Changes In Quality Of Life Scores Research Articles

871P - Adding ADT to PSMA-PET/CT-guided SBRT for oligometastatic prostate cancer improves distant progression-free survival

BackgroundTo report on the local response (LR), biochemical progression-free (bPFS) and distant-progression free (DPFS) survival after stereotactic body radiotherapy (SBRT) for bone and lymph node prostate cancer oligometastases. MethodsWithin the context of a prospective SBRT trial for oligometastases (NCT03486431), 54 bone and lymph node oligometastases, all detected on PSMA-PET/CT, were irradiated in 40 prostate cancer patients between July 2017 and December 2018. Of these patients, 35 had hormone-sensitive and 5 had castration-resistant disease. Short-term concomitant ADT was recommended in all hormone-naïve patients but decided in consultation with the patient. Ultimately, 20 patients received ADT while 20 did not. The two groups were well balanced, with no significant differences in age, Gleason score, PSA, lesion type, number or timing of metastases, and fractionation schedule. All patients received a PSMA-PET/CT at 6 months after SBRT. PSMA-RADS v1.0 was used to categorize the response of the treated lesion. Quality-of-life (QOL) scoring was performed using the EORTC QLQ-C30 questionnaire at baseline, 3 and 6 months. ResultsMedian follow-up for all patients was 9.6 months (IQR 6.3 – 12.9 months). Up till now, 42 lesions could be reevaluated at 6 months after SBRT with PSMA-PET/CT, of which 30 showed complete response, 8 partial response and 4 stable disease. No symptomatic or local progression was observed in the irradiated lesions. There was no statistically significant influence of ADT, fractionation, type of lesion or lesion size on LR. Patients who received ADT had significantly improved bPFS (median bPFS of 6.9 months versus median not reached; p=0.0017) and DPFS (median DPFS of 6.8 months versus 17.3 months; p=0.0021). We did not observe any clinically relevant changes in QOL scores between the patients who received ADT versus those who refused. Overall, QOL scores remained stable for both groups at baseline, 3 and 6 months. ConclusionsThese prospective data, although non-randomized, suggest that oligometastatic prostate cancer patients treated with SBRT could potentially benefit from short-term ADT. Longer follow-up will determine if ADT simply delays progression or truly alters the course of the disease. Clinical trial identificationNCT03486431. Legal entity responsible for the studyThe authors. FundingHas not received any funding. DisclosureAll authors have declared no conflicts of interest.

Analysis the Improvements of the Quality of Life in Ayurvedic Treatment for the Wrist Fracture

Aims: The aim of this study was to analyze the improvements of the quality of life (QOL) in Ayurvedic treatment for the wrist fracture.
 Study Design: This is a Retrospective Cohort Study.
 Place and Duration of Study: This study was carried out among the wrist fracture patients in Kadum bidum (orthopedic) Clinic who got treatment of wrist fracture at Bandaranayaks Memorial Ayurvedic Research Institute (BMARI).
 Methodology: All wrist fracture patients attending the BMIRI clinic were selected for this research study, were interviewed and administrated Qualeffo-41 questionnaire to collect the data. Patients were divided into three groups (A - Patients who took ayurvedic treatment straightly, B - Patients who took ayurvedic treatment after getting western treatment and C - Patients who took ayurvedic treatment after getting alternative treatment). QOL were analyzed in the interventions. There are first visit, after the 6th week, after 3 months, and after the 6th month.
 Results: In group A, they were getting quick improvement seen within 3months. QOL score changes from 16, 39, and 55. In group B, QOL score of patients who were getting treatment for 6th weeks QOL score changes from 18, 38.5. QOL of patients who were getting treatment for 6 months QOL change from 17, 26, 35, and 43. In group C, QOL of patients who were getting treatment for 3 month QOL changes from 21, 31.5, and 42.5. QOL score of patients who were getting treatment for 6 months QOL changes from 17, 24, 35 and 41.
 Conclusion: The study patients were quickly improved by the Ayurvedic treatment indicating its efficacy in fracture management.

Quality of Life During Chemotherapy for Breast Cancer in a West African Population in Dakar, Senegal: A Prospective Study

PURPOSEThe prevalence of breast cancer is increasing in low- to middle-income countries such as Senegal. Our prospective study assessed the quality of life (QoL) of patients with breast cancer undergoing chemotherapy in Senegal.PATIENTS AND METHODSOur study included women with breast cancer undergoing chemotherapy as initial treatment at the Center Aristide Le Dantec University Hospital in Dakar. Clinical, sociodemographic, and QoL data were collected and analyzed at three different times: baseline, 3 months, and 6 months after the start of systemic therapy. Health-related QoL was assessed using a Functional Assessment of Cancer Therapies-Breast (FACT-B) questionnaire after translation into the Wolof language. Linear mixed-effects models were performed to assess the changes in QoL scores.RESULTSBetween July 2017 and February 2018, 120 patients were included in the study. Their median age was 45 years. Most patients (n = 105; 92%) had locally advanced disease (T3 to T4 stage) and lymph node involvement (n = 103; 88%), and half had metastatic disease. The FACT-B total scores significantly improved over time (β = 1.58; 95% CI, 0.50 to 2.67; P < .01). Nausea and vomiting were significantly associated with a decrease in FACT-B total scores (β = −16.89, 95% CI, −29.58 to −4.24, P = .012; and β = −13.44, 95% CI, −25.15 to −1.72, P = .028, respectively).CONCLUSIONOur study confirmed the feasibility of standardized QoL assessment in Senegalese patients with breast cancer. Our results indicated a potential improvement of QoL over the course of chemotherapy. Optimizing nausea and vomiting prevention may improve QoL.

A self-help diet and physical activity intervention with dietetic support for weight management in men treated for prostate cancer: pilot study of the Prostate Cancer Weight Management (PRO-MAN) randomised controlled trial.

Overweight and obesity may increase risk of disease progression in men with prostate cancer, but there have been few studies of weight loss interventions in this patient group. In this study overweight or obese men treated for prostate cancer were randomised to a self-help diet and activity intervention with telephone-based dietitian support or a wait-list mini-intervention group. The intervention group had an initial group meeting, a supporting letter from their urological consultant, three telephone dietitian consultations at 4-week intervals, a pedometer and access to web-based diet and physical activity resources. At 12 weeks, men in both groups were given digital scales for providing follow-up weight measurements, and the wait-list group received a mini-intervention of the supporting letter, a pedometer and access to the web-based resources. Sixty-two men were randomised; fifty-four completed baseline and 12-week measurements, and fifty-one and twenty-seven provided measurements at 6 and 12 months, respectively. In a repeated-measures model, mean difference in weight change between groups (wait-list mini-intervention minus intervention) at 12 weeks was -2·13 (95 % CI -3·44, -0·82) kg (P = 0·002). At 12 months the corresponding value was -2·43 (95 % CI -4·50, -0·37) kg (P = 0·022). Mean difference in global quality of life score change between groups at 12 weeks was 12·3 (95 % CI 4·93, 19·7) (P = 0·002); at 12 months there were no significant differences between groups. Results suggest the potential of self-help diet and physical activity intervention with trained support for modest but sustained weight loss in this patient group.

Identification of Predictive Factors in Endometriosis for Improvement in Patient Quality of Life

To investigate predictive factors for change in quality of life (QOL) between pre- and postoperative periods in patients with endometriosis. A prospective and multicenter cohort study. Five districts including a tertiary referral center and private and general public hospitals. Nine hundred eighty-one patients aged 15 to 50 years underwent laparoscopic treatment (preferred approach) for endometriosis between January 2004 and December 2012. Laparoscopic treatment for endometriosis. All revised American Fertility Society stages were included. QOL was evaluated using the 36-Item Short Form Survey questionnaire. Factors influencing changes for each 36-Item Shorty Form Survey domain score between t0 (before surgery) and 1 year after surgery were predicted on the basis of univariate and multivariable analyses. The effect size (ES) method was used to measure changes in QOL. Univariate analysis revealed that 47% of stage IV endometriosis patients presented an improvement in the postoperative Physical Component Summary (PCS) score (ES ≥ 0.8) versus 26%, 31.3%, and 27.5% of patients with stage I, II, and III, respectively (p <.001). Forty-four percent and 38% of patients with chronic pelvic pain (CPP) presented an improvement in postoperative PCS and Mental Component Summary scores (ES>0.8) versus 23% and 24% of patients without CPP, respectively (p <.001). Multivariable analysis (ES > 0.8 vs ES < 0) revealed that women with CPP were more likely to experience greater improvement in postoperative PCS and Mental Component Summary scores than women without CPP (relative risk [RR] = 2.7; 95% confidence interval [CI], 1.7-4.4; p <.001 and RR = 1.8; 95% CI, 1.2-2.8; p <.01, respectively). Accordingly, fertile patients were more likely to show higher rates of improvement in the postoperative PCS score than infertile patients (RR = 1.8; 95% CI, 1.1-3.1; p <.05). Patients presenting with severe endometriosis and who experience higher levels of pain are more likely to show improvement in QOL after surgery. CPP is the most significant independent predictive factor for changes in QOL scores.

A prospective study of anti-mullerian hormone (AMH) as a predictor of chemotherapy-induced menopause.

e23076 Background: Chemotherapy-induced premature menopause is a distressing side effect of cancer treatment. Currently there are no validated tools to predict the loss of ovarian function. Anti-Mullerian hormone (AMH) in healthy women correlates with ovarian reserve and predicts menopause but its utility in chemotherapy-treated patients is underexplored. We examined the utility of AMH levels as a predictor of chemotherapy-induced amenorrhea at 1-year post chemotherapy - a reliable surrogate for chemotherapy-induced menopause. Methods: Premenopausal women, 45 years or younger, about to receive curative chemotherapy for breast cancer or lymphoma, without ovarian suppression, were assessed for menopausal symptoms using Menopausal Symptom Score (MSS), quality of life (QOL) using EORTC – QLQ-C30 questionnaire, and had serum AMH, oestradiol, FSH, LH collected prior to first chemo, and at 3 and 6 weeks, at completion and 12 months after chemotherapy. Results: Twenty-two premenopausal women, median age 40.5 (37-43) were enrolled. Twenty became amenorrhoeic during chemotherapy and four had return of menses at 1 year after treatment completion. Median AMH level at baseline was 12.9 pmol/L (IQR 5.2 – 26.5), fell sharply following first chemotherapy and remained low at &lt; 3pmol/L (IQR &lt; .3 ) at 1 year with only 2 subjects with AMH levels above 3 pmol/L. Women who regained menses at 12 months had higher baseline AMH than those who remained amenorrheic (p &lt; 0.001). Older age was associated with lower AMH at baseline and at 1 year. Median MSSs increased significantly at 1 year: 0.8 (IQR 0.5-1.8) versus 0.3 (IQR 0-0.4) (p = 0.5). While there was no significant change in QOL scores between baseline and 1 year, there was a significant negative correlation between menopausal symptom score and QOL at 1 year (p = 0.03). Conclusions: In this small study, pre-treatment AMH correlated with amenorrhea at 1-year post chemotherapy suggesting potential role of AMH levels in counselling women regarding their reproductive potential post chemotherapy. Further research in a larger sample of women is needed.

Effect of deinstitutionalisation on quality of life for adults with intellectual disabilities: a systematic review

ObjectiveTo review systematically the evidence on how deinstitutionalisation affects quality of life (QoL) for adults with intellectual disabilities.DesignSystematic review.PopulationAdults (aged 18 years and over) with intellectual disabilities.InterventionsA move from residential...

Effectiveness of the Chronic Care Model in Type 2 Diabetes Management in a Community Health Service Center in China: A Group Randomized Experimental Study.

Objective The Chronic Care Model, based on core elements of team-centered care in chronic diseases, has widely been accepted. This study was aimed at evaluating the effectiveness of the Chronic Care Model in type 2 diabetes management. Methods A group randomized experimental study was conducted. Twelve communities of the Zhaohui Community Health Service Center in Hangzhou, China, were randomly assigned into an intervention group (n = 6) receiving the Chronic Care Model-based intervention and a control group (n = 6) receiving conventional care. A total of three hundred patients, twenty-five for each community, aged ≥18 years with type 2 diabetes for at least 1-year duration, were recruited. Data of health behaviors, clinical outcomes, and health-related quality of life (Short-Form 36-item questionnaire) were collected before and after a 9-month intervention and analyzed using descriptive statistics, t-test, chi-square test, binary logistic regression, and linear mixed regression. A total of 258 patients (134 in intervention and 124 in control) who completed the baseline and follow-up evaluations and the entire intervention were included in the final analyses. Results Health behaviors such as drinking habit (OR = 0.07, 95% CI: 0.01, 0.75), physical activity (OR = 2.92, 95% CI: 1.18, 7.25), and diet habit (OR = 4.30, 95% CI: 1.49, 12.43) were improved. The intervention group had a remarkable reduction in glycated hemoglobin (from 7.17% to 6.60%, P < 0.001). The quality of life score changes of the role limitation due to physical problems (mean = 9.97, 95% CI: 3.33, 16.60), social functioning (mean = 6.50, 95% CI: 2.37, 10.64), role limitation due to emotional problems (mean = 8.06, 95% CI: 2.15, 13.96), and physical component summary score (mean = 3.31, 95% CI: 1.22, 5.39) were improved in the intervention group compared to the control group. Conclusion The Chronic Care Model-based intervention helped improve some health behaviors, clinical outcomes, and quality of life of type 2 diabetes patients in China in a short term.

Changes in health-related quality of life in oesophagogastric cancer patients participating in palliative and curative therapies

Background: Various treatments are used to prolong survival and improve quality of life (QOL). The purpose of this study was to assess the change in QOL scores in patients with Oesophagogastric (OG) cancer undergoing curative intent and palliative therapy. Methods: This was a mix-designed cohort study with a consecutive sampling of patients with OG cancer who underwent curative or palliative treatment regimens. The QOL, as a determinant of efficacy and impact of cancer care, was evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires. QOL data were collected from the eligible subjects at three points of time. The repeated measurement test was used to compare the significance of change in scores. Results: Overall, 149 patients (54.4% male, 61.1% curative intent, 52.3% esophageal, 37.6 % gastric, 10.1% OG junction cancer; with mean age 62 year) with OG cancer were eligible for inclusion in the study. Compared to the palliative group, the curative group was more likely to have an esophageal tumor site, Squamous Cell Carcinoma, and stage 2 (versus stomach, Adenocarcinoma, and stage 4 in the palliative group). In comparing the patients' functional, global health status, and cancer symptom, considering time, group of treatment, and their mutual effect the result indicated significant difference between the intervention groups. Conclusion: Most patients with Oesophagogastric cancer are diagnosed with an incurable form of the disease. Hence in absence of curative treatment, palliative therapy is the most effective therapy to maintain patient independency and relieve pain and symptom in order to improve their QOL. The present study has shown that palliative similar to curative intervention can improve the QOL in cancer patient especially in short term.

Trajectory of HRQOL scores in pediatric patients receiving proton therapy: results from the Pediatric Proton Consortium Registry (PPCR)

Health-related quality of life (QOL) outcomes are an important metric in understanding the perceived health and emotional well-being of pediatric proton radiotherapy (RT) patients. Here we compare reported QOL outcomes at two time points during radiotherapy to determine the effect RT has on the holistic health of a patient. Pediatric patients (<22 years) treated with RT across multiple institutions were prospectively enrolled on an optional QOL study through the PPCR. Child and proxy answers to the PedsQL v.4.0 are evaluated to generate a total core score (QOL score) ranging from 0-100 (best). QOL scores captured during the first (early) and last (late) week of RT were evaluated. Paired t-tests and Wilcoxon sign-ranked tests were used to assess differences in early and late-RT QOL score within groups, independent t-tests and the Kruskal-Wallis test were used to assess differences between groups. One hundred twenty patients (n=69 (57.5%) CNS, n= 51 (42.5%) non-CNS) enrolled between 9/2015 and 1/2018 comprised the study cohort. Among non-CNS patients, 22 (43.1%) had a head/neck primary tumor. Median age was 10.5 years (<1 to 21.8). Median RT total dose was 54 Gy (21.0-76.0). Mean RT QOL score did not change significantly during RT (early: 74.6; late: 74.8, p=0.87). Children with CNS tumors noted a 3-point increase in QOL scores during RT (p=0.03), whereas QOL among children with non-CNS tumors did not significantly change (p=0.13). Non-CNS primary tumor site had no significant effect on change in QOL score (p=0.31). Patients with KPS=100 at the beginning of RT showed a non-significant decline of 5.0-points, but started higher than patients with a KPS of <100 who remained stable during RT. QOL scores did not differ by anesthesia use for RT (p=0.85), age (p=0.09), or by exposure to concurrent chemotherapy (p=0.34). During RT, children with CNS tumors reported an increase in the QOL score which differed from patients with non-CNS primaries who reported a non-significant decrease in scores. Anesthesia use, age, and concurrent chemotherapy did not significantly effect QOL scores. The PedsQL can be used to monitor the QOL of patients receiving proton radiotherapy. Future efforts to determine if QOL monitoring can lead to improvements in patient’s care and thus treatment experience are warranted.Tabled 1Abstract TU_41_3730; Table 1N(%)Early-RT Score Mean (sd)Late-RT Score Mean (sd)P within groupsP between groups PTumor TypeCNS69 (57.5)76.3 (16.1)79.3 (13.8)0.030.003Non-CNS51 (42.5)72.3 (16.4)68.7 (17.9)0.13AnesthesiaYes47(39.2)72.7 (14.8)72.6 (17.1)0.860.85No70 (58.3)76.0(17.1)76.3 (16.2)0.78Age (years)<10.56175.2 (14.8)73.5 (16.1)0.350.09>10.55974.0 (17.9)76.1 (16.9)0.11ChemotherapyYes79 (65.8)72.2 (16.9)71.3 (17.4)0.960.35No38 (31.7)80.7 (13.1)82.0 (12.0)0.51KPS1003080.8 (15.3)75.8 (15.4)0.070.02<1005870.9 (15.7)72.7 (15.7)0.24 Open table in a new tab

Primary dysmenorrhea with and without premenstrual syndrome: variation in quality of life over menstrual phases.

The majority of studies on quality of life (QoL) of women with menstrual disturbances have not taken menstrual cycle phase into account. We aimed to determine the size of changes in QoL score during perimenstrual week compared to those during late follicular phase in women suffering from dysmenorrhea with or without premenstrual syndrome (PMS) and also to compare the two groups. In this observational analytical study, participants were selected purposively from among single students aged 18-30years, who were residing at university dormitories in Tabriz, Iran, and had moderate or severe dysmenorrhea. They reported quality of their life during the past week using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) at two time points, days 3-4 and 11-12, of their menstrual cycle. Among 52 participants with PMS and 64 without PMS, about half reported severe dysmenorrhea. The mean total quality score was significantly lower during perimenstrual week than during late follicular phase in both group with PMS [48 vs 79, mean difference - 31 (95% confidence interval - 37 to - 26)] and group without PMS [56 vs 78, - 1 (- 27 to - 18)]. The score was significantly lower in the group with PMS than in those without PMS during perimenstrual week [- 8 (- 13 to - 2)] but not during late follicular phase [2.1 (- 2.9 to 7.0)]. Dysmenorrhea with or without PMS significantly reduces QoL of women during perimenstrual week. The QoL is slightly lower in group with PMS during perimenstrual week but not during late follicular phase.

Evaluating Quality of Life in Patients With Meniere's Disease Treated as Migraine.

To evaluate the change in quality of life (QOL) of patients with Meniere's disease (MD) after treatment with migraine prophylaxis therapy. Patients with definite MD were given the Meniere's Disease Outcomes Questionnaire-Retrospective (MDOQ-R) after migraine prophylactic therapy to assess QOL. Changes in physical, emotional, and social parameters affected by MD were calculated, along with a global pre- and posttreatment QOL scores. The MDOQ-R was given to 27 consecutive patients with definite MD. Patients who had at least an 18-month follow-up were included, resulting in 25 questionnaires. The mean change in QOL score was 25 ± 16 (range, -3 to 55), P = .02. Quality of life was improved in 23 (92%) of the respondents in every metric measured, unchanged in 1 (4%), and poorer in 1 (4%) of patients after migraine prophylaxis treatment. Majority of MD patients who had all failed diuretic therapy responded positively to medications used for migraine prophylaxis, as indicated by a significant improvement in QOL. This study may further suggest a correlation between the pathophysiologic basis of disease in MD and vestibular migraine. Patients with MD may be successfully managed with medications intended to treat migraine.

The Minimal Clinically Important Difference of the Anterior Skull Base Nasal Inventory-12.

The minimal clinically important difference (MCID) is defined as the smallest change in health-related quality of life (QOL) that patients consider meaningful. The MCID is essential for determining clinically significant changes, rather than simply statistically significant changes, in QOL scores. The Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12), a site-specific sinonasal QOL instrument, has emerged as a standard instrument for assessing QOL in patients who have undergone endonasal transsphenoidal surgery. To determine the MCID for the ASK Nasal-12. Distribution- and anchor-based methods were used to determine the MCID for the ASK Nasal-12 based on raw data from a multicenter prospective QOL study of 218 patients. Two distribution-based statistical methods, the one-half standard deviation method and the effect-size method, both yielded MCIDs of 0.37 (medium effect). The first anchor-based method, using the 2-wk postoperative overall nasal functioning item as the anchor, yielded an MCID of 0.31. The second anchor-based method, using the 2-wk postoperative Short Form Health Survey 8 bodily pain item as the anchor, yielded an MCID of 0.29. The largest MCID obtained for the ASK Nasal-12 using 4 statistical methods 2 wk postoperatively was 0.37. This information provides clinicians with an essential context for determining the clinical significance of changes in QOL scores after interventions. Our results will help clinicians better interpret QOL scores and design future studies that are powered to detect meaningful QOL changes.

Quality of life of patients with gastrointestinal cancers undergoing chemotherapy.

Findings regarding changes in the quality of life (QOL) of patients with gastrointestinal cancers (GI) undergoing chemotherapy (CTX) are inconclusive. Purpose was to evaluate for changes in QOL scores of patients with GI cancers over two cycles of CTX. Patients (n = 397) completed disease-specific [i.e., Quality of Life-Scale-Patient Version (QOL-PV)] and generic [12-item Medical Outcomes Study Short Form Survey (SF-12)] measures of QOL a total of six times over two cycles of CTX. Changes in these QOL scores were evaluated using bootstrapped multilevel regression with full information maximum likelihood estimation. Treatment group (i.e., with or without targeted therapy), age, number of metastatic sites, time from cancer diagnosis, number of prior cancer treatments, GI cancer diagnosis (i.e., colon/rectum/anal vs. other), and CTX regimen were evaluated as covariates in the conditional models for each of the QOL scores. During the second cycle of CTX, QOL-PV scores decreased in the week following CTX administration, and then increased the following week. For both cycles of CTX, the physical component summary and mental component summary scores of the SF-12 decreased in the week following CTX administration and then increased the following week. Increased time from cancer diagnosis and a higher number of prior cancer treatments resulted in worse QOL-PV and SF-12 scores at enrollment. While changes in QOL scores over the two CTX cycles were statistically significant, the differences were not clinically meaningful. Future studies need to determine the optimal timing of QOL assessments to assess changes associated with cancer treatments.

Abstract P5-18-02: Nab-Paclitaxel-based therapy in the first line treatment of metastatic breast cancer (IBCSG 42-12/BIG 2-12 SNAP): Impact of different schedules on quality of life

Abstract Background: The randomized phase II SNAP trial assessed three alternative reduced maintenance chemotherapy regimens using nab-Paclitaxel after a short term induction phase at conventional doses as first line treatment in patients (pts) with metastatic breast cancer (MBC). For all three regimens median progression-free survival was greater than achieved with full dose docetaxel (historical reference). Symptom palliation and quality of life (QoL) are important when deciding on therapeutic agents and schedules in MBC pts. Methods: Of the 258 pts with MBC enrolled from April 2013 to August 2015 in the SNAP trial, 255 were included in the QoL analysis. Pts were randomized to three arms, each receiving the same induction chemotherapy based on 3 cycles of nab-Paclitaxel 150 mg/m2 dd 1, 8, 15 Q28, which was reduced to 125 mg/m2 after a safety review. The schedules of nab-Paclitaxel in maintenance therapy differed in each arm: Arm A) 150 mg/m2 dd 1,15 Q28; Arm B) 100 mg/m2 dd 1,8,15 Q28; Arm C) 75 mg/m2 dd 1,8,15,22 Q28. Pts completed a QoL form to assess global and symptom-specific indicators (range 0-100) at baseline, and at day 1 of every cycle for the first 12 cycles on treatment, or until treatment discontinuation. Changes in QoL scores during induction (day 1 cycle 4 − baseline) and maintenance (day 1 cycle 12 – day 1 cycle 4) therapy were summarized descriptively per arm. Treatment effects on changes in QoL during maintenance therapy were analyzed by repeated measurement models including timepoints (from day 1 of cycle 4 to day 1 of cycle 12), induction start dose, age, and treatment arms as covariates. Results: During induction therapy, mean changes [SD] in hair loss (Arm A:−70.2 [41.9]; Arm B: −77.3 [34.5]; Arm C: −72.6 [32.8]), sensory neuropathy (Arm A: −19.0 [25.2]; Arm B: −20.6 [22.7]; Arm C: −18.8 [23.8]), and treatment burden (Arm A: −12.9 [33.4]; Arm B: −13.4 [33.5]; Arm C: −11.4 [34.8]) showed the most pronounced worsening. During maintenance therapy, scores for sensory neuropathy remained impaired without worsening. No significant differences in changes for sensory neuropathy or the other symptoms were seen between arms, except for hair loss, with pts in arm C (mean difference 10.91; 95% CI [0.35, 21.48]; p=0.04) ] and B (mean difference 18.55; 95% CI [7.52, 29.59]; p=0.001) reporting a greater improvement compared to those in arm A. Pts in arm C reported a significantly greater improvement in mood compared to arm A (mean difference 13.34; 95% CI [6.08, 20.60]; p&amp;lt;0.001) and arm B (mean difference 9.62; 95% CI [2.84, 16.40]; p=0.01)]. Conclusion: The effectiveness of alternative maintenance chemotherapy schedules with reduced doses after a short term induction phase at conventional doses must be weighed against a substantial worsening in sensory neuropathy during induction therapy, and scores continuing to be impaired without worsening with prolonged administration. During maintenance therapy, improvements were seen in the perception of hair loss and in mood, particularly in Arm B and C, with a similar tendency seen for some other QoL domains. A more frequent administration of reduced dose chemotherapy agents is favorable with respect to QoL in this setting. Citation Format: Ribi K, Sun Z, Jerusalem G, Hasler-Strub U, Colleoni M, von Moos R, Cortés J, Vidal M, Hennessy B, Walshe J, Amillano Parraga K, Morales Muriilo S, Pagani O, Barbeaux A, Bortsnar S, Maibach R, Regan MM, Gennari A, Bernhard J. Nab-Paclitaxel-based therapy in the first line treatment of metastatic breast cancer (IBCSG 42-12/BIG 2-12 SNAP): Impact of different schedules on quality of life [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-18-02.

Impact of Tai Chi on Peripheral Neuropathy Revisited: A Mixed-Methods Study.

Exercise may be beneficial to older persons living with peripheral neuropathy (PN), but maintaining an exercise program is challenging. After participating in a 12-week tai chi (TC) study, 12 participants requested classes continue. A mixed-methods design was used to explore long-term engagement of older persons with bilateral PN enrolled in a TC class for 18 months beyond the original 3-month study. Pre- and posttest measures of functional status and quality of life (QOL) were conducted. Focus groups were held after 18 months of twice-weekly classes. Psychosocial support was critical to participants’ long-term commitment to exercise. Participants reported, and objective assessments confirmed, increased strength, balance, and stamina beyond that experienced in the original 12-week study. Changes in QOL scores were nonsignificant; however, qualitative data supported clinical significance across QOL domains. Results from this study support psychosocial and physical benefits of TC to older persons.

Comparison of quality of life between 2-year and 3-or-more-year administration of leuprorelin acetate every-3-months depot in combination with tamoxifen as adjuvant endocrine treatment in premenopausal patients with endocrine-responsive breast cancer: a randomized controlled trial

BackgroundWe conducted an open-label, randomized controlled trial evaluating the appropriate treatment duration of leuprorelin acetate 3-month depot, TAP-144-SR (3M), administered postsurgically every 3 months for 2 years versus 3 or more (up to 5) years, in combination with tamoxifen, for 5 years in premenopausal endocrine-responsive breast cancer patients and reported similar survival benefit in the two treatment groups. We hereby present patient-reported quality of life (QOL) data obtained from this trial.MethodsThree self-administered QOL questionnaires (QOL-ACD, QOL-ACD-B, FACT-ES subscale) were used, and the difference in QOL score changes between the two groups was analyzed using a mixed-effects model for repeated measures.ResultsEligible patients (N = 222) were randomly assigned to a 2-year (2YG, N = 112) or 3-or-more-year treatment group (3YG, N = 110). The time courses of the three QOL scores during the trial period were similar in the two groups. The mean changes in the QOL scores from week 96 were largely stable through week 240 in the 3YG, but showed significantly greater improvement in the score changes from week 96 in the 2YG than the 3YG. Symptoms associated with menopause such as hot flashes and sweating contributed to these results. Menstruation recovery was associated with significantly greater improvement of these symptoms in the 2YG than the 3YG.ConclusionsPatient-reported menopause-associated symptoms and QOL improved after discontinuation of the LH-RH agonist administration and menstruation recovery. QOL information should be a consideration in long-term treatment.

Quality of Life in Children and Youth with Obsessive-Compulsive Disorder.

The study examined clinical correlates of quality of life (QoL), impact of treatment on QoL, and predictors of QoL change among children with obsessive-compulsive disorder (OCD). One hundred forty-two children with primary OCD who were enrolled as part of a larger clinical trial participated. Children were administered a structured diagnostic interview, as well as clinician-administered measures of OCD and depression symptom severity. Children and parents completed reports of QoL, as well as measures of impairment and internalizing and externalizing symptoms. Youth received 10 sessions of family-based cognitive-behavioral therapy (CBT). At baseline, QoL was inversely related to obsessive-compulsive symptom severity, impairment, externalizing and internalizing symptoms, and severity of depression symptoms according to children and parents. After CBT, QoL improved according to parent ratings, but not child ratings. None of the predictors examined were associated with changes in QoL scores over time. Impairment, and externalizing and internalizing symptoms predicted QoL after accounting for OCD symptom severity. After accounting for OCD symptoms, externalizing symptoms inversely predicted changes in QoL. These data suggest that QoL is related to more severe clinical presentation and improves with evidence-based treatment, but QoL improvements may be inversely related to externalizing symptomology.

Quality of life in responders after palliative radiation therapy for painful bone metastases using EORTC QLQ-C30 and EORTC QLQ-BM22: results of a Brazilian cohort.

Bone metastases cause pain, suffering and impaired quality of life (QoL). Palliative radiotherapy (RT) and/or chemotherapy are effective methods in controlling pain, reducing analgesics use and improving QoL. This study goal was to investigate the changes in QoL scores among patients who responded to palliative treatment. A prospective study evaluating the role of radiation therapy in a public academic hospital in São Paulo-Brazil recorded patients' opioid use, pain score, Portuguese version of QLQ-BM22 and QLQ-C30 before and 2 months after radiotherapy. Analgesic use and pain score were used to calculate international pain response category. Overall response was defined as the sum of complete response (CR) and partial response (PR). CR was defined as pain score of 0 with no increase in analgesic intake whereas PR was defined as pain reduction ≥2 without analgesic increase or analgesic reduction in ≥25% without increase in pain at the treated site. From September 2014 to October 2015, 25 patients with bone metastases responded to RT or chemotherapy (1 CR, 24 PR). There were 8 male and 17 female patients. The median age of the 25 patients was 59 (range, 22 to 80) years old. Patient's primary cancer site was breast [11], prostate [5], lung [2], others [7]. For QLQ-BM 22, the mean scores of 4 categories at baseline were: pain site (PS) 39, pain characteristics (PC) 61, function interference (FI) 49 and psycho-social aspects (PA) 57. At 2 month follow up, the scores were PS 27, PC 37, FI 70 and PA 59. Statistical significant improvement (P<0.05) was seen in PS, PC, FI but not PA. In the QLQ-C30, the scores were not statistically different for all categories, except for pain that demonstrated a 33 point decrease in the median pain score domain (66 to 33). Responders to RT at 2 months presented improvement in BM22 and C30 pain domains, and also improvement in functional interference domain of the BM22 questionnaire.

A randomized phase II trial comparing different schedules of nab-paclitaxel (nabP) combined with gemcitabine (GEM) as first line treatment for metastatic pancreatic adenocarcinoma (mPDAC).

4100 Background: NabP+GEM chemotherapy improves survival compared with GEM monotherapy as treatment for mPDAC. A PDAC mouse model suggested that nabP potentiates GEM activity by reducing cytidine deaminase levels and scheduling may be critical to optimise clinical benefit. Methods: Patients (pts) were randomised to receive standard concomitant (CON) nabP+GEM or sequential (SEQ) administration, with nabP given 24 hours before GEM. After 6 cycles, pts benefiting from treatment could continue the same regimen until disease progression. The primary endpoint was progression-free survival (PFS) by RECIST v1.1; secondary endpoints included safety, objective response rate (ORR), overall survival (OS) and quality of life (QoL). Serial blood and baseline tumour samples were collected for exploratory biomarkers. Results: Between March 2014 and 2016, 146 pts (71 SEQ, 75 CON) were recruited. Median age (range) was 66 (45-82) years; Karnofsky performance status was 70 (in 12% pts), 80 (27%), 90 (38%) or 100 (24%); 47% had pancreatic head primaries; 84% had liver metastases. Median no. cycles received was 4 SEQ, 3 CON; 51 pts (35%) received ≥6 cycles of treatment (42% SEQ, 28% CON). A 24+2hr interval was achieved in &gt; 90% SEQ admin. Grade ≥3 adverse events experienced by ≥10% pts (SEQ, CON) were neutropaenia (54%, 30%; p = 0.003), febrile neutropaenia (12%, 12%), fatigue (22%, 15%), vomiting (7%, 11%) and anaemia (10%, 5%). G-CSF was administered at local investigator's discretion to 35 pts (23 SEQ, 12 CON; p = 0.015). To date, 112 pts have died. 6 month (m) PFS by SEQ and CON arms were 47% and 33%; median PFS were 5.8 and 4.0m; hazard ratio (HR) = 0.66, 95% CI = 0.46-0.95; 12m OS by SEQ and CON arms were 29% and 26%; median OS were 10.1 and 7.9m; HR = 0.88, 95% CI = 0.61-1.29. ORR was 50% SEQ and 33% CON (p = 0.065). Mean baseline QoL Global health status score was 60.6 SEQ and 63.4 CON. The mean change in QoL score from baseline at 24 weeks was -2.1 SEQ and -12.1 CON. Conclusions: Sequential delivery of nabP combined with GEM trended towards improving all clinically relevant efficacy end points: PFS, OS, and ORR. Translational correlates will be reported in due course. Clinical trial information: ISRCTN71070888.