A Bio-Psychosocial Intervention Program for Improving Quality of Life in Breast Cancer Survivors - Final Outcome of a Prospective Randomized Trial.

Given the 3.1 million breast cancer survivors in America, quality of life (QoL) is a vital issue. Bio-psychosocial milieu of survivorship is increasingly important. This study assesses the impact of Bio-psychosocial Intervention (BPSI) on the QoL of breast cancer survivors utilizing Functional Assessment of Cancer Therapy - Breast (FACT-B) instrument. A prospective randomized trial was designed; intervention arm included a 4-hour BPSI coping skills class; control arm received standard of cancer and follow-up care (SOC). Women diagnosed within 2 years of study initiation were eligible. Sample size was based on 8-point difference in FACT-B score, 90% power, 5% type I error, and 20% attrition. FACT-B questionnaire was administered to all patients at baseline and at 6-month intervals. SAS 9.3 software was used to analyze data using Chi-square test for categorical and Wilcoxon rank sum for ordinal data; linear mixed modeling was used for longitudinal analysis. One-hundred and three of 120 (86%) patients were available for analysis. Forty-seven patients were in BSPI arm, and 56 received SOC. For BPSI arm versus SOC arm, the median (interquartile) age (60 [52.68] versus 58 [52.68] years, p = 0.9135), cancer-stage (0:1:2:3 = 11%:41%:35%:13% versus 18%:46%:22%:15%, p = 0.4645), and biology (ER+:triple negative:HER2+ = 74%:9%:16% versus 72%:7%:20%, p = 0.8454), respectively, was similar. Median (25th to 75th centile) FACT-B scores in BPSI versus SOC arms at baseline were 109 (95.121) versus 112 (95, 122) (p = 0.6125); mean (SE) change since baseline at 6, 12, 18, and 24 months was: 7.42 (2.22) versus 7.04 (1.97) (p = 0.8862); 17.0 (2.64) versus -6.09 (2.37) (p < 0.0001); 16.03 (2.53) versus 3.58 (2.29) (p = 0.0004), and 15.48 (1.89) versus 16.4 (1.71) (p = 0.7966), respectively. The inter-group differences remained after adjusting for confounding variables at baseline. The p-value for interaction among groups over 2 years remained <0.0001 except for breast cancer specific concerns. BPSI coping skills class significantly improved the QoL of breast cancer survivors by 1 year post-intervention time point; this difference narrowed at 18 months and disappeared at 24 months.

Executive Summary: Enhanced Recovery After Surgery: Best Practice Guideline for Care of Patients With a Fecal Diversion.

Enhanced Recovery After Surgery (ERAS) is a multimodal program developed to decrease postoperative complications, improve patient safety and satisfaction, and promote early discharge. In the province of Ontario, Canada, a standardized approach to the care of adult patients undergoing elective colorectal surgery (including benign and malignant diseases) was adopted by 15 hospitals in March 2013. All colorectal surgery patients with or without an ostomy were included in the ERAS program targeting a length of stay of 3 days for colon surgery and 4 days for rectal surgery. To ensure the individual needs of patients requiring an ostomy in an ERAS program were being met, a Provincial ERAS Enterostomal Therapy Nurse Network was established. Our goal was to develop and implement an evidence-based, ostomy-specific best practice guideline addressing the preoperative, postoperative, and discharge phases of care. The guideline was developed over a 3-year period. It is based on existing literature, guidelines, and expert opinion. This article serves as an executive summary for this clinical resource; the full guideline is available as Supplemental Digital Content 1 (available at: http://links.lww.com/JWOCN/A36) to this executive summary.

Ostomy care and management: a systematic review.

The frequency of ostomy surgery in Canada is not known, but it is estimated that approximately 13,000 ostomy surgeries are performed annually in Canada. This systematic review incorporates evidence for the assessment and management of colostomies, ileostomies, and urostomies, as well as the peristomal skin. The review was completed as part of a best practice guideline document generated by a task force appointed by the Registered Nurses' Association of Ontario.

Phase 1-2 study of docetaxel plus aflibercept in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer.

BACKGROUND: Biologically targeted therapies have been postulated as a viable strategy to improve outcomes for women with ovarian cancer. We assessed the safety, tolerance, pharmacokinetics, relevant circulating and image-derived biomarkers, and clinical activity of combination aflibercept and docetaxel in this population. METHODS: For the phase 1 (pharmacokinetic) study, eligible patients had measurable, recurrent or persistent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with a maximum of two prior chemotherapy regimens. Aflibercept was administered intravenously over three dose levels (2, 4, or 6 mg/kg; one dose every 21 days) to identify the maximum tolerated dose for the phase 2 study. Pharmacokinetics were assessed and dynamic imaging was done during a lead-in phase with single-agent aflibercept (cycle 0) and during combination therapy with intravenous docetaxel (75 mg/m(2)). Eligibility for the phase 2 study was the same as for phase 1. Patients were enrolled in a two-stage design and given aflibercept 6 mg/kg intravenously and docetaxel 75 mg/m(2) intravenously, every 3 weeks. The primary endpoint was objective response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors version 1.0. The trial has completed enrolment and all patients are now off study. The trial is registered at ClinicalTrials.gov, number NCT00436501. FINDINGS: From the phase 1 study, the recommended phase 2 doses of aflibercept and docetaxel were found to be 6 mg/kg and 75 mg/m(2), respectively. Log-linear pharmacokinetics (for unbound aflibercept) were observed for the three dose levels. No dose-limiting toxicities were noted. 46 evaluable patients were enrolled in the phase 2 trial; 33 were platinum resistant (15 refractory) and 13 were platinum sensitive. The confirmed ORR was 54% (25 of 46; 11 patients had a complete response and 14 had a partial response). Grade 3-4 toxicities observed in more than two patients (5%) were: neutropenia in 37 patients (80%); leucopenia in 25 patients (54%); fatigue in 23 patients (50%); dyspnoea in ten patients (22%); and stomatitis in three patients (7%). Adverse events specifically associated with aflibercept were grade 1-2 hypertension in five patients (11%), and grade 2 proteinuria in one patient (2%). INTERPRETATION: Combination aflibercept plus docetaxel can be safely administered at the dose and schedule reported here, and is associated with substantial antitumour activity. These findings suggest that further clinical development of this combination in ovarian cancer is warranted. FUNDING: US National Cancer Institute, US Department of Defense, Sanofi-Aventis, Gynecologic Cancer Foundation, Marcus Foundation, and the Commonwealth Foundation.

Dermoscopy Proficiency Expectations for US Dermatology Resident Physicians: Results of a Modified Delphi Survey of Pigmented Lesion Experts.

Importance: Dermoscopy education in US dermatology residency programs varies widely, and there is currently no existing expert consensus identifying what is most important for resident physicians to know. Objectives: To identify consensus-based learning constructs representing an appropriate foundational proficiency in dermoscopic image interpretation for dermatology resident physicians, including dermoscopic diagnoses, associated features, and representative teaching images. Defining these foundational proficiency learning constructs will facilitate further skill development in dermoscopic image interpretation to help residents achieve clinical proficiency. Design, Setting, and Participants: A 2-phase modified Delphi surveying technique was used to identify resident learning constructs in 3 sequential sets of surveys-diagnoses, features, and images. Expert panelists were recruited through an email distributed to the 32 members of the Pigmented Lesion Subcommittee of the Melanoma Prevention Working Group. Twenty-six (81%) opted to participate. Surveys were distributed using RedCAP software. Main Outcomes and Measures: Consensus on diagnoses, associated dermoscopic features, and representative teaching images reflective of a foundational proficiency in dermoscopic image interpretation for US dermatology resident physicians. Results: Twenty-six pigmented lesion and dermoscopy specialists completed 8 rounds of surveys, with 100% (26/26) response rate in all rounds. A final list of 32 diagnoses and 116 associated dermoscopic features was generated. Three hundred seventy-eight representative teaching images reached consensus with panelists. Conclusions and Relevance: Consensus achieved in this modified Delphi process identified common dermoscopic diagnoses, associated features, and representative teaching images reflective of a foundational proficiency in dermoscopic image interpretation for dermatology residency training. This list of validated objectives provides a consensus-based foundation of key learning points in dermoscopy to help resident physicians achieve clinical proficiency in dermoscopic image interpretation.

Radical cystectomy for bladder cancer: a qualitative study of patient experiences and implications for practice.

Patients being treated for bladder cancer share issues in common with other cancer patients, but also experience issues that are unique to their surgical treatment. This study used a descriptive qualitative approach to explore the experiences of patients who had undergone radical cystectomy for bladder cancer Twenty-two participants were interviewed in-depth on one occasion and were invited to attend a focus group session following the analysis of the interview transcripts. Participants described the shock of their diagnosis, their lack of information about bladder cancer, the importance of clear communication with care providers, and the types of adjustments they had to make following surgery. Specifically, changes in bodily function, body image, sexual relationships, and intimacy presented challenges for these participants. Although there was a sense of acceptance about the treatment-related events, there were still significant adjustments required by individuals following their surgery. Information, open communication, and support from family and friends were seen as important factors in helping patients adjust after surgery. Patients require clear, concise and consistent information about their cancer, treatment options, and course of care. Nurses caring for patients following surgery for bladder cancer need to understand the unique needs of these patients.

Adapting home telehealth group appointment model (CoYoT1 clinic) for a low SES, publicly insured, minority young adult population with type 1 diabetes.

As more individuals from diverse backgrounds are diagnosed with Type 1 Diabetes (T1D), the need to address resulting disparities in diabetes outcomes among these populations also escalates. Although young adulthood proves challenging for all patients with diabetes, young adults (YA) from racial/ethnic minorities and low socioeconomic backgrounds face even greater T1D management obstacles. The poorer outcomes in these populations drive an urgent need for alternative care models to improve YA's engagement in their T1D clinical care and address barriers to improved health outcomes. Previous telemedicine initiatives for T1D have yielded positive diabetes care results, especially in YA, offering one promising way to reach this high-risk population. To serve these patients better, an established and successful home telehealth group appointment model, "CoYoT1 Clinic" (Colorado Young Adults with T1D), was adapted to provide care to YA with T1D at a large urban children's hospital in Southern California. At this location, ~70% of patients have public/no insurance, and 85% are racial/ethnic minorities. In this paper, we report the process of adapting the CoYoT1 Clinic model and designing a randomized controlled trial (RCT) to evaluate its efficacy. The adapted model uses meticulous study-design methods that incorporate patient advisors, quantitative and qualitative data collection, collaboration with local stakeholders, intervention development, and patient randomization into a factorial design analyzing telemedicine versus in-person and patient-centered versus standard care. The new model addresses the needs of high-risk YA in Southern California, with the goal of increasing access to care, improving follow-up frequency, and strengthening patient and provider satisfaction. The study is registered with ClinicalTrials.gov (Clinical Trials Number: NCT03793673).

Skin cancer screening: recommendations for data-driven screening guidelines and a review of the US Preventive Services Task Force controversy.

Melanoma is usually apparent on the skin and readily detected by trained medical providers using a routine total body skin examination, yet this malignancy is responsible for the majority of skin cancer-related deaths. Currently, there is no national consensus on skin cancer screening in the USA, but dermatologists and primary care providers are routinely confronted with making the decision about when to recommend total body skin examinations and at what interval. The objectives of this paper are: to propose rational, risk-based, data-driven guidelines commensurate with the US Preventive Services Task Force screening guidelines for other disorders; to compare our proposed guidelines to recommendations made by other national and international organizations; and to review the US Preventive Services Task Force's 2016 Draft Recommendation Statement on skin cancer screening.

'I-We' boundary fluctuations in couple adjustment to rectal cancer and life with a permanent colostomy.

This study investigates couples' adjustment to rectal cancer and a colostomy using the 'Classification System of Couple Adjustment to Cancer', a framework delineating fluctuations in couples' sense of 'I' and 'We' in response to cancer. Nine couples affected by rectal cancer and adjusting to life with a colostomy were interviewed. A theoretical thematic analysis of the transcripts was conducted; nearly all 'I-We' shifts of the Classification System of Couple Adjustment to Cancer were observed - often in unique ways in response to rectal cancer-specific challenges - and one new shift was described. The results provide a novel and experientially grounded means of conceptualizing complex dyadic coping processes.

Engineered feature used to enhance gardening at a 3800-year-old site on the Pacific Northwest Coast.

Humans use a variety of deliberate means to modify biologically rich environs in pursuit of resource stability and predictability. Empirical evidence suggests that ancient hunter-gatherer populations engineered ecological niches to enhance the productivity and availability of economically significant resources. An archaeological excavation of a 3800-year-old wetland garden in British Columbia, Canada, provides the first direct evidence of an engineered feature designed to facilitate wild plant food production among mid-to-late Holocene era complex fisher-hunter-gatherers of the Northwest Coast. This finding provides an example of environmental, economic, and sociopolitical coevolutionary relationships that are triggered when humans manipulate niche environs.

The FRIENDS emotional health program for minority groups at risk.

BACKGROUND: Despite the existence of evidence-based interventions for promoting mental health in children, the number of children at risk remains high. One of the reasons is that such interventions are not reaching specific groups at risk such as low socioeconomic status and ethnic minority groups. This study evaluated an adaptation of a school-based psychosocial program for nonreferred students aged 11 to 12 years attending a multicultural school from a low socioeconomic status area. METHODS: The FRIENDS Program was adapted for a multicultural population. A quasi-experimental design was used, involving a pre/post-test, to evaluate the impact of the intervention on participants' outcomes on the Strengths and Difficulties Questionnaire (SDQ). Participants were divided into 2 categories ("at risk"/"not at risk") based on their scores in the SDQ at pre-test. Post-test data were collected to evaluate the overall effectiveness and acceptability of the program. RESULTS: Analyses showed significant improvement for the group initially identified as "at risk," with 30% of the students being no longer at risk after the intervention. Most students rated the intervention as being highly acceptable and useful. CONCLUSIONS: Adaptations to existing evidence-based programs for implementation with specific minority groups at risk represents a promising approach to promote emotional health in children.