Tuberous sclerosis complex (TSC) is a rare genetic disorder caused by pathogenic variants in the TSC1 or TSC2 genes. Apart from multisystem physical manifestations, most individuals with TSC experience TSC-associated neuropsychiatric disorders (TAND). Little is known about how TAND severity changes over time and what factors may predict these changes. Preliminary data suggest the presence of differential TAND severity trajectories. Caregiver well-being may act as a mediator of TAND severity, and a well-being intervention designed for caregivers of children with developmental disabilities may improve caregiver well-being.

The study aims are to (1) examine longitudinal trajectories of TAND severity in a large sample of individuals with TSC and to examine potential predictors of differential trajectories, (2) evaluate the association between caregiver well-being characteristics, TAND severity, and severity trajectories, and (3) adapt and evaluate the feasibility, acceptability, and potential efficacy of a brief, online group-based well-being intervention for family caregivers.

For the first 2 aims, 500 individuals with TSC or their caregivers will be recruited in an accelerated longitudinal design to document TAND severity at 5 time points over 12 months via a web-based app. At each time point, participants will complete demographic, TSC characteristics, intervention, and well-being questionnaires. Data will be analyzed using latent class mixed and multinomial regression modeling (aim 1) and structural equation and mediation modeling (aim 2). Participatory methods will be used to adapt an existing caregiver well-being intervention for the TSC community (aim 3). Thirty caregivers will be invited to participate in the adapted group-based online well-being intervention.

This study was funded from July 2024 (HT94252410790 and HT94252410791), and ethics approvals were obtained from the University of Cape Town (July 2024), Vrije Universiteit Brussel (November 2024), and the Department of Defense Office of Human Research Oversight (December 2024). The TAND Toolkit app was adapted for longitudinal data collection (aims 1 and 2). Recruitment started in December 2025 and will continue until 500 participants are enrolled (anticipated December 2026). Primary outputs are expected by July 2028. For aim 3, experiential and adaptation workshops were completed in June 2025, the pilot intervention was delivered in November 2025, and data collection will continue till May 2026. Outputs are expected by December 2026.

Identification of differential longitudinal TAND trajectories and their correlates will stimulate research in TSC and generate evidence for the self-report quantified TAND checklist as a clinical outcome measure. Understanding the association between caregiver well-being and TAND severity will provide support for targeted well-being interventions. A successful pilot trial will provide preliminary data for larger-scale clinical trials, with the potential to support caregivers and improve TAND outcomes. Together, the findings from the study will help close the gap in interventions for TAND.

ClinicalTrials.gov NCT06879665; https://clinicaltrials.gov/study/NCT06879665.

DERR1-10.2196/91726.

Chemotherapy-induced peripheral neurotoxicity (CIPN) is the most common neurologic complication of cancer treatment. Sarcopenia, characterized by muscle mass loss, has been associated with treatment-related toxicity, but its association with CIPN remains unclear. We aimed to assess the association of pretreatment sarcopenia with the development of CIPN.

A single-center, prospective observational study at the Hospital Universitari de Bellvitge-Institut Català d'Oncologia was conducted on patients with cancer scheduled to receive brentuximab vedotin (BV), oxaliplatin (OXA), or paclitaxel (PTX). A pretreatment CT or PET-CT (≤30 days) was required. Sarcopenia was assessed using the skeletal muscle index at the third lumbar vertebra. Patients were evaluated before (T0) and after (T1) chemotherapy treatment. All patients were assessed using the Total Neuropathy Score-clinical version (TNSc) and Common Terminology Criteria for Adverse Events (CTCAE) at T0 and T1. Nerve conduction studies (NCS) and blood measurements (neurofilament [NfL], myostatin, and albumin) were conducted at the same time points. Clinically relevant (CR) CIPN was defined as CTCAE grade ≥2. Associations were analyzed using multivariate logistic regression.

A total of 105 patients (47.6% female; median age 55 years) were studied. Before treatment (T0), 47.6% of patients had sarcopenia. CIPN occurred in 84.7% of patients, with CR-CIPN observed in 39% (33.3% grade 2; 5.7% grade 3). At T1, NfL and TNSc scores increased significantly, while distal sensory and motor NCS amplitudes decreased. Sarcopenia was more common in patients developing CR-CIPN (61.9% vs 38.1%; p = 0.028). Multivariate analysis identified sarcopenia as an independent risk factor of CR-CIPN (odds ratio [OR] 2.5; 95% CI 1.07-5.83; p = 0.033), and patients receiving microtubule-based agents-PTX (OR 0.17, 95% CI 0.03-0.92, p = 0.04) or BV (OR 0.37, 95% CI 0.15-0.90, p = 0.027)-had lower odds of CR-CIPN compared with those receiving OXA.

Pretreatment sarcopenia is associated with 2.5-fold higher odds of moderate-to-severe CIPN. Assessing sarcopenia using routine prechemotherapy imaging techniques can help identify individuals at higher risk of CR-CIPN.

Cancer clinical trials are essential for advancing therapeutic innovations; however, patient enrollment remains a persistent challenge globally. Understanding the attitudes and willingness of patients with cancer to participate in clinical trials is critical for improving recruitment strategies. While previous studies have explored barriers and facilitators, few have integrated multiple data sources or used emerging analytical approaches, such as large language models (LLMs), to capture the multidimensional nature of patient decision-making. Furthermore, limited research has examined these perspectives within the Chinese health care context, where cultural, economic, and systemic factors may uniquely influence participation decisions.

This study aimed to examine the attitudes and willingness of patients with cancer to participate in drug clinical trials in China by (1) identifying key themes influencing patients' decision-making processes, (2) comparing thematic findings derived from investigator-led qualitative analysis with those generated by 2 LLMs (Gemini Pro 2.5 and DeepSeek R1), and (3) evaluating the complementary value of hybrid analytical approaches in qualitative health research.

A multistage qualitative study was conducted using 2 data sources: semistructured face-to-face interviews with patients with cancer (n=11) from a tertiary hospital in Shanghai and publicly available comments from 2 Chinese online health communities (Zhihu and Yuaigongwu). Of the 3148 initial comments, 219 met the inclusion criteria after systematic screening. Three parallel analytical approaches were used: investigator-led thematic analysis, Gemini Pro 2.5-assisted analysis, and DeepSeek R1-assisted analysis. Both LLMs received identical, structured prompts. Thematic outputs were systematically compared to identify convergent and divergent findings.

The 3 analytical methods jointly identified 7 core themes: treatment selection, financial burden relief, uncertain therapeutic efficacy, uncertainty regarding control groups, lack of cognition, misconceptions, and physician trust. Substantial thematic overlap was observed between investigator-led and DeepSeek R1 analyses (8 shared themes, including family-involved decisions and service-related factors) and between investigator-led and Gemini Pro 2.5 analyses (3 shared themes, including regional disparities and autonomous decision-making). Method-specific themes included recognition of medical value (investigator only), insufficient clinical data (DeepSeek R1 only), and lack of information resource (Gemini Pro 2.5 only). These findings highlight the multidimensional nature of trial participation decisions, encompassing treatment expectations, economic considerations, risk perceptions, cognitive factors, trust relationships, and structural barriers to accessibility.

The willingness of patients with cancer to participate in clinical trials is shaped by a complex interplay of treatment expectations, economic considerations, risk perceptions, cognitive factors, and relational dynamics. The hybrid analytical framework demonstrated complementary strengths: human analysis provided contextual depth and cultural sensitivity, while LLMs offered efficiency and identified additional thematic dimensions. These findings underscore the need for patient-centered communication strategies, transparent trial information, and culturally tailored recruitment approaches. Future research should expand sample diversity and further validate the use of LLMs in qualitative health research.

Patients with advanced cancer participating in phase I clinical trials often face limited survival while experiencing significant symptom burden. Despite evidence supporting early palliative care integration alongside active cancer treatment to improve quality of life, the role of palliative care in phase I trials remains unclear.

To explore perspectives of patients, informal caregivers, and healthcare providers on quality of life and palliative care in phase I oncology trials, including perceived benefits, barriers, and integration strategies.

We conducted a multi-perspective qualitative interview study across three Belgian university hospitals from September 2022 to July 2024, using convenience and snowball sampling. The semi-structured interviews were analyzed using qualitative content analysis. Ethical approval was gained from the relevant institutions.

Participants included sixteen patients, five informal caregivers, twelve phase I staff, six oncologists, five palliative care specialists, and four general practitioners. Patients generally reported positive experiences with trial participation, often viewing it as a final opportunity that provided hope and structure. However, quality of life support was inconsistently addressed and largely reactive. While patients reported feeling supported, non-trial providers and caregivers noted limited person-centered care. No systematic approach for introducing palliative care was in place. Palliative care was rarely discussed, hindered by misconceptions such as equating palliative care with terminal care, reluctance from patients and clinicians, and lack of communication between providers. Participants suggested the introduction of routine yet flexible palliative care conversations, as well as improved communication between providers, as strategies towards integration.

Despite recognized care needs, palliative care is not systematically integrated in phase I oncological trials. Quality of life remains a secondary concern. Integrating palliative care in a structured yet flexible manner could support more holistic, patient-centered care. These findings underscore the need to normalize palliative care as a complementary component of phase I oncological trials.

Esophageal cancer surgery frequently leads to post-extubation atelectasis. The efficacy of high-flow nasal cannula (HFNC) oxygen therapy in the post-anesthesia care unit (PACU) for these patients remains unvalidated.

This randomized controlled trial enrolled 100 patients after esophageal cancer surgery, allocated to a control group (conventional oxygen therapy at 5 L/min, n = 50) or an HFNC group (heated and humidified oxygen at 40% FiO₂, 37°C, 10 L/min, n = 50). The primary outcome was the lung ultrasound score at pre-extubation (T1), 30 minutes post-intervention (T2), and before PACU discharge (T3). The secondary outcome measures included PaO2/FiO2, hypoxemia, incidence of pulmonary complications within 7 days post-intervention.

The reduction in lung ultrasound score from T1 to T3 was significantly greater in the HFNC group (mean change: -5.6 points) than in the control group (mean change: -1.4 points), with a between-group difference of -4.2 points (95% CI: -4.7 to -3.7; P < 0.001). At T2 and T3, lung ultrasound score were significantly lower in the HFNC group (T2: 8.7 ± 1.2 vs. 12.7 ± 1.5; T3: 7.6 ± 1.0 vs. 11.7 ± 1.1; both P < 0.001). The HFNC group also had significantly higher PaO₂/FiO₂ ratios at T2 (325 ± 38 vs. 295 ± 35 mmHg) and T3 (340 ± 32 vs. 305 ± 30 mmHg) (both P < 0.001), and a lower incidence of hypoxic events (12.0% vs. 28.0%, P = 0.046) and 7-day postoperative pulmonary complications (10.0% vs. 36.0%, P = 0.002). No significant differences were found in sedation scores or hemodynamic parameters.

The utilization of HFNC oxygen therapy in the PACU may provide a safe and effective means of mitigating the severity of atelectasis subsequent to extubation, enhancing oxygenation levels, and decreasing the incidence of early pulmonary complications in patients who have undergone surgical interventions for esophageal cancer.

This study investigated whether elevated ward noise aggravates cancer-related fatigue (CRF) in lung cancer patients.

This retrospective single-centre study allocated 86 patients who underwent thoracoscopic lobectomy (March 2021-June 2022) into high- and low-noise groups (43 patients each) in accordance with postoperative ward decibel levels. Data on CRF (Visual Analogue Scale [VAS] and Brief Fatigue Inventory [BFI]), sleep quality (Athens Insomnia Scale [AIS]), psychological status (Hospital Anxiety and Depression Scale), quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30), clinical recovery and satisfaction were collected 2 weeks postsurgery. Multivariable linear regression analysed the noise-CRF association, adjusting for age, gender, body mass index, and clinical stage.

The high-noise group had a significantly higher noise level (A-weighted equivalent continuous sound level: 58.2 ± 2.1 dB vs. 50.8 ± 2.4 dB) and exhibited more severe CRF (BFI: 6.8 ± 1.5 vs. 5.2 ± 1.7, P < 0.001; VAS: 7.5 ± 1.3 vs. 5.9 ± 1.6, P < 0.001), poorer sleep (AIS: 10.2 ± 2.8 vs. 6.1 ± 2.9), higher anxiety/depression, poorer quality of life, delayed ambulation (28.5 ± 6.1 h vs. 23.2 ± 5.8 h), longer hospital stays (7.5 ± 1.4 days vs. 6.4 ± 1.2 days), and lower satisfaction than the low-noise group. After adjustment, higher A-weighted equivalent continuous sound level was independently associated with higher BFI ( β  = 0.380) and VAS scores ( β  = 0.420).

High ward noise independently predicts increased CRF, suggesting noise reduction as a key management approach.

A significant proportion of patients with leukemia experience anxiety disorders, which negatively affect their quality of life and sense of hope. Music therapy, a noninvasive and cost-effective treatment, may help regulate emotions, reduce anxiety, and alleviate pain.

This study examined the effects of music therapy as an adjunct treatment on mood and hope levels in patients with leukemia and anxiety disorders.

We analyzed 86 adult patients with leukemia and anxiety admitted between August 2023 and October 2024. Patients were divided into a standard treatment group ( n  = 43, the conventional treatment) and a music group ( n  = 43, the conventional treatment plus 12 music therapy sessions over 4 weeks, each lasting 60 min, based on mindfulness). General data, Medical Coping Modes Questionnaire (MCMQ, coping styles), Profile of Mood States (POMS, mood states), Herth Hope Index (HHI, hope levels), Hamilton Anxiety Rating Scale (HAMA, anxiety), World Health Organization Quality of Life Measurement Scale Brief Form (WHOQOL-BREF, quality of life), and Piper Fatigue Scale (PFS, fatigue) were compared at admission ( T1 ) and 1 month later ( T2 ).

At T1 , no significant differences existed between the groups ( P > 0.05). At T2 , the music group showed reduced MCMQ avoidance/resignation scores ( P < 0.05), increased POMS positive mood, diminished negative mood ( P < 0.05), and elevated HHI scores ( P < 0.05). Additionally, their HAMA, PFS, and WHOQOL-BREF scores improved significantly ( P < 0.05).

In this study, we found that self-reported levels of hope and mood improved in patients with leukemia and anxiety disorder following music therapy treatment. Further studies are needed to optimize treatment timing and methods to improve efficacy.

To evaluate the effects of music relaxation training combined with hierarchical nursing management on vomiting symptoms and psychological resilience in patients with chemotherapy-induced nausea and vomiting (CINV).

In this retrospective study, 142 patients with CINV treated between June 2023 and January 2025 were stratified into three groups: the control group ( n  = 46, routine multidisciplinary care), the observation group 1 ( n  = 47, additional hierarchical nursing) and the observation group 2 ( n  = 49, hierarchical nursing plus music relaxation training). All care continued over three chemotherapy cycles. Outcomes were assessed by using the Index of Nausea, Vomiting and Retching (INVR), Connor-Davidson Resilience Scale (CD-RISC), State Anxiety Inventory (S-AI), Cancer Fatigue Scale (CFS), Functional Living Index-Emesis (FLIE) and compared pre- and post-intervention. Data were analysed using the chi-squared test, t -test and one-way analysis of variance.

After care, observation groups 1 and 2 showed superior outcomes to the control group across all measures. Specifically, INVR subscale scores (nausea, vomiting and retching) were significantly lower in the observation groups than in the control group, with the observation group 2 demonstrating further reductions compared with the observation group 1 (e.g., nausea: 2.81 vs. 3.87; P < 0.05). All CD-RISC dimension scores were higher in the observation groups than in the control groups and again were highest in the observation group 2 (e.g., optimism: 11.42 vs. 9.64; P < 0.05). Similarly, S-AI and CFS scores were lower in the observation groups, with the observation group 2 showing the lowest scores amongst all groups (S-AI: 29.46 vs. 34.25; CFS: 27.97 vs. 31.24; P < 0.05). Finally, FLIE nausea and vomiting subscale scores were higher in the observation groups than in the control group, with the observation group 2 scoring highest amongst groups (nausea: 56.64 vs. 53.46; vomiting: 53.48 vs. 51.37; P < 0.05).

Integrated music relaxation training and hierarchical nursing may alleviate CINV symptoms, enhance psychological resilience, reduce anxiety and fatigue and improve quality of life.

This study aimed to examine the effects of an optimised environmental noise management protocol on sleep quality and fatigue levels in patients with colorectal cancer.

A retrospective analysis was conducted. Patients admitted before the implementation of the optimised protocol (January 2023 to December 2023, receiving conventional noise management) were assigned to the conventional care group ( n  = 63). Those admitted after implementation (January 2024 to December 2024, receiving optimised environmental noise management) were assigned to the optimised management group ( n  = 64). A comparison was made between the two groups regarding noise decibel levels (daytime and nighttime), sleep quality (Pittsburgh Sleep Quality Index [PSQI]), fatigue (Cancer Fatigue Scale [CFS]) and comfort status (General Comfort Questionnaire [GCQ]).

The optimised management group demonstrated significantly lower noise decibel levels during daytime and nighttime compared with the conventional care group ( P < 0.05). Significantly reduced scores were observed in all PSQI domains and the global PSQI score in the optimised management group ( P < 0.05). Similarly, scores across all domains of the CFS and its total score significantly decreased in this group ( P < 0.05). Conversely, scores for all domains of the GCQ and its total score were significantly elevated in the optimised management group ( P < 0.05). Pearson correlation analysis revealed a significant positive correlation between noise decibel levels and PSQI ( r > 0, P < 0.05) and CFS scores ( r > 0, P < 0.05). A significant negative correlation was observed between noise decibel levels and GCQ scores ( r < 0, P < 0.05).

Implementing an optimised environmental noise management protocol can effectively reduce noise levels in patient care units, thereby improving sleep quality, reducing fatigue, and enhancing overall patient comfort during hospitalisation.

Percutaneous transhepatic biliary drainage (PTBD) is a well-established palliative intervention for patients with malignant biliary obstruction, yet outcomes remain heterogeneous across patient populations. A clear understanding of factors influencing survival and complications is essential for optimizing patient selection and procedural strategies.

To evaluate clinical and procedural predictors of outcome in a large single-center cohort of patients undergoing PTBD for malignant biliary obstruction.

This retrospective study included 383 consecutive patients, who underwent PTBD over a 9-year period at a tertiary referral center. Demographic parameters, underlying malignancy type, laboratory values, procedural details, and post-procedural complications were recorded. Survival outcomes were analyzed using Kaplan-Meier methods and multivariable regression models to identify independent predictors of mortality and complication-related outcomes.

Pancreatic cancer (41.5%) and cholangiocarcinoma (30.5%) were the most common etiologies. Post-procedural complications occurred in 33.7% of patients, led by cholangitis (17.8%), and overall, in-hospital mortality was 30.3%. For in-hospital mortality, total bilirubin (AUC: 0.613, P < 0.001), direct bilirubin (AUC: 0.610, P < 0.001), and WBC count (AUC: 0.597, P = 0.002) were significant predictors. The presence of complications (HR: 1.92) and specifically sepsis/septic shock (HR: 3.89) were strongly associated with increased mortality risk. Median in-hospital survival was 62 days, and it was significantly shorter in patients, who developed complications (49 vs. 82 days, P < 0.001).

PTBD remains an effective and indispensable palliative treatment for malignant biliary obstruction. However, patient outcomes are strongly influenced by baseline clinical status and post-procedural complications.