Nuevo Amanecer: Promoting the Psychosocial Health of Latinas

NCT ID: NCT01383174

Last Updated: 2019-01-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-05-31

Brief Summary

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The purpose of this study is to test whether a new program Nuevo Amanecer (A New Dawn), improves the quality of life of Latinas diagnosed with breast cancer. Trained Latina counselors who have had breast cancer provide support to recently diagnosed women. The investigators call these counselors peer support counselors.

Detailed Description

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This study will assess the effectiveness of a cognitive-behavioral stress management (CBSM) intervention for newly diagnosed Latina breast cancer patients. In our prior work, the investigators established the appropriate content of the intervention, the need for early intervention, and the value of culturally competent peer support. In this study the investigators will adapt an evidence-based CBSM intervention designed to meet these needs. This study will use a randomized controlled trial (RCT) design with a wait-listed usual care control group to adapt the intervention and test its effectiveness in improving breast cancer specific quality-of-life, and decreasing anxiety and breast cancer specific distress. The new, adapted intervention will be called "Nuevo Amanecer" (A New Dawn).

Conditions

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Breast Neoplasms Psychology, Social

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Peer Support Program

Nuevo Amanecer is the peer support program. Participants receive the peer support program as soon as possible after randomization.

Group Type EXPERIMENTAL

Peer Support Program

Intervention Type BEHAVIORAL

* 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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Nuevo Amanecer (A New Dawn)

Eligibility Criteria

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Inclusion Criteria

* Self-identifies as Latina
* 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

* Previous cancer diagnosis except for non-melanoma skin cancer
* Terminal illness
* Stage IV breast cancer (distant metastasis)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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California Breast Cancer Research Program

OTHER

Sponsor Role collaborator

Circulo de Vida Cancer Support and Resource Center

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Gregorich, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Multiple Locations, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34998436 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33937611 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33563263 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28275966 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25905829 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24577971 (View on PubMed)

Other Identifiers

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15BB-1301

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

15BB-1300

Identifier Type: -

Identifier Source: org_study_id

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