Value in care: The contribution of supportive care to value-based lung cancer services-A qualitative semistructured interview study.

INTRODUCTION: Despite significant advances in the management of lung cancer, patients continue to experience a high burden of unmet need impacting quality of life and outcomes of care. Achieving value-based health care, where investment is targeted to services that deliver optimal experience and outcomes of care relative to the cost of delivering that care, requires attention to what people value most in meeting their needs. To date there has been little attention to what matters most to patients with lung cancer (i.e., what they value) as a component of achieving value-based cancer care. This qualitative study was undertaken to investigate components of care valued by people with lung cancer in Australia. METHODS: This qualitative study used semistructured interviews with 23 people with lung cancer. Participants were recruited using a purposive sampling strategy from two metropolitan tertiary public health services. Data collected included demographic characteristics and patient perspectives regarding their priority concerns and components of care identified as most valuable in meeting their needs. Demographic characteristics of participants were analysed descriptively, and qualitative data were analysed thematically using Interpretive Description. RESULTS: Data analysis generated three key themes: valued components of care; benefits of receiving valued care components and consequences of missed opportunities for care. The components of care valued by patients reflect the core dimensions of cancer supportive care, with particular emphasis on ongoing opportunities for consultation (screening for unmet needs) and provision of person-centred information. The facilitation of trust between patients and their treating team, as a consequence of having these valued components evident in their care, was identified as a key characteristic of value-based care. CONCLUSIONS: This study has identified valued components of care described by people with lung cancer. Importantly, the care components identified have been proven to improve access to and coordination of care, and demonstrate the importance of integrating supportive care into care provision to achieve value-based cancer care. PATIENT OR PUBLIC CONTRIBUTION: This study was informed by perspectives of lung cancer patients who participated in semistructured interviews. We acknowledge that this contribution does not meet the criteria for patient and public involvement in research as defined by Health Expectations, but this study forms part of a larger program of cancer supportive care work being undertaken by this team, where comprehensive consumer engagement and co-design approaches are embedded in our work.

Development of consensus quality indicators for cancer supportive care: a Delphi study and pilot testing.

BACKGROUND: High quality supportive care is fundamental to achieve optimal health outcomes for people affected by cancer. Use of quality indicators provides comparative information for monitoring, management, and improvement of care within and across healthcare systems. The aim of this Australian study was to develop and test a minimum viable set of cancer supportive care quality indicators that would be feasible to implement and generate usable data for policy and practice. METHODS: A two-round, modified reactive Delphi process was employed firstto develop the proposed indicators. Participants with expertise in cancer control in Australia, the United Kingdom, and Canada rated their level of agreement on a 7-point Likert scale against criteria assessing the importance, feasibility, and usability of proposed indicators. Relative response frequencies were assessed against pre-specified consensus criteria and a ranking exercise, which delivered the list of proposed indicators. Draft indicators were then presented to a purposive sample of clinicial and health management staff via qualitative interviews at two acute care settings in Melbourne, Australia for feedback regarding feasibility. Desktop audits of online published health service policy and practice descriptions were also conducted at participating acute care settings to confirm health service data availability and feasibility of collection to report against proposed indicators. RESULTS: Sixteen quality indicators associated with the delivery of quality cancer supportive care in Australian acute healthcare settings met pre-specified criteria for inclusion. Indicators deemed 'necessary' were mapped and ranked across five key categories: Screening, Referrals, Data Management, Communication and Training, and Culturally Safe and Accessible Care. Testing confirmed indicators were viewed as feasible by clinical and health management staff, and desktop audits could provide a fast and reasonably effective method to assess general adherence and performance. CONCLUSIONS: The development of quality indicators specific to cancer supportive care provides a strong framework for measurement and monitoring, service improvement, and practice change with the potential to improve health outcomes for people affected by cancer. Evaluation of implementation feasibility of these expert consensus generated quality indicators is recommended.

Availability and accessibility of services to address financial toxicity described by Australian lung cancer patients and healthcare professionals.

PURPOSE: Although the financial burden and impact of a cancer diagnosis has been widely described in international literature, less understood is the availability and accessibility of services to ameliorate this need. This study reports the experiences of Australian lung cancer patients and health professionals delivering care, regarding factors that exacerbate and mitigate financial stress, and availability and accessibility of services to support people following a cancer diagnosis. METHODS: Qualitative semi-structured interviews with twenty-three lung cancer patients attending two metropolitan tertiary health services and eleven health professionals delivering care were undertaken during July-August 2021. RESULTS: Neither health service systematically screened for financial toxicity nor routinely provided information regarding potential financial impacts during consultations. Patients experienced lengthy delays in accessing welfare supports, provoking financial stress and worry. Health professionals reported limited resources and referral services to support patients with financial need; this was especially problematic for patients with lung cancer. They described its psychological impact on patients and their family members or carers and warned of its impact on ability to adhere to treatment. CONCLUSION: Available and accessibility of services addressing financial toxicity in Australian lung cancer patients is inadequate. Although financial stress is a common, distressing problem, health professionals feel hampered in their ability to help due to limited service availability. Left unaddressed, financial toxicity can impact treatment adherence, directly influencing health outcomes, and increase risk of poverty, amplifying social inequities. Findings highlight opportunity for actionable interventions like financial consent and routine screening and discussion of financial toxicity across care pathways.

Chemotherapy-induced thrombocytopenia in Ewing sarcoma: Implications and potential for romiplostim supportive care.

BACKGROUND: Maintaining dose-dense, interval-compressed chemotherapy improves survival in patients with Ewing sarcoma but is limited by myelosuppression. Romiplostim is a thrombopoietin receptor agonist that may be useful in the treatment of chemotherapy-induced thrombocytopenia (CIT). METHODS: Patients aged between 3 and 33 years with Ewing sarcoma from 2010 to 2020 were reviewed. CIT was defined as a failure to achieve 75,000 platelets per microliter by day 21 after the start of any chemotherapy cycle. Fisher's exact test was used for univariate analysis and Pearson's correlation coefficient was used for the association between continuous variables. RESULTS: Twenty-seven out of 42 patients (64%) developed isolated CIT, delaying one to four chemotherapy cycles per patient. CIT occurred during consolidation therapy in 24/27(88.9%) and with ifosfamide/etoposide cycles in 24/27 (88.9%). Univariate analysis failed to identify risk factors for CIT. The use of radiation approached significance (p-value = .056). Ten patients received romiplostim. The median starting dose was 3 µg/kg (range 1-5). Doses were escalated weekly by 1-2 to 4-10 µg/kg and continued throughout chemotherapy. A higher romiplostim dose was associated with a higher change in average platelet counts from baseline, r = .73 (p = .04). No romiplostim-related adverse events were identified aside from mild headache. CONCLUSIONS: CIT is the primary reason for the inability to maintain treatment intensity in Ewing sarcoma. The concurrent use of romiplostim with chemotherapy was safe and feasible, and efficacy was associated with higher romiplostim doses.

Distress experienced by lung cancer patients and their family caregivers in the first year of their cancer journey.

OBJECTIVES: Diagnosis of cancer is emotionally threatening not only for patients but also for their family caregivers (FC) who witness and share much of the illness experience. This study compares distress experienced by lung cancer patients and their FC during the year following the diagnosis. METHODS: A prospective cohort study of 206 patients recently diagnosed with inoperable lung cancer (participation rate 79.5%) and 131 FC (participation rate 63.6%) was conducted in an ambulatory oncology clinic in Quebec City (Canada). They completed validated questionnaires regarding their personal and psychological characteristics (Hospital and Anxiety Depression Scale-HADS), in the first months after the diagnosis of lung cancer and after 6 and 12 months. Univariate, bivariate, and linear mixed models were conducted to compare patient and FC distress. RESULTS: At baseline, 7.8% of patients reported distress (HADS total score >15) and their mean distress score was 7.0 ± 4.9 (range 0-42). In contrast, 33.6% of FC presented significant distress and their mean distress score was 12.0 ± 7.2 (P < 0.0001). Proportions of patients and FC with distress remained relatively stable at 6 and 12 months, and at every time point, FC reported higher levels of distress compared to their relative with cancer (P < 0.0001). Comparable trends were found when looking at the mean scores of distress, anxiety, and depression throughout the study. SIGNIFICANCE OF RESULTS: Being diagnosed with lung cancer and going through its different phases seems to affect more FC than patients. The psychological impact of such diagnosis appears early after the diagnosis and does not significantly change over time. These findings reinforce the importance for oncology teams, to include FC in their systematic distress screening program, in order to help them cope with their own feelings and be able to play their role in patient support and care throughout the cancer journey.

Engagement in an Interactive App for Symptom Self-Management during Treatment in Patients With Breast or Prostate Cancer: Mixed Methods Study.

BACKGROUND: Using mobile technology for symptom management and self-care can improve patient-clinician communication and clinical outcomes in patients with cancer. The interactive app Interaktor has been shown to reduce symptom burden during cancer treatment. It includes symptom assessment, an alert system for contact with health care professionals, access to self-care advice, and visualization of symptom history. It is essential to understand how digital interventions operate; one approach is to examine engagement by assessing usage and exploring user experiences. Actual usage in relation to the intended use-adherence-is an essential factor of engagement. OBJECTIVE: This study aimed to describe engagement with the Interaktor app among patients with breast or prostate cancer during treatment. METHODS: Patients from the intervention groups of two separate randomized controlled trials were included: patients with breast cancer receiving neoadjuvant chemotherapy (n=74) and patients with locally advanced prostate cancer receiving treatment with radiotherapy (n=75). The patients reported their symptoms daily. Sociodemographic and clinical data were obtained from baseline questionnaires and medical records. Logged data usage was retrieved from the server and analyzed descriptively and with multiple regression analysis. Telephone interviews were conducted with patients about their perceptions of using the app and analyzed using content analysis. RESULTS: The median adherence percentage to daily symptom reporting was 83%. Most patients used the self-care advice and free text message component. Among the patients treated for breast cancer, higher age predicted a higher total number of free text messages sent (P=.04). Among the patients treated for prostate cancer, higher age (P=.01) and higher education level (P=.04), predicted an increase in total views on self-care advice, while higher comorbidity (P=.004) predicted a decrease in total views on self-care advice. Being married or living with a partner predicted a higher adherence to daily symptom reporting (P=.02). Daily symptom reporting created feelings of having continuous contact with health care professionals, being acknowledged, and safe. Being contacted by a nurse after a symptom alert was considered convenient and highly valued. Treatment and time-related aspects influenced engagement. Daily symptom reporting was perceived as particularly meaningful at the beginning of treatment. Requests were made for advice on diet and psychological symptoms, as well as for more comprehensive and detailed information as the patient progressed through treatment. CONCLUSIONS: Patient engagement in the interactive app Interaktor was high. The app promoted patient participation in their care through continuous and convenient contact with health care professionals. The predictive ability of demographic variables differed between patient groups, but higher age and a higher educational level predicted higher usage of specific app functions for both patient groups. Patients' experience of relevance and interactivity influenced their engagement positively.

Comparison of perceptions of unmet supportive care needs between cancer patients and their oncologists.

PURPOSE: The prevalence of cancer in the Middle East is increasing and predicted to nearly double by 2030. In the United Arab Emirates (UAE), cancer ranks as the third leading cause of death. Yet, there are limited data describing the needs of cancer patients in the region. The purpose of this study is to compare cancer patients' reports of unmet supportive care needs with the perceptions of their oncologists. METHODS: A cross-sectional survey of cancer patients and their oncologists, using an Arabic translation of the short form of the Supportive Care Needs Survey (SCNS-SF34), was conducted at a major oncology center in the UAE between December 2014 and March 2017. Descriptive statistics and McNemar test were calculated to determine differences in unmet need responses between oncologists and patients. RESULTS: Nine physicians (100%) and 210 of 268 (78.3%) patients completed the questionnaire. Oncologists accurately assessed the level of unmet physical needs of their patients, but significantly underestimated unmet psychological supportive care needs of the patients. Male patients expressed significantly lower (p < 0.05) physical and psychological unmet needs, compared to female patients. CONCLUSION: Our findings reveal a general concordance between physician and patient perspectives of unmet supportive care needs. This is reassuring as physician perceptions impact the care patients receive. We present multifaceted supportive care strategies for oncology patients in the region.

Practice insights on patient care-management overview for chemoradiation toxic mucositis-guidelines, guideline-supported therapies and high potency polymerized cross-linked sucralfate (ProThelial).

AIM: To offer a practice insight for the management of chemoradiation toxic mucositis. METHOD: Review chemoradiation toxic mucositis, its pathobiology and breadth of symptom presentation. Review mucositis guidelines and guideline-supported anti-mucositis therapies. Offer guidance on guidelines and an abbreviated review of high potency cross-linked sucralfate for management of chemoradiation toxic mucositis. RESULT: There are six major mucositis guidelines but only one that is current and regularly updated. Guidelines from the Multinational Association Supportive Cancer Care suggest 14 interventions gleaned from controlled trials, 12 of which are off-label uses of therapies that offer statistically significant but incrementally beneficial outcomes. Several evidence-based limitations of guidelines are discussed. Data on high potency polymerized cross-linked sucralfate confirming complete prevention and rapid (2-3 days) elimination, sustained throughout cancer treatment is verified as high quality evidence in accordance to standards adopted by Agency for Healthcare Research and Quality. A 96-97% reduction in mucositis duration qualifies as a positive Glasziou treatment effect, which is discussed as an additional measure of evidence-based medicine. CONCLUSION: Statistically significant but fractional treatment effects of guideline-supported interventions are not likely to substantially alter the course of mucositis when it occurs nor completely prevent its onset. Complete prevention and rapid sustained elimination should be the goal, therefore high potency polymerized cross-linked sucralfate may be useful. Where guidelines fail, institution-based protocols led by oncology pharmacists could succeed. In an effort to eliminate toxic mucositis, enhance compliance to chemoradiation regimens, and improve survival, such protocols for practice may verify pharmacoeconomic benefits, if any, in using high potency polymerized cross-linked sucralfate to manage toxic mucositis.

Effects of an interactive mHealth innovation for early detection of patient-reported symptom distress with focus on participatory care: protocol for a study based on prospective, randomised, controlled trials in patients with prostate and breast cancer.

BACKGROUND: Cancer patients are predominantly treated as out-patients and as they often experience difficult symptoms and side effects it is important to facilitate and improve patient-clinician communication to support symptom management and self-care. Although the number of projects within supportive cancer care evaluating mobile health is increasing, few evidence-based interventions are described in the literature and thus there is a need for good quality clinical studies with a randomised design and sufficient power to guide future implementations. An interactive information and communications technology platform, including a smartphone/computer tablet app for reporting symptoms during cancer treatment was created in collaboration with a company specialising in health care management. The aim of this paper is to evaluate the effects of using the platform for patients with breast cancer during neo adjuvant chemotherapy treatment and patients with locally advanced prostate cancer during curative radiotherapy treatment. The main hypothesis is that the use of the platform will improve clinical management, reduce costs, and promote safe and participatory care. METHOD: The study is a prospective, randomised, controlled trial for each patient group and it is based on repeated measurements. Patients are consecutively included and randomised. The intervention groups report symptoms via the app daily, during treatment and up to three weeks after end of treatment, as a complement to standard care. Patients in the control groups receive standard care alone. Outcomes targeted are symptom burden, quality of life, health literacy (capacity to understand and communicate health needs and promote healthy behaviours), disease progress and health care costs. Data will be collected before and after treatment by questionnaires, registers, medical records and biomarkers. Lastly, participants will be interviewed about participatory and meaningful care. DISCUSSION: Results will generate knowledge to enhance understanding about how to develop person-centred care using mobile technology. Supporting patients' involvement in their care to identify problems early, promotes more timely initiation of necessary treatment. This can benefit patients treated outside the hospital setting in regard to maintaining their safety. CLINICAL TRIAL REGISTRATION: June 12 2015 NCT02477137 (Prostate cancer) and June 12 2015 NCT02479607 (Breast cancer).

Helsinn: 20 years in primary cancer supportive care.

Sergio Cantoreggi speaks to Henry Ireland, Commissioning Editor: Sergio Cantoreggi, PhD, is the Chief Scientific Officer and Global Head of Research and Development of the Helsinn Group, a mid-sized pharmaceutical company headquartered in Lugano, Switzerland, and focused on providing cancer supportive care solutions to oncology patients worldwide. Dr Cantoreggi has overall responsibility for all R&D activities of the Helsinn Group and has contributed to six major regulatory approvals of cancer supportive care agents in the USA, Europe and Japan. Dr Cantoreggi joined Helsinn Healthcare in 2000 as drug development scientist and was appointed Head of R&D in 2005. In 2010, he was promoted to his current role. From 1994 to 2000 he worked as toxicologist and regulatory scientist for Du Pont, Sandoz and Novartis. Prior to joining industry, Dr Cantoreggi completed a postdoctoral fellowship and earned a Master of Science degree in chemistry and a Doctoral degree in natural sciences with a thesis on the mechanism of chemical carcinogenesis from the Swiss Federal Institute of Technology in Zürich, Switzerland. Sergio Cantoreggi discusses Helsinn's role in cancer supportive care, describing current treatment options for patients, the company's pipeline and Helsinn's work in supporting the field as a whole.

The role of mobile technologies in health care processes: the case of cancer supportive care.

BACKGROUND: Health care systems are gradually moving toward new models of care based on integrated care processes shared by different care givers and on an empowered role of the patient. Mobile technologies are assuming an emerging role in this scenario. This is particularly true in care processes where the patient has a particularly enhanced role, as is the case of cancer supportive care. OBJECTIVE: This paper aims to review existing studies on the actual role and use of mobile technology during the different stages of care processes, with particular reference to cancer supportive care. METHODS: We carried out a review of literature with the aim of identifying studies related to the use of mHealth in cancer care and cancer supportive care. The final sample size consists of 106 records. RESULTS: There is scant literature concerning the use of mHealth in cancer supportive care. Looking more generally at cancer care, we found that mHealth is mainly used for self-management activities carried out by patients. The main tools used are mobile devices like mobile phones and tablets, but remote monitoring devices also play an important role. Text messaging technologies (short message service, SMS) have a minor role, with the exception of middle income countries where text messaging plays a major role. Telehealth technologies are still rarely used in cancer care processes. If we look at the different stages of health care processes, we can see that mHealth is mainly used during the treatment of patients, especially for self-management activities. It is also used for prevention and diagnosis, although to a lesser extent, whereas it appears rarely used for decision-making and follow-up activities. CONCLUSIONS: Since mHealth seems to be employed only for limited uses and during limited phases of the care process, it is unlikely that it can really contribute to the creation of new care models. This under-utilization may depend on many issues, including the need for it to be embedded into broader information systems. If the purpose of introducing mHealth is to promote the adoption of integrated care models, using mHealth should not be limited to some activities or to some phases of the health care process. Instead, there should be a higher degree of pervasiveness at all stages and in all health care delivery activities.

Global disparities in cancer supportive care: An international survey.

BACKGROUND: The global cancer burden is rising, particularly in low- and middle-income countries (LMIC), highlighting a critical research gap in understanding disparities in supportive care access. To address this, the Multinational Association of Supportive Care in Cancer (MASCC) Health Disparities Committee initiated a global survey to investigate and delineate these disparities. This study aims to explore and compare supportive care access disparities between LMIC and High-Income Countries (HIC). METHODS: An online cross-sectional survey was conducted among active members of MASCC. Members, representing diverse healthcare professions received email invitations. The survey, available for 3 weeks, comprised sections covering (1) sociodemographic information; (2) clinical service/practice-related disparities in their region/nation; (3) population groups facing disparities within their region or country. Chi-squared or Fisher's exact test for cross-sectional analyses, and a multivariable logistic regression model was employed for statistical analysis. RESULTS: A total of 218 active members participated, with one-quarter (26.6%) from LMIC and 18.4% ethnic minorities, timely cancer care (43.7%) and timely supportive care (45.0%) emerged as the most pressing disparities globally. Notably, participants from LMIC underscored cancer drug affordability (56.4%) and supportive care guideline implementation (56.4%) as critical issues. Economically disadvantaged populations were noted as more likely to face disparities by both LMIC and HIC (non-US-based) respondents, while US-based respondents identified racial/ethnic minorities as facing more disparities. CONCLUSION: This global survey reveals significant disparities in cancer supportive care between LMIC and HIC, with a particular emphasis on medication affordability and guideline implementation in LMIC. Addressing these disparities requires targeted intervention, considering specific regional priorities.

Optimal use of granulocyte colony-stimulating factor prophylaxis to improve survival in cancer patients receiving treatment : An expert view.

BACKGROUND: Febrile neutropenia (FN) is a relatively common complication of cytotoxic chemotherapy. Prophylaxis with granulocyte colony-stimulating factor (G-CSF) can prevent FN and chemotherapy dose delays and enable the use of the higher dose intensities associated with a survival benefit; however, G­CSF is not always used optimally. Five medical oncologists with a special interest in supportive care met to discuss the evidence for prophylaxis with G­CSF to improve survival in cancer patients, identify reasons why this is not always done, and suggest potential solutions. The dose intensity of chemotherapy is critical for maximizing survival in cancer patients but may be reduced as a result of hematological toxicity, such as FN. Use of G­CSF has been shown to increase the chances of achieving the planned dose intensity in various cancers, including early-stage breast cancer and non-Hodgkin lymphoma. All physicians treating cancer patients should consider the use of G­CSF prophylaxis in patients receiving chemotherapy, paying particular attention to patient-related risk factors. KEY MESSAGES: Strategies to optimize G­CSF use include educating medical oncologists and pharmacists on the appropriate use of G­CSF and informing patients about the efficacy of G­CSF and its potential adverse effects. It is hoped that the evidence and opinions presented will help to encourage appropriate use of G­CSF to support cancer patients at risk of FN in achieving the best possible outcomes from chemotherapy.

Promoting Self-management and Patient Activation Through eHealth: Protocol for a Systematic Literature Review and Meta-analysis.

BACKGROUND: Major advances in different cancer treatment modalities have been made, and people are now living longer with cancer. However, patients with cancer experience a range of physical and psychological symptoms during and beyond cancer treatment. New models of care are needed to combat this rising challenge. A growing body of evidence supports the effectiveness of eHealth interventions in the delivery of supportive care to people living with the complexities of chronic health conditions. However, reviews on the effects of eHealth interventions are scarce in the field of cancer-supportive care, particularly for interventions with the aim of empowering patients to manage cancer treatment-related symptoms. For this reason, this protocol has been developed to guide a systematic review and meta-analysis to assess the effectiveness of eHealth interventions for supporting patients with cancer in managing cancer-related symptoms. OBJECTIVE: This systematic review with meta-analysis is conducted with the aim of identifying eHealth-based self-management intervention studies for adult patients with cancer and evaluating the efficacy of eHealth-based self-management tools and platforms in order to synthesize the empirical evidence on self-management and patient activation through eHealth. METHODS: A systematic review with meta-analysis and methodological critique of randomized controlled trials is conducted following Cochrane Collaboration methods. Multiple data sources are used to identify all potential research sources for inclusion in the systematic review: (1) electronic databases such as MEDLINE, (2) forward reference searching, and (3) gray literature. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for conducting the review were followed. The PICOS (Population, Interventions, Comparators, Outcomes, and Study Design) framework is used to identify relevant studies. RESULTS: The literature search yielded 10,202 publications. The title and abstract screening were completed in May 2022. Data will be summarized, and if possible, meta-analyses will be performed. It is expected to finalize this review by Winter 2023. CONCLUSIONS: The results of this systematic review will provide the latest data on leveraging eHealth interventions and offering effective and sustainable eHealth care, both of which have the potential to improve quality and efficiency in cancer-related symptoms. TRIAL REGISTRATION: PROSPERO 325582; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=325582. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38758.

Photobiomodulation therapy in management of cancer therapy-induced side effects: WALT position paper 2022.

Disclaimer: This article is based on recommendations from the 12th WALT Congress, Nice, October 3-6, 2018, and a follow-up review of the existing data and the clinical observations of an international multidisciplinary panel of clinicians and researchers with expertise in the area of supportive care in cancer and/or PBM clinical application and dosimetry. This article is informational in nature. As with all clinical materials, this paper should be used with a clear understanding that continued research and practice could result in new insights and recommendations. The review reflects the collective opinion and, as such, does not necessarily represent the opinion of any individual author. In no event shall the authors be liable for any decision made or action taken in reliance on the proposed protocols. Objective: This position paper reviews the potential prophylactic and therapeutic effects of photobiomodulation (PBM) on side effects of cancer therapy, including chemotherapy (CT), radiation therapy (RT), and hematopoietic stem cell transplantation (HSCT). Background: There is a considerable body of evidence supporting the efficacy of PBM for preventing oral mucositis (OM) in patients undergoing RT for head and neck cancer (HNC), CT, or HSCT. This could enhance patients' quality of life, adherence to the prescribed cancer therapy, and treatment outcomes while reducing the cost of cancer care. Methods: A literature review on PBM effectiveness and dosimetry considerations for managing certain complications of cancer therapy were conducted. A systematic review was conducted when numerous randomized controlled trials were available. Results were presented and discussed at an international consensus meeting at the World Association of photobiomoduLation Therapy (WALT) meeting in 2018 that included world expert oncologists, radiation oncologists, oral oncologists, and oral medicine professionals, physicists, engineers, and oncology researchers. The potential mechanism of action of PBM and evidence of PBM efficacy through reported outcomes for individual indications were assessed. Results: There is a large body of evidence demonstrating the efficacy of PBM for preventing OM in certain cancer patient populations, as recently outlined by the Multinational Association for Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Building on these, the WALT group outlines evidence and prescribed PBM treatment parameters for prophylactic and therapeutic use in supportive care for radiodermatitis, dysphagia, xerostomia, dysgeusia, trismus, mucosal and bone necrosis, lymphedema, hand-foot syndrome, alopecia, oral and dermatologic chronic graft-versus-host disease, voice/speech alterations, peripheral neuropathy, and late fibrosis amongst cancer survivors. Conclusions: There is robust evidence for using PBM to prevent and treat a broad range of complications in cancer care. Specific clinical practice guidelines or evidence-based expert consensus recommendations are provided. These recommendations are aimed at improving the clinical utilization of PBM therapy in supportive cancer care and promoting research in this field. It is anticipated these guidelines will be revised periodically.

Mind-Body and Psychosocial Interventions May Similarly Affect Heart Rate Variability Patterns in Cancer Recovery: Implications for a Mechanism of Symptom Improvement.

BACKGROUND: Advancements in early detection and treatment of cancer have led to increased survival rates and greater need to identify effective supportive care options for resolving symptoms of survivorship. Many non-pharmacological approaches to symptom management during and after cancer treatment involve emotional self-regulation as a central strategy for improving well-being. Identifying commonalities among these strategies' mechanisms of action may facilitate understanding of what might be useful for optimizing intervention effects. Heart rate variability (HRV) parameters are indicative of improved autonomic nervous system (ANS) balance and resiliency and reduced emotional distress and are thus identified as a mechanism to discuss as a marker of potential for intervention efficacy and a target for optimization. METHODS: HRV data from 2 studies, 1 examining a mind-body intervention and 1 examining a psychosocial intervention, are presented as a point of discussion about preliminary associations between the interventions, change in HRV, and emotional distress reduction. RESULTS: HRV significantly decreased in sympathetic activity in response to a mind-body intervention (Qigong/Tai Chi), and increased vagal tone in response to a psychosocial (storytelling) intervention. In both, these changes in HRV parameters were associated with improved emotional states. CONCLUSION: Our preliminary data suggest that HRV may serve as an important marker of underlying changes that mediate emotional regulation; this observation deserves further investigation. If identified as a worthy target, focusing on interventions that improve HRV within the context of interventions for cancer patients may be important to key outcomes and clinical practice.

Psychometric Properties of the French Adaptation of the Basic Documentation for Psycho-Oncology (Po-Bado): A Distress Screening Tool.

We translated and adapted the French version of the Basic Documentation for Psycho-Oncology (Po-Bado standard version) and we report its psychometric properties. The Po-Bado is a 12-item documentation instrument that measures psychosocial burden in cancer patients (all types and stages). The intensity of a patient's psychological suffering is evaluated by a health care professional (e.g., doctor, psychologist, nurse) in a semiguided interview. Overall, 252 cancer patients (Mage = 57 years, SD = 12.8 years) participated, completing the Po-Bado during a supportive care consultation following initial diagnosis. Our results show good reliability of the Po-Bado scores, with high internal consistency and interrater coefficients. Low temporal stability indicated that the Po-Bado measures a state-like phenomenon (vs. trait-like). Validity analysis showed significant correlations between cancer-specific psychosocial burden and negative mood (i.e., depression, anxiety) and psychological disturbance as assessed by the General Health Questionnaire (GHQ-12). Confirmatory factor analysis validated the Po-Bado's two-factor structure (i.e., somatic and psychological burdens). A receiver operating characteristic (ROC) curve determined the optimal cutoff score of 7.5. These results suggest that the Po-Bado is an easily applicable tool for clinicians and researchers to screen effectively for psychosocial burden in oncology.

Dusquetide: Reduction in oral mucositis associated with enduring ancillary benefits in tumor resolution and decreased mortality in head and neck cancer patients.

Innate immunity is a key component in the pathogenesis of oral mucositis, a universal toxicity of chemoradiation therapy (CRT). Dusquetide, a novel Innate Defense Regulator, has demonstrated both nonclinical and clinical efficacy in ameliorating severe oral mucositis (SOM). Long term follow-up studies from the Phase 2 clinical study evaluating dusquetide as a treatment for SOM in head and neck cancer (HNC) patients receiving CRT have now been completed. Extended analysis indicates that dusquetide therapy was well-tolerated and did not contribute to increased infection, tumor growth or mortality. Potential ancillary benefits of duquetide therapy were also identified.

Dusquetide: A novel innate defense regulator demonstrating a significant and consistent reduction in the duration of oral mucositis in preclinical data and a randomized, placebo-controlled phase 2a clinical study.

Dusquetide, a novel Innate Defense Regulator, modulates the innate immune system at a key convergence point in intracellular signaling pathways and has demonstrated activity in both reducing inflammation and increasing clearance of bacterial infection. Innate immunity has also been implicated in the pathogenesis of oral mucositis (OM), a universal toxicity of chemoradiation therapy (CRT). Testing the hypothesis that dusquetide can mitigate the development and duration of OM, preclinical studies have been completed and correlated with interim results from a Phase 2 clinical study in patients undergoing CRT for head and neck cancer. Dusquetide reduced the duration of OM in mouse and hamster models by approximately 50%, which was recapitulated by the 50% reduction of severe OM (SOM) in the Phase 2 trial. A reduction in the clinical rate of infection was also observed, consistent with previously reported preclinical studies. In aggregate, these results not only demonstrate the safety and efficacy of dusquetide in addressing this unmet medical need, but also provide proof of concept for the translation of dusquetide action between animal models and the human clinical setting, and further support the contention that innate immunity is an important driver for the initiation and continued impact of OM.

They lift my spirit up: stakeholders' perspectives on support teams for African Americans facing serious illness.

BACKGROUND: Active social and spiritual support for persons with cancer and other serious illnesses has been shown to improve psychological adjustment to illness and quality of life. OBJECTIVE: To evaluate a community-based support team intervention within the African American community using stakeholder interviews. METHODS: Support team members were recruited from African American churches, community organizations, and the social network of individuals with serious illness. Support teams provided practical, emotional, and spiritual care for persons with cancer and other serious illness. The intervention was evaluated using semistructured interviews with 47 stakeholders including those with serious illness, support team volunteers, clergy, and medical providers. RESULTS: Stakeholders report multiple benefits to participation in the support team; themes included provision of emotional and spiritual support, extension of support to patients' family, and support complementary to medical care. Reported barriers to participation were grouped thematically as desiring to maintain a sense of independence and normalcy; limitations of volunteers were also discussed as a barrier to this model of supportive care. CONCLUSIONS: This qualitative evaluation provides initial evidence that a support team intervention helped meet the emotional and spiritual needs of African American persons with cancer or other serious illness. Volunteer support teams merit further study as a way to improve quality of life for persons facing serious illness.