Clinical trial NCT02931552: Nuevo Amanecer II: Translating a Stress Management Program for Latinas
Official title: Translating a Stress Management Program for 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
Rural
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: California Breast Cancer Research Program
name: National Institute on Aging (NIA)
name: Circulo de Vida Cancer Support and Resource Center
name: Cancer Resource Center of the Desert
name: Family Service Agency of the Central Coast
name: Kaweah Delta Health Care District
name: San Francisco State University
First posted: 2016-10-13
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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)

Primary outcomes:
measure: Change in Physical Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
timeFrame: Baseline and 6 month assessment
measure: Change in Social/Family Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
timeFrame: Baseline and 6 month assessment
measure: Change Emotional Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
timeFrame: Baseline and 6 month assessment
measure: Change in Breast Cancer Concerns Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
timeFrame: Baseline and 6 month assessment
measure: Change in Functional Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
timeFrame: Baseline and 6 month assessment
measure: Change in 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: Change Anxiety Score, a Subscale of the Brief Symptom Inventory (BSI)
timeFrame: Baseline and 6 month assessment
measure: Change Somatization Score, a Subscale of the Brief Symptom Inventory (BSI)
timeFrame: Baseline and 6 month assessment
measure: Change in Personal Health Questionnaire Depression Scale (PHQ-8) Score
timeFrame: Baseline and 6 month assessment
measure: Change Perceived Stress Scale (PSS-10) Score
timeFrame: Baseline and 6 month assessment
measure: Change MOS Health Distress Scale Score
timeFrame: Baseline and 6 month assessment
measure: Change in long-term stress level measured by cortisol levels collected from hair sample.
timeFrame: Baseline and 6 month assessment
measure: Change in telomere length, a measure of biological aging, in DNA collected from saliva sample.
timeFrame: Baseline and 6 month assessment
measure: Change in diurnal cortisol rhythm to assess regulatory patterns through saliva samples collected over 3 days, 3 times/day.
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: Samayoa C, Santana-Ufret V, Santoyo-Olsson J, Strassle PD, Stewart A, Bonilla J, Escalera C, Mendez RM, Marquez-Magana L, Ortiz C, Ceballos RM, Napoles AM. Cortisol levels in rural Latina breast cancer survivors participating in a peer-delivered cognitive-behavioral stress management intervention: The Nuevo Amanecer-II RCT. Compr Psychoneuroendocrinol. 2022 Jun 24;11:100153. doi: 10.1016/j.cpnec.2022.100153. eCollection 2022 Aug.
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: 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: Samayoa C, Santoyo-Olsson J, Escalera C, Stewart AL, Ortiz C, Marquez-Magana L, Urias A, Gonzalez N, Cervantes SA, Torres-Nguyen A, Parada-Ampudia L, Napoles AM. Participant-Centered Strategies for Overcoming Barriers to Biospecimen Collection among Spanish-Speaking Latina Breast Cancer Survivors. Cancer Epidemiol Biomarkers Prev. 2020 Mar;29(3):606-615. doi: 10.1158/1055-9965.EPI-19-0942.