Clinical trial NCT01383174: Nuevo Amanecer: Promoting the Psychosocial Health of Latinas
Official title: Nuevo Amanecer: Promoting the Psychosocial Health of Latinas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Psychology, Social
Keywords: Breast cancer
Latinas
Peer support counselor
Spanish speaking
Community based
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: California Breast Cancer Research Program
name: Circulo de Vida Cancer Support and Resource Center
First posted: 2011-06-28
Enrollment: 151
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
timeFrame: Baseline and 6 month assessment
measure: Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
timeFrame: Baseline and 6 month assessment
measure: Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
timeFrame: Baseline and 6 month assessment
measure: Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
timeFrame: Baseline and 6 month assessment
measure: Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
timeFrame: Baseline and 6 month assessment
measure: Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
timeFrame: Baseline and 6 month assessment
Secondary outcomes:
measure: Anxiety a Subscale of the Brief Symptom Inventory (BSI)
timeFrame: Baseline and 6 month assessment
measure: Depression a Subscale of the Brief Symptom Inventory (BSI)
timeFrame: Baseline and 6 month assessment
measure: Somatization a Subscale of the Brief Symptom Inventory (BSI)
timeFrame: Baseline and 6 month assessment
measure: Breast Cancer-Specific Distress of the Intrusive Thoughts Scale
timeFrame: Baseline and 6 month assessment
Other outcomes:
Locations:
city: Multiple Locations
country: United States
state: California
Study officials:
affiliation: University of California, San Francisco
name: Steven Gregorich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.