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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.

ABSTRACT: We evaluated a community-based, translational stress management program to improve health-related quality of life in Spanish-speaking Latinas with breast cancer.We adapted a cognitive-behavioral stress management program integrating evidence-based and community best practices to address the needs of Latinas with breast cancer. Spanish-speaking Latinas with breast cancer were randomly assigned to an intervention or usual-care control group. Trained peers delivered the 8-week intervention between February 2011 and February 2014. Primary outcomes were breast cancer-specific quality of life and distress, and general symptoms of distress.Of 151 participants, 95% were retained at 6 months (between May 2011 and May 2014). Improvements in quality of life from baseline to 6 months were greater for the intervention than the control group on physical well-being, emotional well-being, breast cancer concerns, and overall quality of life. Decreases from baseline to 6 months were greater for the intervention group on depression and somatization.Results suggest that translation of evidence-based programs can reduce psychosocial health disparities in Latinas with breast cancer. Integration of this program into community-based organizations enhances its dissemination potential.

SUBMITTER: Napoles AM

PROVIDER: S-EPMC4455521 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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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.

Nápoles Anna María AM Ortíz Carmen C Santoyo-Olsson Jasmine J Stewart Anita L AL Gregorich Steven S Lee Howard E HE Durón Ysabel Y McGuire Peggy P Luce Judith J

American journal of public health 20150423

<h4>Objectives</h4>We evaluated a community-based, translational stress management program to improve health-related quality of life in Spanish-speaking Latinas with breast cancer.<h4>Methods</h4>We adapted a cognitive-behavioral stress management program integrating evidence-based and community best practices to address the needs of Latinas with breast cancer. Spanish-speaking Latinas with breast cancer were randomly assigned to an intervention or usual-care control group. Trained peers deliver ...[more]

PMID: 25905829

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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:BackgroundDespite the efficacy of methadone to treat opioid use disorder (OUD), retention is an urgent priority, particularly among low-income, minoritized populations. Peer recovery specialists are well-positioned to engage vulnerable patients, particularly when trained in an evidence-based intervention to promote retention. This hybrid effectiveness-implementation pilot trial aimed to demonstrate the proof of concept of a peer recovery specialist-delivered behavioral activation and problem solving-based approach (Peer Activate) to improve methadone retention.MethodsImplementation outcomes included feasibility, acceptability, and fidelity. Feasibility and acceptability were defined by the percentage of participants who initiated the intervention (≥75%) and completed ≥75% of core sessions, respectively. Fidelity was assessed via independent rating of a randomly selected 20% of sessions. The primary effectiveness outcome was methadone retention at three-months post-intervention vs. a comparison cohort initiating methadone during the same time period. Secondary outcomes included methadone adherence, substance use frequency, and substance use-related problems.ResultsBenchmarks for feasibility and acceptability were surpassed: 86.5% (32/37) initiated the intervention, and 81.3% of participants who initiated attended ≥75% of core sessions. The mean independent rater fidelity score was 87.9%, indicating high peer fidelity. For effectiveness outcomes, 88.6% of participants in Peer Activate were retained in methadone treatment at three-months post-intervention-28.9% higher than individuals initiating methadone treatment alone in the same time period [χ2(1) = 10.10, p = 0.001]. Among Peer Activate participants, urine-verified methadone adherence reached 97% at post-intervention, and there was a significant reduction in substance use frequency from 48% of past two-week days used at baseline to 31.9% at post-intervention [t(25) = 1.82, p = .041]. Among participants who completed the core Peer Activate sessions (n = 26), there was a significant reduction in substance use-related problems [t(21) = 1.84, p = 0.040].ConclusionGiven the rapid scale-up of peer recovery specialist programs nationwide and the urgent need to promote methadone retention, these results, although preliminary, have important potential clinical significance. The next steps are to conduct a Type 1 hybrid effectiveness-implementation randomized trial with a larger sample size and longer-term follow-up to further establish the implementation and effectiveness of the Peer Activate approach.

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.

Project description:ImportancePatients coping with rare diseases need psychosocial support.ObjectiveTo evaluate the efficacy of a brief, transdiagnostic, peer-delivered intervention for patients with rare diseases in addition to care as usual (CAU) compared with CAU only.Design, setting, and participantsIn this 2-group randomized clinical trial conducted from October 5, 2017, to July 12, 2019, patients were recruited via specialized clinics and patient organizations across Germany and participated from home. The study included consecutive adult patients with neurofibromatosis type 1, Marfan syndrome, primary sclerosing cholangitis, and pulmonary arterial hypertension who have limited functionality because of the disease. Exclusion criteria were a life-threatening health status and ongoing psychotherapeutic treatment. Of 143 patients screened for eligibility with a semistructured telephone interview, 54 were excluded, and 89 were randomized: 45 patients were randomly allocated to the peer-delivered intervention group, and 44 to the control group; 87 patients (98%) completed the 6-month follow-up assessment. The analysis was performed using an intention-to-treat principle. Data cleansing and analysis were conducted between April 25, 2019, and February 13, 2020.InterventionsThe 6-week intervention consisted of a self-help book and telephone-based peer counseling in addition to CAU. The control group received CAU alone. Peer counselors received training, structured consultation guidelines, and supervision.Main outcomes and measuresThe primary outcome was acceptance of the disease as assessed using the Illness Cognition Questionnaire (ICQ; mean sum scores range from 0 to 18, with higher values representing more acceptance) 6 months after the intervention. Secondary outcomes included self-reported coping strategies (Health Education Impact Questionnaire), illness cognition (ICQ and Illness Perception Questionnaire), depression severity (Patient Health Questionnaire 9-item depression scale), anxiety severity (Generalized Anxiety Disorder Scale), quality of life (12-Item Short-Form Health Survey), and social support (Social Support Questionnaire). Outcomes were assessed before the intervention, after the intervention, and at a 6-month follow-up.ResultsThe mean (SD) age of the 89 participating patients was 46.3 (14.9) years; 59 (66%) were women. There were no group differences regarding baseline variables. All patients allocated to the intervention group completed the intervention. Six months after the intervention, but not directly after completing the program, the intervention group had significantly higher rates of acceptance (ICQ) of the disease (primary outcome) compared with the CAU group. Mean (SD) baseline ICQ scores were 9.61 (3.79) in the control group and 9.86 (3.40) in the intervention group. Mean (SE) ICQ scores at 6 months were 10.32 (0.42) for the control group and 11.79 (0.42) for the intervention group, with a significant mean difference of -1.47 (95% CI, -2.63 to -0.31; P = .01). Several secondary outcomes, including different coping strategies, social support, and mental quality of life, were significantly higher after the intervention compared with the control group.Conclusions and relevanceIn this randomized clinical trial, a self-help and peer counseling intervention improved patients' acceptance of their rare chronic diseases. Self-management and peer support can efficiently address the unique care needs of patients with rare diseases.Trial registrationisrctn.org Identifier: ISRCTN13738704.

Project description:BackgroundPain self-management is an effective, evidence-based treatment for chronic pain. Peer support, in which patients serve as coaches for other patients, has been effective in other chronic conditions and is a potentially promising approach to implementing pain self-management programs using fewer clinical resources.ObjectiveTo test a peer coach-delivered pain self-management program for chronic pain.DesignRandomized controlled trial.ParticipantsVeterans with chronic musculoskeletal pain.InterventionIntervention patients were assigned a trained peer coach for 6 months. Coaches, who were volunteers, were asked to contact their assigned patients, either by phone or in person, twice per month. Coaches and patients were given an intervention manual to guide sessions. The control group was offered a 2-hour pain self-management class.Main measuresThe primary outcome was total pain, assessed by the Brief Pain Inventory (BPI). Secondary outcomes were anxiety, depression, pain catastrophizing, self-efficacy, social support, patient activation, health-related quality of life, and healthcare utilization. Outcomes were measured at baseline, 6 months, and 9 months.Key resultsTwo hundred fifteen patients enrolled (120 intervention, 95 control). Adherence to intervention protocol was low, with only 13% of patients reporting having at least the recommended 12 peer coach meetings over the 6-month intervention. BPI total decreased from baseline to 6 months and baseline to 9 months in both groups. At 9 months, this change was statistically significant (intervention, - 0.40, p = 0.018; control, - 0.47, p = 0.006). There was not a statistically significant difference between groups on BPI at either time point. No secondary outcomes improved significantly in either group after adjusting for multiple comparisons.ConclusionsPatients randomized to peer support did not differ from control patients on primary and secondary outcomes. Other peer support models that do not rely on volunteers might be more effective.Trial registrationClinicalTrials.gov Identifier: NCT02380690.

Dataset Information

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.

Publications

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.

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