Evaluating the feasibility and acceptability of an adapted fencing intervention in breast cancer surgery post-operative care: the RIPOSTE pilot randomized trial.

Background: Adapted physical activity programs have shown promising results in reducing the physical, social and psychological side effects associated with breast cancer, but the extent to which they can be effectively adopted, implemented and maintained is unclear. The aim of this study is to use the framework to guide the planning and evaluation of programs according to the 5 following keys: Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to evaluate a fencing program under the French acronym RIPOSTE (Reconstruction, Image de soi, Posture, Oncologie, Santé, Thérapie, Escrime) literally in English (Reconstruction, Self-Image, Posture, Oncology, Health, Therapy, Fencing). This program is an innovative intervention focused on improving the quality of life (QoL) of breast cancer surgery patients through fencing. Methods: A convergent mixed methods pilot study was conducted to preliminary evaluate the different RE-AIM dimension of the pilot program. Twenty-four participants who have just undergone surgery for invasive breast cancer were randomly allocated in two groups: one group started immediately after their inclusion (Early RIPOSTE group) and the other started 3 months following their inclusion (Delayed RIPOSTE group). Participants answered a questionnaire at inclusion and at the end of the program on QoL, shoulder functional capacity, fatigue, anxiety-depression and physical activity. Results: RIPOSTE program was able to reach mainly young and dynamic participants, attracted by the originality of fencing and keen to improve their physical condition. Regarding effectiveness, our results suggest a trend to the improvement of QoL, shoulder functional capacity, fatigue and anxiety-depression state, even without any significant differences between the Early RIPOSTE group and the Delayed RIPOSTE group. Discussions: The cooperation, exchanges and cohesion within the group greatly facilitated the adoption of the program, whereas interruptions during school vacations were the main barriers. The intervention was moderately well implemented and adherence to the protocol was suitable. Conclusion: RIPOSTE is an acceptable and effective program for involving breast cancer survivors in physical activity, that needs to be tested at a larger scale to investigate its effectiveness, but has the potential to be transferred and scaled up worldwide.

Validation and optimization of the French Generic Adherence for Chronic Diseases Profile (GACID-P) using classical test and item response theory.

BACKGROUND: The Generic Adherence for Chronic Diseases Profile is a French generic scale (GACID-P) developed to measure adherence in several disease areas such as cardiology, rheumatology, diabetes, cancer and infectiology. METHOD: We aimed to study the measurement invariance of the Generic Adherence for Chronic Diseases Profile by an item response model, optimize the new instrument version from item response model and qualitative content analyses results, and validate the instrument. The metric properties of the optimized version were studied according to classical test theory and item response model analysis. RESULTS: A sample of 397 patients consulting at two French hospitals (in diabetes, cardiology, rheumatology, cancerology and infectiology) and in four private practices was recruited; 314 (79%) patients also completed the questionnaire 15 days later. Factor analyses revealed four dimensions: "Forgetting to take medication", "Intention to comply with treatment", "Limitation of risk-related consumer habits" and "Healthy lifestyle". The item response model and content analyses optimized these four dimensions, regrouping 32 items in four dimensions of 25 items, including one item conditioned on tobacco use. The psychometric properties and scale calibration were satisfactory. One score per dimension was calculated as the sum of the items for the dimensions "Forgetting to take medication" and "Intention to comply with treatment" and as a weighted score according to the item response model analysis for the two other dimensions because of differential item functioning found for two items. CONCLUSION: Four adherence profile scores were obtained. The instrument validity was documented by a theoretical approach and content analysis. The Generic Adherence for Chronic Diseases Profile is now available for research targeting adherence in a broad perspective.

Oncology health professionals' perspectives of determinants of exercise by cancer patients: A socio-ecological approach.

PURPOSE: Scientific evidence has shown that practicing exercise reduced the risk of overall and cancer-specific mortality for cancer patients. Numerous studies have shown limited support has been provided by cancer and general health professionals. This present study identifies determinants of suggesting of exercise from the oncology health professionals' perspective by using a socio-ecological approach. METHOD: Health professionals from two oncology services in France were contacted, which resulted in 36 semi-structured interviews questioning elements of support for exercise, from individual to political determinants. RESULTS: intrapersonal-level findings revealed that exercise is considered complementary to treatment, not recommended at all times of the disease duration and not to all patients. For interpersonal determinants, health professionals discuss exercise based on their own sport practice and their exercise knowledge. Health professionals interchangeably use exercise, sport, or exercise. Examination of institutional determinants showed that the oncology services did not use tools to evaluate or follow up on exercise. Only one of the services had an exercise referral scheme. Examination of community determinants showed that health professionals identified a diversity of exercise providers, without the ability to differentiate exercise program quality. Public policy findings have shown that despite an exercise prescription law, health professionals do not prescribe exercise, do not know how to prescribe it, and consider that the exercise useless because of no refund system for patients. CONCLUSIONS: The results provide a systemic understanding of the determinants helping cancer patients and health professionals improve adherence to exercise.

Adapted Fencing for Patients With Invasive Breast Cancer: The RIPOSTE Pilot Randomized Controlled Trial.

Introduction: Even if indications for mastectomy have been progressively reduced in loco-regional breast cancer (BC) treatment, the harmful effects of surgery are still numerous and can impact physical and psychological wellbeing of women. The RIPOSTE (Reconstruction, self-Image, Posture, Oncology, "Santé"-Health, Therapy, "Escrime"-Fencing) program aimed to propose adapted fencing to patients with BC. This study aims to investigate the effect and conditions of effectiveness of the RIPOSTE program. Methods and analysis: This is a prospective randomized controlled trial including 24 patients with invasive BC who have just undergone surgery. The study will be proposed to the patient and if interested, the patient will be referred to a sports physician for a medico-sportive evaluation. At the end the evaluation, if the patient meets the inclusion criteria, she will be randomly assigned to one of the 2 groups based on a 1:1 principle: Early RIPOSTE group (receive one fencing session per week for 3 months immediately after their inclusion), Delayed RIPOSTE group (receive one fencing session per week for 3 months but within the 3 months following their inclusion). Patients will be included for 6 months with 3 follow-up times (0, 3, and 6 months) by a sport physician. The primary outcome is the evolution of quality of life score. Secondary outcomes are disability score, fatigue, anxiety-depression, cost-effectiveness and process evaluation. Ethics and dissemination: The study protocol has been approved by a French ethics committee (CPP Sud Méditerranée IV, N°ID-RCB: 2020-A01916-33). Results will be submitted for publication, at scientific conferences and through press releases. Trial Registration: NCT04627714.

EMDR in Telemental Health Counseling for Healthcare Workers Caring for COVID-19 Patients: A Pilot Study.

BACKGROUND: The COVID-19 pandemic is putting a strain on health systems around the world. Healthcare workers, on the front lines of the epidemic, are facing major and potentially traumatic stressful events, overwhelming their ability to cope and their resources. OBJECTIVE: The objective of this article will be to show how the use of the URG-EMDR protocol in a telemental health setting has proven to be feasible and effective in the treatment of a group of healthcare professionals working in nursing homes or hospital services that were highly mobilized during the acute phase of COVID-19. METHOD: 17 participants, registered nurses (N = 7) and licensed practical nurses (N = 10), were remotely treated using the URG-EMDR protocol in a single session. The assessment focused on anxiety and depressive symptoms (HAD scale) and the level of perceived disturbance (SUD). An additional evaluation of the satisfaction with the remote psychotherapy intervention was conducted. RESULTS: As the URG-EMDR protocol has already proven itself during emergency interventions, it is interesting to note that its remote use in the treatment of healthcare providers caring for COVID-19 patients allows for an improvement in the emotional state and a decrease in perceived disturbance, in a single session. This result is maintained 1 week after the intervention, despite the continued professional activities of the participants and the continuity of the event. Moreover, the remote therapy setting was judged satisfactory by the patients, even if it required adjustments and certain recommendations for practice. DISCUSSION: The remote use of the URG-EMDR protocol opens up innovative perspectives for early interventions and the prevention of the development of psychological disorders in the long term following a situation of acute stress.

Trajectory analysis combining pain and physical function in individuals with knee and hip osteoarthritis: results from the French KHOALA cohort.

OBJECTIVES: The aims of this study were to identify homogeneous subgroups of knee and/or hip OA patients with distinct trajectories of the combination of pain and physical function (PF) over time and to determine the baseline factors associated with these trajectories. METHODS: We used data from the Knee and Hip Osteoarthritis Long-term Assessment (KHOALA) cohort, a French population-based cohort of 878 patients with symptomatic knee and/or hip OA. Pain and PF were measured annually over 5 years with the Medical Outcomes Study Short Form 36 questionnaire. First, trajectory models were estimated with varying numbers of groups for each of the outcomes separately then fitted into a multi-trajectory model. We used multinomial logistic regression to determine the baseline characteristics associated with each trajectory. RESULTS: Univariate four-class models were identified as most appropriate for pain and PF. Comparison of separate trajectories showed that 41% of patients included in the severe functional limitations trajectory did not belong to the more severe pain trajectory (Cramér's V statistic = 0.45). Group-based multi-trajectory modelling revealed four distinct trajectories of pain and PF. On multivariate analyses, female sex, older age, high Kellgren grade, low physical activity intensity, low psychosocial distress score (high distress) and low vitality score were associated with the more severe symptoms trajectory. CONCLUSION: Over 5 years, we identified four distinct trajectories combining pain and PF. Management of weight, fatigue and psychosocial distress and the practice of physical activity seem important to maintain function and limit pain in patients with lower-limb OA.

What Have We Learned About the Course of Clinical Outcomes After Total Knee or Hip Arthroplasty?

OBJECTIVE: To review homogeneous subgroups with a distinct course of clinical outcomes, to review the course of clinical outcomes in the study population as a whole, where applicable, and to determine the patient characteristics associated with the distinct courses after total knee or hip arthroplasty. METHODS: MEDLINE and PsycInfo databases were searched for relevant studies. Selection criteria were patients ≥18 years old, patients at high risk of or diagnosed with knee or hip osteoarthritis, studies aiming to identify homogeneous subgroups with distinct trajectories or describe the mean change of clinical outcomes, and methodology and analysis designed to identify trajectories (longitudinal design and repeated measures). RESULTS: Of the 5,128 abstracts retrieved, 23 met inclusion criteria. Most studies (12 of 23) focused on the mean course of outcomes after knee arthroplasty, and the most frequent outcomes reported were pain and physical function. Statistical approaches used, the number of trajectories, and predictors identified were heterogeneous across studies. Strong evidence was found that female sex, a high body mass index, poor mental health, a high number of painful sites, high preoperative pain level, a low preoperative lower-extremity functioning, and knee arthroplasty were predictors of bad evolution. CONCLUSION: Few studies have used trajectory analysis to describe the course of clinical outcomes in homogeneous subgroups of patients. Yet this approach could lead to the identification of predictors of poor postsurgery outcomes that are specific to patients and thus to earlier identification of poor responders to total arthroplasty.

What Have We Learned From Trajectory Analysis of Clinical Outcomes in Knee and Hip Osteoarthritis Before Surgery?

OBJECTIVE: The past decade has seen a rapid increase in the publication of studies using trajectory analysis to describe the course of osteoarthritis (OA) symptoms. The aim of this systematic review was to describe the distinct trajectories for OA outcomes and the predictors of these trajectories. METHODS: Medline and PsycInfo databases were searched for relevant studies. Selection criteria were 1) patients ≥18 years of age, 2) patients at high risk of or diagnosed with knee or hip OA, 3) studies aiming to identify homogeneous subgroups with distinct trajectories of clinical outcomes, and 4) methodology and analysis designed to identify trajectories (longitudinal design and repeated measures). The search was limited to publications in English or French. RESULTS: Of the 5,177 abstracts retrieved, 44 studies met the inclusion criteria; 21 described the disease progression before surgery. The most frequent outcomes were pain and physical function. Up to 6 trajectories of pain were found for hip and knee OA. For function, between 1 and 5 trajectories were identified for knee OA. Low educational level, high body mass index, and high number of comorbidities were the most reported predictors of bad evolution. CONCLUSION: Although studies were heterogeneous (outcome, subgroup number, and composition), they revealed stable OA trajectories over time. This finding suggests that OA is a chronic disease that does not inevitably worsen in terms of patient-reported symptoms.

Factors of the evolution of fatigue dimensions in patients with breast cancer during the 2 years after surgery.

Women with breast cancer are increasingly being cured of the disease but fatigue remains the most frequently reported symptom. The aims of our study were to identify distinct trajectories in four fatigue dimensions during 2 years after breast cancer surgery and to explore the demographic, clinical and personality characteristics associated with these profiles. We included women from the prospective longitudinal multicenter FATSEIN cohort in France. They completed the Multidimensional Fatigue Inventory for nine follow-ups over 24 months after surgery. A group-based trajectory model identified distinct trajectories in each fatigue dimension. Multinomial logistic regression determined the factors associated with each profile. From the 459 women followed, 3-5 fatigue trajectories were revealed in each fatigue dimension, from its absence to its severest degree. In our multivariate analysis, the risk of severe fatigue was decreased in all dimensions by a high quality of life before surgery (measured by the European Organization for Research and Treatment of Cancer 30-item QoL questionnaire; e.g., for general and physical fatigue: OR = 0.93, 95% CI 0.91, 0.96), especially a high physical and emotional functions for general and physical fatigue, and a high cognitive function for mental fatigue. Both severe mental fatigue and severely reduced motivation worsened with low optimism before surgery (e.g., for mental fatigue: OR = 0.93, 95% CI 0.89, 0.97). Severely reduced activities increased by having chemotherapy (OR = 9.41, 95% CI 2.28, 38.79). Targeting women at risk for severe fatigue can provide early preventive and curative treatment and appropriate psychological support.

Psychological and social determinants of physical activity from diagnosis to remission among French cancer patients (PERTINENCE): protocol for a mixed-method study.

BACKGROUND: Many effective physical activity (PA) interventions have focused on individual factors or a single theoretical model, limiting our understanding of the determinants of PA practice and their interactions in the cancer trajectory. The present mixed-method study aims to capture social and psychological determinants of PA practice from diagnosis to remission among cancer patients, and to identify key levers for PA practice. METHODS/DESIGN: A nested sequential mixed-method design QUAN (QUAL+QUAL) will be used, with qualitative studies embedded in the quantitative study to broaden our understanding of the determinants of PA practice. The design is sequential, since qualitative data on medical staff will be collected before patient inclusion (Phase 1), followed by quantitative patient data collection lasting one year (Phase 2) and a final qualitative data collection one year after inclusion (Phase 3). Phase 1 will be a case study in the two hospitals involved in the study, exploring knowledge of and support for PA practice among medical staff. Through interviews and documental analyses, the PA support dynamic will be evaluated with regard to PA prescription. Phase 2 will be a one-year observational study among 693 cancer patients. Quantitative medical, social, dispositional and psychological data, PA practices and preferences, will be collected at diagnosis, and six months and one year thereafter. Phase 3 will be a retrospective study, evaluating societal and policy factors, as well as unexpected factors playing a role in PA levels and preferences among cancer patients. For this phase thirty patients will be identified six months after inclusion on the basis of their PA profiles. Quantitative data will provide the main dataset, whilst qualitative data will complete the picture, enabling determinants of PA practice and their interactions to be captured throughout the cancer trajectory. DISCUSSION: The present study aims to identify key levers and typical trajectories for PA practice among cancer patients, adapted to different times in the course of cancer and taking into account "what works", "for whom", "where" and "how". The challenge is the tailoring of PA interventions to patients at different times in their cancer trajectory, and the implication of medical staff support. TRIAL REGISTRATION: Clinical Trial NCT03919149 , 18 April 2019. Prospectively registered.

Serum albumin or body mass index: Which prognostic factor for survival in patients with acute myeloblastic leukaemia?

Obesity has been associated with an increased risk of developing acute myeloblastic leukaemia (AML). The outcome of AML patients could thus be dependent on their nutritional status that can be evaluated by the simple measurement of serum albumin (SA) and body mass index (BMI). These two parameters could have a value as prognostic factors to guide patients' management. We evaluated the association between SA levels, BMI, and survival, evaluated as overall survival (OS) and event-free survival. Furthermore, we investigated the association between BMI, SA, and other prognostic factors of interest in AML. This retrospective single-center study included 159 patients diagnosed with AML at Nancy Hospital between 2005 and 2013, treated with aracytine and anthracycline. Forty-four percent of patients presented with normal weight while 56% were obese/overweight. Serum albumin levels were <30 g/L for 49 patients, and ≥30 g/L for 110. Thirty-four patients with low SA levels were also obese. Favourable OS was associated with SA levels ≥30 g/L (HR = 0.467; 95% CI 0.230-0.946; P = .034) but was not impacted by the BMI. Serum albumin levels appear to be an independent prognostic factor in AML and a better parameter than BMI for evaluating the nutritional status of patients at diagnosis.

Qualitative Methods Used to Generate Questionnaire Items: A Systematic Review.

A systematic review of articles using qualitative methods to generate questionnaire items identified in MEDLINE and PsycINFO from 2000 to 2014 was carried out. Articles were analyzed for (a) year of publication and journal domain, (b) qualitative data collection methods, (c) method of data content analysis, (d) professional experts' input in item generation, and (e) debriefing of the newly developed items. In total, 371 articles were included and results showed (a) an acceleration of published articles, (b) individual interviews and focus groups were common ways of generating items and no emergent approach was identified, (c) the content analysis was usually not described (43% of articles), (d) experts were involved in eliciting concepts in less than a third of articles, (e) 61% of articles involved a step of further submission of newly developed items to the population of interest. This review showed an insufficient reporting of qualitative methods used to generate new questionnaires despite previous recommendations.

Can the e-OAKHQOL be an alternative to measure health-related quality of life in knee osteoarthritis?

OBJECTIVE: To assess the validity of the e-OAKHQOL questionnaire and analyze whether the answers were affected by the form of administration (electronic vs. paper). METHODS: Two samples of patients with knee osteoarthritis were constituted. The first was recruited by general practitioners. Patients could choose to respond to the electronic or paper version. The second included subjects who responded to the paper version and were matched with respondents to the electronic version in the first sample. The OAKHQOL questionnaire measures health-related quality of life in five dimensions (43 items): physical activity, mental health, pain, social functioning, and social support. Validity was assessed by the classical test theory (CTT) and a Rasch measurement model (partial credit model). RESULTS: The electronic form was preferred by 471 (89.7%) patients: 345 were matched to respondents of the paper version. The percentage of missing responses was lower with the electronic than paper form (1.6 vs. 2.0%, p = .01). Rasch analysis revealed four items with underfitting. Internal consistency was excellent for physical activity (PSI = 0.96) and mental health (PSI = 0.93) but was slightly < 0.85 for the other dimensions. The top-down purification highlighted the significance of DIF by gender in the pain dimension and by form of questionnaire in the mental health dimension. CONCLUSION: CTT and Rasch analysis demonstrated acceptable measurement properties for the five dimensions of the e-OAKHQOL, so it may be a valuable alternative to the paper form for measuring HRQoL.

The impact of physical activity on fatigue and quality of life during and after adjuvant treatment for breast cancer.

BACKGROUND: Although physical activity (PA) can alleviate fatigue and improve quality of life (QoL) in patients with breast cancer (BC), not all domains of PA may have equal impact. The objective of the current study was to examine the longitudinal impact of PA components on the evolution of fatigue and QoL during and after adjuvant treatment for BC. METHODS: The women included in the study were participants in the 2-year longitudinal FATSEIN ("Fatigue dans le cancer du Sein") study. Fatigue and QoL were measured using the Multidimensional Fatigue Inventory and the European Organization for Research and Treatment of Cancer 30-item QoL questionnaire, respectively. Group-based trajectory analysis was used to determine patterns of PA evolution (frequency, duration, and intensity). Cross-sectional and longitudinal associations between PA patterns and fatigue and QoL were analyzed by using multivariable linear regression and a mixed model. RESULTS: Among the 424 women who were included (mean ± standard deviation age, 57.1 ± 10.4 years), 2 trajectories were identified for each of the 3 PA components: low and insufficient frequency (51.2%) or regular and moderate frequency (48.8%), low and insufficient duration (47.6%) or regular and moderate duration (52.4%), and low intensity (47.2%) or low to moderate intensity (52.8%). Overall, during treatment, fatigue was increased and QoL was decreased, and the reverse was observed after treatment. During treatment, increased fatigue and decreased QoL were limited by regular PA frequency (ß = -8.71 for total fatigue; ß = 14.59 for emotional function), but the results were less significant after treatment. CONCLUSIONS: PA, especially its frequency, is an important determinant of fatigue and QoL during adjuvant treatment for BC. The promotion of regular PA among women who are receiving treatment for BC may be an effective way to reduce fatigue and improve QoL. Cancer 2018;124:797-806. © 2017 American Cancer Society.

Identifying patterns of adaptation in breast cancer patients with cancer-related fatigue using response shift analyses at subgroup level.

Fatigue is the most prevalent symptom in breast cancer. It might be perceived differently among patients over time as a consequence of the differing patients' adaptation and psychological adjustment to their cancer experience which can be related to response shift (RS). RS analyses can provide important insights on patients' adaptation to cancer but it is usually assumed that RS occurs in the same way in all individuals which is unrealistic. This study aimed to identify patients' subgroups in which different RS effects on self-reported fatigue could occur over time using a combination of methods for manifest and latent variables. The FATSEIN study comprised 466 breast cancer patients followed over a 2-year period. Fatigue was measured with the Multidimensional Fatigue Inventory questionnaire (MFI-20) during 10 visits. A novel combination of Mixed Models, Growth Mixture Modeling, and Structural Equation Modeling was used to assess the occurrence of RS in fatigue changes to identify subgroups displaying different RS patterns over time. An increase in fatigue was evidenced over the 8-month follow-up, followed by a decrease between the 8- and 24-month. Four latent classes of patients were identified. Different RS patterns were detected in all latent classes between the inclusion and 8 months (last cycle of chemotherapy). No RS was evidenced between 8- and 24-month. Several RS effects were evidenced in different groups of patients. Women seemed to adapt differently to their treatment and breast cancer experience possibly indicating differing needs for medical/psychological support.

Effect of Multimorbidity on Health-Related Quality of Life in Adults Aged 55 Years or Older: Results from the SU.VI.MAX 2 Cohort.

INTRODUCTION: Multimorbid chronic diseases are usually considered separately in trials. Here, we aimed to describe overall multimorbidity patterns in adults aged 55 years or older and assess their effect on health-related quality of life (HRQoL). METHODS: We used data for 5,647 participants included in the SUpplémentation en VItamines et Minéraux AntioXydants 2 (SU.VI.MAX 2) population-based trial. HRQoL was assessed by the French versions of the Medical Outcome Study Short Form 36 and the Duke Health Profile. An exploratory factor analysis was used to determine multimorbidity patterns, and a multimorbidity score for each resulting pattern was calculated. Adjusted multiple linear regression was used to examine the association between the identified multimorbidity and HRQoL scores by gender and for each age group (55-59, 60-64, 65-69, ≥ 70 years). RESULTS: More than 63% of the sample reported two or more chronic conditions (from 55.8% for those 55-59 years to 74.4% for those ≥ 70 years). Multimorbidity was more common among women than men (67.3% vs 60%). Two different multimorbidity patterns were identified. Pattern A was represented mainly by mental illness and bone impairments. Pattern B was represented mainly by cardiovascular and metabolic disorders. After adjusting for covariates, a high pattern A score was associated with reduced HRQoL for the physical and mental components of each HRQoL questionnaire, and a high pattern B score was associated with reduced HRQoL for only the physical component of each questionnaire. These multimorbidity scores affected HRQoL differently by age group. CONCLUSION: Our study used a novel methodological approach to account for multimorbidity patterns in determining the link with chronic conditions. These multimorbidity scores (counted and weighted) can be used in clinical research to control for the effect of multimorbidity on patients' HRQoL and may be useful for clinical practice. CLINICAL TRIAL REGISTRATION: Clinicaltrial.gov (number NCT00272428).

Early Psychological Preventive Intervention For Workplace Violence: A Randomized Controlled Explorative and Comparative Study Between EMDR-Recent Event and Critical Incident Stress Debriefing.

This randomized controlled trial study aims to investigate the efficacy of an early psychological intervention called EMDR-RE compared to Critical Incident Stress Debriefing on 60 victims of workplace violence, which were divided into three groups: 'EMDR-RE' (n = 19), 'CISD' (n = 23), and 'delayed EMDR-RE' (n = 18). EMDR-RE and CISD took place 48 hours after the event, whilst third intervention was delayed by an additional 48 hours. Results showed that after 3 months PCLS and SUDS scores were significantly lower with EMDR-RE and delayed EMDR-RE compared to CISD. After 48 hours and 3 months, none of the EMDR-RE-treated victims showed PTSD symptoms.

Impact of TG4010 Vaccine on Health-Related Quality of Life in Advanced Non-Small-Cell Lung Cancer: Results of a Phase IIB Clinical Trial.

BACKGROUND: This study describes the effect of TG4010 vaccine on Health related Quality of Life (HRQOL) in patients with stage IIIb and IV non-small-cell lung cancer (NSCLC). METHODS: 148 patients with advanced NSCLC expressing MUC1 were randomly assigned to receive TG4010 plus chemotherapy or chemotherapy alone. HRQOL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) at baseline and every 6 weeks until disease progression. Time until definitive deterioration (TUDD) of the four well-being dimensions of the FACT-L physical (PWB), functional (FWB), emotional (EWB) and social well-being (SWB) and the Lung Cancer Subscale (LCS) domains were analyzed for a 5-point minimal clinically important difference. RESULTS: No difference of TUDD of HRQOL has been found between treatment arms. No prognostic factors have been found to have a significant impact on the TUDD of PWB, SWB and LCS domains. The gender, the performance status and the smoking habits seemed to be associated with a shorter TUDD of EWB domain. The smokers and the former smokers seemed to present a shorter TUDD of FWB domain. CONCLUSION: This study suggests that adding therapeutic vaccination with TG4010 to standard chemotherapy in patients with advanced NSCLC is associated with a similar evolution in HRQOL compared to chemotherapy alone.

Factors associated with fatigue after surgery in women with early-stage invasive breast cancer.

PURPOSE: Fatigue is one of the most frequent symptoms in patients with cancer. However, the precise determinants of fatigue are still unknown. This study was conducted to investigate factors correlated with cancer-related fatigue before surgery and just before subsequent adjuvant therapy. METHODS: Patients completed the Multidimensional Fatigue Inventory (MFI-20), the European Organization for Research and Treatment of Cancer 30-item quality-of-life questionnaire before and after surgery, the Trait Anxiety Inventory and the Life Orientation Test before surgery, and the State Anxiety Inventory before the start of adjuvant therapy. Multiple regression analysis of determinants of change in MFI-20 total score after surgery was conducted. RESULTS: A series of 466 eligible patients with stage I-III breast cancer with planned surgery were recruited. An increase in MFI-20 total score after surgery was significantly correlated with higher preoperative fatigue and lower role functioning before surgery; a decrease in role functioning, physical functioning, and cognitive functioning after surgery; an increase in insomnia after surgery; and a higher state anxiety after surgery. Disease stage, lymph node metastases, surgical procedure, and demographic characteristics (e.g., age, marital status, having children, educational level) were not correlated with fatigue in multivariate analysis. CONCLUSION: These results suggest that worsening fatigue after surgery for breast cancer is associated with a decrease in physical functioning and an increase in psychological distress rather than with the cancer characteristics. Therefore, screening measures should be implemented at the time of diagnosis-before starting treatment-to identify psychologically vulnerable patients and to offer them professional support.

Responsiveness of EORTC QLQ-C30, QLQ-CR38 and FACT-C quality of life questionnaires in patients with colorectal cancer.

BACKGROUND: The aim of this study was to compare the responsiveness of the European Organization for Research and Treatment (EORTC) quality of life questionnaires (QLQ-C30, QLQ-CR38) and the Functional Assessment of Cancer Therapy-colorectal version 4 questionnaire (FACT-C). METHOD: This prospective study included 127 patients with colorectal cancer: 71 undergoing chemotherapy and 56 radiation therapy. Responsiveness statistics included the Standardized Response Mean (SRM) and the Effect Size (ES). The patient's overall assessment of his/her change in state of health status was the reference criterion to evaluate the responsiveness of the QoL questionnaires. RESULTS: 34 patients perceived their health as stable and 17 as improved between the first and the fourth courses of chemotherapy. 21 patients perceived their health as stable and 22 as improved between before and the last week of radiotherapy.The responsiveness of the 3 questionnaires differed according to treatments. The EORTC QLQ-C30 questionnaire was more responsive in patients receiving chemotherapy, particulary functional scales (SRM > 0.55). The QLQ-CR38 and the FACT-C questionnaires provided little clinically relevant information during chemotherapy or radiotherapy. CONCLUSION: The EORTC QLQ-C30 questionnaire appears to be more responsive in patients receiving chemotherapy.