Electronic health intervention to manage symptoms of immunotherapy in patients with cancer (SOFIA): Results from a randomized controlled pilot trial.

BACKGROUND: For patients receiving immune checkpoint inhibitors, early detection of immune-related adverse events (irAEs) is critical for one's safety. To this end, a smartphone app (SOFIA) was developed that featured the assessment of electronic patient-reported outcomes (ePROs) focusing on irAEs as well as a set of comprehensive supportive information. Its feasibility and preliminary efficacy were evaluated in a randomized controlled trial (RCT). METHODS: Patients who received immune checkpoint inhibition therapy were randomly assigned to an intervention group (IG) or a control group (CG; care as usual). During the 12-week intervention period, IG patients used SOFIA to report twice weekly ePROs and receive cancer- and immunotherapy-relevant contents. Before a patient's next clinical visit, the physician in charge was given the ePRO reports. The primary objective was to test the feasibility of SOFIA. Furthermore, the preliminary efficacy of SOFIA for health-related quality of life (HRQOL), psychosocial outcomes, and medical data was examined. Clinical outcomes were assessed at baseline (T0), post-intervention (T1), and a 3-month follow-up (T2). RESULTS: Seventy-one patients were randomized to the IG (n = 34) or the CG (n = 37). SOFIA showed high feasibility and acceptance. At T1, patients in the IG reported significantly better HRQOL and role functioning and less depression, distress, and appetite loss. No significant differences were revealed regarding medical data, the utilization of supportive care services, or survival. CONCLUSIONS: SOFIA showed high feasibility and acceptance and improved HRQOL and psychosocial outcomes. These results suggest further evaluation of efficacy in a large-scale confirmatory multicenter RCT.

Health-related quality of life and fear of progression in individuals with Li-Fraumeni syndrome.

Li-Fraumeni syndrome (LFS) is a rare autosomal dominant cancer predisposition syndrome associated with a highly elevated lifetime cancer risk. This and the recommended intense surveillance program represent a large psychological burden on families. In order to develop targeted psychosocial interventions, we conducted a needs assessment. Adults (≥18 years) with LFS were included via regular hospital visits and online support groups and newsletters. Individuals filled out a questionnaire addressing among others: fear of progression (FoP-questionnaire, short-form), health-related quality of life (HRQoL, Short-Form Health Survey-12), distress (National Comprehensive Cancer Network distress thermometer), perceived cancer risk, and aspects of surveillance adherence. Collecting data over a 14-month period (March 2020 - June 2021), 70 adults were recruited (female = 58, 82.9%; mean age = 41.53 years). With mean mental component scores (MCS) of 42.28 (SD = 10.79), and physical component scores (PCS) of 48.83 (SD = 10.46), HRQoL was low in 34.8% (physical) and 59.4% (mental) of individuals when applying a mean cut-off of 45.4 (PCS) and 47.5 (MCS) to indicate poor HRQoL. High levels of FoP and distress were present in 68.6% and 69.1% of the participants, respectively. Performing a multiple linear regression on MCS and PCS, no sociodemographic variable was shown to be significant. FoP (ß = -0.33, p < 0.05) and distress (ß = -0.34, p < 0.05) were significantly associated with MCS. Individuals in our sample were burdened more than expected, with the majority reporting low levels of (mental) HRQoL, high distress, and FoP. Psychosocial support is necessary to help individuals with LFS (survivors as well as "previvors") increase their HRQoL, as it is crucial to survival.

[ORPHYS - Treatment Manual for a Short-Term Psychodynamic Psychotherapy in Patients with Serious Physical Illness]. / ORPHYS ­ Behandlungsmanual für eine psychodynamische Kurzzeitpsychotherapie bei schwerer körperlicher Erkrankung.

The diagnosis of a life-threatening illness may lead to a breakdown of psychological processing patterns and a reactualization of existential conflicts. The sudden loss of continuity, physical integrity and social roles can overwhelm patients' ability to cope psychologically. Psychosocial and medical care is likely compromised if patients suffer from affective disorders or symptoms of existential distress. Psychodynamic treatments may strengthen the experience of closeness and connectedness in order to cope with losses and enable farewell processes. ORPHYS describes a short-term psychodynamic psychotherapy (12-24 sessions) that aims to address the existential distress of seriously physically ill patients by taking into account relational conflicts at the end of life. The combination of supportive and expressive treatment techniques that focus on patients' subjective experience and illness situation may enable patients to integrate painful affective states and to explore their relationship and coping patterns. ORPHYS can thus facilitate a shared mourning process, in which the intense desire for connectedness at the end of life and the reality of dying can be reconciled.

Patient-physician communication about cancer-related fatigue: a survey of patient-perceived barriers.

PURPOSE: Cancer-related fatigue is a subjective, distressing, and common sequela of cancer which is often disregarded and underdiagnosed. Fatigue is assessed by self-report requiring communication between patient and physician. In this study, we investigated the patients' perspective on the patient-physician communication about fatigue. METHODS: On average five months after diagnosis 1179 cancer patients, recruited in Germany, completed a survey as part of the LIFT project. The survey included questions on sociodemographic data, fatigue, depression, fatigue management, patient-physician communication, and communication barriers. Data were analyzed descriptively and using logistic regression analyses. RESULTS: Half of the participants reported that their physician had never asked them whether they felt exhausted. Patients undergoing chemo-, radio-, or immunotherapy were more likely to be asked about fatigue, while older age and major depression decreased the likelihood. Sixty-four percent of the patients felt impeded by communication barriers. Common barriers were not knowing who to turn to for fatigue (39%), time constraints (31%), and the fear of being perceived as weak (22%). Almost half of the participants indicated that their physicians were not appreciative and did not deal adequately with fatigue-related questions. CONCLUSION: This study revealed gaps in the patient-physician communication regarding cancer-related fatigue. Contrary to guideline recommendations a minority of physicians addressed fatigue. On the other hand, cancer patients felt reluctant to bring up this topic due to structural barriers and fears. Physicians should routinely address fatigue and adopt a communication style which encourages patients to likewise state their symptoms and raise their questions. TRIAL REGISTRATION: Clinicaltrials.gov, identifier: NCT04921644. Registered in June 2021.

Cancer-related fatigue: Quality, credibility, usability, and readability of information on websites of health care institutions in Germany.

OBJECTIVES: This study aimed to portray available information on cancer-related fatigue on German health care institution websites considering the idea of patient empowerment. METHODS: Based on website quality criteria, we developed a website-rating tool comprising 18 items. Descriptive analyses, a KruskalWallis test, and corresponding post hoc tests comparing rating sum scores between institution groups were performed. RESULTS: Websites of 283 systematically compiled health care institutions were included in the rating. Cancer-related fatigue was introduced on 21.9% and detailed information was provided on 27.9% of the websites. Information material was offered on 9.2% of the websites, while fatigue treatment offers were presented on 21.6% of the websites. The rating sum scores differed between institution groups (p < 0.001), with Comprehensive Cancer Centers scoring significantly higher than the others. CONCLUSION: The rating revealed an overall sparse provision of information, with fatigue being addressed on less than half of the websites. PRACTICE IMPLICATIONS: For patients who have access to at least one introduction about fatigue, institutions need to extend their websites. Patients could further be referred to external institutions or information booklets. The naming of contact persons may help linking patients to providers.

The impact of divergent forms of social support on health-related quality of life in patients with multiple myeloma and its precursor states.

PURPOSE: Multiple myeloma is a largely incurable disease. Patients suffer from the cancer, therapeutic side effects, and often psychological symptoms. Not only multiple myeloma patients but also patients with precursor diseases show high psychological distress. Today, treatment option evaluations are increasingly performed in combination with health-related quality of life (HRQoL) assessments. One factor that is positively associated with HRQoL is social support. METHODS: Our recent study used questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20, Illness-specific Social Support Scale) to investigate the influence of positive and negative aspects of social support on HRQoL in patients with multiple myeloma and its precursors. RESULTS: Multiple linear regression analyses with sex, age, treatment line, hemoglobin level, and number of comorbidities as control variables show that positive social support had a significant beneficial association with emotional function (ß = 0.323) and social function (ß = 0.251). Detrimental interactions had a significant negative association with social function (ß = - 0.209) and a significant positive association with side effects of treatment (ß = 0.266). CONCLUSION: Therefore, screening for social support and, if needed, psycho-oncological care can be an important resource and should be implemented in routine care. CLINICAL TRIAL REGISTRATION: This study was registered with clinicaltrials.gov (NCT04328038).

12-Month Trajectories of Health-Related Quality of Life Following Hospitalization in German Cancer Centers-A Secondary Data Analysis.

Patient-reported outcomes (PROs) offer a diverse array of potential applications within medical research and clinical practice. In comparative research, they can serve as tools for delineating the trajectories of health-related quality of life (HRQoL) across various cancer types. We undertook a secondary data analysis of a cohort of 1498 hospitalized cancer patients from 13 German cancer centers. We assessed the Physical and Mental Component Scores (PCS and MCS) of the 12-Item Short-Form Health Survey at baseline (t0), 6 (t1), and 12 months (t2), using multivariable generalized linear regression models. At baseline, the mean PCS and MCS values for all cancer patients were 37.1 and 44.3 points, respectively. We observed a significant improvement in PCS at t2 and in MCS at t1. The most substantial and significant improvements were noted among patients with gynecological cancers. We found a number of significant differences between cancer types at baseline, t1, and t2, with skin cancer patients performing best across all time points and lung cancer patients performing the worst. MCS trajectories showed less pronounced changes and differences between cancer types. Comparative analyses of HRQoL scores across different cancer types may serve as a valuable tool for enhancing health literacy, both among the general public and among cancer patients themselves.

The WERA cancer center matrix: Strategic management of patient access to precision oncology in a large and mostly rural area of Germany.

PURPOSE: Providing patient access to precision oncology (PO) is a major challenge of clinical oncologists. Here, we provide an easily transferable model from strategic management science to assess the outreach of a cancer center. METHODS: As members of the German WERA alliance, the cancer centers in Würzburg, Erlangen, Regensburg and Augsburg merged care data regarding their geographical impact. Specifically, we examined the provenance of patients from WERA´s molecular tumor boards (MTBs) between 2020 and 2022 (n = 2243). As second dimension, we added the provenance of patients receiving general cancer care by WERA. Clustering our catchment area along these two dimensions set up a four-quadrant matrix consisting of postal code areas with referrals towards WERA. These areas were re-identified on a map of the Federal State of Bavaria. RESULTS: The WERA matrix overlooked an active screening area of 821 postal code areas - representing about 50 % of Bavaria´s spatial expansion and more than six million inhabitants. The WERA matrix identified regions successfully connected to our outreach structures in terms of subsidiarity - with general cancer care mainly performed locally but PO performed in collaboration with WERA. We also detected postal code areas with a potential PO backlog - characterized by high levels of cancer care performed by WERA and low levels or no MTB representation. CONCLUSIONS: The WERA matrix provided a transparent portfolio of postal code areas, which helped assessing the geographical impact of our PO program. We believe that its intuitive principle can easily be transferred to other cancer centers.