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BACKGROUND: Hematopoietic stem cell transplant (HSCT) survivors frequently experience persistent sexual dysfunction, which is associated with impaired quality of life (QOL) and increased psychological distress. The lack of availability of clinicians with expertise in sexual health limits the capacity to address sexual health concerns in HSCT survivors. Digital health applications may offer a patient-centered and scalable solution to address sexual health concerns in cancer survivors. The objective of this report is to delineate the iterative process of adapting an in-person sexual health intervention into a self-administered digital application called "Sexual Health and Intimacy Following Transplant (SHIFT)" and the refinement of SHIFT using stakeholder feedback. METHODS: We used a five-step development model to adapt SHIFT that included: 1) implementation of a multimodal bio-psycho-social conceptual framework, 2) development of a comprehensive intervention manual and SHIFT content, 3) translation of the intervention manual into an interactive storyline with a focus on enhancing patient engagement, 4) creation of initial SHIFT wireframes, and 5) refinement of SHIFT through iterative alpha and beta testing. At each step, key stakeholders including HSCT survivors, HSCT clinicians, and experts in sexual health, psychology, and digital health provided iterative feedback. RESULTS: We adapted SHIFT based on our conceptual framework, prior in-person intervention work, and iterative stakeholder feedback in each application development stage. SHIFT incorporates medical information, educational materials, intimacy exercises, and activities to address the multiple etiologies of sexual health concerns in HSCT survivors. SHIFT includes strategies to enhance engagement including gamification, personalization, and incorporation of video from HSCT survivors and clinicians. Based on stakeholder feedback, SHIFT was refined with a focus on inclusivity of gender, sexual orientation, relationship status, and body image concerns. CONCLUSIONS: SHIFT is novel, patient-centered digital application to address sexual dysfunction in HSCT survivors. Iterative feedback from key stakeholders including HSCT survivors guided SHIFT adaptation and refinement, to optimize patient engagement and ensure inclusivity. The final prototype of SHIFT was initially acceptable to key stakeholders and is now under further testing in a pilot randomized trial to assess its feasibility and preliminary efficacy for improving sexual health outcomes in HSCT survivors.
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With improved medical treatments, the prognosis for many malignancies has improved, and more patients are presenting for transplant evaluation with a history of treated cancer. Solid organ transplant (SOT) recipients with a prior malignancy are at higher risk of posttransplant recurrence or de novo malignancy, and they may require a cancer surveillance program that is individualized to their specific needs. There is a dearth of literature on optimal surveillance strategies specific to SOT recipients. A working group of transplant physicians and cancer-specific specialists met to provide expert opinion recommendations on optimal cancer surveillance after transplantation for patients with a history of malignancy. Surveillance strategies provided are mainly based on general population recurrence risk data, immunosuppression effects, and limited transplant-specific data and should be considered expert opinion based on current knowledge. Prospective studies of cancer-specific surveillance models in SOT recipients should be supported to inform posttransplant management of this high-risk population.
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PURPOSE: To assess efficacy and toxicity of cisplatin (C) and gemcitabine (G) with intensity-modulated radiation therapy (IMRT) in patients with locally advanced vulvar cancer not amenable to surgery. METHODS: Patients enrolled in a single-arm phase II study. Pretreatment inguinal-femoral nodal assessment was performed. Sixty-four Gy IMRT was prescribed to the vulva, with 50-64 Gy delivered to the groins/low pelvis. Radiation therapy (RT) plans were quality-reviewed pretreatment. C 40 mg/m2 and G 50 mg/m2 were administered once per week throughout IMRT. Complete pathologic response (CPR) was the primary end point. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method, and adverse events were assessed with Common Terminology Criteria for Adverse Events v 4.0. RESULTS: Fifty-seven patients enrolled, of which 52 were evaluable. The median age was 58 years (range, 25-58), and 94% were White. Forty (77%) had stage II or III disease, and all had squamous histology. A median of six chemotherapy cycles (range, 1-8) were received. Eighty-five percent of RT plans were quality-reviewed with 100% compliance to protocol. Seven patients came off trial because of toxicity or patient withdrawal. Of 52 patients available for pathologic assessment, 38 (73% [90% CI, 61 to 83]) achieved CPR. No pelvic exenterations were performed. With a median follow-up of 51 months, the 12-month PFS was 74% (90% CI, 62.2 to 82.7) and the 24-month OS was 70% (90% CI, 57 to 79). The most common grade 3 or 4 adverse events were hematologic toxicity and radiation dermatitis. There was one grade 5 event unlikely related to treatment. CONCLUSION: Weekly C and G concurrent with IMRT sufficiently improved CPR in women with locally advanced vulvar squamous cell carcinoma not amenable to surgical resection.
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Protocolos de Quimioterapia Combinada Antineoplásica , Carcinoma de Células Escamosas , Cisplatino , Desoxicitidina , Gemcitabina , Radioterapia de Intensidad Modulada , Neoplasias de la Vulva , Humanos , Femenino , Persona de Mediana Edad , Neoplasias de la Vulva/patología , Neoplasias de la Vulva/radioterapia , Neoplasias de la Vulva/tratamiento farmacológico , Neoplasias de la Vulva/mortalidad , Neoplasias de la Vulva/terapia , Radioterapia de Intensidad Modulada/métodos , Radioterapia de Intensidad Modulada/efectos adversos , Cisplatino/administración & dosificación , Cisplatino/uso terapéutico , Adulto , Carcinoma de Células Escamosas/patología , Carcinoma de Células Escamosas/terapia , Carcinoma de Células Escamosas/radioterapia , Carcinoma de Células Escamosas/mortalidad , Carcinoma de Células Escamosas/tratamiento farmacológico , Desoxicitidina/análogos & derivados , Desoxicitidina/administración & dosificación , Desoxicitidina/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Quimioradioterapia/métodos , Supervivencia sin ProgresiónRESUMEN
Breast cancer is the most prevalent malignancy among adolescents and young adults (AYAs). Despite the efficacy of chemotherapy, AYA patients contend with psychosocial challenges, including psychological distress and financial toxicity, exacerbated further by those with dependent children. Parenting responsibilities intersect with cancer care, impacting both family dynamics and treatment adherence. Despite recognized needs, however, the impact of parenting concerns or even parenting status and the presence of dependents has not been systematically addressed and there is a paucity of interventional research regarding patients with cancer as concomitant caregivers. A feasibility study conducted by the Brown University Oncology Cooperative Group demonstrated the potential benefits of providing financial assistance for childcare, both improving treatment adherence and reducing distress among participants. Similar interventions have shown promise in addressing financial hardships for AYA patients with cancer who are concomitant caregivers. Ultimately, parenting concerns have a significant impact on medical decision-making, and further interventional research on childcare support is required to examine the ways in which health systems can improve family stability, stress, and quality of life.
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Neoplasias , Humanos , Femenino , Neoplasias/psicología , Neoplasias/terapia , Neoplasias/tratamiento farmacológico , Cuidado del Niño , Adolescente , Padres/psicología , Cuidadores/psicología , Niño , Calidad de Vida , Adulto Joven , Responsabilidad Parental/psicología , Neoplasias de la Mama/psicología , Neoplasias de la Mama/terapia , Neoplasias de la Mama/tratamiento farmacológicoRESUMEN
BACKGROUND: Optimal methods for deploying electronic patient-reported outcomes to manage symptoms in routine oncologic practice remain uncertain. The electronic symptom management (eSyM) program asks chemotherapy and surgery patients to self-report 12 common symptoms regularly. Feedback from nurses and patients led to changing the recall period from the past 7 days to the past 24 hours. METHODS: Using questionnaires submitted during the 16 weeks surrounding the recall period change, we assessed the likelihood of reporting severe or moderate and severe symptoms across 12 common symptoms and separately for the 5 most prevalent symptoms. Interrupted time-series analyses modeled the effects of the change using generalized linear mixed-effects models. Surgery and chemotherapy cohorts were analyzed separately. Study-wide effects were estimated using a meta-analysis method. RESULTS: In total, 1692 patients from 6 institutions submitted 7823 eSyM assessments during the 16 weeks surrounding the recall period change. Shortening the recall period was associated with lower odds of severe symptom reporting in the surgery cohort (odds ratio = 0.65, 95% confidence interval = 0.46 to 0.93; P = .02) and lower odds of moderate and severe symptom reporting in the chemotherapy cohort (odds ratio = 0.83, 95% confidence interval = 0.71 to 0.97; P = .02). Among the most prevalent symptoms, 24-hour recall was associated with a lower rate of reporting postoperative constipation but no differences in reporting rates for other symptoms. CONCLUSION: A shorter recall period was associated with a reduction in the proportion of patients reporting moderate-severe symptoms. The optimal recall period may vary depending on whether electronic patient-reported outcomes are collected for active symptom management, as a clinical trial endpoint, or another purpose. ClinicalTrials.gov ID NCT03850912.
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Neoplasias , Medición de Resultados Informados por el Paciente , Humanos , Femenino , Masculino , Neoplasias/terapia , Neoplasias/tratamiento farmacológico , Persona de Mediana Edad , Autoinforme/estadística & datos numéricos , Anciano , Encuestas y Cuestionarios , Adulto , Índice de Severidad de la Enfermedad , Estreñimiento/epidemiología , Estreñimiento/etiología , Náusea/epidemiología , Náusea/etiologíaRESUMEN
Background: Electronic patient-reported outcome (ePRO)-based symptom management improves cancer patients' outcomes. However, implementation of ePROs is challenging, requiring technical resources for integration into clinical systems, substantial buy-in from clinicians and patients, novel workflows to support between-visit symptom management, and institutional investment. Methods: The SIMPRO Research Consortium developed eSyM, an electronic health record-integrated, ePRO-based symptom management program for medical oncology and surgery patients and deployed it at six cancer centers between August 2019 and April 2022 in a type II hybrid effectiveness-implementation cluster randomized stepped-wedge study. Sites documented implementation strategies monthly using REDCap, itemized them using the Expert Recommendations for Implementation Change (ERIC) list and mapped their target barriers using the Consolidated Framework for Implementation Research (CFIR) to inform eSyM program enhancement, facilitate inter-consortium knowledge sharing and guide future deployment efforts. Results: We documented 226 implementation strategies: 35 'foundational' strategies were applied consortium-wide by the coordinating center and 191 other strategies were developed by individual sites. We consolidated these 191 site-developed strategies into 64 unique strategies (i.e., removed duplicates) and classified the remainder as either 'universal', consistently used by multiple sites (N=29), or 'adaptive', used only by individual sites (N=35). Universal strategies were perceived as having the highest impact; they addressed eSyM clinical preparation, training, engagement of patients/clinicians, and program evaluation. Across all documented SIMPRO strategies, 44 of the 73 ERIC strategies were addressed and all 5 CFIR barriers were addressed. Conclusion: Methodical collection of theory-based implementation strategies fostered the identification of universal, high-impact strategies that facilitated adoption of a novel care-delivery intervention by patients, clinicians, and institutions. Attention to the high-impact strategies identified in this project could support implementation of ePROs as a component of routine cancer care at other institutions.
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Sexual health problems are prevalent among women affected by gynecologic or breast cancer. It is important to understand the effects cancer treatment can have on sexual health and to have the tools necessary to identify and treat sexual health problems. This Clinical Expert Series discusses practical methods for routinely screening for sexual dysfunction and reviews sexual health treatment options for women affected by cancer. We review the limitations of the current literature in addressing sexual health problems among sexually and gender minoritized communities. Finally, we discuss appropriate timing of referrals to sexual health experts, physical therapists, and sex therapists. Multiple resources available for both patients and clinicians are included.
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Neoplasias de la Mama , Disfunciones Sexuales Fisiológicas , Salud Sexual , Humanos , Femenino , Neoplasias de la Mama/terapia , Conducta Sexual , Disfunciones Sexuales Fisiológicas/diagnóstico , Disfunciones Sexuales Fisiológicas/etiología , Disfunciones Sexuales Fisiológicas/terapiaRESUMEN
Background: Multidisciplinary clinics (MDCs) are a care model in which patients see several physicians across specialties and/or other allied health professionals in a single appointment in a shared space. This study sought to better understand patients' experiences with breast cancer (BC) MDC. Methods: A total of 429 patients diagnosed with BC and seen in a MDC between November 2020 and November 2021 were invited to participate in a patient experience survey. Results: In total, 116 patient respondents (27%) with representative demographics described their experience. Most patients report feeling "somewhat prepared" for the BC MDC experience (67%, median = 3.7, interquartile range [IQR] = 1.9), but with variability. The major areas of positive feedback were that the MDC was convenient (89.3%), efficient use of time (65.2%), and a good way to get questions answered (65.2%). Major criticisms included that the MDC was overwhelming (16.1%) and/or too long (4.5%). When asked to rate the top three satisfaction areas of MDCs, patients chose seeing multiple providers during a single visit (80.4%), communication about the process before and throughout the MDC (48.2%), and inclusivity of their support system (38.4%). The highest rated dissatisfiers were the volume of information presented (42.9%) and patients' emotional comfort (anxiety/stress) during MDC appointment (30.2%). Overall, 83% of patients with BC rate the MDC experience as excellent (median = 4.8, IQR = 0.9) and would be "very likely" to recommend BC MDC (median = 4.8, IQR = 0.9). Conclusion: Patients value seeing multiple providers simultaneously in an environment inclusive of their support systems, which is described as convenient and efficient. Improving emotional distress is a key opportunity to improve patient experience.
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Neoplasias de la Mama , Humanos , Femenino , Neoplasias de la Mama/terapia , Neoplasias de la Mama/psicología , Estudios Prospectivos , Instituciones de Atención Ambulatoria , Encuestas y Cuestionarios , Evaluación del Resultado de la Atención al PacienteRESUMEN
PURPOSE: While the use of electronic patient-reported outcomes (ePROs) in routine clinical practice is increasing, barriers to patient engagement limit adoption. Studies have focused on technology access as a key barrier, yet other characteristics may also confound readiness to use ePROs including patients' confidence in using technology and confidence in asking clinicians questions. METHODS: To assess readiness to use ePROs, adult patients from six US-based health systems who started a new oncology treatment or underwent a cancer-directed surgery were invited to complete a survey that assessed access to and confidence in the use of technology, ease of asking clinicians questions about health, and symptom management self-efficacy. Multivariable ordinal logistic regression models were fit to assess the association between technology confidence, ease of asking questions, and symptom management self-efficacy. RESULTS: We contacted 3,212 individuals, and 1,043 (33%) responded. The median age was 63 years, 68% were female, and 75% reported having access to patient portals. Over 80% had two or more electronic devices. Most patients reported high technology confidence, higher ease of asking clinicians questions, and high symptom management self-efficacy (n = 692; 66%). Patients with high technology confidence also reported higher ease of asking nurses about their health (adjusted odds ratio [AOR], 4.58 [95% CI, 2.36 to 8.87]; P ≤ .001). Those who reported higher ease of asking nurses questions were more likely to report higher confidence in managing symptoms (AOR, 30.54 [95% CI, 12.91 to 72.30]; P ≤ .001). CONCLUSION: Patient readiness to use ePROs likely depends on multiple factors, including technology and communication confidence, and symptom management self-efficacy. Future studies should assess interventions to address these factors.
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Pacientes , Programas Informáticos , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Comunicación , Medición de Resultados Informados por el Paciente , Encuestas y CuestionariosRESUMEN
Ovarian carcinosarcoma (OCS) is a rare malignancy with a poor prognosis. It is a biphasic tumor with malignant epithelial and mesenchymal components. A few mutations commonly seen in cancer have been identified in OCS, including TP53, PIK3CA, c-myc, ZNF217, ARID1A, and CTNNB1. Some OCS tumors have shown vascular endothelial growth factor positivity and limited HER2 expression. There is evidence of homologous recombination deficiency in OCS. This malignancy can be categorized as copy number high but has not been shown to have a high tumor mutational burden. There are mixed findings regarding the presence of biomarkers targeted by immune checkpoint inhibitors in OCS. For treatments other than systemic chemotherapy, the data available are largely based on in vitro and in vivo studies. In addition, there are case reports citing the use of poly-ADP ribose polymerase inhibitors, vascular endothelial growth factor inhibitors, and immunotherapy with varying degrees of success. This review paper will discuss the molecular and genomic characteristics of OCS, which can guide future treatment strategies.
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Carcinosarcoma , Neoplasias Ováricas , Femenino , Humanos , Factor A de Crecimiento Endotelial Vascular/genética , Neoplasias Ováricas/terapia , Neoplasias Ováricas/tratamiento farmacológico , Inhibidores de Poli(ADP-Ribosa) Polimerasas/uso terapéutico , Genómica , Carcinosarcoma/terapia , Carcinosarcoma/tratamiento farmacológicoRESUMEN
BACKGROUND: Systematic approaches are needed to accurately characterize the dynamic use of implementation strategies and how they change over time. We describe the development and preliminary evaluation of the Longitudinal Implementation Strategy Tracking System (LISTS), a novel methodology to document and characterize implementation strategies use over time. METHODS: The development and initial evaluation of the LISTS method was conducted within the Improving the Management of SymPtoms during And following Cancer Treatment (IMPACT) Research Consortium (supported by funding provided through the NCI Cancer MoonshotSM). The IMPACT Consortium includes a coordinating center and three hybrid effectiveness-implementation studies testing routine symptom surveillance and integration of symptom management interventions in ambulatory oncology care settings. LISTS was created to increase the precision and reliability of dynamic changes in implementation strategy use over time. It includes three components: (1) a strategy assessment, (2) a data capture platform, and (3) a User's Guide. An iterative process between implementation researchers and practitioners was used to develop, pilot test, and refine the LISTS method prior to evaluating its use in three stepped-wedge trials within the IMPACT Consortium. The LISTS method was used with research and practice teams for approximately 12 months and subsequently we evaluated its feasibility, acceptability, and usability using established instruments and novel questions developed specifically for this study. RESULTS: Initial evaluation of LISTS indicates that it is a feasible and acceptable method, with content validity, for characterizing and tracking the use of implementation strategies over time. Users of LISTS highlighted several opportunities for improving the method for use in future and more diverse implementation studies. CONCLUSIONS: The LISTS method was developed collaboratively between researchers and practitioners to fill a research gap in systematically tracking implementation strategy use and modifications in research studies and other implementation efforts. Preliminary feedback from LISTS users indicate it is feasible and usable. Potential future developments include additional features, fewer data elements, and interoperability with alternative data entry platforms. LISTS offers a systematic method that encourages the use of common data elements to support data analysis across sites and synthesis across studies. Future research is needed to further adapt, refine, and evaluate the LISTS method in studies with employ diverse study designs and address varying delivery settings, health conditions, and intervention types.
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In 2017, ASCO issued the position statement, Strategies for Reducing Cancer Health Disparities Among Sexual and Gender Minority Populations, outlining five areas of recommendations to address the needs of both sexual and gender minority (SGM, eg, LGBTQ+) populations affected by cancer and members of the oncology workforce who identify as SGM: (1) patient education and support; (2) workforce development and diversity; (3) quality improvement strategies; (4) policy solutions; and (5) research strategies. In 2019, ASCO convened the SGM Task Force to help actualize the recommendations of the 2017 position statement. The percentage of the US population who publicly identify as SGM has increased dramatically over the past few years. Although increased national interest in SGM health equity has accompanied a general interest in research, policy change, and education around diversity, equity, and inclusion, resulting from public concern over discrimination in health care against Black, Indigenous, and People of Color, this has been accompanied by a surge in discriminatory legislation directly impacting the SGM community. Although much progress has been made in advancing SGM cancer health equity since 2017, more progress is needed to reduce disparities and advance equity. The five focus areas outlined in the 2017 ASCO position statement remain relevant, as we must continue to promote and advance equity in quality improvement, workforce development, patient care, research, and SGM-affirming policies. This article reports on the progress toward reducing SGM cancer disparities and achieving equity across these five areas and identifies future directions for the work that still remains.
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Equidad en Salud , Neoplasias , Minorías Sexuales y de Género , Humanos , Neoplasias/epidemiología , Neoplasias/terapia , Oncología Médica , Atención a la SaludRESUMEN
PURPOSE: Recurrent gene mutations in speckle-type POZ protein (SPOP), the substrate-binding component of E3 ubiquitin ligase, are associated with tumor progression in prostate and endometrial cancers. Here, we characterized SPOP mutations in these cancers and explored their association with molecular and immune signatures and patient outcomes. METHODS: There were 7,398 prostate cancer and 19,188 endometrial cancer samples analyzed for clinical and molecular profiles at Caris Life Sciences. Overall survival (OS) was analyzed using Kaplan-Meier survival curves. Statistical significance was determined using chi-square and Mann-Whitney U tests, with P values adjusted for multiple comparisons. RESULTS: SPOP mutations were identified in 9.2% of prostate and 4.3% of endometrial cancers. Mutations clustered in the SPOP meprin and TRAF-C homology domain, with no significant overlap between cancer types. SPOP mutation was associated with differential comutation profiles and opposing tumor immune microenvironment signatures for each cancer, with greater immune infiltration in SPOP-mutated endometrial cancer. SPOP-mutated prostate and endometrial cancers displayed altered epigenetic gene expression, including opposite regulation of BRD2 transcripts. In SPOP-mutant prostate cancer, higher expression of androgen receptor-regulated transcripts and improved OS after treatment with hormonal agents were observed. In endometrial cancer, hormone receptor expression was significantly lower in SPOP-mutated tumors and differences in OS were highly dependent on the particular hotspot mutation and histologic subtype. CONCLUSION: These data indicate that SPOP mutations drive opposing molecular and immune landscapes in prostate and endometrial cancers-suggesting a loss-of-function mechanism in prostate cancer and gain-of-function mechanism in endometrial cancer-and provide a rationale for tailored therapeutic approaches.
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Neoplasias Endometriales , Neoplasias de la Próstata , Masculino , Femenino , Humanos , Próstata , Factores de Transcripción , Neoplasias Endometriales/genética , Neoplasias de la Próstata/genética , Mutación/genética , Microambiente TumoralRESUMEN
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.