Nuevo Amanecer II: Translating a Stress Management Program for Latinas

April 3, 2019 updated by: University of California, San Francisco

Translating a Stress Management Program for Latinas

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 life (QoL) and reducing distress, compared to a usual care control group (that is offered the program at the end of the 6 months). The investigators will also test 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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, the investigators 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), the investigators will develop a guide to implementation for community-based organizations.

The investigators 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 the study team and community advisors to adapt NA-I to create NA-II and create the implementation guide.

The investigators will identify key individual, organizational, and community factors that facilitate implementation and support scalability and statewide dissemination through a process evaluation where the investigators 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.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Multiple Locations, California, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nuevo Amancer-II Stress Management Program
Nuevo Amanecer-II (NA-II) is a 10-week peer-delivered cognitive-behavioral stress management program. Participants receive the stress management program as soon as possible after randomization.
Behavioral: Nuevo Amancer-II Stress Management Program
Participant meets weekly with a trained interventionist called a Compañera (a peer who has had breast cancer) to complete a structured 10-week program designed to develop cognitive and behavioral skills to manage stress and distress, improve communication with family and clinicians, and increase knowledge of self-management after breast cancer.
Other Names:
  • Nuevo Amanecer II (A New Dawn) cognitive-behavioral stress management program
No Intervention: Wait-list Control Group
Waits six months and at the end of the six months is offered the option of receiving the NA-II program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Physical Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
Time Frame: Baseline and 6 month assessment
Baseline and 6 month assessment
Change in Social/Family Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
Time Frame: Baseline and 6 month assessment
Baseline and 6 month assessment
Change Emotional Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
Time Frame: Baseline and 6 month assessment
Baseline and 6 month assessment
Change in Breast Cancer Concerns Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
Time Frame: Baseline and 6 month assessment
Baseline and 6 month assessment
Change in Functional Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
Time Frame: Baseline and 6 month assessment
Baseline and 6 month assessment
Change in Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
Time Frame: Baseline and 6 month assessment
Baseline and 6 month assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Anxiety Score, a Subscale of the Brief Symptom Inventory (BSI)
Time Frame: Baseline and 6 month assessment
Baseline and 6 month assessment
Change Somatization Score, a Subscale of the Brief Symptom Inventory (BSI)
Time Frame: Baseline and 6 month assessment
Baseline and 6 month assessment
Change in Personal Health Questionnaire Depression Scale (PHQ-8) Score
Time Frame: Baseline and 6 month assessment
Baseline and 6 month assessment
Change Perceived Stress Scale (PSS-10) Score
Time Frame: Baseline and 6 month assessment
Baseline and 6 month assessment
Change MOS Health Distress Scale Score
Time Frame: Baseline and 6 month assessment
Baseline and 6 month assessment
Change in long-term stress level measured by cortisol levels collected from hair sample.
Time Frame: Baseline and 6 month assessment
Study staff will collect hair sample pre-intervention (baseline) and at the 6-month follow-up. All hair samples will then be picked up by San Francisco State University Health Equity Research Laboratory (HER) staff for cortisol characterization.
Baseline and 6 month assessment
Change in telomere length, a measure of biological aging, in DNA collected from saliva sample.
Time Frame: Baseline and 6 month assessment
Study staff will collect a saliva sample pre-intervention (baseline) and at the 6-month follow-up. All saliva samples will then be picked up by San Francisco State University Health Equity Research Laboratory (HER) staff to process to extract DNA and measure telomeres.
Baseline and 6 month assessment
Change in diurnal cortisol rhythm to assess regulatory patterns through saliva samples collected over 3 days, 3 times/day.
Time Frame: Baseline and 6 month assessment
Participants will collect nine saliva samples pre-invention (baseline) and at the 6-month follow-up. The first two samples will be taken within the first half hour of waking (first upon awakening and 30 minutes after waking). Participants will collect the last sample right before they go to bed. All saliva samples will then be picked up by San Francisco State University Health Equity Research Laboratory (HER) staff for cortisol characterization.
Baseline and 6 month assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute on Aging (NIA)
San Francisco State University
California Breast Cancer Research Program
Circulo de Vida Cancer Support and Resource Center
Cancer Resource Center of the Desert
Family Service Agency of the Central Coast
Kaweah Delta Health Care District

Investigators

  • Principal Investigator: Steven Gregorich, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-18737
  • 21OB-0135 (Other Grant/Funding Number: California Breast Cancer Research Program)
  • 4P30AG015272-20 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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