Randomized controlled trial of Nuevo Amanecer: a peer-delivered stress management intervention for Spanish-speaking Latinas with breast cancer.

BACKGROUND: Latinas with breast cancer suffer symptom and psychosocial health disparities. Effective interventions have not been developed for or tested in this population. PURPOSE: We describe community-based participatory research methods used to develop and implement the Nuevo Amanecer program, a culturally tailored, peer-delivered cognitive-behavioral stress management intervention for low-income Spanish-speaking Latinas with breast cancer, and unique considerations in implementing a randomized controlled trial to test the program in community settings. METHODS: We applied an implementation science framework to delineate the methodological phases used to develop and implement the Nuevo Amanecer program and trial, emphasizing community engagement processes. RESULTS: In phase 1, we established project infrastructure: academic and community co-principal investigators, community partners, community advisory board, steering committee, and funding. In phase 2, we identified three program inputs: formative research, a community best-practices model, and an evidence-based intervention tested in non-Latinas. In phase 3, we created the new program by integrating and adapting intervention components from the three sources, making adaptations to accommodate low literacy, Spanish language, cultural factors, community context, and population needs. In phase 4, we built community capacity for the program and trial by training field staff (recruiters and interventionists embedded in community sites), compensating field staff, and creating a system for identifying potential participants. In phase 5, we implemented and monitored the program and trial. Engaging community partners in all phases has resulted in a new, culturally tailored program that is suitable for newly diagnosed Latinas with breast cancer and a trial that is acceptable and supported by community and clinical partners. Lessons learned Engagement of community-based organizations and cancer survivors as research partners and hiring recruiters and interventionists from the community were critical to successful implementation in community settings. Having culturally and linguistically competent research staff with excellent interpersonal skills facilitated implementation. Facilitating and maintaining excellent communication among community partners was imperative to troubleshoot implementation issues. Randomization was challenging due to community concerns about assigning women to a control group. Patient privacy regulations and the need for extensive outreach to establish relationships between community partners and clinical sites hampered initial recruitment. LIMITATIONS: These were resource-intensive processes to develop and implement the program that need to be compared to less-intensive alternatives. CONCLUSION: Engaging community members in design and implementation of community-based programs and trials enhances cultural appropriateness and congruence with the community context. If the randomized trial demonstrates that the intervention is effective, it will fill a gap in evidence-based programs to address ethnic disparities in quality of life among Spanish-speaking Latinas with breast cancer.

Long-term survival in AIDS-related primary central nervous system lymphoma.

BACKGROUND: The optimal therapeutic approach for patients with AIDS-related primary central nervous system lymphoma (AR-PCNSL) remains undefined. While its incidence declined substantially with combination antiretroviral therapy (cART), AR-PCNSL remains a highly aggressive neoplasm for which whole brain radiotherapy (WBRT) is considered a standard first-line intervention. METHODS: To identify therapy-related factors associated with favorable survival, we first retrospectively analyzed outcomes of AR-PCNSL patients treated at San Francisco General Hospital, a public hospital with a long history of dedicated care for patients with HIV and AIDS-related malignancies. Results were validated in a retrospective, multicenter analysis that evaluated all newly diagnosed patients with AR-PCNSL treated with cART plus high-dose methotrexate (HD-MTX). RESULTS: We provide evidence that CD4+ reconstitution with cART administered during HD-MTX correlates with long-term survival among patients with CD4 <100. This was confirmed in a multicenter analysis which demonstrated that integration of cART regimens with HD-MTX was generally well tolerated and resulted in longer progression-free survival than other treatments. No profound differences in immunophenotype were identified in an analysis of AR-PCNSL tumors that arose in the pre- versus post-cART eras. However, we detected evidence for a demographic shift, as the proportion of minority patients with AR-PCNSL increased since advent of cART. CONCLUSION: Long-term disease-free survival can be achieved in AR-PCNSL, even among those with histories of opportunistic infections, limited access to health care, and medical non-adherence. Given this, as well as the long-term toxicities of WBRT, we recommend that integration of cART plus first-line HD-MTX be considered for all patients with AR-PCNSL.

Survivorship Care Plan Information Needs: Perspectives of Safety-Net Breast Cancer Patients.

PURPOSE: Despite the Institute of Medicine's (IOM) 2005 recommendation, few care organizations have instituted standard survivorship care plans (SCPs). Low health literacy and low English proficiency are important factors to consider in SCP development. Our study aimed to identify information needs and survivorship care plan preferences of low literacy, multi-lingual patients to support the transition from oncology to primary care and ongoing learning in survivorship. METHODS: We conducted focus groups in five languages with African American, Latina, Russian, Filipina, White, and Chinese medically underserved breast cancer patients. Topics explored included the transition to primary care, access to information, knowledge of treatment history, and perspectives on SCPs. RESULTS: Analysis of focus group data identified three themes: 1) the need for information and education on the transition between "active treatment" and "survivorship"; 2) information needed (and often not obtained) from providers; and 3) perspectives on SCP content and delivery. CONCLUSIONS: Our data point to the need to develop a process as well as written information for medically underserved breast cancer patients. An SCP document will not replace direct communication with providers about treatment, symptom management and transition, a communication that is missing in participating safety-net patients' experiences of cancer care. Women turned to peer support and community-based organizations in the absence of information from providers. IMPLICATIONS FOR CANCER SURVIVORS: "Clear and effective" communication of survivorship care for safety-net patients requires dedicated staff trained to address wide-ranging information needs and uncertainties.

Breast Cancer Beliefs and Behaviors at the San Francisco General Hospital.

This study compared an ethnically mixed population of lower socioeconomic status women regarding their breast cancer beliefs, surgical decision making, sources of information, reactions to the diagnosis, and use of support groups. A 20-item oral survey was administered to a convenience sample recruited at the San Francisco General Hospital breast clinic during 1997. Data were analyzed by chi-square analysis with stratification according to age, ethnicity, education, and language. Corrections were made for small frequencies. P values of less than 0.05 were considered significant. The mean age (n = 30) was 56 years (range 39-72 years). Ten participants were African American, 7 Caucasian, 6 Filipino, 4 Chinese, and 3 Latina. Education averaged 12 years. Ten were non-English speakers. Breast cancer beliefs varied by ethnicity, age, and education. Surgical decision making showed that less formally educated women tended to include the doctor in decision making more often. Sources of information varied by English language capacity. Reactions to the diagnosis and use of support groups showed no difference among the categories. Some results of this study corroborate reports of breast cancer beliefs and decision-making styles published in the literature. Differences noted in the study may be explained in part by socioeconomic and ethnic differences between our population and those commonly sampled in the literature. These results suggest the need for further research in multiethnic and low-income populations with breast cancer. They also suggest some important implications for understanding community educational needs.

Persistent arm pain is distinct from persistent breast pain following breast cancer surgery.

UNLABELLED: Persistent pain following breast cancer surgery is well documented. However, it is not well characterized in terms of the anatomic site affected (ie, breast, arm). In 2 separate growth mixture modeling analyses, we identified subgroups of women (N = 398) with distinct breast pain and arm pain trajectories. The fact that these latent classes differed by anatomic site, types of tissue affected, and neural innervation patterns suggests the need for separate evaluations of these distinct persistent pain conditions. The purposes of this companion study were to identify demographic and clinical characteristics that differed between the 2 arm pain classes and determine if differences existed over time in sensitivity in the upper inner arm and axillary lymph node dissection sites, pain qualities, pain interference, and hand and arm function, as well as to compare findings with persistent breast pain. Higher occurrence rates for depression and lymphedema were found in the moderate arm pain class. Regardless of pain group membership, sensory loss was observed in the upper inner arm and axillary lymph node dissection site. Arm pain was described similarly to neuropathic pain and interfered with daily functioning. Persistent arm pain was associated with sustained impairments in shoulder mobility. PERSPECTIVE: For persistent breast and arm pain, changes in sensation following breast cancer surgery were notable. Persistent arm pain was associated with sustained interference with daily functioning and upper body mobility impairments. Long-term management of persistent pain following breast cancer surgery is warranted to improve the quality of survivorship for these women.

Associations between cytokine gene variations and severe persistent breast pain in women following breast cancer surgery.

UNLABELLED: Persistent pain following breast cancer surgery is a significant clinical problem. Although immune mechanisms may play a role in the development and maintenance of persistent pain, few studies have evaluated for associations between persistent breast pain following breast cancer surgery and variations in cytokine genes. In this study, associations between previously identified extreme persistent breast pain phenotypes (ie, no pain vs severe pain) and single nucleotide polymorphisms (SNPs) spanning 15 cytokine genes were evaluated. In unadjusted analyses, the frequency of 13 SNPs and 3 haplotypes in 7 genes differed significantly between the no pain and severe pain classes. After adjustment for preoperative breast pain and the severity of average postoperative pain, 1 SNP (ie, interleukin [IL] 1 receptor 2 rs11674595) and 1 haplotype (ie, IL10 haplotype A8) were associated with pain group membership. These findings suggest a role for cytokine gene polymorphisms in the development of persistent breast pain following breast cancer surgery. PERSPECTIVE: This study evaluated for associations between cytokine gene variations and the severity of persistent breast pain in women following breast cancer surgery. Variations in 2 cytokine genes were associated with severe breast pain. The results suggest that cytokines play a role in the development of persistent postsurgical pain.