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Young adult cancer survivors (YACS) are at elevated risk for chronic insomnia, even years after completing treatment. In addition to potential health consequences, insomnia can interrupt social, educational, and vocational development just as they are trying to \"make up\" for time lost to cancer. Cognitive behavioral therapy for insomnia (CBTI) is recommended as first-line treatment for insomnia but remains largely unavailable to YACS due to several barriers (ie, shortage of trained providers, geographic limitations, financial limitations). Traditional CBTI has not been adapted to meet YACS' unique developmental and circadian challenges. To improve availability of effective behavioral insomnia treatment for this population, we developed the Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA), a low-intensity educational intervention delivered virtually online. In this phase 2 \"proof of concept\" trial, primary aims are to test the efficacy of STEP-YA to improve insomnia symptoms and mood in YACS and assess the utility of individualized coaching to improve treatment effects. A secondary aim will explore participant variables associated with clinically significant response to STEP-YA. This 2-arm randomized prospective trial will enroll 74 off-treatment YACS aged 20 years to 39 years with clinically significant insomnia. Each participant completes the STEP-YA intervention in a 1-on-1 synchronous online session led by a trained interventionist following a structured outline. The 90-minute intervention presents educational information on the development of insomnia after cancer and offers specific suggestions for improving insomnia symptoms. During the session, participants review the suggestions and develop a personalized sleep action plan for implementing them. After the session, participants are randomized to either the coaching condition, in which they receive 2 telephone coaching sessions, or the no-coaching condition, which offers no subsequent coaching. The Insomnia Severity Index (ISI) and the Profile of Mood States: Short Form (POMS-SF) are assessed at baseline and 4 and 8 weeks postintervention. Enrollment began in November 2022, with 28 participants currently enrolled. We anticipate recruitment will be completed in 2024. The primary endpoint is a change in ISI score from baseline to 8 weeks postintervention. The secondary endpoint is change in mood symptoms (POMS-SF) from baseline to 8 weeks postintervention. Change scores will be treated as continuous variables. Primary analyses will use ANOVA methods. A within-subjects analysis will examine if the STEP-YA intervention is associated with significant changes in insomnia and mood over time. A 2-way ANOVA will be used to evaluate the utility of coaching sessions to improve treatment effects. Chronic insomnia has significant negative effects on YACS' medical, educational, and psychological functioning. STEP-YA aims to address their needs; study results will determine if the intervention warrants future effectiveness and dissemination studies and if individualized coaching is necessary for adequate treatment response. ClinicalTrials.gov NCT05358951: https://clinicaltrials.gov/study/NCT05358951. DERR1-10.2196/52315.

Cancer survivors are at increased risk for chronic insomnia, even years after treatment completion. As insomnia is associated with a variety of long-term health consequences, access to insomnia treatment is critically important for the survivor population. Cognitive behavioral therapy for insomnia (CBTI) is the recommended first-line treatment for insomnia but remains largely unavailable to survivors. Treatment barriers include geographic limitations, a shortage of trained providers, and demanding treatment regimens. Designed with these limitations in mind, the Sleep Treatment Education Program (STEP-1) delivers components of CBTI in a low-intensity educational intervention delivered online. This is a phase II pilot randomized controlled trial. The primary aims are to test the efficacy of STEP-1 to improve (1) insomnia symptoms and (2) mood in cancer survivors compared to a control condition. The secondary aims will (1) explore participant factors associated with clinically significant response, (2) evaluate acceptability of the control intervention, (3) explore feasibility of delivering individualized coaching sessions for participants who do not have a significant response to STEP-1, and (4) describe participants' satisfaction with STEP-1 and suggestions for improvement. This 2-arm randomized controlled trial enrolled 70 off-treatment cancer survivors aged 40-89 years with clinically significant insomnia. Participants are randomized to receive either the STEP-1 intervention or control condition (relaxation education); interventions are delivered in one-on-one, synchronous, virtual videoconference sessions by trained interventionists. The STEP-1 intervention presents educational information on the development of insomnia after cancer and offers suggestions for improving insomnia symptoms based on the CBTI elements of sleep hygiene, stimulus control, and cognitive restructuring. With the interventionist, participants review the suggestions and develop a personalized sleep action plan for implementation. The relaxation education session provides information on the potential benefits of relaxation and how to independently access online relaxation exercises. The Insomnia Severity Index is used to measure insomnia symptoms, and the Profile of Mood States Short Form is used to measure mood at baseline and 4 and 8 weeks after intervention. The primary end point is change in the Insomnia Severity Index score at 8 weeks, and the secondary end point is change in mood symptoms (Profile of Mood States Short Form) at 8 weeks. This trial was funded in July 2022. Enrollment and data collection began in February 2023 and concluded in October 2024, with 70 participants enrolled. The analysis will begin in fall 2024, and the results are expected in winter 2025. Trial results will determine if STEP-1 effects go beyond those that could be attributed to placebo and other nonspecific treatment factors. Should results support the efficacy of STEP-1 to improve mood and insomnia symptoms, we anticipate developing efficacy and implementation trials of STEP-1 in larger and more diverse samples. ClinicalTrials.gov NCT05519982; https://clinicaltrials.gov/study/NCT05519982. DERR1-10.2196/60762.

PurposeCancer-related fatigue (CRF) is a common and challenging late effect for many cancer survivors. Clinical trials demonstrate robust placebo effects on CRF in blinded trials. Recently, open-label placebo (OLP) has been shown to improve a variety of symptoms in other populations. We conducted a randomized controlled trial to investigate the effect of OLP on CRF in cancer survivors, and to explore biologic and psychological correlates of placebo efficacy.MethodsForty cancer survivors (92.5% female; mean age 47.3 years) were randomized to OLP or no treatment control. OLP participants were prescribed two placebo tablets twice daily, for 3 weeks. All participants completed assessments at Baseline, Day 8, and Day 22. The primary endpoint was change in CRF (FACIT-F), and secondary outcomes included exercise frequency, mood, and quality of life. We examined whether personality characteristics or a genetic variation important in dopamine catabolism (catechol-O-methyltransferase; COMT) affected the placebo response.ResultsThe OLP group reported significantly improved CRF at both Day 8 (p = 0.005) and Day 22 (p = .02), while the control group did not (ps > .05). CRF improvement differed by COMT genotype, but was not associated with personality characteristics. Marginal improvements were noted in the placebo group for some secondary outcomes (exercise frequency and quality of life), but not in the control group.ConclusionsResults demonstrate that even when administered openly, placebos improve CRF in cancer survivors and dopaminergic systems may be associated with this response. This novel research has meaningful implications for the use of OLP in symptom management for cancer survivors.

Purpose Insomnia is commonly experienced by cancer survivors. Chronic insomnia is associated with significant physical and psychosocial consequences if not properly treated. Both the National Cancer Institute (NCI) and the National Comprehensive Cancer Network (NCCN) recommend the evaluation of sleep disturbances and evidence-based treatment of insomnia during routine survivorship care. To better understand current clinical practices, we conducted a survey of major cancer centers across the United States (US). Methods Adult survivorship programs at the 25 US cancer centers that are both NCI-designated comprehensive cancer centers and NCCN member institutions were surveyed about the evaluation and treatment of insomnia in their hospital. Results All institutions responded to the survey. Thirteen centers (56 %) reported screening <25 % of survivors for sleep disorders, and few clinicians providing survivorship care were well-prepared to conduct a proper sleep evaluation. Insomnia was most commonly treated with sleep hygiene, or pharmacotherapy, rather than cognitive-behavioral therapy. No program reported that >50 % of their survivors were receiving optimal insomnia-related care. A variety of methods to improve insomnia care were endorsed by respondents. Conclusions There is a clear need to improve the evaluation and treatment of insomnia for cancer survivors at institutions across the country. Cancer centers deemed a number of modalities relevant for improving provider confidence in addressing sleep challenges. Implications for cancer survivors To improve the quality of insomnia care for survivors, systematic interventions to increase standardized screening for sleep disorders, providing additional sleep medicine training for survivorship clinicians, and optimizing the role of sleep medicine specialists in the oncology setting should be considered.

Citation: Zhou ES, Michaud AL, Owens J, Recklitis CJ. Sleep in young-adult cancer survivors during the COVID-19 pandemic. J Clin Sleep Med . 2020;16(11):1991.

PurposeSexual dysfunction is one of the most prevalent and distressing treatment-related side effects for both male and female cancer survivors. Survivorship care guidelines recommend therapeutic sexual aids to help improve sexual problems. However, little is known about the availability of sexual aids and resources at cancer centers.MethodsTwenty-five comprehensive cancer centers affiliated with both the National Cancer Institute and the National Comprehensive Care Network were surveyed using the “mystery shopper” method to determine whether various types of sexual aids were available at the centers. Staffs from cancer center staff retail stores and patient boutiques were queried in separate telephone calls regarding the availability of these aids for and women.ResultsOf the 25 centers contacted, 23 (92%) responded about aids for men, and 22 (88%) responded about aids for women. Eighty-seven percent of the centers reported having no sexual aids available for men, and 72% of centers reported having no aids available for women. The most common advice given to mystery shoppers was a suggestion to use the internet. Only one center had numerous aids/resources for both men and women.ConclusionsThe large majority of cancer centers reported having no sexual aids or other sexual health resources available for men or women.Implications for Cancer SurvivorsResults underscore the widespread lack of resources to promote sexual health rehabilitation at major cancer centers, both for male and female survivors.

Introduction Cancer treatments are associated with many long-term health consequences. Insomnia is one of the most common. Though behavioral treatments for insomnia are effective, access is limited, especially at cancer centers. There is increasing interest in the implementation of stepped care models in the treatment of insomnia to potentially improve patient accessibility. We evaluated the efficacy of stepped insomnia treatment at a comprehensive cancer center. Methods 51 survivors (mean age=55 years) with elevated Insomnia Severity Index (ISI) scores (≥12) first received a single, hour-long sleep education session, and were reassessed 1-month later. Those continuing to report elevated ISI scores (≥12) were then offered a 3-session cognitive-behavioral treatment for insomnia (CBT-I) program that we previously demonstrated to be efficacious in cancer survivors. Participants were considered “treatment responders” if their ISI score improved by ≥6 points, and considered “remitted” if their post-treatment ISI score was <12. Mood was assessed with the Profile of Mood States (POMS). Results Following the single sleep education session, mean ISI scores improved (17.1 to 11.2; p<.001), with 45% of survivors responding to treatment and 41% remitted. Insomnia remission at this step was associated with lower insomnia severity and shorter duration of sleep problems at baseline. Of the 30 survivors (59%) with persistent insomnia after the single session, 14 (47%) participated in the 3-session CBT-I program. Participation in the second step of care was associated with interest in help for sleep problems, but not with any demographic, disease, or insomnia characteristics. Following the CBT-I program, mean ISI scores improved (16.9 to 8.8; p<.001), with 79% of survivors responding to treatment and 71% remitted. Mood improved significantly after both treatment steps (POMS total score; p<.001). Conclusion A stepped-care approach to treating cancer survivors’ insomnia can improve treatment accessibility for this underserved population. A sizable proportion of survivors can benefit from a low-intensity session that can be delivered by non-specialists. For those requiring more intensive care, an assessment of treatment interest can identify those likely to engage in therapy. Support (If Any) NCI R03CA201459-01.

Purpose Young adult cancer survivors (YACS) are at risk for secondary skin cancers but relevant interventions have not been validated in this population. To address this, we designed and tested SunSmart, a set of two educational videos designed to promote sun protection (SP). One provides SP education (Information) and the second combines SP education with content on negative appearance consequences of sun exposure (Information + Appearance). Methods One hundred ninety-three YACS (aged 18–35) were randomized to one of three groups: (1) Information, (2) Information + Appearance, or (3) control (sleep hygiene video). Participants completed measures on SP behaviors at baseline and follow-up. One-way ANCOVAs examined the intervention effect on follow-up SP behaviors controlling for baseline behaviors. Results The intervention did not significantly affect SP behaviors. However, secondary analyses limited to participants with the lowest baseline SP adherence found that the Information + Appearance group had significantly lower intentional sun exposure than the control group ( p = 0.02) at follow-up. Conclusions Contrary to hypotheses, the SunSmart intervention did not significantly improve sun protection in YACS, even when it presented information on negative appearance consequences of sun exposure. However, secondary analyses suggest SunSmart may be more effective in YACS with the lowest SP adherence. Future research is required to improve intervention efficacy with YACS (e.g., increased focus on secondary cancer risks). Implications for Cancer Survivors Despite their increased risk of secondary skin cancer, YACS in the current study reported significant sun exposure and inadequate SP. The need for development and validation of effective interventions to address these concerns remains.

Overview of infectious and non-infectious diseases in French Guiana in 2022Source of many myths, French Guiana represents an exceptional territory due to the richness of its biodiversity and the variety of its communities. The only European territory in Amazonia, surrounded by the Brazilian giant and the little-known Suriname, Ariane 6 rockets are launched from Kourou while 50% of the population lives below the poverty line. This paradoxical situation is a source of health problems specific to this territory, whether they be infectious diseases with unknown germs, intoxications or chronic pathologies.Some infectious diseases such as Q fever, toxoplasmosis, cryptococcosis or HIV infection are in common with temperate countries, but present specificities leading to sometimes different management and medical reasoning. In addition to these pathologies, many tropical diseases are present in an endemic and / or epidemic mode such as malaria, leishmaniasis, Chagas disease, histoplasmosis or dengue.Besides, Amazonian dermatology is extremely varied, ranging from rare but serious pathologies (Buruli ulcer, leprosy) to others which are frequent and benign such as agouti lice (mites of the family Trombiculidae) or papillonitis. Envenomations by wild fauna are not rare, and deserve an appropriate management of the incriminated taxon. Obstetrical, cardiovascular and metabolic cosmopolitan pathologies sometimes take on a particular dimension in French Guiana that must be taken into account in the management of patients. Finally, different types of intoxication are to be known by practitioners, especially due to heavy metals.European-level resources offer diagnostic and therapeutic possibilities that do not exist in the surrounding countries and regions, thus allowing the management of diseases that are not well known elsewhere.Thanks to these same European-level resources, research in Guyana occupies a key place within the Amazon region, despite a smaller population than in the surrounding countries. Thus, certain pathologies such as histoplasmosis of the immunocompromised patient, Amazonian toxoplasmosis or Q fever are hardly described in neighboring countries, probably due to under-diagnosis linked to more limited resources. French Guiana plays a leading role in the study of these diseases.The objective of this overview is to guide health care providers coming to or practicing in French Guiana in their daily practice, but also practitioners taking care of people returning from French Guiana.Panorama des pathologies infectieuses et non infectieuses de Guyane en 2022Source de nombreux mythes, la Guyane représente un territoire exceptionnel par la richesse de sa biodiversité et par la variété des communautés qui la composent. Seul territoire européen en Amazonie, entouré du géant brésilien et du méconnu Suriname, on y lance des fusées Ariane 6 depuis Kourou tandis que 50 % de la population vit en dessous du seuil de pauvreté. Cette situation paradoxale est source de problématiques de santé spécifiques à ce territoire, qu’il s’agisse de maladies infectieuses à germes méconnus, d’intoxications, ou de pathologies chroniques.Certaines maladies infectieuses telles que la fièvre Q, la toxoplasmose, la cryptococcose ou l’infection à VIH sont communes aux pays tempérés, mais présentent en Guyane des spécificités entraînant une prise en charge et un raisonnement médical parfois différents. Parallèlement à ces pathologies, de nombreuses maladies tropicales sont par ailleurs présentes sur un mode endémique et / ou épidémique telles que le paludisme, la leishmaniose, la maladie de Chagas, l’histoplasmose ou la dengue.De plus, la dermatologie amazonienne est extrêmement variée, allant de pathologies rares, mais graves (ulcère de Buruli, lèpre), à d’autres fréquentes et bénignes telles que les poux d’agouti (acariens de la famille des Trombiculidae) ou la papillonite. Les envenimations par la faune sauvage ne sont pas rares, et méritent une prise en charge appropriée au taxon incriminé. Les pathologies obstétricale, cardiovasculaire et métabolique cosmopolites prennent parfois en Guyane une dimension particulière à prendre en compte dans la prise en charge des patients. Enfin, différents types d’intoxication sont à connaître par les praticiens, notamment aux métaux lourds.Les ressources de niveau européen offrent des possibilités diagnostiques et thérapeutiques inexistantes dans les pays et régions des environs, permettant ainsi la prise en charge de maladies peu connues ailleurs.Du fait de ces mêmes ressources de niveau européen, la recherche en Guyane occupe une place clé au sein de la région amazonienne, malgré une population moins nombreuse que dans les pays alentour. Ainsi, certaines pathologies telles que l’histoplasmose du patient immunodéprimé, la toxoplasmose amazonienne ou la fièvre Q ne sont pratiquement pas décrites dans les pays voisins, probablement du fait d’un sous-diagnostic lié à des ressources plus limitées. La Guyane joue ainsi un rôle moteur dans l’étude de ces pathologies.L’objectif de ce panorama est d’orienter les soignants venant ou exerçant en Guyane dans leur pratique quotidienne, mais également les praticiens prenant en charge des personnes au retour de Guyane.

Most patients treated with immune checkpoint blockade (ICB) do not have durable treatment responses. Therefore, there is a critical need to identify early non-invasive biomarkers of response. We performed plasma proteomic analysis (>700 proteins) at three timepoints on 174 metastatic melanoma patients treated with ICB. We leverage independent training and testing cohorts to build a predictor of immunotherapy response that outperforms several tissue-based approaches. We found 217 differentially expressed proteins between ICB responders (R) and non-responders (NR), including a co-regulated module of proteins enriched in certain NR patients. By analyzing single-cell RNA-sequencing data of tumor biopsies from 32 patients, we dissected the relative contribution of cells in the tumor to proteins in circulation. The majority of proteins in the co-regulated NR module derived from tumor and myeloid cells. Amongst myeloid cells, we identified a subset of tumor-associated macrophages (TAMs) with a suppressive phenotype that expressed high levels of the co-regulated NR module, thus suggesting they are key drivers of non-response signatures. Together, our data demonstrates the utility of plasma proteomics in biomarker discovery and in understanding the biology of host response to tumors. Competing Interest Statement AM has served a consultant/advisory role for Third Rock Ventures, Asher Biotherapeutics, Abata Therapeutics, Flare Therapeutics, venBio Partners, BioNTech, Rheos Medicines and Checkmate Pharmaceuticals, is an equity holder in Asher Biotherapeutics and Abata Therapeutics, and has a sponsored research agreement with Bristol-Myers Squibb and Olink Proteomics. RWJ. is a member of the advisory board for and has a financial interest in Xsphera Biosciences Inc., a company focused on using ex vivo profiling technology to deliver functional, precision immune-oncology solutions for patients, providers, and drug development companies. The interests of RWJ were reviewed and are managed by Massachusetts General Hospital and Partners HealthCare in accordance with their conflict-of-interest policies. SJK has served a consultant/advisory role for Astellas, Daiichi-Sankyo, Merck, Bristol Myers Squibb, Eli Lilly, Sanofi-Aventis, Natera, and AstraZeneca. SJK reports stock ownership in Turning Point Therapeutics. All other authors have no disclosures. RJS has served as a consultant/advisory role for BMS, Merck, Pfizer and Novartis. KTF serves on the Board of Directors of Clovis Oncology, Strata Oncology, Kinnate, Checkmate Pharmaceuticals, and Scorpion Therapeutics; Scientific Advisory Boards of PIC Therapeutics, Apricity, Tvardi, ALX Oncology, xCures, Monopteros, Vibliome, and Soley Therapeutics, and is a consultant to Takeda, Novartis and Transcode Therapeutics. NH has sponsored research agreements with BMS, holds equity in BioNTech, and is a consultant for Related Sciences. GMB has sponsored research agreements with Olink Proteomics, InterVenn Biosciences, Palleon Pharmaceuticals. GMB is on scientific advisory boards for Merck, Novartis, Nektar Therapeutics, Iovance, and Ankyra Therapeutics, and consults for Merck and Ankyra Therapeutics.