Toward an improved conceptualization of emotions in patients with cancer.

Cancer and its associated treatment is a major stressor, leading to emotions such as anxiety or depressive mood. Human emotions have developed through the course of evolution because they facilitate adaptation to important events, such as cancer and its associated treatment. On the other hand, emotions can be maladaptive and interfere with adaptation to cancer. Emotions are maladaptive if they are disproportionally severe or persistent, and if they interfere with functioning. We aim to expand the conceptualization of adaptive and maladaptive emotions in patients with cancer. We draw on major theories in the field of mental disorder and mental health, and apply these theories to conceptualize adaptive and maladaptive emotions in patients with cancer. (i) Maladaptive emotions have two essential features: mental dysfunction and patient harm. Maladaptive emotions are characterized by a network of strongly associated emotional symptoms, which may include cancer-related somatic symptoms. The dysfunctional symptom network is hypothesized to be the result of disturbance of life goal pursuit caused by cancer. (ii) Adaptive emotions have two essential features: ability to deal with cancer and functioning well. The ability to use emotions in an adaptive way depends on skills to recognize, express, and regulate emotions in a flexible manner. A secure attachment style facilitates adaptive emotional responses to cancer. The present conceptualization of adaptive and maladaptive emotions is expected to contribute to better understanding and management of emotions in patients with cancer.

Exploring resonance theory and uncontrollability during co-creative art making: A qualitative study among cancer patients.

PURPOSE: Co-creation, characterised by artists and patients creating a joint work of art, may support patients with the integration of life events, such as living with cancer, into their life story. In the process of co-creation, resonance relationships between patients, artists and material may evolve that support such integration. Using the framework of resonance theory, we aim to investigate if and how patients move through the three phases of resonance during a process of co-creation and explore the role of uncontrollability in this process. METHODS: Ten patients who received cancer treatment with palliative intent completed co-creation processes, which were audio recorded. These recordings were imported in Atlas-Ti and analysed by applying content analysis. We searched for the three phases of resonance, Being affected, touched and moved; Self-efficacy and responding; Adaptive transformation. We additionally searched for signs of uncontrollability. RESULTS: Patients used 4-8 sessions (median 5 sessions) with a duration 90-240 min per session (median duration 120 min). We found that patients move through the three phases of resonance during co-creation processes. Uncontrollability both presents a challenge and an invitation to integrate experiences of contingency into one's life narrative. Patients express self-recognition and the experience of contingency in their work of art. CONCLUSIONS: Integration of experiences of contingency into a life narrative can be supported by the process of co-creation of art, which invites patients to relate to their illness, their environment and themselves. The phases of resonance in combination with uncontrollability as a continuously present factor, provide a means to both study and support the integration of experiences of contingency into the life narrative.

Network analysis used to investigate the interplay among somatic and psychological symptoms in patients with cancer and cancer survivors: a scoping review.

PURPOSE: Patients with cancer often experience multiple somatic and psychological symptoms. Somatic and psychological symptoms are thought to be connected and may reinforce each other. Network analysis allows examination of the interconnectedness of individual symptoms. The aim of this scoping review was to examine the current state of knowledge about the associations between somatic and psychological symptoms in patients with cancer and cancer survivors, based on network analysis. METHODS: This scoping review followed the five-stage framework of Arksey and O'Malley. The literature search was conducted in May, 2023 in PubMed, APA PsycINFO, Embase Cochrane central, and CINAHL databases. RESULTS: Thirty-two studies were included, with eleven using longitudinal data. Seventeen studies reported on the strength of the associations: somatic and psychological symptoms were associated, although associations among somatic as well as among psychological symptoms were stronger. Other findings were the association between somatic and psychological symptoms was stronger in patients experiencing more severe symptoms; associations between symptoms over time remained rather stable; and different symptoms were central in the networks, with fatigue being among the most central in half of the studies. IMPLICATIONS FOR CANCER SURVIVORS: Although the associations among somatic symptoms and among psychological symptoms were stronger, somatic and psychological symptoms were associated, especially in patients experiencing more severe symptoms. Fatigue was among the most central symptoms, bridging the somatic and psychological domain. These findings as well as future research based on network analysis may help to untangle the complex interplay of somatic and psychological symptoms in patients with cancer.

Defining and operationalizing personalized psychological treatment - a systematic literature review.

This systematic literature review aimed to propose a definition of personalized psychological treatment and to suggest how the definition can be operationalized. PsycINFO, Cochrane Library, MEDLINE and EMBASE were searched up to 11 December 2023 for studies in which a definition of personalized psychological treatment was included or a systematic operationalization of personalized psychological treatment was described. Based on a narrative synthesis of the collected definitions, summary categories were developed that informed the proposed definition. Operationalizations were described according to what aspect of treatment, how and when treatment was personalized. The extent to which the operationalizations deviated from the proposed definition was assessed. Thirty-four studies with definitions and 200 with operationalizations were included. The following definition was proposed: personalized psychological treatment aims to optimize treatment outcome for the individual patient by tailoring treatment to unique or specific needs, preferences or other characteristics and includes a systematic adaptation of treatment or a differentiation between treatment strategies. Based on the operationalizations, timing of personalization, specification of the systematic approach and treatment elements that could be personalized were added to the proposed definition. Evidence-based personalization of psychological treatments can be enhanced by clear operationalization based on a comprehensive definition of personalization.

Response shift results of quantitative research using patient-reported outcome measures: a descriptive systematic review.

PURPOSE: The objective of this systematic review was to describe the prevalence and magnitude of response shift effects, for different response shift methods, populations, study designs, and patient-reported outcome measures (PROM)s. METHODS: A literature search was performed in MEDLINE, PSYCINFO, CINAHL, EMBASE, Social Science Citation Index, and Dissertations & Theses Global to identify longitudinal quantitative studies that examined response shift using PROMs, published before 2021. The magnitude of each response shift effect (effect sizes, R-squared or percentage of respondents with response shift) was ascertained based on reported statistical information or as stated in the manuscript. Prevalence and magnitudes of response shift effects were summarized at two levels of analysis (study and effect levels), for recalibration and reprioritization/reconceptualization separately, and for different response shift methods, and population, study design, and PROM characteristics. Analyses were conducted twice: (a) including all studies and samples, and (b) including only unrelated studies and independent samples. RESULTS: Of the 150 included studies, 130 (86.7%) detected response shift effects. Of the 4868 effects investigated, 793 (16.3%) revealed response shift. Effect sizes could be determined for 105 (70.0%) of the studies for a total of 1130 effects, of which 537 (47.5%) resulted in detection of response shift. Whereas effect sizes varied widely, most median recalibration effect sizes (Cohen's d) were between 0.20 and 0.30 and median reprioritization/reconceptualization effect sizes rarely exceeded 0.15, across the characteristics. Similar results were obtained from unrelated studies. CONCLUSION: The results draw attention to the need to focus on understanding variability in response shift results: Who experience response shifts, to what extent, and under which circumstances?

Impact of Short-Course Palliative Radiation Therapy on Pancreatic Cancer-Related Pain: Prospective Phase 2 Nonrandomized PAINPANC Trial.

PURPOSE: Clinical evidence is limited regarding palliative radiation therapy for relieving pancreatic cancer-related pain. We prospectively investigated pain response after short-course palliative radiation therapy in patients with moderate-to-severe pancreatic cancer-related pain. METHODS AND MATERIALS: In this prospective phase 2 single center nonrandomized trial, 30 patients with moderate-to-severe pain (5-10, on a 0-10 scale) of pancreatic cancer refractory to pain medication, were treated with a short-course palliative radiation therapy; 24 Gy in 3 weekly fractions (2015-2018). Primary endpoint was defined as a clinically relevant average decrease of ≥2 points in pain severity, compared with baseline, within 7 weeks after the start of treatment. Secondary endpoint was global quality of life (QoL), with a clinically relevant increase of 5 to 10 points (0-100 scale). Pain severity reduction and QoL were assessed 9 times using the Brief Pain Inventory and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C15-PAL, respectively. Both outcomes were analyzed using joint modeling. In addition, acute toxicity based on clinician reporting and overall survival (OS) were assessed. RESULTS: Overall, 29 of 30 patients (96.7%) received palliative radiation therapy. At baseline, the median oral morphine equivalent daily dose was 129.5 mg (range, 20.0-540.0 mg), which decreased to 75.0 mg (range, 15.0-360.0 mg) after radiation (P = .021). Pain decreased on average 3.15 points from baseline to 7 weeks (one-sided P = .045). Patients reported a clinically relevant mean pain severity reduction from 5.9 to 3.8 points (P = .011) during the first 3 weeks, which further decreased to 3.2 until week 11, ending at 3.4 (P = .006) in week 21 after the first radiation therapy fraction. Global QoL significantly improved from 50.5 to 60.8 during the follow-up period (P = .001). Grade 3 acute toxicity occurred in 3 patients and no grade 4 to 5 toxicity was observed. Median OS was 11.8 weeks, with a 13.3% 1-year actuarial OS rate. CONCLUSIONS: Short-course palliative radiation therapy for pancreatic cancer-related pain was associated with rapid, clinically relevant reduction in pain severity, and clinically relevant improvement in global QoL, with mostly mild toxicity.

The expression of ultimate life goals in co-creative art processes with palliative cancer patients.

BACKGROUND: Co-creation, characterized by artists and patients creating a joint work of art, may support patients with the integration of disruptive life events into their life story, such as living with cancer. Focusing on experiences of contingency and life goals could support this process. The research questions are: (1) 'how are patient's ultimate life goals and experiences of contingency expressed in the work of art as created in a process of co-creation?'; (2) 'how do the four phases of integration of experiences of contingency unfold during co-creation?' METHODS: Ten patients who were in a palliative stage of cancer treatment completed co-creation processes. Audio recordings of these co-creation processes were imported in Atlas-Ti and analysed by applying directed content analysis. We searched for life goals and experiences of contingency in the four phases of co-creation; Art communications, Element compilation, Consolidation, Reflection. RESULTS: Patients used 4-8 sessions (median 5 sessions) with a duration of 90-240 min each (median duration 120 min). All patients expressed their experience of contingency and their ultimate life goals within the four phases of co-creation and in their work of art. A case description is presented illustrating the co-creation process. CONCLUSIONS: During co-creation, patients move through four phases in which experiences of contingency and ultimate life goals can be made explicit through art making and can be expressed in the work of art, supporting integration of experiences of contingency into one's life narrative.

Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial.

BACKGROUND: Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. METHODS/DESIGN: The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-ß), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. DISCUSSION: The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. TRIAL REGISTRATION: ISRCTN27483786. Registered on August 2, 2023.

The course of health-related quality of life in the first 2 years after a diagnosis of head and neck cancer: the role of personal, clinical, psychological, physical, social, lifestyle, disease-related, and biological factors.

PURPOSE: The aim of this prospective cohort study was to estimate the relationship between the course of HRQOL in the first 2 years after diagnosis and treatment of head and neck cancer (HNC) and personal, clinical, psychological, physical, social, lifestyle, HNC-related, and biological factors. METHODS: Data were used from 638 HNC patients of the NETherlands QUality of life and BIomedical Cohort study (NET-QUBIC). Linear mixed models were used to investigate factors associated with the course of HRQOL (EORTC QLQ-C30 global quality of life (QL) and summary score (SumSc)) from baseline to 3, 6, 12, and 24 months after treatment. RESULTS: Baseline depressive symptoms, social contacts, and oral pain were significantly associated with the course of QL from baseline to 24 months. Tumor subsite and baseline social eating, stress (hyperarousal), coughing, feeling ill, and IL-10 were associated with the course of SumSc. Post-treatment social contacts and stress (avoidance) were significantly associated with the course of QL from 6 to 24 months, and social contacts and weight loss with the course of SumSc. The course of SumSc from 6 to 24 months was also significantly associated with a change in financial problems, speech problems, weight loss, and shoulder problems between baseline and 6 months. CONCLUSION: Baseline clinical, psychological, social, lifestyle, HNC-related, and biological factors are associated with the course of HRQOL from baseline to 24 months after treatment. Post-treatment social, lifestyle, and HNC-related factors are associated with the course of HRQOL from 6 to 24 months after treatment.

Minimally important differences for interpreting EORTC QLQ-C30 change scores over time: A synthesis across 21 clinical trials involving nine different cancer types.

INTRODUCTION: Early guidelines for minimally important differences (MIDs) for the EORTC QLQ-C30 proposed ≥10 points change as clinically meaningful for all scales. Increasing evidence that MIDs can vary by scale, direction of change, cancer type and estimation method has raised doubt about a single global standard. This paper identifies MID patterns for interpreting group-level change in EORTC QLQ-C30 scores across nine cancer types. METHODS: Data were obtained from 21 published EORTC Phase III trials that enroled 13,015 patients across nine cancer types (brain, colorectal, advanced breast, head/neck, lung, mesothelioma, melanoma, ovarian, and prostate). Anchor-based MIDs for within-group change and between-group differences in change over time were obtained via mean change method and linear regression, respectively. Separate MIDs were estimated for improvements and deteriorations. Distribution-based estimates were derived and compared with anchor-based MIDs. RESULTS: Anchor-based MIDs mostly ranged from 5 to 10 points. Differences in MIDs for improvement vs deterioration, for both within-group and between-group, were mostly within a 2-points range. Larger differences between within-group and between-group MIDs were observed for several scales in ovarian, lung and head/neck cancer. Most anchor-based MIDs ranged between 0.3 SD and 0.5 SD distribution-based estimates. CONCLUSIONS: Our results reinforce recent claims that no single MID can be applied to all EORTC QLQ-C30 scales and disease settings. MIDs varied by scale, improvement/deterioration, within/between comparisons and by cancer type. Researchers applying commonly used rules of thumb must be aware of the risk of dismissing changes that are clinically meaningful or underpowering analyses when smaller MIDs apply.

Late Toxicity and Health-Related Quality of Life Following Definitive Chemoradiotherapy for Esophageal Cancer: A Systematic Review and Meta-analysis.

PURPOSE: Definitive chemoradiotherapy (dCRT) is a treatment option with curative intent for patients with esophageal cancer that could result in late toxicities and affect health-related quality of life (HRQoL). This study aimed to review the literature and perform a meta-analysis to investigate the effect of dCRT on late toxicities and HRQoL in esophageal cancer. METHODS AND MATERIALS: A systematic search was performed in MEDLINE, EMBASE, and PsychINFO. Prospective phase II and III clinical trials, population-based studies, and retrospective chart reviews investigating late toxicity or HRQoL after dCRT (≥50 Gy) were included. The HRQoL outcomes were analyzed using linear mixed-effect models with restricted cubic spline transformation. Any HRQoL changes of ≥10 points were considered clinically relevant. The risk of toxicities was calculated using the number of events and the total study population. RESULTS: Among 41 included studies, 10 assessed HRQoL and 31 late toxicity. Global health status remained stable over time and improved after 36 months compared with baseline (mean change, +11). Several tumor-specific symptoms, including dysphagia, eating restrictions, and pain, improved after 6 months compared with baseline. Compared with baseline, dyspnea worsened after 6 months (mean change, +16 points). The risk of any late toxicity was 48% (95% CI, 33%-64%). Late toxicity risk of any grade for the esophagus was 17% (95% CI, 12%-21%), pulmonary 21% (95% CI, 11%-31%), cardiac 12% (95% CI, 6%-17%), and any other organ 24% (95% CI, 2%-45%). CONCLUSIONS: Global health status remained stable over time, and tumor-specific symptoms improved within 6 months after dCRT compared with baseline, with the exception of dyspnea. In addition, substantial risks of late toxicity were observed.

Co-creative art processes with cancer patients from the artists' perspective: a qualitative study exploring resonance theory.

PURPOSE: Co-creation, characterised by artists and patients creating a joint work of art, may support patients with the integration of life events into their life story, such as living with cancer. In the process of co-creation, resonance relationships between patients, artists and material may evolve that support integration. We aim to investigate if and if so, how resonance relationships occur from the perspective of the artist. METHODS: We used the first 10 audio recordings of supervision sessions between eight artists and their two supervisors on ongoing co-creation processes with cancer patients. By conducting a qualitative template analysis in AtlasTi, we searched for the presence of resonance, as defined by its four main characteristics, Being affected, touched and moved; Self-efficacy and responding; Moments of uncontrollability; and Adaptive transformation. In addition, two case descriptions are presented. RESULTS: We found resonance relationships to be present in the studied co-creation processes where moments of uncontrollability can lead to a next step in the process of co-creation and as such form an important factor within co-creation. CONCLUSIONS: The current study suggests focus on elements of resonance relationships within co-creation, specifically practising with uncontrollability while working with art, could strengthen interventions targeting integration of life events in advanced cancer patients.

Implications of the syntheses on definition, theory, and methods conducted by the Response Shift - in Sync Working Group.

PURPOSE: Our aim is to advance response shift research by explicating the implications of published syntheses by the Response Shift - in Sync Working Group in an integrative way and suggesting ways for improving the quality of future response shift studies. METHODS: Members of the Working Group further discussed the syntheses of the literature on definitions, theoretical underpinnings, operationalizations, and response shift methods. They outlined areas in need of further explication and refinement, and delineated additional implications for future research. RESULTS: First, the proposed response shift definition was further specified and its implications for the interpretation of results explicated in relation to former, published definitions. Second, the proposed theoretical model was further explained in relation to previous theoretical models and its implications for formulating research objectives highlighted. Third, ways to explore alternative explanations per response shift method and their implications for response shift detection and explanation were delineated. The implications of the diversity of the response shift methods for response shift research were presented. Fourth, the implications of the need to enhance the quality and reporting of the response shift studies for future research were sketched. CONCLUSION: With our work, we intend to contribute to a common language regarding response shift definitions, theory, and methods. By elucidating some of the major implications of earlier work, we hope to advance response shift research.

Long-term fear of cancer recurrence in patients treated endoscopically for early Barrett's neoplasia.

Previous studies on fear of cancer recurrence after endoscopic treatment for early Barrett's neoplasia focused on fear during a relatively short period after the intervention. The aim of this study was to explore whether fear of cancer (recurrence) persists during long-term follow-up in patients treated endoscopically for Barrett's neoplasia compared to patients treated surgically for a more advanced stage of esophageal adenocarcinoma. Participants previously participated in a prospective longitudinal study investigating quality of life and fear of cancer recurrence and were treated endoscopically for early Barrett's neoplasia (high-grade dysplasia-T1sm1N0M0) or surgically for a more advanced esophageal adenocarcinoma (T1N0M0-T3N1M0). For the present study, participants were again invited to complete a set of questionnaires including the fear of cancer recurrence scale (FORS), worry for cancer scale (WOCS), and the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS Anxiety). Thirty-nine patients were eligible in the endoscopy group and 28 in the surgical group. The median time between the baseline measurement (original study) and the long-term follow-up assessment was 4 years (interquartile range 3-5 years). Fear and worry for cancer recurrence and general anxiety diminished over time in both treatment groups. However, at long-term follow-up, endoscopically treated patients had significantly higher levels of worry for cancer and general anxiety than surgically treated patients. Fear of cancer recurrence did not significantly differ between endoscopically and surgically treated patients. We found that worry and fear of cancer recurrence and general anxiety in endoscopically treated patients declined over time, but not as much as in surgically treated patients.

Response Shift After Cognitive Behavioral Therapy Targeting Severe Fatigue: Explorative Analysis of Three Randomized Controlled Trials.

BACKGROUND: Cognitive behavioral therapy (CBT) is an evidence-based intervention for severe fatigue. Changes in patients' fatigue scores following CBT might reflect not only the intended relief in fatigue but also response shift, a change in the meaning of patients' self-evaluation. Objectives were to (1) identify the occurrence of response shift in patients undergoing CBT, (2) determine the impact of response shift on the intervention effect, and (3) investigate whether changes in fatigue-related cognitions and perceptions, targeted during CBT, are associated with response shift. METHODS: Data of three randomized controlled trials testing the efficacy of CBT in individuals with chronic fatigue syndrome (CFS, n = 222), cancer (n = 123), and diabetes (n = 107) were re-analyzed. Fatigue severity was measured with 8 items from the Checklist Individual Strength, a valid and widely used self-report questionnaire. Structural equation modelling was applied to assess lack of longitudinal measurement invariance, as indication of response shift. RESULTS: As expected, in all three trials, response shift was indicated in the CBT groups, not the control groups. Response shift through reprioritization was indicated for the items "Physically, I feel exhausted" (CFS) and "I tire easily" (cancer, diabetes), which became less vs. more important to the measurement of fatigue, respectively. However, this did not affect the intervention effects. Some changes in cognitions and perceptions were associated with the response shifts. CONCLUSIONS: CBT seems to induce response shift through reprioritization across patient groups, but its occurrence does not affect the intervention effect. Future research should corroborate these findings and investigate whether patients indeed change their understanding of fatigue.

Clinical judgment of the need for professional mental health care in patients with cancer: a qualitative study among oncologists and nurses.

PURPOSE: In daily practice, oncologists and nurses frequently need to decide whether or not to refer a patient for professional mental health care. We explored the indicators oncologists and nurses use to judge the need for professional mental health care in patients with cancer. METHODS: In a qualitative study, oncologists (n = 8) and nurses (n = 6) were each asked to select patients who were or were not referred for professional mental health care (total n = 75). During a semi-structured interview, they reflected on their decision concerning the possible referral of the patient. Thematic analysis was used to analyze the data. RESULTS: Respondents reported using a strategy when judging whether professional mental health care was needed. They allowed patients time to adjust, while monitoring patients' psychological well-being, especially if patients exhibited specific risk factors. Risk and protective factors for emotional problems included personal, social, and disease- and treatment-related factors. Respondents considered referral for professional mental health care when they noted specific indicators of emotional problems. These indicators included lingering or increasing emotions, a disproportionate intensity of emotions, and emotions with a negative impact on a patient's daily life or treatment. CONCLUSIONS: This study identified the strategy, risk and protective factors, and the indicators of emotional problems used by oncologists and nurses when judging the need for professional mental health care in patients with cancer. IMPLICATIONS FOR CANCER SURVIVORS: Oncologists and nurses can play an important role in the identification of patients in need of professional mental health care.

Predicting viral load suppression by self-reported adherence, pharmacy refill counts and real time medication monitoring among people living with HIV in Tanzania.

INTRODUCTION: Monitoring of adherence to antiretroviral treatment (ART) is of utmost importance to prevent treatment failure. Several measures to monitor adherence have been applied in low-resource settings and they all have pros and cons. Our objective was to examine whether any of the following adherence measures is a better predictor of participants' viral load suppression: (1) self-report, (2) pharmacy refill count, (3) Real Time Medication Monitoring (RTMM), (4) a combination of self-report and pharmacy refill count or (5) all three adherence assessment methods combined. METHODOLOGY: This was a post-hoc analysis of data from our 48-week REMIND-HIV randomized controlled trial in which adherence to ART was measured using self-report, pharmacy refill counts and RTMM among ART-experienced adults living with HIV subjectively judged to be nonadherent to ART. For each adherence measure, we calculated sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for predicting virological failure defined as a viral load (VL) of > 20 copies/mL. To determine at which percentage of adherence the prediction was strongest, we evaluated adherence cut-offs of 80%, 85%, 90%, 95% and 100% using receiver operating characteristic (ROC) curves. VL data were obtained after 48 weeks of follow-up in the trial. RESULTS: A total of 233 people living with HIV (PLHIV) were included in this analysis. When comparing the ability of self-reported adherence with pharmacy refill count and RTMM adherence to predict viral load > 20 copies/ml, self-reported adherence had the lowest sensitivity, ranging from 6 to 17%, but the highest specificity, ranging from 100 to 86%, depending on cut-off values from 80 to 100%. Area under the ROC curves (AUC) were 0.54 for RTMM, 0.56 for pharmacy refill count and 0.52 for self-report, indicating low discriminatory capacity for each of the adherence measures. When we combined the self-report and pharmacy refill count measures, sensitivity increased, ranging from 28 to 57% but specificity decreased, ranging from 83 to 53%. When all three measures were combined, we observed the highest value of sensitivity, ranging from 46 to 92%, and PPV, ranging from 32 to 36%, at high cut-offs ranging from 80 to 100%. Upon combination of three adherence measures, the AUC increased to 0.59. CONCLUSION: Our results show that adherence assessed exclusively by self-report, pharmacy refill count or RTMM were insufficiently sensitive to predict virologic failure. Sensitivity markedly improved by combining all three measures, but the practical feasibility of such an approach would need to be studied.

Co-creative art processes with patients: A theoretical framework and qualitative study among artists.

A cancer diagnosis may be experienced as a contingent life event. Co-creation-in which artists together with patients create a work of art reflecting on aspects of the patients' life story-may be used to support patients to integrate such a contingent life event into their life story. We conducted a qualitative study in which we interviewed 10 professional artists to explore if co-creative art processes could facilitate integration of experiences of contingency in patients. Template analyses were performed in AtlasTi. We identified co-creation as a specific form of support to the process of integration of experiences of contingency. In the formation of a new life narrative, patients transcend the boundaries of their previous life narrative by changing their perspective. Self-transcendence forms a pivotal point in co-creation, which may be helpful for patients to integrate experiences of contingency into their life narratives.

Minimally important differences of EORTC QLQ-C30 scales in patients with lung cancer or malignant pleural mesothelioma - Interpretation guidance derived from two randomized EORTC trials.

OBJECTIVES: A minimally important difference (MID) is the smallest difference in quality of life (QoL) perceived as relevant by patients or clinicians. MIDs aid interpretation of QOL data in research and clinical practice. We aimed to determine MIDs for the EORTC QLQ-C30 for patients with lung cancer or malignant pleural mesothelioma. MATERIALS AND METHODS: Data were drawn from two EORTC-sponsored randomized clinical trials (RCTs): a three-arm RCT of two cisplatin-based treatments and paclitaxel plus gemcitabine in advanced non-small-cell lung cancer, and an RCT comparing cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma. MIDs for interpreting within-group change and between-group differences in change over time were computed using anchor-based approaches, for improvements and deteriorations separately. Distribution-based approaches provided corroborative evidence. RESULTS: The combined data from the trials comprised 730 patients. Available data allowed us to determine 8/14 anchor-based MIDs for EORTC scales for improvements, and 9/14 MIDs for deterioration. Furthermore, we provided distribution-based estimates for all 14 QLQ-C30 scales. Most MIDs for improvements ranged between 5 and 10, for both within-group and between-group differences. Outliers were appetite loss and constipation, with MIDs up to 15 score points. MIDs were slightly larger for within-group deterioration, ranging from -5 to - 15, with the largest for Nausea/vomiting (-1 to 4) and Appetite loss (-1 to 5). MIDs for between-group differences in deterioration ranged from - 4 (Physical, Role, and Social functioning, and Global quality of life) to -9 (Nausea/vomiting, Appetite loss and Constipation). CONCLUSIONS: MIDs vary over scales and for between- versus within-group comparisons; this must be taken into account when interpreting changes. Nevertheless, the majority of MIDs range between 5 and 10 score points, in line with previously used thresholds for QLQ-C30. These findings and those from other tumor-specific MID analyses will inform a planned consensus process identifying commonalities and differences across tumor sites.