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The aim in radiotherapy treatment planning is to have sufficient target coverage and as low a dose to the Organs at Risk (OARs) as possible, adhering to the relevant guidelines. A high and consistent radiotherapy plan quality is vital when treatment plans are used as the foundation for patient selection in clinical trials. Proton therapy, being a substantially newer treatment modality than conventional photon therapy, is at risk of having a steeper learning curve in treatment planning. This inequality is important to investigate in a clinical study comparing the two, as this could influence the trial results. This study aims to evaluate the development of radiotherapy treatment plan quality for head and neck cancer patients receiving photon and proton therapy over time in the context of the DAHANCA 35 trial. From May 2019 to June 2023,189 patients were included in the ongoing DAHANCA 35 trial, with 63 patients in the pilot phase and 126 in the subsequent randomisation phase. In the pilot phase, all included patients were offered proton treatment, and in the randomisation phase, patients were randomised 1:2 (photon:proton). Patients were first seen at a local treatment centre, where a photon and comparative proton plan were prepared. If patients were offered proton treatment, a new clinical proton plan was made at the proton treatment centre and subsequently used for treatment. This study analysed 189 photon plans, 189 comparative proton plans, and 140 clinical proton plans. The treatment plans were prepared conforming to the DAHANCA guidelines [1] to ensure the clinical relevance of all treatment plans The plan quality was assessed separately for photon plans, comparative proton plans, and clinical proton plans in three time intervals. The mean dose was investigated individually for 13 OARs relevant for head and neck cancer: oesophagus, glottic larynx, supraglottic larynx, mandible, extended oral cavity, left and right parotid glands, upper-, middle-, and lower pharyngeal constrictor muscles, left and right submandibular glands, and thyroid gland. Furthermore, treatment plan quality was analysed using a new metric called Normalised Toxicity Index (NTI), calculated as a normalised average of the mean dose to the OARs compared to the threshold mean dose recommended by the DAHANCA guidelines. An NTI > 1 indicated that the OARs, on average, received a dose higher than the recommended thresholds, and an NTI < 1 indicated that the OARs received a dose below the thresholds. Hence, a lower NTI indicated better plan quality concerning OAR doses. The Kruskal-Wallis test was used to investigate a potential difference in the intervals for mean dose and NTI for each treatment type. The significance level was Bonferroni adjusted to account for multiple testing. The three time intervals were defined with 63 patients in the pilot phase constituting one interval (Pilot phase), the subsequent 64 patients from the randomisation phase in the next interval (Randomisation 1), and the remaining 62 patients from the randomisation phase in the third interval (Randomisation 2). The periods were 22 months for the Pilot phase, 19 months for Randomisation 1, and 14 months for Randomisation 2. Across the 13 OARs, the mean dose to individual OARs did not show a general time-dependent change, except for the right parotid gland in the clinical proton plans. Figure 1 shows a box plot with samples overlaid for the mean dose to the extended oral cavity as an example of the OARs. [Display omitted] The NTI was not significantly different for the photon plans, comparative proton plans, and clinical proton plans in the three consecutive intervals, as shown in Figure 2. The median NTI for the clinical proton plans was 0.88 (interquartile range [0.70,1.00]) for the Pilot phase, 0.83 [0.75,0.89] for Randomization 1, and 0.79 [0.67,0.98] for Randomization 2. The plan quality of the clinical proton plans appears stable from this new NTI metric. [Display omitted] The analyses conducted in this study did not show a general time-dependent change in plan quality in any of the three types of plans. This could be caused by the nationally developed proton treatment planning template. A stable treatment plan quality can help ensure a consistent selection for clinical trials, thus providing transparency for analysis of the outcome of the trials. The plan quality will continuously be followed to ensure consistency. [ABSTRACT FROM AUTHOR]

Throughout a child's cancer treatment, health professionals (HPs) constitute an important source of support for the entire family. However, the understanding of their presence and essential attributes is unclear. This study explored HPs' presence and attributes in connecting with parents and identified facilitators and barriers for connectedness. This qualitative study was undertaken in a compassion paradigm, designed and guided by Heidegger's and Gadamer's philosophical concepts, and employed compassionate methods. Data were generated through ethnographic fieldwork (144 h), parent interviews (n = 16), and focus group interviews with parents of cancer survivors (n = 2) and HPs (n = 3). Inductive content analysis was utilised to analyse data. Many HP-parent contacts developed into close, genuine connections based on HPs' great commitment and ability to balance the act of closeness and distance. This involved HPs' sensitivity, humanity, humility, honest communication, genuine interest, and high clinical competencies; all promoting trust. Adapting and ending close relationships when approaching the end of treatment had little attention and was difficult for families, making some find ways of keeping contact on a personal level. Barriers disclosed were structural work changes, busyness, dishonest, poor, or lack of communication, and poor or lack of interpersonal chemistry. Human interconnectedness is powerful in long-term professional relationships and strengthens the parents. More research and clinical attention are needed to develop the understanding and help target actions toward building, maintaining, and ending relationships. Further, cultivating being present in the moment, through mindfulness and compassion, may support HPs in maintaining a receptive mind and a caring role. • Building relationships in care receives much attention, contrary to ending them. • Health professionals' attributes include sensitivity, humanity, humility, and honesty. • Barriers to connectedness include busyness and lack of communication and chemistry. • Human connectedness is powerful in professional relationships, benefitting parents. • Cultivating being present in the moment can support health professionals' presence. [ABSTRACT FROM AUTHOR]

Parents of children/adolescents with cancer are placed in a state of severe suffering due to serious concerns, fears, and radical daily life changes. Human support is an important source of support for successful coping. This study explored fundamental aspects of parents' daily, social, and personal life during their child's treatment to deepen our understanding of 'who' plays a significant role in supporting parents, and how, and to what extent this support is provided. This qualitative study was undertaken in a compassion paradigm, designed and guided by Heidegger's and Gadamer's philosophy and compassionate methods. Data were generated through ethnographic observations (144 h), focus group interviews (n = 2), and individual/couple interviews (n = 16) at two Danish hospitals. Inductive content analysis was used to analyse data. Overall, support from peers, health professionals, and social networks constituted significant sources of support. Especially peers and health professionals had a continuous support role, which was fundamental for establishing interpersonal closeness and relieving suffering. Sharing responsibilities between parents and among social networks seemed to ease the emotional and practical burden. However, to ensure effectiveness, social networks must be available, outreach, and responsive to needs. Moreover, parents disclosed little self-awareness and resources and options for self-care due to a combination of lack of awareness, time, and space in the hospitals. Safeguarding interpersonal and interparental understanding and closeness in parental care is essential. One way is building resilience and a broader human-to-human-based safety net around the family, including social networks and professional psychosocial support, advantageously using compassion. • A compassionate approach to qualitative research is applicable. • Professional and social networks are important and need to be present and active. • Providing support for parents at the hospital and those at home is necessary. • Shared responsibilities between parents and amongst relatives may ease the burden. • Creating a greater community sense using compassion may provide broader safety nets. [ABSTRACT FROM AUTHOR]

Lactate serves as an alternative energy fuel but is also an important signaling metabolite. We aimed to investigate whether oral lactate administration affects appetite-regulating hormones, slows gastric emptying rate, and dampens appetite. Ten healthy male volunteers were investigated on two separate occasions: 1) following oral ingestion of D/L-Na-lactate and 2) following oral ingestion of isotonic iso-voluminous NaCl and intravenous iso-lactemic D/L-Na-lactate infusions. Appetite was evaluated by questionnaires and ad libitum meal tests were performed at the end of each study day. Gastric emptying rate was evaluated using the acetaminophen test. Plasma concentrations of growth differential factor 15 (GDF15, primary outcome) increased following oral and iv administration of lactate (p < 0.001) with no detectable difference between interventions (p = 0.15). Oral lactate administration lowered plasma concentrations of acylated ghrelin (p = 0.02) and elevated glucagon like peptide-1 (GLP-1, p = 0.045), insulin (p < 0.001), and glucagon (p < 0.001) compared with iv administration. Oral lactate administration slowed gastric emptying (p < 0.001), increased the feeling of being "full" (p = 0.008) and lowered the "anticipated future food intake" (p = 0.007) compared with iv administration. Food intake during the ad libitum meal test did not differ between the two study days. Oral lactate administration has a direct effect on the upper gastrointestinal tract, affecting gut hormone secretion, motility and appetite sensations which cannot be mediated through lactate in the systemic circulation alone. These data suggest that compounds rich in lactate may be useful in the treatment of metabolic disease. NCT0429981 , https://clinicaltrials.gov/ct2/show/NCT04299815. [ABSTRACT FROM AUTHOR]

A small proportion of patients account for most of the healthcare costs. Previous studies of supportive interventions have several methodological limitations and results are mixed. This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov , NCT03628469). The main aim of the intervention is to reduce hospital admissions and improve quality of life at six months. A sample size of 4400 is needed and individuals with the highest risk of hospital admission in Denmark are invited by electronic communication and telephone to participate in a 1:1 randomized controlled trial. The intervention group receives one face-to-face start-up session followed by telephone sessions about individual goals regarding participants' knowledge, coping and need of healthcare. Quality of life was assessed with the mental health composite score of the SF-36v2 questionnaire. Primary analyses are done using the intention-to-treat principle. The trial has been approved by The Regional Committee on Health Research Ethics (SJ-677). Intervention nurses do not assume clinical responsibility for the participants and the intervention is an addition to the general healthcare services. The intervention is complex due to challenging skills and behaviors required by nurses, individual tailoring of the intervention, and interacting intervention components. The study therefore includes process evaluation. The research program comprises: 1. Development initiation, 2. Intervention effect, 3. Cost-effectiveness, 4. Organizational implementation, and 5. Participants' experiences. Inclusion to the trial began April 9th, 2018, was completed July 1st, 2019 and follow-up will be completed February 1st, 2020. [ABSTRACT FROM AUTHOR]