Nuevo Amanecer: Promoting the Psychosocial Health of Latinas
NCT ID: NCT01383174
Last Updated: 2019-01-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
151 participants
INTERVENTIONAL
2011-02-28
2014-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nuevo Amanecer II: Translating a Stress Management Program for Latinas
NCT02931552
Empowering Latinas to Obtain Breast Cancer Screenings
NCT02964234
A Research Study for Latina Women After Breast Cancer Treatment
NCT03645005
Psychotherapy Intervention for Latinos With Adv Cancer
NCT04537936
Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers
NCT02222337
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Peer Support Program
Nuevo Amanecer is the peer support program. Participants receive the peer support program as soon as possible after randomization.
Peer Support Program
* Work with a trained counselor who is a breast cancer survivor
* Meet 8 times in-person over the 8 week program with the counselor
* Counselor helps participant develop a personalized support program to help her improve her quality of life
* Receives information on breast cancer, its treatments, and stress management
Wait-list Control
Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Peer Support Program
* Work with a trained counselor who is a breast cancer survivor
* Meet 8 times in-person over the 8 week program with the counselor
* Counselor helps participant develop a personalized support program to help her improve her quality of life
* Receives information on breast cancer, its treatments, and stress management
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Terminal illness
* Stage IV breast cancer (distant metastasis)
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
California Breast Cancer Research Program
OTHER
Circulo de Vida Cancer Support and Resource Center
OTHER
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven Gregorich, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Multiple Locations, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bonilla J, Alhomsi A, Santoyo-Olsson J, Stewart AL, Ortiz C, Samayoa C, Torres-Nguyen A, Palomino H, Coleman V, Urias A, Gonzalez N, Cervantes SA, Duron Y, Napoles AM. Sharing research results with Latina breast cancer survivors who participated in a community-engaged behavioral RCT study: a descriptive cross-sectional survey study. Trials. 2022 Jan 8;23(1):25. doi: 10.1186/s13063-021-05945-8.
Chacon L, Santoyo-Olsson J, Samayoa C, Alhomsi A, Stewart AL, Ortiz C, Escalera C, Napoles AM. Self-Efficacy for Coping with Breast Cancer Treatment Among Spanish-Speaking Latinas. Health Equity. 2021 Apr 26;5(1):245-252. doi: 10.1089/heq.2020.0152. eCollection 2021.
Bonilla J, Escalera C, Santoyo-Olsson J, Samayoa C, Ortiz C, Stewart AL, Napoles AM. The importance of patient engagement to quality of breast cancer care and health-related quality of life: a cross-sectional study among Latina breast cancer survivors in rural and urban communities. BMC Womens Health. 2021 Feb 9;21(1):59. doi: 10.1186/s12905-021-01200-z.
Napoles AM, Santoyo-Olsson J, Stewart AL, Ortiz C, Garcia-Jimenez M. Evaluating the Implementation of a Translational Peer-Delivered Stress Management Program for Spanish-Speaking Latina Breast Cancer Survivors. J Cancer Educ. 2018 Aug;33(4):875-884. doi: 10.1007/s13187-017-1202-y.
Napoles AM, Ortiz C, Santoyo-Olsson J, Stewart AL, Gregorich S, Lee HE, Duron Y, McGuire P, Luce J. Nuevo Amanecer: results of a randomized controlled trial of a community-based, peer-delivered stress management intervention to improve quality of life in Latinas with breast cancer. Am J Public Health. 2015 Jul;105 Suppl 3(Suppl 3):e55-63. doi: 10.2105/AJPH.2015.302598. Epub 2015 Apr 23.
Napoles AM, Santoyo-Olsson J, Ortiz C, Gregorich S, Lee HE, Duron Y, Graves K, Luce JA, McGuire P, Diaz-Mendez M, Stewart AL. Randomized controlled trial of Nuevo Amanecer: a peer-delivered stress management intervention for Spanish-speaking Latinas with breast cancer. Clin Trials. 2014 Apr;11(2):230-8. doi: 10.1177/1740774514521906. Epub 2014 Feb 26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15BB-1301
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
15BB-1300
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.