Intimacy and survivors of cancer with ostomies: findings from the Ostomy Self-management Training trial.

BACKGROUND: Many people with abdominal or pelvic cancers require an ostomy during surgical treatment, which can cause significant issues with physical and emotional intimacy in relationships. AIM: To evaluate the effect of a telehealth-based education program on intimacy over time for survivors of cancer with ostomies. METHODS: We performed a secondary analysis of our multicenter randomized controlled trial to determine intimacy outcomes and to compare the effects of the Ostomy Self-management Training (OSMT) program vs usual care. Partnered patients were included who provided answers to the City of Hope Quality of Life-Ostomy survey for at least 2 time points during the study. We evaluated the effect of baseline information, such as gender on intimacy. OUTCOMES: The primary outcome was intimacy, estimated by a composite score created from questions within the City of Hope Quality of Life-Ostomy survey. RESULTS: Of 216 enrolled volunteers, 131 had a partner: 68 in the OSMT arm and 63 in the usual care arm. Of these, 48 were women and 83 were men. The tumor types represented in this study were colorectal (n = 69), urinary (n = 45), gynecologic (n = 10), and other (n = 7; eg, melanoma, liposarcoma). From the cohort, 87 answered the 5 composite intimacy score questions at 2 time points, including baseline. There was significant improvement over time in composite intimacy scores for participants in the OSMT arm vs the usual care arm. CLINICAL IMPLICATIONS: Our OSMT intervention had a positive effect on factors that contribute to intimacy for survivors of cancer with ostomies, suggesting that a survivorship curriculum can improve their experiences after ostomy surgery. STRENGTHS AND LIMITATIONS: OSMT allowed for discussion of intimacy and other sensitive topics, which can be challenging. These discussions demonstrate benefit to participants and can serve as frameworks for cancer treatment providers. The focus of this work on partnered participants provides insight into the interpersonal challenges of a life with an ostomy, but it may overlook the important perspectives of nonpartnered participants and the partners themselves. Furthermore, limited power prevented us from conducting subgroup analyses exploring the effects of factors such as gender and tumor type on intimacy. CONCLUSION: At 6-month follow-up, the novel intimacy composite score indicated improvement for participants completing the OSMT intervention. Future research studies with higher power will validate this intimacy measurement and identify intimacy differences in similar populations based on tumor type.

Global Breast Cancer Initiative: A platform to address the psycho-oncology of cancer in low- and middle-income countries for improving global breast cancer outcomes.

BACKGROUND: Psycho-oncology is a clinical specialty in which the humanistic aspects of cancer diagnoses and treatment are addressed to reduce the psychological burden for patients and their caregivers to optimize patient participation, cancer outcomes and quality-of-life, which is especially critical in cultures where cancer is perceived as invariably fatal. Psycho-oncology programs face multiple barriers in low- and middle-income countries, including limited resource allocation and lack of training, both of which have been impediments to psycho-oncology programs becoming recognized as core competencies in cancer management and part of a standard medical curriculum. PURPOSE: This paper discusses the role of the Global Breast Cancer Initiative (GBCI) in helping to overcome inequities in breast cancer care and improve clinical outcomes from a psycho-oncology perspective as a model for improved cancer care in limited resource settings. FINDINGS: GBCI applies a comprehensive framework encompassing all phases of cancer care (defined through three pillars spanning the continuum of cancer management) and includes addressing the physical, psychological, and social needs of women throughout the life-course. Efforts to promote policies that increase access to early detection and treatment programs and improve health literacy among the public are important strategies to mitigate the most common emotional and physical challenges reported by people with cancer accessing care. CONCLUSIONS: Future efforts will focus on the integration of culturally appropriate guidance to promote early cancer detection and treatment completion through training programs for clinicians to establish core competencies in psycho-oncology. Emerging advocacy efforts in the oncology arena may help guide the integration of psycho-oncology services into routine care in countries where these services are not already integrated into the standard curriculum.

Patient navigation (PN) support to timely access to radiotherapy in the Brazilian public health system.

PURPOSE: Patient navigation (PN) is a community-based service delivery intervention designed to promote access to timely diagnosis and treatment of cancer and other chronic diseases by eliminating barriers to integral care. Considering the complex difficulties in accessing treatment and the positive results of PN in high-income countries, our group decided to evaluate this tool to improve radiotherapy (RT) access in the public system in Brazil. PATIENTS AND METHODS: This pilot study took place in a public school hospital, with a historical cohort as the control arm. The primary endpoint was the time from histologic diagnosis and RT initiation among cancer patients receiving RT with curative intent in a PN program. The secondary objectives were the following time frames: referral to the first consultation by the RT team; first consultation up to RT beginning; RT beginning to RT end; referral to the end of RT and identifying/describing obstacles to the treatment; and assessing patient satisfaction with PN program. RESULTS: A total of 124 patients were included in the retrospective arm and 73 in the navigation arm. Most had the loco-regionally advanced disease from the esophagus, head/neck, and rectum. PN decreased the median time from the biopsy result to the beginning of RT from 108 to 74 days (p < 0.001). PN reduced the time between biopsy results and referral to RT (53 to 40.5 days, p = 0.011), between the referral and the first consultation in the RT (25 to 13 days, p < 0.001), and between the referral to the end of the RT (98 to 78 days, p < 0.003). CONCLUSIONS: Proper identification of barriers, especially in a low-resource setting, is mandatory to guide PN programs in LMICs. In an oncological context of socioeconomic vulnerability, PN is a financially viable and efficient tool to optimize access to timely RT.

Netiquette for social media engagement for oncology professionals.

Social media growth has revolutionized health care, facilitating user-friendly, rapid and global sharing of content. Within oncology, this allows for new frontiers in communication for cancer patients, caregivers and healthcare providers. As more physicians engage in online spaces, it is imperative that there are resources to assist in establishing a professional presence on social media. This article describes how to create a social media identity, best practices for engaging both in patient and caregiver spaces and professional communities, and how to address antagonistic and inappropriate behavior on social media with the goal of helping physicians develop an engaging, productive and enjoyable experience online.

Using Social Media for Clinical Research: Recommendations and Examples From the Brown-Lifespan Center for Digital Health.

Social media integration into research has increased, and 92% of American social media participants state they would share their data with researchers. Yet, the potential of these data to transform health outcomes has not been fully realized, and the way clinical research is performed has been held back. The use of these technologies in research is dependent on the investigators' awareness of their potential and their ability to innovate within regulatory and institutional guidelines. The Brown-Lifespan Center for Digital Health has launched an initiative to address these challenges and provide a helpful framework to expand social media use in clinical research.

Pretransplant solid organ malignancy and organ transplant candidacy: A consensus expert opinion statement.

Patients undergoing evaluation for solid organ transplantation (SOT) often have a history of malignancy. Although the cancer has been treated in these patients, the benefits of transplantation need to be balanced against the risk of tumor recurrence, especially in the setting of immunosuppression. Prior guidelines of when to transplant patients with a prior treated malignancy do not take in to account current staging, disease biology, or advances in cancer treatments. To develop contemporary recommendations, the American Society of Transplantation held a consensus workshop to perform a comprehensive review of current literature regarding cancer therapies, cancer stage-specific prognosis, the kinetics of cancer recurrence, and the limited data on the effects of immunosuppression on cancer-specific outcomes. This document contains prognosis based on contemporary treatment and transplant recommendations for breast, colorectal, anal, urological, gynecological, and nonsmall cell lung cancers. This conference and consensus documents aim to provide recommendations to assist in the evaluation of patients for SOT given a history of a pretransplant malignancy.

Preexisting melanoma and hematological malignancies, prognosis, and timing to solid organ transplantation: A consensus expert opinion statement.

Patients undergoing evaluation for solid organ transplantation (SOT) frequently have a history of malignancy. Only patients with treated cancer are considered for SOT but the benefits of transplantation need to be balanced against the risk of tumor recurrence, taking into consideration the potential effects of immunosuppression. Prior guidelines on timing to transplant in patients with a prior treated malignancy do not account for current staging, disease biology, or advances in cancer treatments. To update these recommendations, the American Society of Transplantation (AST) facilitated a consensus workshop to comprehensively review contemporary literature regarding cancer therapies, cancer stage specific prognosis, the kinetics of cancer recurrence, as well as the limited data on the effects of immunosuppression on cancer-specific outcomes. This document contains prognosis, treatment, and transplant recommendations for melanoma and hematological malignancies. Given the limited data regarding the risk of cancer recurrence in transplant recipients, the goal of the AST-sponsored conference and the consensus documents produced are to provide expert opinion recommendations that help in the evaluation of patients with a history of a pretransplant malignancy for transplant candidacy.

Immunohistochemical HER2 score correlates with response to neoadjuvant chemotherapy in HER2-positive primary breast cancer.

PURPOSE: The accuracy of biomarker assessment in breast cancer (BC) is paramount for therapy decisions and informs prognosis. We investigated neoadjuvant chemotherapy (NAC) response in HER2-positive BC with respect to immunohistochemistry (IHC) and in situ hybridization (ISH) results. We aimed to determine the role of HER2 protein expression in predicting NAC response and long-term outcome in two HER2-positive groups: IHC 3 + versus IHC 2 + ISH amplified groups. METHODS: This retrospective study included 192 consecutive HER2 + primary BCs diagnosed from 2007 to 2019 treated with NAC and HER2-targeted agent (NACH). There were 158 HER2 3 + and 34 HER2 2 + ISH + cases. Clinicopathological parameters and long-term outcomes were analyzed. RESULTS: The Pathological Complete Response (pCR) rate was 85.7% (72/84) in ER-/HER2 + BCs and was lower in ER + /HER2 + BCs (42.6%, 46/108). The pCR was 55.1% (86/156) in the HER2 3 + group and was only 17.6% in HER2 2 + ISH + group (p < 0.001). Patients who achieved pCR in HER2 2 + ISH + group did not show a significantly higher HER2/CEP17 ratio or HER2 copy number. The overall survival (OS) and progression-free survival (PFS) were significantly higher in pCR compared to non-pCR cases (p = 0.011 and p = 0.015, respectively). CONCLUSIONS: There is significant heterogeneity in response to the NACH regimens in HER2 + cases. Our findings indicate that HER2 IHC score and ER expression determine NACH response in HER2 + BC. We recommend considering HER2 protein expression and ISH value to better select patients and assess the response for HER2-targeted therapy.

"Going Flat" After Mastectomy: Patient-Reported Outcomes by Online Survey.

BACKGROUND: The Going Flat movement aims to increase awareness and acceptance of mastectomy alone as a viable option for patients. Little is known about motivations and satisfaction with surgical outcomes in this population. METHODS: An online survey was administered to 931 women who had a history of uni- or bilateral mastectomy for treatment of breast cancer or elevated breast cancer risk without current breast mound reconstruction. Satisfaction with outcome and surgeon support for the patient experience were characterized using 5-level scaled scores. RESULTS: Mastectomy alone was the first choice for 73.7% of the respondents. The top two reasons for going flat were desire for a faster recovery and avoidance of a foreign body placement. Overall, the mean scaled satisfaction score was 3.72 ± 1.17 out of 5. In the multivariable analysis, low level of surgeon support for the decision to go flat was the strongest predictor of a satisfaction score lower than 3 (odds ratio [OR], 3.85; 95% confidence interval [CI], 2.59-5.72; p < 0.001). Dissatisfaction also was more likely among respondents reporting a body mass index (BMI) of 30 kg/m2 or higher (OR, 2.74; 95% CI, 1.76-4.27; p < 0.001) and those undergoing a unilateral procedure (OR, 1.99; 95% CI, 1.29-3.09; p = 0.002). Greater satisfaction was associated with receiving adequate information about surgical options (OR, 0.48; 95% CI, 0.32-0.69; p < 0.0001) and having a surgeon with a specialized breast surgery practice (OR, 0.56; 95% CI, 0.38-0.81; p = 0.002). CONCLUSIONS: Most patients undergoing mastectomy alone are satisfied with their surgical outcome. Surgeons may optimize patient experience by recognizing and supporting a patient's decision to go flat.

Molecular Profiles of Brain and Pulmonary Metastatic Disease in Cancer of Unknown Primary.

Cancers of unknown primary (CUP) are histologically confirmed malignancies but for which further investigation cannot identify a primary site. Improvements in histopathologic modalities for diagnosis have lessened the frequency of CUPs to 3%-5% of all malignancies compared with historical estimates of 5%-10%. Despite this, there is an ongoing debate as to whether CUPs are malignancies where the primary is not found or if they are otherwise a fully separate entity. Improvements in molecular analysis holds promise for improved identification and treatment of CUPs with mixed preliminary results. Here we present a woman with CUP and metastases in her brain and lung. We performed genomic profiling to compare the molecular makeup of each site in order to establish treatment targets. KEY POINTS: Cancer of unknown primary remains a diagnostic and therapeutic challenge. Molecular analysis may provide improvements in diagnosis and novel treatment options. Different sites of metastatic disease have subtle variations in molecular profile. Sequencing of different sites may offer therapeutic options that are either already approved or available in clinical trial.

Combined pembrolizumab and pegylated liposomal doxorubicin in platinum resistant ovarian cancer: A phase 2 clinical trial.

OBJECTIVE: Pegylated liposomal doxorubicin (PLD) in vitro may have immunomodulatory abilities and preclinical evidence suggests it synergizes with immune checkpoint blockade. We hypothesized that combining PLD and pembrolizumab would be active in patients with platinum-resistant ovarian cancer (PROC). METHODS: This was a single-arm, multi-center phase II trial. Eligible patients had PROC with ≤2 prior lines of cytotoxic therapy for recurrent or persistent disease. Twenty-six patients were enrolled and given pembrolizumab 200 mg intravenously (IV) every 3 weeks and PLD 40 mg/m2 IV every 4 weeks. Patients were assessed radiographically every 8 weeks. The primary endpoint was clinical benefit rate (CBR), defined as complete response (CR) + partial response (PR) + stable disease (SD) ≥24 weeks. The study was powered to detect an improvement in CBR from 25% to 50%, with rejection of the null hypothesis if at least 10 patients achieved clinical benefit. T-cell inflamed gene expression profiles (GEP) and PD-L1 were assessed and correlated with clinical outcome. RESULTS: Twenty-three patients were evaluable for best overall response. The study satisfied its primary endpoint, with 12 patients achieving clinical benefit for a CBR of 52.2% (95% CI 30.6-73.2%). There were 5 PRs (21.7%) and 1 CR (4.3%), for an overall response rate (ORR) of 26.1%. Six patients had SD lasting at least 24 weeks. Combination therapy was well tolerated without unexpected toxicities. CONCLUSIONS: The combination of pembrolizumab and PLD was manageable, without unexpected toxicities, and showed preliminary evidence of clinical benefit in the treatment of platinum resistant ovarian cancer. ORR and median PFS of combination therapy in this study was higher than historical comparisons of PLD alone or anti-PD-1/PD-L1 agents alone. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02865811.

Phase II study of axalimogene filolisbac (ADXS-HPV) for platinum-refractory cervical carcinoma: An NRG oncology/gynecologic oncology group study.

OBJECTIVE: Women with persistent, recurrent, and/or metastatic cervical cancer have a poor prognosis. Even with the availability of cisplatin plus paclitaxel and bevacizumab, median overall survival (OS) is only 17.0 months, with median post-progression survival of approximately seven months. We studied the therapeutic vaccine, Axalimogene filolisbac (ADXS-HPV), in women who had progressed following at least one prior line of therapy (Gynecologic Oncology Group protocol 265/NCT01266460). METHODS: Volunteers ≥18 years with advanced cervical cancer and GOG performance status score of 0 or 1 were eligible for participation in this 2-stage, phase II trial. In stage 1, women received up to three doses of ADXS-HPV (1 × 109 colony-forming units in 250 mL IV over 15 min every 28 days) and were monitored for tumor progression. In stage 2, women were treated until progression, intolerable adverse events (AEs), or voluntary withdrawal of consent. Co-primary endpoints were safety and proportion of volunteers surviving ≥12 months. An estimated, combined (stages 1 + 2) 12-month OS of 35% was calculated from historical GOG cohorts to declare ADXS-HPV sufficiently active in this platinum-pre-treated population. Secondary endpoints were OS and progression-free survival (PFS). RESULTS: Among 50 evaluable volunteers, the 12-month OS was 38% (n = 19). Median OS was 6.1 months (95% CI: 4.3-12.1) and median PFS was 2.8 months (95% CI: 2.6-3.0). The most common treatment-related AEs were fatigue, chills, fever, nausea, and anemia. The majority of AEs were grade 1 or 2 and resolved spontaneously or with appropriate treatment. CONCLUSION: At the dose and schedule studied, ADXS-HPV immunotherapy was tolerable and met the protocol-specified benchmark for activity required to warrant further investigation in volunteers with cervical carcinoma.

Protecting Patient Privacy in Narratives: The Lifespan-Brown Checklist for Appropriate Use of Patient Narratives.

How can we support narratives written by clinicians in a way that promotes reflection without breaching the confidentiality inherent within the patient­provider relationship? This narrative provides some guidance, with the Brown­Lifespan Checklist for Narratives.

Distress: Characterizing What Causes the Thermometer to Shift in Patients with Newly Diagnosed Breast Cancer Attending a Multidisciplinary Clinic.

BACKGROUND: A diagnosis of breast cancer (BC) can result in multifactorial stress. If not addressed, distress can have a negative impact on outcomes. The experience of patients with newly diagnosed BC has not been sufficiently investigated. This study characterizes distress among new patients in a multidisciplinary care (MDC) clinic. The study aimed to determine the degree of distress at presentation, to characterize the sources, and to evaluate the impact of an MDC visit. METHODS: A retrospective review was performed from January 2015 to November 2017. Charts were accessed for demographics, tumor characteristics, and treatment data. Distress scores (DS) and problems as captured using the National Comprehensive Cancer Network (NCCN) Distress Thermometer were completed before evaluation and in a subgroup after an MDC visit. Predictors of severe distress (DS ≥4) were investigated using multivariable logistic regression. The paired t test was used to determine the impact of an MDC visit. RESULTS: The mean initial DS (n = 474) was 4.98. The top four sources of distress were worry, anxiety, fears, and sadness. Age younger than 65 years was significantly associated with a higher DS at presentation (p < 0.003). Among the patients queried before and after MDC (n = 137), a significant reduction in distress was identified (5.58-2.94; p < 0.0005). CONCLUSIONS: Severe distress was found in 66 % of the patients with a recent diagnosis of BC, with younger age related to higher distress scores at presentation. Emotional stressors were the predominant factors accounting for distress. A same-day MDC visit was associated with a significant reduction in DS. These data indicate the importance and feasibility of proactively screening patients. Our research lends support to the value of multidisciplinary evaluation in this setting.

Pilot study of a multimodal intervention to enhance sexual function in survivors of hematopoietic stem cell transplantation.

BACKGROUND: Although sexual dysfunction is common after hematopoietic stem cell transplantation (HCT), interventions to address sexual function are lacking. METHODS: We conducted a pilot study to assess the feasibility and preliminary efficacy of a multimodal intervention to address sexual dysfunction in allogeneic HCT survivors. Transplant clinicians screened HCT survivors ≥3 months post-HCT for sexual dysfunction causing distress. Those who screened positive attended monthly visits with a trained transplant clinician who: 1) performed an assessment of the causes of sexual dysfunction; 2) educated and empowered the patient to address his or her sexual concerns; and 3) implemented therapeutic interventions targeting the patient's needs. Feasibility was defined as having approximately 75% of patients who screened positive agreeing to participate and 80% attending at least 2 intervention visits. We administered the Patient-Reported Outcomes Measurement Information System (PROMIS) sexual function and satisfaction measure, the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT), and the Hospital Anxiety and Depression Scale (HADS) to evaluate sexual function, quality of life (QOL), and mood, respectively, at baseline and 6 months postintervention. RESULTS: Approximately 33.1% of patients (50 of 151 patients) screened positive for sexual dysfunction causing distress and 94.0% (47 of 50 patients) agreed to participate, with 100% attending 2 intervention visits. Participants reported improvements in satisfaction (P<.0001) and interest in sex (P<.0001), as well as orgasm (P<.0001), erectile function (P<.0001), vaginal lubrication (P = .0001), and vaginal discomfort (P = .0005). At baseline, approximately 32.6% of participants were not sexually active, compared with 6.5% after the intervention (P = .0005). Participants reported improvement in their QOL (P<.0001), depression (P = .0002), and anxiety (P = .0019). CONCLUSIONS: A multimodal intervention to address sexual dysfunction integrated within the transplant clinic is feasible with encouraging preliminary efficacy for improving sexual function, QOL, and mood in HCT survivors. Cancer 2018;124:2438-46. © 2018 American Cancer Society.