Nuevo Amanecer II: Translating a Stress Management Program for Latinas

Breast Neoplasms Clinical Trial

Official title:

Translating a Stress Management Program for Latinas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931552
• Other study ID #: 16-18737
• Secondary ID: 21OB-01354P30AG0
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: February 2019

Study information

• Verified date: April 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: February 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasms
• Psychology, Social

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
University of California, San Francisco	California Breast Cancer Research Program, Cancer Resource Center of the Desert, Circulo de Vida Cancer Support and Resource Center, Family Service Agency of the Central Coast, Kaweah Delta Health Care District, National Institute on Aging (NIA), San Francisco State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physical Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)		Baseline and 6 month assessment
Primary	Change in Social/Family Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)		Baseline and 6 month assessment
Primary	Change Emotional Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)		Baseline and 6 month assessment
Primary	Change in Breast Cancer Concerns Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)		Baseline and 6 month assessment
Primary	Change in Functional Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)		Baseline and 6 month assessment
Primary	Change in Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)		Baseline and 6 month assessment
Secondary	Change Anxiety Score, a Subscale of the Brief Symptom Inventory (BSI)		Baseline and 6 month assessment
Secondary	Change Somatization Score, a Subscale of the Brief Symptom Inventory (BSI)		Baseline and 6 month assessment
Secondary	Change in Personal Health Questionnaire Depression Scale (PHQ-8) Score		Baseline and 6 month assessment
Secondary	Change Perceived Stress Scale (PSS-10) Score		Baseline and 6 month assessment
Secondary	Change MOS Health Distress Scale Score		Baseline and 6 month assessment
Secondary	Change in long-term stress level measured by cortisol levels collected from hair sample.	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.	Baseline and 6 month assessment
Secondary	Change in telomere length, a measure of biological aging, in DNA collected from saliva sample.	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.	Baseline and 6 month assessment
Secondary	Change in diurnal cortisol rhythm to assess regulatory patterns through saliva samples collected over 3 days, 3 times/day.	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.	Baseline and 6 month assessment