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Completed

NCT Number: NCT02931552

Nuevo Amanecer II: 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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Psychology, Social Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Multiple Locations, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nuevo Amancer-II Stress Management Program

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Change Anxiety Score, a Subscale of the Brief Symptom Inventory (BSI)

    Time frame: Baseline and 6 month assessment

  2. Change Somatization Score, a Subscale of the Brief Symptom Inventory (BSI)

    Time frame: Baseline and 6 month assessment

  3. Change in Personal Health Questionnaire Depression Scale (PHQ-8) Score

    Time frame: Baseline and 6 month assessment

  4. Change Perceived Stress Scale (PSS-10) Score

    Time frame: Baseline and 6 month assessment

  5. Change MOS Health Distress Scale Score

    Time frame: Baseline and 6 month assessment

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Official study title

Translating a Stress Management Program for Latinas

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Oct 13, 2016
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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