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Nuevo Amanecer II: Translating a Stress Management Program for Latinas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02931552
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
California Breast Cancer Research Program
National Institute on Aging (NIA)
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
San Francisco State University
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Psychology, Social Behavioral: Nuevo Amancer-II Stress Management Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Translating a Stress Management Program for Latinas
Actual Study Start Date : September 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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 Name: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931552


Locations
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United States, California
Multiple Locations, California, United States
Sponsors and Collaborators
University of California, San Francisco
California Breast Cancer Research Program
National Institute on Aging (NIA)
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
San Francisco State University
Investigators
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Principal Investigator: Steven Gregorich, PhD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02931552    
Other Study ID Numbers: 16-18737
21OB-0135 ( Other Grant/Funding Number: California Breast Cancer Research Program )
4P30AG015272-20 ( U.S. NIH Grant/Contract )
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of California, San Francisco:
Breast cancer
Latinas
Peer support counselor
Spanish speaking
Community based
Rural
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases