Dataset Information

Nuevo Amanecer-II: Results of a randomized controlled trial of a community-based participatory, peer-delivered stress management intervention for rural Latina breast cancer survivors.

ABSTRACT:

Objective

We report results of a community-based multisite, randomized controlled trial of Nuevo Amanecer (NA-II), a 10-week stress management program for rural, low literacy Latina breast cancer survivors.

Methods

Trained peers delivered NA-II to Spanish-speaking Latinas with non-metastatic breast cancer in three rural communities. Women were randomized to receive the program immediately or wait 6 months. Assessments were conducted at baseline, 3 months, and 6 months. Primary outcomes were breast cancer-specific quality of life domains; secondary outcomes included general distress symptoms and stress management skills. Intention-to-treat analyses using repeated-measures linear regression models estimated changes in slope between groups.

Results

Of 153 participants (76 randomized to intervention, 77 to control group), 92% were retained at 6 months. Mean age was 54.8?years (SD = 10.5); 80% had less than high school education. There were no statistically significant treatment × time effects on quality of life. Compared to women in the control group, intervention group women reported greater improvements in anxiety at 6 months (-0.20 vs -0.02, P = .049; range 0-4) as well as three stress management skills: relaxation at 3 months (+0.98 vs -0.07, P?ConclusionsStress management programs delivered by trained peers in rural community settings can reduce anxiety and improve stress management skills among Latina breast cancer survivors.

SUBMITTER: Napoles AM

PROVIDER: S-EPMC7754127 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Publications

Nuevo Amanecer-II: Results of a randomized controlled trial of a community-based participatory, peer-delivered stress management intervention for rural Latina breast cancer survivors.

Nápoles Anna María AM Santoyo-Olsson Jasmine J Stewart Anita L AL Ortiz Carmen C Samayoa Cathy C Torres-Nguyen Alma A Palomino Helen H Coleman LaVerne L Urias Aday A Gonzalez Nayeli N Cervantes Silvia Araceli SA Totten Vicken Y VY

Psycho-oncology 20200807 11

<h4>Objective</h4>We report results of a community-based multisite, randomized controlled trial of Nuevo Amanecer (NA-II), a 10-week stress management program for rural, low literacy Latina breast cancer survivors.<h4>Methods</h4>Trained peers delivered NA-II to Spanish-speaking Latinas with non-metastatic breast cancer in three rural communities. Women were randomized to receive the program immediately or wait 6 months. Assessments were conducted at baseline, 3 months, and 6 months. Primary out ...[more]

PMID: 32672864

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Project description:BackgroundCompared to their White counterparts, Latina breast cancer survivors have poorer survival rates and health-related quality of life, and higher rates of depression and anxiety which may be a result of chronic stress. Chronic stress impacts the hypothalamic-pituitary-adrenal (HPA) axis, resulting in cortisol dysregulation which may be associated with breast cancer survival. However, cortisol levels and cortisol profiles of Latina breast cancer survivors are poorly characterized due to their underrepresentation in biomedical research.ObjectiveThe objective of this study was to describe cortisol levels and patterns of cortisol secretions in rural Latina breast cancer survivors participating in an RCT study of Nuevo Amanecer-II, an evidence-based peer-delivered cognitive behavioral stress management intervention.MethodsParticipant-centered recruitment and collection strategies were used to obtain biospecimens for cortisol analysis. Nine saliva samples (3/day for 3 days) and a hair sample were obtained at baseline and 6-months (3-months post-intervention). We describe cortisol levels and profiles, explore correlations of biomarkers with self-report measures of stress and psychological distress, and compare women who received the intervention with a delayed intervention group on biomarkers of stress. Mean hair cortisol concentration (HCC) was used to assess chronic stress. Based on daily measures of cortisol (awakening, 30 min post-awakening, and bedtime), we calculated three summary measures of the dynamic nature of the cortisol awakening response (CAR): 1) the CAR slope, 2) whether CAR demonstrates a percent change ≥40, and 3) total daily cortisol output (AUCg). Linear and log-binomial regression, accounting for multiple samples per participant, were used to compare cortisol measures at 6-month follow-up by treatment arm.ResultsParticipants (n = 103) were from two rural California communities; 76 provided at least one saliva sample at baseline and follow-up and were included in the analysis. At baseline, mean age was 57 years, mean years since diagnosis was 2 years, 76% had a high school education or less, and 34% reported financial hardship. The overall median CAR slope was 0.10, and median cortisol AUCg (in thousands) was 11.34 (range = 0.93, 36.66). Mean hair cortisol concentration was 1751.6 pg/mg (SD = 1148.6). Forty-two percent of samples had a ≥40% change in CAR. We found no statistically significant correlations between the cortisol measures and self-reported measures of stress and psychological distress. At follow-up, no differences were seen in HCC (mean difference between intervention and control: -0.11, 95% CI -0.48, 0.25), CAR slope (0.001, 95% CI -0.005, 0.008), cortisol AUCg (-0.15, 95% CI -0.42, 0.13), or ≥40% change in CAR (prevalence ratio 0.87, 95% CI 0.42, 1.77) between treatment arms.ConclusionOur findings of flattened cortisol profiles among more than half of the sample suggest potential HPA-axis dysregulation among rural Spanish-speaking Latina breast cancer survivors that merits further study due to its implications for long-term survival.Trial registrationhttp://www.ClinicalTrials.gov identifier NCT02931552.

Project description:Information is needed on implementation processes involved in translating evidence-based interventions (EBIs) into health disparity communities. In an RCT, Nuevo Amanecer, a cognitive-behavioral stress management (CBSM) program delivered by breast cancer survivors (compañeras) in community settings to Spanish-speaking Latina breast cancer survivors, was effective in improving quality of life and decreasing breast cancer concerns and depressive and bodily symptoms. Using mixed methods, we evaluated the processes of implementing Nuevo Amanecer. Program delivery was assessed by direct observation. Treatment receipt was assessed by participants' mastery and homework completion. Perceived benefits, quality, ease of use, usefulness of components, and suggested improvements were evaluated through participant surveys and semi-structured interviews of participants and compañeras. Eighty percent of women completed six or more of eight sessions. Observer ratings of program delivery indicated compañeras demonstrated fidelity 80-90% of the time for three components (e.g., following the manual), but only 10% for two components (e.g., modeling skills). Regarding treatment receipt, most participants completed all homework. Knowledge and skills mastery was high (mostly >85%). In program evaluations, 93% indicated the program helped them cope with breast cancer "quite a bit/extremely." Participants reported improved self-management skills and knowledge. Suggested improvements were to add more sessions to practice cognitive-behavioral coping skills and simplify exercises and homework. We conclude that CBSM programs can be delivered in community settings by trained peers with high fidelity, acceptability, and perceived usefulness. Results provided some areas where the program could be improved. Our rigorous evaluation illustrates methods for evaluating processes of translating EBIs for community implementation. TRIAL REGISTRATION:NCT01383174 (ClinicalTrials.gov).

Project description:PurposeMedication expertise and close patient contact position community pharmacists to make significant contributions to combatting the opioid epidemic. This position facilitated the development and initial implementation of the Brief Intervention Medication Therapy Management (BIMTM) model to detect and address patient opioid misuse. BIMTM is an intervention consisting of 9 sessions. One medication management session is delivered by a pharmacist in a community pharmacy setting, and the remaining sessions are delivered telephonically by a patient navigator to follow up with goals established with the pharmacist and address concomitant health concerns that increase risk for misuse.MethodsWe employed the Consolidated Framework for Implementation Research (CFIR) to summarize and present key findings from 4 distinct studies. CFIR domains addressed were (1) intervention characteristics, (2) outer setting, (3) inner setting, (4) process, and (5) characteristics of individuals. The study results show sequential development of evidence for BIMTM.ResultsA multistate cross-sectional pharmacist survey (n = 739) demonstrated limited pharmacist training and/or resources to address misuse, suggesting the need for external intervention development. Our multistakeholder intervention planning project showed limitations of current evidence-based models of care and of intervention implementation, which resulted in construction of the BIMTM. A multisite cross-sectional screening survey of patients (n = 333) established an electronic misuse screening protocol within 4 community pharmacies and identified opioid misuse in 15% of screened patients; among those patients, 98% had concomitant health conditions that contribute to the risk of opioid misuse. Presentation of study results to pharmacy leaders produced commitment for intervention implementation and a partnership to develop a grant proposal supporting this action. Our small-scale randomized trial evinced success in recruitment and retention and BIMTM patient benefit. The small-scale randomized trial likewise showed high levels of satisfaction with BIMTM.ConclusionThe establishment of BIMTM supports community pharmacist identification and intervention with patients engaged in misuse. Continued use of this research-based strategy may further empower pharmacists to address the opioid epidemic.

Dataset Information

Nuevo Amanecer-II: Results of a randomized controlled trial of a community-based participatory, peer-delivered stress management intervention for rural Latina breast cancer survivors.

Objective

Methods

Results

Publications

Nuevo Amanecer-II: Results of a randomized controlled trial of a community-based participatory, peer-delivered stress management intervention for rural Latina breast cancer survivors.

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