Quality Of Life In Patients Research Articles

Impact of Anxiety, Depression, and Coping Strategies on Health-Related Quality of Life in Patients with Cystic Fibrosis.

With the significant increase in the life expectancy of cystic fibrosis (CF) patients, many individuals now reach adulthood and develop specific coping strategies to maintain their physical and mental well-being. This study aims to evaluate coping styles and their relationship with mental health and Health-Related Quality of Life (H-RQoL) in adult CF patients. Thirty adult CF patients completed the Hospital Anxiety and Depression Scale to assess anxiety and depression, the Cystic Fibrosis Questionnaire-Revised to evaluate quality of life, and the Brief Coping Orientation to Problems Experienced questionnaire to assess coping strategies. Twelve individuals (40%) met the diagnostic criteria for being at risk of experiencing anxiety and/or depression. Anxiety risk group exhibited lower life quality scores in the domains of vitality, emotional functioning, and role limitations (P = .027, P = .001, and P = .001, respectively). Patients reporting depressive symptoms had lower scores in emotional functioning and role limitations domains of quality of life (P = .005 and P = .018, respectively). Multivariate analysis indicated that depression and anxiety scores were significant predictors of emotional quality of life. In terms of coping strategies, "acceptance" was the most commonly preferred, while "substance use" was the least preferred strategy among all participants. Patients at risk of anxiety and/or depression often chose "avoidance" as their coping strategy. Anxiety and depressive symptoms are prevalent and associated with poorer H-RQoL in adult CF patients. These patients preferred to employ giving up strategy when dealing with the disease. Therefore, it is essential to screen adult CF patients for mental health risks and to work on improving their coping strategies.

Advances in Bone-Targeting Drug Delivery: Emerging Strategies Using Adeno-Associated Virus.

The development of bone-targeting drug delivery systems holds immense promise for improving the treatment of skeletal diseases. By precisely delivering therapeutic agents to the affected areas of bone, these strategies can enhance drug efficacy, minimize off-target effects, and promote patient adherence, ultimately leading to improved treatment outcomes and an enhanced quality of life for patients. This review aims to provide an overview of the current state of affinity-based bone-targeting agents and recent breakthroughs in innovative bone-targeting adeno-associated virus (AAV) strategies to treat skeletal diseases in mice. In particular, this review will delve into advanced AAV engineering, including AAV serotype selection for bone targeting and capsid modifications for bone-specific tropism. Additionally, we will highlight recent advancements in AAV-mediated gene therapy for skeletal diseases and discuss challenges and future directions of this promising therapeutic approach.

Associations Among Tremor Amplitude, Activities of Daily Living, and Quality of Life in Patients with Essential Tremor.

Essential tremor (ET) is a disabling syndrome consisting of tremor, primarily in the upper limbs. We assessed the correlation of The Essential Tremor Rating Assessment Scale (TETRAS) Performance Item 4 ratings of upper limb tremor with the TETRAS activities of daily living (ADL) subscale and with 2 quality of life (QoL) scales. This noninterventional, cross-sectional, point-in-time survey of neurologists(n = 60), primary care physicians (n = 38), and their patients with ET (n = 1,003) used real-world data collected through the Adelphi ET Disease Specific Programme™. Physician-reported measures (TETRAS Performance Item 4 and TETRAS ADL total) and patient-reported QoL measures (generic EuroQol-5 Dimension 5 Level [EQ-5D-5 L] and ET-specific Quality of Life in Essential Tremor Questionnaire (QUEST)) were assessed with bivariate and multivariable analyses. Sensitivity analyses were also conducted. The bivariate association between TETRAS Performance Item 4 score and TETRAS ADL total score was high (Pearson r = 0.761, P < 0.001). The bivariate associations between TETRAS Performance Item 4 score and EQ-5D-5 L index score (r = -0.410, P < 0.001) and between TETRAS ADL total score and EQ-5D-5 L index score (r = -0.543, P < 0.001) were moderate. The bivariate associations between TETRAS Performance Item 4 score and QUEST total score (r = 0.457, P < 0.001), and between TETRAS ADL total score and QUEST total score (r = 0.630, P < 0.001) were also moderate. These associations were unaltered by the inclusion of covariates. This study showed that greater tremor severity (TETRAS Performance Item 4) was positively correlated with ADL impairment (TETRAS ADL) and negatively associated with QoL (EQ-5D-5 L and QUEST). TETRAS Performance Item 4 score is a robust predictor of TETRAS ADL total score, and TETRAS Performance Item 4 and TETRAS ADL total scores were robust predictors of the 2 QoL scales. The results demonstrate the value of TETRAS scores as valid endpoints for future clinical trials. This real-world study assessed TETRAS scores as predictors of impaired QoL in ET. TETRAS Performance Item 4 and ADL were associated with EQ-5D-5 L and QUEST. TETRAS scores may serve as valid endpoints for future clinical trials.

Evaluation of the therapeutic effects of rehabilitation therapy on patients with amyotrophic lateral sclerosis-a meta-analysis.

To investigate the effect of rehabilitation therapy on the global function, respiratory function, and quality of life in patients with amyotrophic lateral sclerosis (ALS). PubMed, Web of Science, and The National Library of Medicine (NLM) were systematically searched and the search period was between the date of database establishment and December 31, 2023. The outcome measures finally analyzed included the ALS functional rating scale/revised (ALSFRS/ALSFRS-R), forced vital capacity percentage predicted (FVC%), fatigue severity scale (FSS), and maximal expiratory pressure (MEP). A total of 13 randomized controlled trials (RCTs) were included, and 5 outcome measures were pooled and analyzed. A total of 657 patients with ALS were enrolled, with 299 in the experimental group (rehabilitation therapy, such as resistance training, endurance training, aerobic training, respiratory muscle training, and standard rehabilitation therapy) and 358 in the control group (conventional interventions, such as simple joint movements or daily stretching). The ALSFRS scores were better in the experimental group than in the control group at 0-4 months (MD = 3.36, 95% CI: 0.82, 5.91, Z = 2.59, p = 0.009) and at 5-8 months (MD = 5.00, 95% CI: -2.42, 7.58, Z = 3.80, p < 0.001). Moreover, the ALSFRS-R scores of the experimental group was better than that of the control group at 5-8 months (MD = 2.83, 95% CI: 1.21, 4.45, Z = 3.42, p < 0.001) and 9-12 months (MD = 1.87, 95% CI: -0.37, 4.11, Z = 1.63, p = 0.10). It was also found that the MEP value of the experimental group was significantly better than that of the control group after intervention (MD = 18.49, 95% CI: 1.47, 35.50, Z = 2.13, p = 0.03). However, there were no significant differences in FVC% value and FSS scores at 0-5 months and 6-12 months between the two groups. Rehabilitation therapy is helpful in improving the short-, medium-, and long-term global function score of patients with ALS, with positive effects on respiratory function.

Cognitive dysfunction and its relationship with psychopathology and quality of life in patients with schizophrenia: a protocol for a cross sectional study

Background One central characteristic of schizophrenia is cognitive dysfunction, which typically has modest to severe effects on a variety of cognitive areas. Evidence suggests that cognitive impairment may occur far sooner than the clinical symptoms. The connection between cognitive deficiencies and functional outcome indicators has attracted increasing attention in recent years. Cognitive deficits are widely known to affect overall functioning, In India, few studies have been conducted to determine the profile of cognitive abnormalities in individuals in the chronic phase of schizophrenia as well as those in remission. Research from developing nations is crucial because schizophrenia prevalence in these nations is thought to be lower than that in industrialized nations. The aim of this study will be to assess the prevalence of cognitive dysfunction in individuals with schizophrenia and examine the relationship between cognitive dysfunction with psychopathology and quality of life in individuals with schizophrenia. Protocol This will be a cross sectional hospital-based study. After ethical clearance, all patients in the Psychiatry Department meeting the criteria of Schizophrenia, according to the ICD-10, will be part of the study. The expected number of participants is 228. All participants within the age group of 18 to 65 years who are clinically diagnosed to have schizophrenia using ICD-10 and who are able to give written informed consent will be included in the study. The patient’s sociodemographic data will be collected in Outpatient or inpatient basis and then the following questionnaires will be applied to them: i) Socio-demographic Proforma; ii) The Positive and Negative Syndrome Scale (PANSS); iii) The World Health Organization Quality of Life-BREF scale (WHOQOL-BREF); and iv) Addenbrooke’s cognitive examination III (ACE). Once the aforementioned questionnaires are completed, the prevalence of cognitive dysfunction in patients with schizophrenia will be assessed, and its relationship with psychopathology and quality of life will be studied.

Decellularized Descemet Membrane Anterior Keratoplasty With Allogeneic Simple Limbal Epithelial Transplantation for Partial Limbal Stem Cell Deficiency Following Partial Keratolimbal Allograft Failure.

The purpose of this study was to describe the use of Descemet membrane anterior keratoplasty (DMAK) with modified allogeneic simple limbal epithelial transplantation to treat a case of partial limbal stem cell deficiency (LSCD) following keratolimbal allograft failure. Case report. A 21-year-old woman with autoimmune polyglandular syndrome-related LSCD presented with pain and decreased vision. There was partial failure and recurrence of LSCD after a severe/acute keratolimbal allograft rejection that led to persistent epithelial defects refractory to conservative therapy. This was treated with a superficial keratectomy and placement of a DMAK. A modified allogeneic simple limbal epithelial transplantation was performed with an overlying amniotic membrane and temporary tarsorrhaphy. There was epithelialization of the corneal surface by 3 to 4 weeks with an improved ocular surface. Despite partial recurrence of late staining, the cornea has remained epithelized, vision has improved, and the patient has remained pain-free more than 1.5 years following the procedure. DMAK may be a long-term substrate to help improve and maintain epithelization of the cornea up to 1.5 years. DMAK may be a viable alternative to using amniotic membrane as a scaffold in allogeneic simple limbal epithelial transplantation for treatment of partial LSCD. While late epithelial staining recurred in our patient, DMAK appears to prevent recurrent epithelial defects and reduce ocular surface pain, conveying an improvement in quality of life in patients at high risk of rejection/failure.

Role of Radiotherapy in Improving Quality of Life in Patients with Hepatocellular Carcinoma and Liver Metastasis

Background: Hepatocellular carcinoma (HCC) and liver metastases (LM) are often associated with significant symptoms such as pain and abdominal discomfort, impacting the quality of life (QoL) of affected patients. Current treatments vary in effectiveness and often leave a substantial unmet medical need in symptom management. Objective: This study aimed to assess the efficacy of external radiation therapy (ERT) in alleviating symptoms and improving the QoL in patients with HCC and LM, focusing on those presenting primarily with pain or abdominal discomfort. Methods: After institutional review board approval, patients with HCC or painful LM, not previously treated with tumor resection, radiofrequency ablation, or systemic therapy, were included. Eligible participants exhibited symptoms such as pain, nausea, and fatigue, and had a performance status of 0-2. A single fraction dose of ERT was administered, and symptom relief was evaluated using the Brief Pain Inventory (BPI) and QoL using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30). Completion rates of these questionnaires were tracked at baseline, one week, and one month post-treatment. Results: Of the 43 patients enrolled (23 HCC, 20 LM), significant improvement in the FACT-G TOI was observed in 34% of patients at one month post-ERT. When focusing on those with pain or abdominal discomfort, 59% reported clinically significant symptom relief. However, QoL improvement was noted in only about one quarter of patients, with one third experiencing worsening QoL at one month. Questionnaire completion rates were high initially but decreased over time, reflecting the challenging nature of the patient population. Conclusion: ERT demonstrated potential benefits in symptom relief, particularly for pain and abdominal discomfort in patients with HCC and LM. Nonetheless, the impact on overall QoL was mixed, highlighting the need for further research into optimizing therapeutic strategies for this patient group.

HEALTH-RELATED QUALITY OF LIFE IN POSTMENOPAUSAL WOMEN WITH ADVANCED BREAST CANCER RECEIVING ADJUVANT HORMONE THERAPY (RIBOCICLIB AND LETROZOLE)

Breast cancer is a type of cancer that affects many women in Indonesia. Adjuvant hormone therapies, such as letrozole and ribociclib, have succeeded in improving the patient's quality of life. This study aimed to assess the quality of life of postmenopausal women with advanced breast cancer who received adjuvant hormone therapy with ribociclib and letrozole. A cross-sectional study was conducted using retrospective data from postmenopausal female breast cancer patients at Dharmais Cancer Hospital between 2020 and 2023 who met the inclusion criteria. To determine the impact of sociodemographics on patient quality of life, data were examined using the quality of life score (EQ5D5L) and Spearman test. There were 29 patients, with a mean age of 54.9 years (SD = 8.65); the highest education level was high school (34.5%); The majority of occupations are housewives (69%), and the majority are stage IV (34.5%). The mean utility and VAS values of Ribociclib were 0.885 and 81.66, respectively, whereas those for letrozole were 0.725 and 78.46, respectively. Analysis of the relationship between quality of life and patient characteristics showed that the quality of life of patients with breast cancer treated with adjuvant ribociclib and letrozole therapy was influenced by the stage of breast cancer (p = 0.008). These findings indicate that patients receiving ribociclib and letrozole therapy have a good quality of life, which quality of life quality of life is influenced by the stage of malignancy. Keywords: breast cancer, quality of life, letrozole, ribociclib, post menopause

Topical and Systemic Retinoids in the Management of Hidradenitis Suppurativa: A Comprehensive Literature Review.

Hidradenitis suppurativa (HS) is a debilitating chronic skin disorder characterized by painful inflammatory nodules, abscesses and sinus tracts involving intertriginous areas and has an adverse impact on patient quality of life. Over the past decade, the therapeutic options of HS have increased significantly to comprise multiple modalities, including topical medication, systemic therapies (mainly antibiotics, retinoids, and biologics), surgical approaches, and lifestyle modifications. Biologics alone or in combination with surgery remain the treatment of choice for moderate to severe disease. However, non-biologic therapies (including retinoids) may be used as monotherapy for mild disease and in combination with biologics and surgical treatment in moderate to severe disease. Retinoids, specifically isotretinoin, acitretin, and alitretinoin, are historically used in the management of HS, supported by anecdotal evidence and with variable treatment response. Although the current American and European guidelines offer different recommendations on the use of retinoids in HS, retinoids remain a valuable ally in HS management. This review provides a comprehensive analysis of the current scientific literature on retinoid therapy (topical and systemic) in HS, highlighting disparities in mechanisms of action, efficacy, and safety to clarify their role in HS treatment.

Examining the Relationship between Quality of Life and Baseline Hemoglobin Level in Lung Cancer with Chemotherapy Treatment Using EORTC QLQ-LC13

Background: The effect of lung cancer and its various treatments on the overall well-being can be substantial. This study seeks to examine the correlation between quality of life and baseline hemoglobin (Hb) levels in lung cancer patients who are receiving chemotherapy. Method: This study involved 30 patients with non-small cell lung cancer (NSCLC) who underwent platinum-based chemotherapy. Baseline Hb level were collected from medical records. The patients' quality of life was assessed using interviews utilizing the EORTC QLQ-LC13 questionnaire. Result: Baseline Hb levels and pain relief after medication score was positively correlated (r=0.559, p=0.001). Baseline Hb levels and difficulty swallowing score was negatively correlated (r=-0.386, p=0.035). Determined cut-off point for the total score was 303.5. However, the correlation between Hb levels and overall quality of life was insignificant (r=-0.096, p=0.615). Conclusion: According to the quality of life indicators in the questionnaire, there is a notable association between lower baseline Hb levels and reduced effectiveness of pain relief medication, as well as an increase in difficulty swallowing. However, the underlying cause for this correlation is unclear. On the other hand, the correlation between baseline Hb levels and the overall scores of quality of life in the questionnaire was not found to be significant.

Acceptance of digital apps in the follow-up of patients with head and neck tumors

Patient-reported outcome (PRO) measures lead to improved quality of life in cancer patients and possibly to earlier detection of tumor recurrence. Patient interest in complementing tumor follow-up care with apps for recording PROs was assessed using a questionnaire. An independently created questionnaire to record the interest of tumor patients in adigitalized form of tumor follow-up care was evaluated (n = 110). In the study, the majority of tumor patients were interested in using an app for tumor disease. Taking age into account, the number increased even further for patients < 60years of age, as expected. In line with this, human papillomavirus (HPV)-positive patients showed significantly greater interest (p = 0.021). The introduction of an app is supported by the majority of tumor patients. In addition to recording PROs, other applications (appointment reminders, patient files, sports/nutrition programs) could also be integrated.

The effect of somatic pain and comorbid mental distress on oral health-related quality of life in orthodontic patients.

The purpose of the present study was to evaluate the prevalence of somatic pain in orthodontic patients and determine whether somatic pain contributes to worsening oral health-related quality of life (OHRQoL) through the mediating effect of psychological discomfort. Scale measurements and analyses were conducted on a cohort of 769 orthodontic outpatients, encompassing Patient Health Questionnaire-15-pain (PHQ-15-P), Hua-Xi Emotional-Distress Index (HEI), Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ), and Oral Health Impact Profile-14 (OHIP-14). Among the respondents, 56.3% (N = 433) reported somatic pain and 20.0% (N = 154) had mental discomfort based on PHQ-15-P and HEI scores. Patients with somatic pain symptoms had significantly higher scores of HEI and OHIP-14 (P < 0.001), and higher PHQ-15-P and HEI scores emerged as statistically significant predictors of lower OHIP-14 scores (P < 0.001). HEI scores which assessed anxiety and depression partially mediated the correlation between PHQ-15-P and OHIP-14 scores, of which anxiety accounted for 52.9% of the overall mediation effect, dominating the indirect effect. Orthodontic patients reporting somatic pains were at a significantly higher risk of worsening OHRQoL during treatment, and this adverse effect is partially mediated by anxiety and depression. Our findings highlight the necessity for the assessment of general health and mental well-being during orthodontic interventions. To prevent delays in treating general disorders and the potential failure of orthodontic treatments, we encourage increased attentiveness towards patients with somatic symptoms and consideration of the adverse effects of comorbid mental distress.

Long-term effects of the titanium butterfly implant on quality of life: a prospective cohort study.

Nasal valve insufficiency is known to have a negative impact on both nasal patency and quality of life. The titanium butterfly implant is a surgical treatment proven to have a positive effect on these aspects up to 6months postoperative. This study aimed to determine the long-term effects of the titanium butterfly implant on nasal obstruction symptoms and quality of life in adult patients with nasal valve insufficiency up to 5years after procedure. A prospective single cohort study was performed including 29 patients that underwent the titanium butterfly implant in one tertiary medical center. Data was obtained before and at least 5years after surgery using three questionnaires: the Nasal Obstruction and Septoplasty Effectiveness questionnaire, the Sino-Nasal Outcome Test 22 and the Glasgow Benefit Inventory questionnaire. A significant decrease in total NOSE score was seen compared to baseline measurements. The SNOT-22 scores also showed a significant decrease, whereas the GBI scores showed no significant changes at the late follow-up. Seven years after placement the titanium butterfly implant still has a statistically significant improvement on otorhinologic-related quality of life compared to preoperative measurements.

Predictive factors and quality of life assessment among patients with spinal cord injury in the Middle East: a systematic review.

Spinal cord injury (SCI) is impairment of the spinal cord that adversely affects patients' health and quality of life (QoL). The aim of the study was to assess the quality of life (QoL) and related factors in patients with traumatic spinal cord injury in Middle Eastern countries. PubMed, Ovid Medline, Cumulative Index to Nursing and Allied Health Literature (CINAHL), EBSCOhost, psycINFO, and Google Scholar were systematically searched for eligible studies published in peer-reviewed journals up till October 2023. Out of 1060 papers found in the literature, only 18 studies from Iran, Lebanon, and Turkey met the inclusion criteria. The majority of the studies employed the SF-36 scale to assess for QoL. In general, all SCI patients had reduced QoL scores when compared to the healthy population. Some of the factors such as age, education level, the level of injury, time since injury onset, marriage, and job opportunities were correlated with SCI subjects QoL. Our papers were assessed and found to be of both good and high quality. This review emphasizes the significant shortage of QoL studies among SCI patients in the Middle East countries and highlights the importance of improving the QoL of this marginalized population. This work should enhance the governments to establish rehabilitation centers, social and economic support systems, and mental health services to diminish complications arising from SCI.

Abstract GS02-10: Effects of a structured and individualized exercise program on fatigue and health-related quality of life in patients with metastatic breast cancer: the multinational randomized controlled PREFERABLE-EFFECT study

Abstract INTRODUCTION: Patients with metastatic breast cancer (mBC) often experience cancer- and treatment-related side effects that can impair daily life activities and health-related quality of life (HRQoL). Interventions are needed that improve HRQoL by alleviating fatigue and other side effects during palliative BC cancer treatment. Recent evidence-based international guidelines (ASCO, ACSM) recommend exercise for patients with BC during adjuvant treatment for reducing side effects. However, evidence of the effectiveness of exercise in patients with mBC is scarce. The PREFERABLE-EFFECT study (NCT04120298) was designed to assess the effects of a 9-month supervised exercise program in patients with mBC on fatigue, HRQoL, and other cancer- and treatment-related side effects. METHODS: PREFERABLE-EFFECT is a multinational, randomized controlled trial including patients with mBC from five European countries (Germany, Poland, Spain, Sweden, The Netherlands) and Australia. Participants were randomly assigned to usual care or an individualized, structured exercise program consisting of aerobic, resistance, and balance training. The first six months included twice weekly supervised exercise sessions of one hour. In the last three months, one supervised session was replaced by an unsupervised session, supplemented by an exercise App. All participants received general exercise advice (physical activity ≥ 30 min/day) and an activity tracker. Our primary outcomes, physical fatigue (subscale of the EORTC QLQ-FA12) and HRQoL (summary score of the EORTC QLQ-C30), were assessed at baseline, 3, 6, and 9 months. Among other physical fitness outcomes, maximal short exercise capacity was assessed with the Steep Ramp Test. The intervention effects (intention-to-treat) were determined by comparing the change from baseline to 3, 6 (i.e., primary endpoint) and 9 months between groups using separate mixed models for repeated measures, adjusted for baseline values of the outcome variable and stratification factors (mBC line of treatment (1st/2nd vs. 3rd or higher) and study center). A significant improvement of either or both primary outcomes (applying the Bonferroni-Holm method) was considered as successful. RESULTS: Between 2019-2022, we included 357 patients with mBC, with 178 patients randomized to the exercise intervention and 179 to usual care. Patients were, on average, 55.4 years of age (SD=11.1), most patients received 1st or 2nd line of treatment at study enrollment (74.8%) and had bone metastases (73.9%). At 6 months (primary endpoint), participation in the exercise intervention resulted in statistically significant positive effects on both primary outcomes, compared to usual care: physical fatigue was lower (mean difference: -5.3, 95% CI -10.0; -0.6, p=0.027, effect size (ES)=0.22) and HRQoL was better (+4.8, 95% CI 2.2; 7.4, p=0.0003, ES=0.33). Beneficial effects were also found at 3 months (physical fatigue: -3.4, -7.8; 1.0, ES=0.14 and QoL: 3.9, 1.5; 6.3, ES=0.27) and 9 months (physical fatigue: -5.6, -10.9; -0.4, ES=0.24 and QoL: +4.3, 1.4; 7.3, ES=0.31). Further, at the primary endpoint, we found positive exercise effects on physical fitness (+24.3 Watts, 15.5; 33.1, ES=0.42) and numerous QLQ-C30 scales, including social functioning (+5.5, 0.2; 10.8, ES=0.20), pain (-7.1, -12.1; -1.9, ES=0.28) and dyspnea (-7.6, -12.2; -3.0, ES=0.28). Two SAEs occurred (one wrist fracture and one sacral stress fracture), neither related to bone metastases. CONCLUSION: This large multinational study demonstrated significant beneficial effects of a supervised exercise intervention offered during palliative treatment on mBC patients’ fatigue, HRQoL, and other clinically relevant outcomes. Based on these findings, we recommend supervised resistance and aerobic exercise as part of supportive care regimens during palliative treatment of mBC. Citation Format: Anne May, Anouk Hiensch, Johanna Depenbusch, Martina Schmidt, Evelyn Monninkhof, Mireia Pelaez, Dorothea Clauss, Philipp Zimmer, Jon Belloso, Mark Trevaskis, Helene Rundqvist, Joachim Wiskemann, Jana Muller, Carlo Fremd, Renske Altena, Joanna Kufel-Grabowska, Rhode Bijlsma, Lobke van Leeuwen-Snoeks, Daan ten Bokkel-Huinink, Gabe Sonke, Bruce Mann, Prudence Francis, Gary Richardson, Isabel Álvarez, Wolfram Malter, Elsken Van der Wall, Neil Aaronson, Elżbieta Senkus, Ander Urriticoechea, Eva Zopf, Wilhelm Bloch, Martijn Stuiver, Yvonne Wengström, Karen Steindorf. Effects of a structured and individualized exercise program on fatigue and health-related quality of life in patients with metastatic breast cancer: the multinational randomized controlled PREFERABLE-EFFECT study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr GS02-10.

Abstract PO1-12-03: Quality of Life in Patients Diagnosed and Treated for Breast Cancer in Uruguay

Abstract Introduction: Breast cancer (BC) and its treatment can impair patient quality of life (QOL), and those undergoing more aggressive treatments may be more severely impacted. Objective: Assess the level of perception of the QOL of patients treated for BC at the Hospital de Clínicas and the Hospital Departamental de Soriano. Materials and Methods: A questionnaire for cancer patients (EORTC, QLQ-C30) and one specific for BC (EORTC QLQ-BR23) were used. Results: A total of 158 patients who had completed chemotherapy treatment at least one year prior to the evaluation were enrolled. The average age was 61 years old. QLQ-C30 questionnaire: the global QOL score (GQOL) was high: 70.9. Patients undergoing conservative surgery (CS) had better scores in physical and emotional functioning (p &amp;lt; 0.005) and presented less frequently with: pain, constipation and financial difficulties (p &amp;lt; 0.005). Those undergoing sentinel lymph node biopsy (SLNB) had higher scores for GQOL and for physical, role and social functioning scales (p &amp;lt; 0.001) and had less fatigue, pain, insomnia and financial difficulties (p &amp;lt; 0.005). Questionnaire QLQ-BR23: sexual functioning and sexual enjoyment scales were relatively low. Patients undergoing CS had better scores on the functional scales: body image and future outlook; and fewer breast symptoms (p &amp;lt; 0.005). Those undergoing SLNB also had better scores on the functional scales for body image and future outlook future and presented less frequently with symptoms (p &amp;lt; 0.005). Conclusion: Patients had high values on the GQOL scale, those undergoing CS and SLNB had better scores on most functional and problem/symptom scales. The implementation of intervention strategies aimed at improving the quality of life and the physical and emotional care of patients is recommended. Citation Format: Natalia Camejo, Dahiana Amarillo, Cecilia Castillo, Maria Guerrina, Florencia Savio, Mariana Carrasco, Noelia Strazzarino, Ana laura Hernandez, Guadalupe Herrera, Gabriel Krygier. Quality of Life in Patients Diagnosed and Treated for Breast Cancer in Uruguay [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-12-03.

Abstract PO2-11-04: Assessing quality of Life in breast cancer patients undergoing mHealth mobile monitoring: A descriptive Analysis

Abstract Background: Breast cancer (BC) can be associated with a significant symptom burden that can be related both to the disease and to administered therapies. In particular, protocol related toxicity has an extreme impact on patient quality of life (QoL), and can lead to lack of adherence and ultimately, compromise therapy success. There is increasing interest in adopting more effective approaches for active/continuous patient-reported symptom monitoring. Emerging evidence, (Denis et al. 2019), shows that this strategy can reduce toxicity, emergency room visits, and improve QoL. Objectives: We aimed to analyze the QoL of women with BC diagnosis who underwent mobile-based continuous monitoring, searching for possible trends and describing the population. Methods: We conducted a retrospective analysis using data from patients with BC undergoing systemic treatment and monitored by a mobile-based application between January 2022 and June 2023 at an outpatient clinic in Brazil. Thummi is a digital platform for remote monitoring of cancer patients which enables them to record symptoms, toxicities and lifestyle variables. Utilizes the data to generate personalized recommendations and advice. It is available in Brazil at no cost. Doctors indicate the use and can monitor their patients in real time. In addition to an algorithm that informs the user if there is a need to go to the emergency room or not, the medical team can exchange real-time messages with patients. Clinicians have access to patient data through a web tool, allowing them to visualize the information, address symptom alerts, and make informed clinical-therapeutic decisions. The evaluated sample is from patients who come from physicians who indicated the use, without control of their origin, indication of treatment or clinical stage. The data were extracted from the platform's total database. Participants were requested to complete the Quality of Life Questionnaire (EORTC EQ-5D) integrated into the app every month. Inclusion criteria comprised a BC diagnosis, age ≥18, and having responded to the QoL questionnaire with at least a one-month interval between scores. Patients who failed to meet these criteria were excluded from the analysis. A comparison of QoL scores was performed between two periods: T0 (the first recorded response) and T1 (the subsequent response with at least a one-month interval between scores). Descriptive statistical analyses were conducted to search for possible trends, describe the population, and comprehensively examine the differences in QoL scores between T0 and T1. Results: There were 134 active patients in the mobile-based platform with a BC diagnosis, but only 86 (64,17%) met the inclusion criteria for the final analysis. The median age of this group was 54 years old (range 22-78). The most common treatments administered were Cyclophosphamide-Doxorubicin (28 patients, 33%) and Trastuzumab-Deruxtecan (18 patients, 21%). The average QoL score in T0 was 0,70 (SD 0,1379) and 1,0 (SD 0,1560) at T1, representing an increase of 30% after using the app for one month. Conclusion: This study suggests that mobile-based monitoring has the potential to improve the QoL for women diagnosed with BC. The difference in average QoL scores between the initial and subsequent periods indicates a positive impact of utilizing the platform. Further research is needed to establish a better correlation and to explore the specific interventions that contribute to these improvements. Implementing mobile-based monitoring in clinical practice could enhance patient well-being, treatment adherence, and survival time and can potentially lessen both burden of disease and resource utilization in BC care. Citation Format: Alessandra Morelle, Carlos Barrios, Carlos Pereira, Vinicius Agibert, Pedhro Lennon Freitas, Matheus Rocha, Paulo Schulze. Assessing quality of Life in breast cancer patients undergoing mHealth mobile monitoring: A descriptive Analysis [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-11-04.

Abstract PO3-19-12: Evaluating the impact of ePRO-based follow-up system (Pink Ribbon Diary) on quality of life and treatment adherence in patients with breast cancer receiving CDK4/6 inhibitors: a single center, randomized controlled study (JPRO-B)

Abstract Background: Treatment-related toxicities (TRT) may decrease patient’s quality of life (QOL) and may result in a decrease of adherence to the therapy. Cyclin-dependent kinase 4/6 inhibitors (CDK4/6is), such as palbociclib (PAL) and abemaciclib (ABM) improved patients’ outcomes with estrogen receptor-positive (ER+) HER2 negative (HER2-) advanced breast cancer (ABC), however, majority of patients who undergo CDK4/6i therapy experience ≥ Grade 2 TRTs, such as hematological abnormalities, gastrointestinal disorders or general fatigue. While prompt management of those TRTs is mandatory to prevent patients from discontinuing the therapy, real-time monitoring of TRTs has been warranted. Recently, efforts have been made to monitor symptoms using electronic patient-reported outcome (ePRO) to detect side effects as early as possible and to provide timely support. However, the efficacy of ePRO in daily clinical practice for those receiving CDK4/6is is still unclear. In addition, the researches in the field of ePRO to date have only focused on drugs administered intravenously in hospitals, where patients’ adherence has no clinical importance. Study design and eligibility criteria: This randomized, open-label, controlled phase 2 trial is designed to assess the efficacy of a new proprietary ePRO system, the Pink Ribbon Diary (PRD), compared with placebo (usual care without the ePRO system) in breast cancer patients with ER+HER2-ABC receiving oral CDK4/6i-based therapy aged ≥ 20 years. All eligible patients who complete training on how to use ePRO system are randomly allocated to either arm A using ePRO system or arm B receiving usual care (1:1). Participants in the arm A are required to record medication taken and physical condition every day for 3 months, and report adverse events using PRO-CTCAETM once a week. Patients in the arm B are also asked to answer to questions concerning adverse events using PRO-CTCAETM at monthly hospital visit for 3 months. All participants are asked to respond to the EORTC QLQ-C30 at their monthly visit and a questionnaire survey on adherence before the study and after completion of the study. Participants in the arm A and healthcare providers, will answer the questionnaire about the feeling of using the PRD. Primary endpoint is the change in global health status/QOL (EORTC QLQ-C30) at 3 months from baseline. Secondary endpoints are RDI (relative dose intensity), other domains of EORTC QLQ-C30, number of days missed medication, PDC (proportion of days covered), survey of medication compliance awareness using MMAS-8 (Morisky Medication Adherence Scale), questionnaire on use of PRD, and comparison between two groups of occurrence of adverse events and incidence of missed medication. Study objective: To assess the clinical efficacy of PRD in patients with ER+HER2-ABC undergoing CDK4/6i-based therapy. Statistical methods: For analysis of QOL, the primary endpoint, the differences in global health status/QOL (EORTC QLQ-C30) before and after the study will be compared between the two groups using the t-test. Present accrual and target accrual: The study was approved by institutional review board in December 2022, and is open for enrollment. The target sample size is 70. The study is on-going and 22 patients have been accrued to date. Trial registration numbers: Japan Registry of Clinical Trials (jRCT) jRCT1030220626 (https://jrct.niph.go.jp/re/reports/detail/30182). Citation Format: Rie Ozeki, Hideo Shimizu, Kotaro Iijima, Misato Okazaki, Junichiro Watanabe, Mitsue Saito. Evaluating the impact of ePRO-based follow-up system (Pink Ribbon Diary) on quality of life and treatment adherence in patients with breast cancer receiving CDK4/6 inhibitors: a single center, randomized controlled study (JPRO-B) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-19-12.

Abstract PO3-20-07: Five years and counting: A case of a 47-year-old female with De Novo Metastatic HER2 positive disease on multiple lines of treatment

Abstract HER2-positive breast cancer refers to a specific subtype of breast cancer characterized by the overexpression or amplification of the human epidermal growth factor receptor 2 (HER2) protein on the surface of cancer cells. The overexpression of HER2 leads to increased signaling pathways that promote cell growth and division, making HER2-positive breast cancer inherently more aggressive compared to other subtypes. The aggressive behaviour of HER2-positive disease may be attributed to its rapid cell growth, high metastatic potential, and increased risk of recurrence. Fortunately, there are targeted therapies that specifically inhibit the HER2 protein. These targeted treatments help to block HER2 signaling, slow down tumor growth, and reduce the risk of recurrence. We report a case 47 year old premenoapausal Filipino female diagnosed with de-novo metastatic HER2-positive breast cancer with liver and lung metastasis in 2018. Advised Pertuzumab Trastuzumab and Taxane therapy but due to financial constraints was amenable only to Trastuzumab and Paclitaxel. During treatment noted symptomatic cardiac decline, hence shifted to Lapatinib &amp; Capecitabine, tolerated well with stable disease for 1 year. Disease then progressed to the contralateral breast, given 6 cycles of Ado Trastuzumab Emtansine with partial response followed by modified radical mastectomy of the right and toilet total mastectomy of the left breast. She was lost to follow up. Her cancer recurred 1 year later as skin lesions on chest wall. She was given 6 cycles of Ado Trastuzumab Emtansine, however still with progression as skin lesions on the chest. Patient was then given 5 cycles of Trastuzumab with Eribulin. Despite treatment, there was progression with symptomatic brain metastasis and further increase in size and number of skin metastasis of the chest wall. Lesions were noted to be ulcerating and bleeding. Hence patient underwent 5 of 5 sessions of Fractionated stereotactic radiation therapy and 10 of 10 sessions of palliative radiotherapy to the chest wall. Patient was then given Pertuzumab &amp; Trastuzumab with note of improvement of chest wall lesions. However, after 7 cycles of treatment, noted progression again as skin metastasis on the chest wall. Hence patient was shifted to Trastuzumab Deruxtecan. At the time of writing, the patient has had a good response with Fam-Trastuzumab Deruxtecan-nxki with partial resolution of her skin metastases on the chest with stable disease of lung and brain target lesions. No bleeding or ulcerations of the lesions and no recurrence of dizziness or imbalance reported. The patient will continue to receive Fam-Trastuzumab Deruxtecan-nxki until disease progression and/or unacceptable toxicity. Here we have a case of patient with extended survival after being fortunate to have received multiple lines of treatment for the disease. In this case we were able to apply the advances of research in HER2-positive breast cancer and see it in the clinical setting. Thus, ultimately translating to extended overall survival for the patient. We see the importance of continuous research on HER2-positive breast cancer disease and how these studies have helped us in overcoming treatment resistance, understanding disease progression, tailoring of therapies to individual patients, optimizing treatment outcomes, developing new therapies, and enhancing the quality of life for patient. Ongoing research continues to explore new therapeutic approaches and strategies to further improve outcomes for individuals with metastatic HER2-positive breast cancer. This is truly an exciting time for cancer research because what used to be a very deadly disease is now becoming something that we are able manage. Citation Format: Sofia Dominique Unson, Rubi Li. Five years and counting: A case of a 47-year-old female with De Novo Metastatic HER2 positive disease on multiple lines of treatment [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-20-07.

Abstract PO4-11-01: Validation of a CARG-BC-based score for the prediction of therapy-induced toxicities in patients with metastatic breast cancer

Abstract Introduction Prediction of treatment-induced toxicities is important in order to tailor and adjust oncologic therapies. As limited tools exist to predict the risk of therapy-induced toxicities in patients with metastatic cancer, we aimed to develop and to validate a score for the prediction of therapy-induced toxicities in patients with metastatic breast cancer treated with chemotherapy and immunotherapy. The score was based on the Cancer and Aging Research Group-Breast Cancer early-stage breast cancer score for prediction of chemotherapy-induced toxicities. Methods All patients treated for metastatic breast cancer with chemotherapy and immunotherapy at the Department of Gynecology, Obstetrics and Reproductive Medicine at Saarland University Hospital between 01/2014 and 05/2022 were included in this retrospective study. Patient characteristics and therapy-relevant oncological parameters were recorded, as well as therapy-induced toxicities (recorded according to CTC), hospitalization rates, toxicity-related dose reductions and therapy discontinuations. In the first cohort (development cohort), a new score for the prediction of therapy-induced toxicities was developed using ROC analysis and multivariate analysis based on the CARG-BC score. In the second cohort (validation cohort), this was validated using Pearson’s correlation coefficient. Results Data from 32 patients were analyzed for the development cohort, and inclusion of 102 patients contributed to the validation cohort. The newly developed score consists of seven independent factors for the prediction of toxicities ≥ CTC III° and includes the parameters “presence of visceral metastases” (yes/no), “received previous lines of therapy” (yes/no), “limited mobility/able to walk less than one kilometer” (yes/no), “a fall in the last six months” (yes/no), “social interactions” (yes/no), “pretherapeutic change of transaminases” (yes/no) and “pretherapeutic change of hemoglobin” (hemoglobin &amp;lt;/&amp;gt; 10 g/dl). Based on the results, three risk groups were defined (low (0-2), medium (3-5) and high (6-15) risk). 28% of patients were in the low-risk group, 37% in the intermediate-risk group and 34% in the high-risk group. Overall, 49% of the patients had toxicities ≥ CTC III°. Distributed across the subgroups, these occurred in 14% in the low-risk group, 34% in the intermediate-risk group and in 52% in the high-risk group (p ≤ 0.01). Risk score results showed a correlation with treatment discontinuation and hospitalization rate (p ≤ 0.01), but not with dose reduction (p = 0.77). Conclusion The available data show a correlation between the risk score results and the occurrence of systemic therapy-induced toxicities in patients with metastatic breast cancer. The results can be used to further identify risk populations and to systematically apply preventive and supportive measures in order to approve quality of life in patients with metastatic breast cancer. Citation Format: Julia SM Zimmermann, Aylin Aygün, Askin Kaya, Marc P Radosa, Christoph G Radosa, Erich F Solomayer, Julia C Radosa. Validation of a CARG-BC-based score for the prediction of therapy-induced toxicities in patients with metastatic breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-11-01.