Targeted drugs and Psycho-oncological intervention for breast cancer patients

Personalized medicine is a new field based on molecular biology and genomics in which targeted tumor therapies are administered to patients. Psycho- oncology is a complementary approach that considers social and psychological aspects of patients as part of the treatments for cancer patients. The aim of this mini-review is to weigh clinical benefits for breast cancer patients of both treatments and possibily enhance benefits by modulating the use of both interventions. We have compared and evaluated on the one hand the use of anti Vascular Endothelial Growth Factor and, on the other hand, psycho-oncological interventions in metastatic and non-metastatic breast cancer patients. Both treatments did not increase survival of metastatic breast cancer patients, while in a selected study psycho-oncological interventions extended lifespan of non-metastatic breast cancer patients and ameliorate psychological and social factors of metastatic breast cancer patients. Because the two approaches address completely different aspects of cancer patients, if the comparison is limited to the extension of survival, the value of these two treatments cannot be assessed and compared. It is likely that by comparing patients reported outcomes, possibly by using standardized Quality of Life questionnaires, both patients and health care providers can weigh the benefits of the two treatments. It is therefore important to evaluate the use of cancer patients’ quality of life measures as a mean to improve their experiences about life and treatment, and possibly to extend their survival

Psychosocial Distress in Women With Breast Cancer and Their Partners and Its Impact on Supportive Care Needs in Partners

Objectives: While both patients and informal caregivers report high levels of cancerrelated distress, supportive care needs of relatives are often not taken into account and little is known about mutual perception of distress within couples. Therefore, we aimed to investigate distress in female patients with breast cancer and their male partners as well as supportive care needs in partners. Methods: In this cross-sectional study, we recruited women with breast cancer during primary cancer care and their male partners, obtained information on mental distress and supportive care needs through visual analog scales for four mood domains and the Short Form of Supportive Care Needs Survey (SCNS-SF34). Results: Among 250 eligible patients with breast cancer, 102 patients (40.8%) and their male partners participated. Partners reported higher levels of distress (p = 0.02), whereas patients (self-assessment) indicated stronger needs for help (p < 0.001). Men with higher levels of distress were younger (p < 0.001), and reported a shorter relationship duration (p = 0.001) compared to partners with lower distress. Partners overestimated distress, anxiety, depression, and need for help in the patient. Patients overestimated partners need for help. The majority of partners (78%) reported at least one unmet need, most frequently related to the health system and information domain. Conclusion: A systematic distress and needs assessment for women with breast cancer and their male partners is mandatory. The provision of optimal supportive care depends on protocols that include not only psychosocial care for patients but also procedures for managing distress and needs for partners including individual and couple-based interventions

Patient Reported Outcome (PRO) Among High-Grade Glioma Patients Receiving TTFields Treatment: A Two Center Observational Study

Study design: A two center, observational study. Introduction: Patient reported outcome (PRO) plays an increasingly important role in the evaluation of novel therapies for tumor patients. It has been shown that tumor treating fields (TTFields) in combination with standard therapy prolong survival in high-grade glioma (hgG) patients. But critics claim that TTFields significantly impacts patients' everyday life due to side effects and average daily time on therapy (18 h) in a patient population with very limited life expectancy and high symptom burden. However, very limited data exist on PRO for TTFields treatment. Methods: This two center, observational study describes PRO of 30 hgG patients receiving TTFields in combination with chemotherapy. We introduced a device-specific questionnaire (DSQ) addressing device-specific restrictions and impact on daily live after 2 months of therapy. Additionally following questionnaires were used: EORTC (European Organization for Research and Treatment of Cancer), QLQ-30 (Quality of life of cancer patients), QLQ BN20 (Quality of life brain cancer module), QLQ FA13 (Cancer-related fatigue), and SSUK-8 (social support). Results: Surveys have been completed by 91% of enrolled patients. EORTC QLQ-30 revealed better physical, emotional, and cognitive function than social and role function of study cohort. TTFields users reported frequently on positive social support and a low level of detrimental interactions. Seventy one percent of patients felt affected in daily life due to TTFields at least 2-3 times per week up to several times per day while maintaining high therapy compliance. Most frequent device-specific restrictions were duration of therapy (74%), size (66%), and weight (70%) of the device and changing time and bonding of the transducer arrays (66%, mean duration: 43.6 min). Restrictions on exercise of hobbies/work (63%/61%), body care (71%), and sexuality/relationship (64%) were most relevant. Seventy percent would recommend TTFields to others and 67% would reuse TTFields treatment again based on their current experience. Conclusion: The study shows that although TTFields treatment frequently affects everyday life in all aspects, therapy compliance was high and 67% of patients would reconsider TTFields for themselves. We propose that findings of PRO be taken into account for medical consultation about TTFields and in future device development to deliver high-value patient-centered care

Practice and Effectiveness of Outpatient Psycho-Oncological Counseling for Cancer Patients

Objective: Because of various types of psychological distress, cancer patients are encouraged to attend outpatient psycho-oncological and psychosocial counseling. The aim of this prospective study was an analysis of the impact and success of existing counseling resources

Cancer patients' expectations when undergoing extensive molecular diagnostics—A qualitative study

Objective: Precision cancer medicine (PCM) aims at identifying tumor-driving molecular characteristics to improve therapy. Despite early successes for some cancers, the approach faces manifold challenges. Patients undergoing extensive molecular diagnostics (MD) may hope for personal benefit, although chances are small. In order to offer suitable support to this group, health-care professionals need to gain insight into patients' experience. Thus, this study sought to explore the expectations of cancer patients undergoing MD of their tumor. Methods: In two German Comprehensive Cancer Centers, 30 patients with advanced-stage cancer who had exhausted conventional treatment and had consented to extensive, research-oriented MD (whole-genome sequencing n = 24, panel sequencing n = 6) participated in semi-structured interviews. Following thematic content analysis by Kuckartz, the interview transcripts were coded for expectations of MD participation and topics closely related. Moreover, patients completed questionnaires on their sociodemographic characteristics, medical history, and psychosocial distress. Results: Patients reported to be expecting (a) an improvement of their treatment, (b) a contribution to research, and/or (c) additional insight to their own cancer. Further, they described to feel individually appreciated and to have a reason to maintain hope for cure or recovery by participating in MD. Conclusions: Molecular diagnostics participation led patients to feel treated in a more “personalized” way, allowing them a greater sense of control in their situation of severe illness. Oncologists and psycho-oncologists need to ensure comprehensive information and empathetic support for patients undergoing extensive MD to balance their expectations and actual chances of clinical benefit

Quality of life and treatment-related burden during ocular proton therapy: a prospective trial of 131 patients with uveal melanoma

Background: Proton beam therapy is a well-established treatment option for patients with uveal melanoma (UM). The treatment procedure, in general, includes placing radiopaque clips to ensure exact eye-positioning during radiotherapy, followed by the delivery of proton irradiation. The short-term burden associated with proton therapy in patients with UM has rarely been addressed. In this prospective study, we investigated the physiological and psychological aspects of proton therapy that might affect the well-being of patients during the different stages of treatment. Methods: During the treatment procedure, we conducted longitudinal assessments of the Quality of life (QOL), organ-specific symptoms, and psychological aspects in patients with UM with three questionnaires (EORTC QLQ-C30, EORTC QLQ-OPT30, and GAD-7). Patients completed questionnaires before clip surgery (T0), before proton therapy (T1), after completing treatment (T2), and three months after treatment completion (T3). We also collected data on tumor characteristics and socio-demographics to identify potential risk factors associated with high treatment burdens. Results: We prospectively included 131 consecutive patients. Questionnaire data showed a significant, temporary decline in global QOL and an increase in eye-related symptoms, as a result of the clip surgery (T0-T1). After treatment completion (T2), global QOL improved gradually, and none of the eye-related symptoms significantly deteriorated over the course of proton therapy. The global QOL returned to baseline levels three months after treatment (T3). We identified baseline anxiety as an independent risk factor for experiencing an acute treatment-related burden. Furthermore, we found interactions between GAD7 and patient sex showing that anxiety had a more pronounced effect on QOL outcome in female patients. Conclusion: The short-term treatment-related burden of ocular proton therapy appeared to be largely associated with the preceding clip surgery, rather than the irradiation procedure. We found that anxiety was strongly associated with experiencing QOL issues during the treatment procedure. Our findings could contribute to the development of future strategies for improving the treatment process and psycho-oncologic patient care

Sense of coherence, mental well-being and perceived preoperative hospital and surgery related stress in surgical patients with malignant, benign, and no neoplasms

Background: This prospective, cross-sectional, observational study examined associations between sense of coherence (SOC), mental well-being, and perceived preoperative hospital and surgery related stress of surgical patients with malignant, benign, and no neoplasms. The objective was to assess a putative association between SOC and preoperative stress, and to test for a statistical mediation by mental well-being. Method: The sample consisted of 4918 patients from diverse surgical fields, of which 945 had malignant neoplasms, 333 benign neoplasms, and 3640 no neoplasms. For each subsample, we conducted simple mediation analyses to test an indirect effect of SOC on preoperative stress mediated by mental well-being. The models were adjusted for age, gender, and essential medical factors. Results: Patient groups did not differ significantly regarding degrees of SOC and mental well-being (SOC, M [SD]: 12.31 [2.59], 12.02 [2.62], 12.18 [2.57]; mental well-being M [SD]: 59.26 [24.05], 56.89 [22.67], 57.31 [22.87], in patients with malignant, benign, and without neoplasms, respectively). Patients without neoplasms reported significantly lower stress (4.19 [2.86], M [SD]) than those with benign (5.02 [3.03], M [SD]) and malignant neoplasms (4.99 [2.93], M [SD]). In all three mediation models, SOC had significant direct effects on stress, with higher SOC being associated with lower stress (- 0.3170 [0.0407], - 0.3484 [0.0752], - 0.2919 [0.0206]; c' [SE], p < 0.001 in patients with malignant, benign, and without neoplasms, respectively). In patients with malignant neoplasms and without neoplasms, SOC showed small indirect effects on stress that were statistically mediated by well-being. Higher SOC was related to higher well-being, which in turn was related to lower stress. In patients with benign neoplasms, however, no significant indirect effects of SOC were found. Conclusions: SOC was directly associated with lower perceived hospital and surgery related stress, over and above the direct and mediation effects of mental well-being. Because the data are cross-sectional, conclusions implying causality cannot be drawn. Nevertheless, they indicate important relationships that can inform treatment approaches to reduce elevated preoperative stress by specifically addressing low SOC

Development of a patient-oriented navigation model for patients with lung cancer and stroke in Germany

Background: The concept of patient navigation was first established in the USA to support vulnerable patient groups in receiving timely and comprehensive access to cancer care. It has recently gained increasing interest in Germany to support patients with chronic diseases in a fragmented healthcare system. The aim of this paper is to present the development of such a model adapted to the German context based on the results of mixed-methods studies investigating the need for and barriers to patient-oriented care. Methods: In a process adapted from Delphi rounds, we conducted regular structured workshops with investigators of the project to discuss results of their studies and identify content and structure of the model based on the data. Workshop discussions were structured along seven core components of a navigation model including target patient groups, navigator tasks, occupational background and education of navigators, and patient-navigator interaction mode. Results: Using an approach based on empirical data of current care practices with special focus on patients' perspectives, we developed a patient-oriented navigation model for patients who have experienced stroke and lung cancer in the German healthcare context. Patients without personal social support were viewed as struggling most with the healthcare system, as well as multimorbid and elderly patients. Navigators should serve as a longer-term contact person with a flexible contact mode and timing based on the individual situation and preferences of patients. Navigator tasks include the provision of administrative and organizational support as well as referral and guidance to available resources and beneficial health programs with special forms of knowledge. Implementation of the navigator should be flexibly located to ensure a reliable outreach to vulnerable patients for first contact in settings like specialized in-patient and out-patient settings, while navigation itself focuses on care coordination in the out-patient setting. Conclusion: Flexibility of navigator tasks needed to be a core characteristic of a navigation model to be perceived as supportive from patients' perspectives. In a subsequent feasibility study, an intervention based on the model will be evaluated according to its acceptance, demand, and practicality

Prevalence of mental disorders, psychosocial distress, and perceived need for psychosocial support in cancer patients and their relatives stratified by biopsychosocial factors: rationale, study design, and methods of a prospective multi-center observational cohort study (LUPE study)

BackgroundDespite remarkable progress, cancer remains a life-threatening disease for millions of people worldwide, also resulting in significant psychosocial limitations. High-quality, comprehensive cancer care requires patient and family involvement and the provision of needs-based, targeted psychosocial services. Although progress has been made in understanding the occurrence of mental comorbidity and psychosocial distress in cancer patients, comparatively little is known about the course of psychological comorbidity and psychosocial distress in early survivorship among patients and their families. We therefore aim to estimate the prevalence of mental disorders according to the DSM-5, psychosocial distress, perceived needs for psychosocial support and utilization of psychosocial support offers in newly diagnosed cancer patients and their relatives, taking into account potential contributing biopsychosocial factors for the occurrence of psychological comorbidity.Methods/designThis study follows a prospective multi-center observational cohort design across four measurement time points: within 2 months after cancer diagnosis (t1), and in the follow-up period at 6 months (t2), at 12 months (t3), and at 18 months (t4) after t1. Patients older than 18 years who have a confirmed initial diagnosis of a malignant solid tumor and are scheduled for cancer treatment at one of the participating cancer centers are eligible for study participation. Relatives of eligible patients are also eligible for study participation if they are older than 18 years. Patients are interviewed using the Structured Clinical Interview for DSM-5 Disorders (SCID-5-CV). In addition, patients and relatives receive a set of validated questionnaires at each measurement time point, covering comorbid conditions and functional performance, perceived psychological distress and quality of life, partnership aspects and social relationships, supportive care needs and use of psychosocial support services, health literacy, and health behavior and meaning in life.DiscussionThis prospective multi-center observational cohort study has a major focus on increasing quality of care and quality of life in cancer survivors through providing rigorous longitudinal data for the development and implementation of target group-specific psychosocial support services.Trial registrationNCT04620564, date of registration 9/11/2020; DKG OnkoZert: Registrier-No.: ST-U134, date of registration 5/11/2021

Quality of Life of Patients with Head and Neck Cancer Receiving Cetuximab, Fluorouracil, Cisplatin Comparing to Cetuximab, Fluorouracil, Cisplatin, and Docetaxel within the CEFCID Trial

Introduction: CeFCiD was a multicenter phase II study comparing the efficacy of cetuximab (C), 5-flourouracil, and cisplatin with the same regimen adding docetaxel (D) in recurrent/metastatic head and neck cancer. The primary analysis trial did not demonstrate survival benefit from therapy intensification in first-line recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). The current analysis of the trial assessed the impact of treatment on quality of life (QoL). Methods: The European Organization for Research and Treatment of Cancer Quality of life Questionnaire QLQ-C30 and the tumor-specific module for head and neck cancer (QLQ-H&N35) were used to assess QoL at baseline (visit 1), after 2 (visit 3), 4 (visit 5), and 6 (visit 7) cycles of chemotherapy. Results: Of 180 patients included in this study, 86 patients (47.8%) completed the questionnaires at baseline. Considering selected scores over treatment time, there was no difference in global QoL, dyspnea, swallowing, and speech between the treatment arms in the course. For fatigue, a significant increase from baseline to visit 3 (p = 0.02), visit 5 (p = 0.002), and to visit 7 (p = 0.003) was observed for patients receiving D, cisplatin or carboplatin (P), 5-fluorouracil (F), and C. At the end of chemotherapy, the manifestation of fatigue was similar compared in the 2 treatment arms. Discussion/Conclusion: Therapy intensification not adversely affects selected scores of QoL of patients with recurrent and/or metastatic SCCHN. Nevertheless, fatigue seems to be pronounced in patients treated with D