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 < .0001; range 0‐4) and 6 months (+0.82 vs +0.04, P < .001), awareness of tension at 3 months (+0.31 vs −0.19, P < .01; range 0‐4) and 6 months (+0.29 vs −0.11, P < .05), and coping confidence at 3 months (+0.12 vs −0.23, P < .01; range 0‐4). Conclusions Stress management programs delivered by trained peers in rural community settings can reduce anxiety and improve stress management skills among Latina breast cancer survivors.

demonstrated in randomized controlled trials (RCTs) to: increase relaxation and positive affect; reduce anxiety, depressive symptoms, and serum cortisol; and improve quality of life among breast cancer survivors. 7,8 Furthermore, such interventions may improve survival and reduce risk of recurrence among women with non-metastatic breast cancer. 8,9 Latina breast cancer survivors report higher rates of anxiety, depression, fear of recurrence, fatigue, pain, and worse health-related quality of life than their White counterparts. [10][11][12] At least five randomized controlled trials (RCTs) have tested psychosocial interventions focused on stress reduction among Latinas. 10,[13][14][15][16] However, RCTs testing psychosocial interventions among rural Latina breast cancer survivors are needed. One small study (N = 14) tested a cognitive-behavioral stress management program in patients with varied types of cancer in rural New England settings. 17 Our original Nuevo Amanecer (NA) program was designed for newly diagnosed Latina breast cancer survivors in urban settings and successfully improved several quality of life domains and decreased breast cancer concerns and depressive and bodily symptoms. 18 We adapted NA for Latina breast cancer survivors living in rural settings and expanded the content to include self-care into survivorship to create NA-II. In this paper, we report the results of a community-based multisite, RCT of NA-II in settings serving rural Latinas with breast cancer.

| METHODS
We provide a brief description of the NA-II program and study.
Detailed descriptions of study settings, design, recruitment, adaptations, and program content are described elsewhere. 19

| Settings
The study was conducted in three California sites serving Community-based participatory research approaches were employed from study conceptualization to dissemination of results.
Numerous individuals from each community setting were involved including field staff who were employees of the partner sites (project director, at least two recruiters, and at least two interventionists called compañeras at each site), clinicians, survivors, and organizational leaders. Ongoing participation of community members occurred through community consultations, weekly calls and monthly videoconferencing or in-person meetings with field staff, and review and pretesting of materials by community members. Trained community field staff implemented the study. A lead CBO and partner in the first RCT, Circulo de Vida Cancer Support and Resource Center (CDV), provided clinical supervision of field staff and assisted with training and implementation. CDV is a San Francisco Bay Area Spanish language cancer support services provider.

| Study design
This was a 6-month RCT to assess the effectiveness of NA-II in improving breast cancer-specific quality of life (primary outcomes) at 3 and 6 months. 19

| Participants
Inclusion criteria, which were broad because this was an effectiveness trial, consisted of: (1) Spanish-speaking Latina (self-identified ethnicity); (2) diagnosis of Stage 0 to IIIC primary breast cancer; and (3) residing in the selected rural California communities (Imperial, Tulare, or Santa Cruz/Monterey counties) served by our community partners.
Exclusion criteria were terminal illness, metastatic breast cancer diagnosis, or plans to move out of the area in six months.

| Recruitment
Eligibility screening and recruitment were conducted with a bilingual script by trained bilingual Latinas employed by the community-based partners. A project director at each site supervised recruiters. For the two CBO sites, recruiters identified potentially eligible women through intake records or outreach and education activities. KDHCD identified potentially eligible women through electronic health records and then mailed them an initial contact letter on their stationery, a study information sheet, and a prepaid refusal postcard to return to KDHCD. If no refusal postcard was received within two weeks, the site recruiter initiated telephone contact with the potential participant. Recruiters verified eligibility through medical or intake records.

| Nuevo Amanecer-II intervention
The NA-II program was adapted from NA to expand its generalizability for rural, low literacy Spanish-speaking Latina breast cancer survivors throughout survivorship. Adaptation processes for this trial are described in detail elsewhere. 19,20 Social cognitive theory was the conceptual framework used for NA and NA-II. 21 Adaptations for NA-II were based on new formative research with survivors, advocates, patient navigators, medical social workers, and iterative consultations with community representatives from the three rural areas. Results led to expansion of the program from 8 to 10 sessions to accommodate more practice of skills and healthy lifestyles content, greater use of audio-visuals, further simplification, and creation of a handout for family members providing information on the program. 20 The NA-II program included ten weekly modules which covered managing the impact of cancer, learning about breast cancer and survivorship, finding cancer information, getting support, identifying helpful and unhelpful thoughts, managing thoughts and mood, stress management techniques, managing activities that affect mood, healthy lifestyles, and goal-setting. The program emphasized cognitive-behavioral coping skills training, coaching, and modeling to actively manage stress and emotions. Core components consist of stress management skills training (eg, deep breathing, guided imagery), cognitive reframing (turning unhelpful thoughts into helpful thoughts), effective communication (with clinicians, family, friends), setting goals, and self-regulation to achieve goals. Women were provided with general information on breast cancer survivorship (potential symptoms and side effects, survivorship care planning) and healthy lifestyles (nutrition and physical activity).
Potential compañeras (interventionists) who were Spanishspeaking breast cancer survivors and at least three years postdiagnosis with no active recurrence were identified by the community sites. The community Co-PI, a clinical psychologist at CDV, interviewed candidates using a structured protocol, selecting women who demonstrated excellent interpersonal communication skills, compassion, cultural awareness, and having processed their personal breast cancer experience.
Compañeras participated in a 3-day training (three eight-hour consecutive days) conducted in Spanish by the PI, Co-PI, and the Co-PI's clinical director. Interactive didactic sessions covered psychosocial reactions to breast cancer among Latinas, the theoretical basis of the program, and hands-on review of the modules with extensive demonstration and role modeling of cognitive-behavioral stress management skills. Compañeras were trained to model skills for participants. 20 Compañeras and participants were provided with a step-by-step Spanish-language manual covering 10-weekly sessions. Each week at participants' homes, one 90-minute module was presented in-person using visuals and hands-on exercises to teach and reinforce concepts and skills.

| Assessments
Baseline, three-month, and six-month assessments corresponded with our aims of evaluating the 10-week intervention soon after completion (three months) and retention of benefits after program termination (six months). Trained, community-based recruiters conducted inperson 60-minute baseline assessments (in Spanish) in the participant's home or community partner office. Three-and six-month assessments (30-minute telephone surveys) were conducted by an experienced, bilingual research associate blinded to participants' group assignment. Study data were managed using REDCap. 22 Participants received $90 for three surveys.

| Measures
Primary outcomes were breast cancer-specific quality of life measures. Secondary outcomes consisted of two types of measures: general distress symptoms and stress management skills. We describe the psychometric properties and descriptive statistics of measures in this sample (Table 1).
Breast cancer-specific quality of life was assessed using the Functional Assessment of Cancer Therapy -Breast (FACT-B), 23 in Spanish. 24 The FACT-B comprises five subscales on four dimensions of well-being (physical, social/family, emotional, functional) and one assessing concerns about breast cancer, and a summary index (FACT-B total score). Women were asked the extent to which statements applied to them during the prior 7 days with five response options ranging from 0 = not at all to 4 = very much. We used scales as modified in the original NA study based on results of psychometric analyses. 18 We re-labeled the FACT-B functional well-being scale as "enjoyment of life" because items pertain to this more general aspect of well-being (eg, enjoy life, enjoy doing things, accepted illness). Item-scale correlations ranged from 0.35 to 0.77 and Cronbach alphas were ≥ 0.74 for all scales, except for breast cancer concerns, which had item-scale correlations of 0.14 to 0.60 and Cronbach alpha = 0.62 (Table 1). We retained the breast cancer concerns scale since it is a part of the FACT-B, a widely validated measure of breast cancer-specific quality of life.
Secondary outcomes of general distress symptoms were assessed with four measures: depressive symptoms, perceived stress, anxiety, and somatization. Depressive symptoms were assessed with thePHQ-8. 25 Respondents reported the frequency with which they were bothered by the symptoms over the last 2 weeks on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day). The score is calculated as the sum of the 8 items; scores range from 0 to 24; higher scores indicate more depressive symptoms. Itemscale correlations ranged from 0.49 to 0.62 and Cronbach alpha was 0.83.
Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS Spanish version from the HCHS/SOL Sociocultural Ancillary Study). 26,27 Scores range from 0 to 40; higher scores indicate more stress. Item-scale correlations ranged from 0.38 to 0.73 and Cronbach alpha was 0.85.
Anxiety and somatization were assessed with two scales from the Brief Symptom Inventory (BSI). 28 Women were asked how much each symptom distressed or bothered them during the past 2 weeks with response options ranging from 0 = not at all to 4 = extremely. Scores are calculated as the mean of non-missing items (possible range 0-4); higher scores indicate more anxiety or somatization. In our sample,

| Randomization
Randomization was stratified by recruitment site. Before initiating recruitment, stratum-specific sequential identification numbers were generated and randomly preassigned in blocks of random sizes. The individual was the unit of randomization with 1:1 allocation to experimental groups. Women were randomized to the NA-II intervention or a wait-list control group. After the baseline assessment, the recruiter gave the participant a sealed envelope with the next sequential identification number from her stratum indicating to which experimental group she had been assigned. Control group participants received usual care until after the 6-month assessment at which time they were offered the intervention.  scales and secondary outcomes of general distress symptoms (depressive symptoms, perceived stress, anxiety, and somatization), and stress management skills(relaxation, awareness of tension, assertiveness, coping confidence).

| RESULTS
The RCT was conducted between September 2016 and October 2018. Figure 1 shows  partner. Slightly less than half were in poor or fair health, and more than a third reported having poor or fair mental health.
The greatest proportion were diagnosed at stage II, with equal proportions of women receiving breast conserving vs mastectomy surgery and the majority receiving radiotherapy and chemotherapy.
We found no significant baseline differences between intervention and control groups on demographics, clinical characteristics, quality of life, or distress outcomes, except for educational attainment and self-rated health, with the intervention group tending to be slightly better educated and more likely to report poor or fair health.
Baseline levels of breast cancer-specific quality of life were low, indicating poor quality of life (Table 2). In general, scores on anxiety, somatization, depressive symptoms, and perceived stress were low, indicating fairly low levels of general distress symptoms. Breast cancer self-management skills were fair (2.0-2.6 on a 0-4 scale). There were no significant differences between intervention and control groups at baseline on quality of life, general distress, or stress management skills.
A large percentage (86%) of the intervention group completed at least 7 of 10 weekly sessions (9% completed 1 to 6 sessions, and 5% completed no sessions). Six-month retention was 88% for the intervention group and 95% for the control group (92% overall Primary outcomes: breast cancer-specific quality of life. There were no statistically significant treatment × time interaction effects on quality of life outcomes at 3 or 6 months (Table 3). For assertiveness, we did not observe any treatment × time interaction effects, but 3-month scores were significantly higher for the intervention (2.64) than control group (2.33) (P < 0.05).
For coping confidence, we observed significant treatment × time interaction effects at 3 months (P < 0.01). The intervention group improved their coping confidence from 2.45 to 2.57 (+0.12) at 3 months while the control group's scores declined from 2.53 to 2.30 (−0.23) ( Figure 2).

| DISCUSSION
In this study, we continued translation of our cognitive-behavioral stress management program to be suitable for rural and urban  18 Also, possibly due to their longer time since diagnosis, baseline levels of quality of life among women in this study were better than those in our prior RCT, leaving less room for improvement. Our positive results with respect to anxiety in this trial are consistent with one other single-arm trial in a small group of Latinas that found significant improvements in anxiety with an 8-week mindfulness stress reduction program 14 .
Women in this study had several vulnerabilities including rural residence, low socioeconomic status, financial hardship, dependency on public insurance, high level of unemployment and disability, limited English proficiency, and immigrant status. For breast cancer survivors facing these vulnerabilities, providing a sense of confidence in their ability to cope with problems and reduce anxiety may be especially helpful. Since we did not see significant improvements in a general stress measure among the intervention group compared to the control group, it is possible that a more intensive or longer stress management program or a different type of program may be needed to effectively reduce stress in this especially vulnerable group. At a minimum, community partners increased their capacity to deliver evidencebased stress management skills training. Latinas. Therefore, it is likely that the program would generalize to Latinas from other national origin groups in the U.S.

| Clinical implications
Among breast cancer survivors, stress has been linked to immunological suppression and cancer progression, thus, reducing stress has important implications for preventing recurrence. 34 There are significant disparities in self-reported stress by socioeconomic status and race, and these stressors are known to have downstream effects on a range of psychological, neurobiological, and physiological processes and health behaviors. 35 Providing vulnerable populations with the skills to reduce chronic stress in their lives could provide broader advantages to their health and well-being given the cascade of illeffects and suffering that such stress can inflict.

| CONCLUSIONS
A 2017 report by the National Academies of Sciences, Engineering, and Medicine provides a strong rationale for the community as the locus for confronting health inequities. They argue persuasively that solutions for health disparities involve local community action with a range of partners. 36 Contributing to community infrastructure to address root causes of social and economic inequities and accompanying stress is a promising pathway to health equity, 36 particularly for vulnerable cancer survivors.