0, I, II, or III (non-metastatic) breast cancer
  • Primarily Spanish-speaking, or Spanish monolingual
  • Aged 18 or older
  • Living in surrounding areas of Tulare (Visalia, Dinuba), Santa Cruz (Eastside Santa Cruz, Watsonville, Freedom), or Imperial Valley (El Centro) counties, California.

You CAN'T join if...

  • Terminal illness
  • Stage IV breast cancer (distant metastasis)

Location

  • Tulare, Santa Cruz, Imperial Valley counties, California, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02931552
Lead Scientist
Anna M Napoles
Study Type
Interventional
Last Updated
October 1, 2016
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