Linear Analog Scale Assessment Research Articles

An Investigation of the Effect of Virtual Reality on Alleviating Anxiety in Patients With Breast Cancer Undergoing Radiation Therapy: A Randomized Controlled Trial

The aim of this study was to evaluate the anxiety-reducing effects of virtual reality (VR) on patients with breast cancer undergoing adjuvant radiation therapy (RT). This randomized controlled trial was conducted among patients with breast cancer receiving RT at a single institution. Of 196 enrolled and randomized patients, 97 were assigned to a VR explanation group (intervention) and 99 were assigned to the standard-of-care group (control). Anxiety levels were measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) as the primary endpoint and the State-Trait Anxiety Inventory (STAI) and Linear Analogue Scale Assessment (LASA) as secondary endpoints. Knowledge of the RT procedure, patient satisfaction, and time spent for counseling were also assessed. Intervention significantly reduced patient anxiety immediately, not only on the primary endpoint, APAIS, but also on the STAI and LASA anxiety scales. Specifically, in the intervention group, there were immediate reductions of 26.0%, 16.1%, and 55.8% for APAIS, STAI, and LASA, respectively, whereas in the control group, the respective reductions were 8.1%, 8.5%, and 13.7%. Among the 3 anxiety scales, long-term anxiety reduction was observed only when anxiety was measured by LASA. Subgroup analyses showed that the effect on anxiety did not differ based on the physician, baseline anxiety level, use of hormone therapy, or health literacy. The intervention also significantly improved knowledge of the RT procedure (81.9/100 vs 76.8/100; P=.006) and patient satisfaction with the explanation manner (6.56 vs 5.72; P < .001) compared with the control group. Immersive VR applied to the current procedure reduces anxiety during RT planning for patients with breast cancer. Further research is necessary to investigate the long-term effects of VR on anxiety.

Greek Caregivers of Chronically Ill Patients Struggling in Everyday Life.

Caregivers of chronically ill geriatric patients face several problems throughout the disease progression of the patients under their care. This is a prospective crosssectional study conducted from September 2017 to September 2018, including 130 caregivers of geriatric patients from Attica, Greece. This study investigates caregivers' anxiety, perception of changes in their lives, and quality of life. The questionnaires administered were the revised Bakas Caregiving Outcomes Scale (rBCOS), the State-Trait Anxiety Inventory (STAI), and the Linear Analogue Scale Assessment (LASA). Influencing factors associated with rBCOS, STAI and LASA were care timespan and energy levels. Only the State Anxiety Scale and the Patient-caregiver Relationship rBCOS questionnaire seemed to be affected by a cancer diagnosis. Our findings revealed that anxiety, low quality of life, and perception of changes in the lives of caregivers are the underlying factors. Significant factors were time spent caring for the patient, the status of their relationship, the diagnosis, especially in life-threatening and life-limiting diseases, and the caregivers' energy levels. These results are important in order to comprehend the lives of caregivers and assess by what means could the healthcare system and society further assist them.

S303: EFFECT OF PEGCETACOPLAN ON QUALITY OF LIFE IN COMPLEMENT-INHIBITOR NAÏVE PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA: RESULTS FROM THE PHASE 3 PRINCE STUDY

Background: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, life-threatening disease characterized by complement-mediated hemolysis and thrombosis. Historically, PNH was treated with C5 inhibitors (eculizumab [ECU)/ravulizumab). Despite their proven efficacy in the control of intravascular hemolysis (IVH), up to 72% of patients experience persistent hemolysis leading to suboptimal hemoglobin (Hb) levels and 36% require transfusions despite ECU treatment which results in a significant impact on the quality of life (QoL), including persistent fatigue. Pegcetacoplan (PEG) is an FDA/EMA-approved C3 complement-inhibitor that provides broad hemolysis control (including IVH and extravascular hemolysis) in patients with PNH. Aims: This analysis evaluates QoL measures in the Phase 3 PRINCE study (NCT04085601), a multicenter, randomized, open-label, controlled study evaluating the efficacy and safety of PEG compared to control treatment (CTRL; excluding complement-inhibitors) in complement-inhibitor naïve patients with PNH. Methods: PRINCE has been described previously and was superior for the coprimary endpoints of hemoglobin (Hb) stabilization (avoidance of >1 g/dL decrease in Hb from baseline), change from baseline in lactate dehydrogenase at 26 weeks and PEG-treated patients saw clinically meaningful increases in the FACIT-Fatigue scores (Wong SR, et al. Blood 2021; 138 [Supplement 1]: 606). Secondary endpoints specific to QoL measures included the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Scale (EORTC QLQ-C30), Linear Analog Scale Assessment (LASA) and The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). The EORTC QLQ-C30 contains 30 questions comprising 5 functional, 9 individual symptoms, and one global health status/QoL item(s), where a ≥10-point change in score is considered clinically meaningful. The LASA consists of 3 sections asking to rate the perceived level of functioning (scale 0-100, where a higher score corresponds to a better QoL) and contains specific domains for activity level, ability to carry out daily activities, and overall QoL. The FACIT-Fatigue is a 13-item Likert scaled instrument (scale 0-51), where a ≥3-point increase is considered clinically meaningful. Results: Relevant baseline characteristics for PRINCE are reported in Table A. Mean baseline scores of the EORTC QLQ-C30 functional and symptom scales were generally similar between groups (except for role and cognitive functioning and insomnia; Table B). After 26 weeks of PEG-treatment, patients displayed clinically meaningful improvements in most of the functional scales and the global health status/QoL at Week 26 as indicated by a ≥10-point score increase from baseline (Table B). Improvements in the symptom scales, including fatigue and dyspnea scales, were also observed in the PEG group at Week 26 as indicated by a reduction in the symptom score close to the general population norms (general population norm: fatigue: 24.1, dyspnea: 10.9). Mean total LASA scores increased in the patients receiving PEG treatment for 26 weeks (Table B). FACIT-Fatigue scores increased for PEG-treated patients to near the general population norm [43.6], supporting the gains shown in the EORTC QLQ-C30-Fatigue scale. Image:Summary/Conclusion: Substantial and clinically relevant improvements in QoL were consistently observed with PEG across both EORTC QLQ-C30, total LASA and FACIT-Fatigue scores and clinically significant improvements in fatigue and dyspnea are highly relevant to the symptomology of PNH.

Effect of Pegcetacoplan on Quality of Life in Patients with Paroxysmal Nocturnal Hemoglobinuria from the Pegasus Phase 3 Trial Comparing Pegcetacoplan to Eculizumab

Effect of Pegcetacoplan on Quality of Life in Patients with Paroxysmal Nocturnal Hemoglobinuria from the Pegasus Phase 3 Trial Comparing Pegcetacoplan to Eculizumab

Hearing and Heeding the Voices of those With Advanced Illnesses.

To describe the feasibility of a chaplain-led spiritually focused life review interview and the development of a spiritual legacy document (SLD) for patients with advanced diseases and to describe changes in spiritual well-being (SWB), spiritual coping strategies (SC), and quality of life (QOL) after receiving the SLD. In all, 130 patients and support person (SP) pairs were recruited from July 2012 to January 2019. Following enrollment, demographic information was gathered and baseline questionnaires were administered. Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12) and a linear analog scale assessment (LASA) measured SWB. LASAs also measured QOL and emotional well-being (EWB). Positive Religious Coping Scale (RCOPE) measured SC. After completion of baseline forms, participants were interviewed (individually) by a chaplain. Interviews were digitally recorded, transcribed, and verified. Transcripts were edited and participants were given the opportunity to make adaptations. The participant-approved draft was then developed into a professionally printed SLD. Follow-up questionnaires were administered to assess change. Significant improvements from baseline to post-SLD follow-up were found for patients on the LASAs: SWB (average 7.7-8.3, P = .01), QOL (average 6.7-7.3, P = .03), EWB (average 6.9-7.5, P = .01), and on the positive RCOPE (average 1.8-2.0, P = .007). Effect sizes were approximately 0.25. Considering any improvement, 61.0% improved their positive RCOPE score, 46.6% improved EWB, and 39.7% improved SWB. No significant changes were found on the FACIT-Sp-12. No significant changes were found for SPs. The results suggest that the primary participants who completed the study benefited by significantly increasing their QOL, SWB, EWB, and SC.

3 fraction pencil-beam scanning proton accelerated partial breast irradiation: early provider and patient reported outcomes of a novel regimen

Background and purposeTo report dosimetry and early adverse effects, aesthetic, and patient-reported outcomes of a prospective study of 3-fraction pencil-beam scanning (PBS) proton accelerated partial irradiation (APBI).Materials and methodsEligibility included women age ≥ 50 years with estrogen receptor positive (ER+), sentinel lymph node negative invasive or in-situ breast cancer measuring ≤2.5 cm. The prescription was 21.9 Gy (RBE 1.1) in 3 daily fractions to the post-operative tumor bed with a 1 cm expansion. Toxicities were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, 10-point Linear Analog Scale Assessment, Patient-Reported Outcomes Version of the CTCAE, and the Harvard Breast Cosmesis Scale.ResultsSeventy-six women were treated between 2015 and 2017. The median breast volume receiving 50% of prescription or more was 28%. Median mean heart, mean ipsilateral lung, and maximum skin dose were 0 Gy, 0.1 Gy, and 20.6 Gy, respectively. With a median follow-up of 12 months, no treatment-related toxicity grade ≥ 2 has been observed. Most common grade 1 adverse events were dermatitis (68%) and skin hyperpigmentation (18%). At 12 months, the only persistent toxicities were one patient with grade 1 breast edema and one patient with a grade 1 seroma. 90% of patients reported quality of life as ≥7 out of 10 (0 indicating “as bad as it can be” and 10 indicating “as good as it can be”) and 98% of patients reported excellent or good cosmesis.Conclusion3-fraction PBS proton APBI is well tolerated with low rates of physician and patient reported early adverse effects. Follow-up is ongoing to assess late toxicities and disease control outcomes. Further investigation of this novel adjuvant treatment strategy is warranted.

Quality of life impact of EUS in patients at risk for developing pancreatic cancer.

Background and Objectives:The current knowledge about the psychological impact of pancreatic cancer (PC) screening is limited. We aimed to assess the changes in quality of life (QOL) and level of distress after undergoing EUS in individuals with pancreatic cystic lesions (PCLs) and in patients at high risk for PC based on genetic and familial factors.Methods:Eighty patients with PCL and/or increased genetic or familial risk for PC who had undergone EUS were contacted. Fifty percent of those patients successfully completed the brief profile of mood states (POMS) and the linear analog scale assessment (LASA) QOL questionnaires to evaluate their pre/post-EUS overall QOL. The effect size (ES) method was used to assess clinically meaningful changes in the scores.Results:There was a significant difference in patients’ overall QOL scores before and after the EUS procedure (LASA, mean difference 0.73, standard deviation (SD) 1.76, ES 0.58, P < 0.01; brief POMS, mean difference −5.46, SD −6.72, ES 0.81, P < 0.01).Conclusions:QOL of patients with PCL or increased risk factors for PC is significantly improved after a EUS/EUS-guided fine-needle aspiration (FNA) negative for malignancy.

Identifying patient-reported anxiety and depression in older adults with cancer.

11556 Background: Anxiety and depression are associated with decreased quality of life, treatment adherence, and survival in patients with cancer. Mental Health Inventory (MHI-17) is a validated screening tool for psychological well-being, but cut points for older adults with cancer are unknown. The goal of this study is to identify cut points on MHI-17 Anxiety (MHI-A) and Depression (MHI-D) subscales which correlate with patient-reported anxiety and depression in older adults with cancer. Methods: This is a secondary analysis of baseline data from a randomized controlled trial in adults aged 65+ with solid tumors starting chemotherapy. At baseline, patients completed MHI-17. MHI-A and MHI-D were calculated (range 0-100; higher scores represent better mental health). Self-reported anxiety was obtained from single-item Linear Analog Scale Assessment (0-5 = low, 6-10 = high). Self-reported depression was obtained from Yale Depression Screen, “Do you often feel sad or depressed?” The association of MHI-A and MHI-D with the patient-reported outcomes was analyzed using logistic regression. Youden’s index was used to determine the optimal cut points for MHI-A and MHI-D for identifying patients with high anxiety and depression. Results: 458 patients (median age 71 (range 65-91), 57% female, 55% non-Hispanic white) were included in this analysis. The most common cancer types were: GI (31%), breast (19%), GU (18%), and pulmonary (16%); 75% had stage IV cancer. Twenty-four percent (N = 110) reported high anxiety and 21% (N = 97) depression. Median scores for MHI-A and MHI-D were 75 (range 0-100) and 80 (range 0-100). The optimal cut point for high anxiety on MHI-A was 65; this had an accuracy of 76.1%, a sensitivity of 71.8%, and a specificity of 77.5%. The optimal cut point for depression on MHI-D was 70; this had an accuracy of 80.1%, a sensitivity of 80.4%, and a specificity of 79.8%. Conclusions: The current study identified optimal cut points for MHI-Anxiety and MHI-Depression subscales to identify older adults with cancer starting chemotherapy with self-reported anxiety and depression. In the absence of patient-reported anxiety and depression, these cut points could be used to identify older patients with cancer at risk for poor mental health.

P074 SUSTAINED IMPROVEMENTS IN FATIGUE AND QUALITY OF LIFE IN PATIENTS WITH IBD AND IRON DEFICIENCY ANEMIA FOLLOWING A SINGLE COURSE OF FERUMOXYTOL: RESULTS OF A 6-MONTH EXTENSION STUDY

Iron deficiency anemia (IDA), common in patients with inflammatory bowel disease (IBD) due to blood loss, inflammation and malabsorption, negatively impacts patients’ health-related quality of life (HRQOL). Oral iron is often first-line treatment, but many patients do not tolerate it, or do not adequately respond; many live with chronic anemia and its related negative effects. A Phase 3 double-blind, placebo-controlled trial (NCT01114139) previously found that patients unsuccessfully treated with oral iron, including those with IBD, had very poor baseline HRQOL scores associated with fatigue, and that IV iron treatment resulted in significant, clinically meaningful improvement. To explore the durability of this treatment effect, this subgroup analysis reports on the impact on patient-reported outcomes (PRO) of a single course of IV ferumoxytol, received during the double-blind trial, over the subsequent 6-month extension study (NCT01114217) in patients with IBD. Patients with persistent or recurrent IDA (Hgb <11.0 g/dL and TSAT <20%) at any time during the extension study received ferumoxytol (1 course = 2x510 mg IV, 3 to 8 days apart). The same validated PRO instruments were administered as in the preceding double-blind trial: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue), and Linear Analogue Scale Assessment (LASA) -Energy, -Activities of Daily Living (ADL) and -HRQOL. This analysis reports on the subgroup of patients who did not receive any additional ferumoxytol during the entire 6-month extension study. Most patients who had received a dose of ferumoxytol in the double-blind trial did not require any further doses during the extension study (285/471; 61% Overall) including 61% (23/30) of those with IBD. Among this cohort, the IBD patients’ mean Hgb had increased from 8.9 ± 0.7 g/dL at Baseline to 12.0 ± 0.8 at Week 5 of the double-blind trial and remained above 12.0 throughout the 6-month extension study visits (Month 7 Hgb 12.1 ± 1.0) despite receiving no further ferumoxytol. At Baseline of the double-blind trial, their FACIT-Fatigue scores were lower (Overall 24.3 ± 12.3; IBD 18.7 ± 12.6) than general (non-anemic) US population norms (40.1-43.6), and comparable to the scores of anemic cancer patients receiving chemotherapy (23.9, Cella 2002). By Week 5, FACIT-Fatigue scores increased significantly (Overall 36.1 ± 11.2; IBD 31.9 ± 13.4), and the improvement was sustained over 6 months (Month 7 score Overall 38.8 ± 11.5; IBD 37.0 ± 13.7). Significant improvements in the LASA domains that were observed in the double-blind study were also maintained. This study found that for the majority of patients, significant improvements in fatigue and quality of life domains, greater than the previously reported Minimal Clinically Important Differences (MID), were achieved and sustained for 6 months following a single treatment of ferumoxytol. Tabled 1Change from Baseline PRO Measures in IBD PatientsPRO InstrumentPretreatment BaselineMean (SD)Month 4 Change Mean (95% CI)Month 7 Change Mean (95% CI)MIDLASA-Energy36.2 (24.15)24.6 (12.8, 36.3)14.7 (4.5, 24.9)9.61LASA-Activity44.4 (23.7)15.9 (5.4, 26.3)13.3 (2.9, 23.8)8.74LASA-QOL46.9 (25.3)18.6 (8.2, 29.1)13.6 (4.5, 22.6)9.81FACIT-Fatigue18.7 (12.6)15.9 (9.3, 22.5)14.2 (8.1, 20.3)3.0PRO = Patient-reported outcomes; CI = confidence interval; MID = Minimum Important Difference (Patrick et al, Euro J Cancer 2003; Norman et al, Med Care 2003; Cella et al, J Pain Symptom Management 2002). Open table in a new tab PRO = Patient-reported outcomes; CI = confidence interval; MID = Minimum Important Difference (Patrick et al, Euro J Cancer 2003; Norman et al, Med Care 2003; Cella et al, J Pain Symptom Management 2002).

A prospective study to evaluate the efficacy of ultrasound-guided ganglion impar block in patients with chronic perineal pain.

Background:The blockade of the ganglion impar has been described to relieve the intractable perineal pain of sympathetic origin in patients with coccydynia. Chronic perineal pain (CPP) has been effectively managed by ganglion impar block. The feasibility, safety, and efficacy of ultrasound (US)-guided ganglion impar block by transsacrococcygeal approach was analyzed in the present study.Methods:A total of 15 patients with CPP were administered US-guided ganglion impar block using out of plane approach. Patients were followed for VAS and quality of life using Karnofsky performance status (KS), Linear Analog Scale Assessment (LASA), and constipation score up to 2 months at different time intervals. Time required to perform the procedure, number of attempts, and any complications were also noted.Results:The mean time required to perform the procedure was 7.67 ± 1.23 min. There were no adverse events. All the patients had significant pain relief during 2 month follow-up (P < 0.05 compared to baseline VAS). The KS and LASA score improved post block which was statistically significant. The dose of nonsteroidal anti-inflammatory drugs (NSAIDS) decreased from preblock state with statistically significant difference, while the difference in dose of tramadol and morphine was statistically insignificant.Conclusion:US-guided ganglion impar block is technically feasible and safe technique. USG can be used to locate sacrococcygeal junction (SCJ) and facilitate the performance of ganglion impar block. The efficacy and safety of the US-guided ganglion impar blockades needs a proper evaluation in the randomized controlled trials.

Three-Fraction Intracavitary Accelerated Partial Breast Brachytherapy: Early Provider and Patient-Reported Outcomes of a Novel Regimen

To report early adverse events and patient-reported outcomes (PROs) of 3-fraction intracavitary catheter-based partial breast brachytherapy (ICBB). Eligible women ≥50years of age with ≤2.5-cm, lymph node-negative invasive or in situ breast cancer underwent breast-conserving surgery and placement of a brachytherapy applicator. ICBB was initiated on the second weekday after surgery and prescribed to 21Gy in 3 once-daily fractions. Common Terminology Criteria for Adverse Events, version 4.0; 10-point linear analog scale assessment; the PRO version of the Common Terminology Criteria for Adverse Events; and the Harvard Breast Cosmesis Scale were used for provider and patient-reported assessments. Seventy-three women were treated for invasive (79%) or in situ (21%) breast cancer. The median time to completion of surgery and radiation therapy was 6days. After 14-months median follow-up, 2 patients (3%) had developed breast infections that resolved with oral antibiotics. There was no other treatment-associated adverse event grade ≥2. The grade 1 seroma rate at 3months was 20%, which dropped to 8% at 12months; no events required intervention. At 12months, 91% of patients reported an overall quality of life score as ≥8 of 10, and patient-reported cosmesis was good or excellent in 95%. All patients are alive without relapse at the last follow-up. Three-fraction ICBB is associated with low rates of early provider and patient- reported adverse events and compares favorably with early outcomes of more protracted ICBB regimens, including twice-daily (3.4Gy×10) fractionation studied in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-39. Further investigation is warranted.

Sustained Improvements in Fatigue and Quality of Life in Iron Deficiency Anemia Patients Following a Single Course of Ferumoxytol: Results of a 6-Month Extension Study

Introduction: Iron is essential for the function of many key proteins including hemoglobin (Hgb) and myoglobin (involved in oxygen transport/exchange), cytochromes (involved in energy generation), various enzymes (involved in cell proliferation and neurotransmission), and immune function. Iron deficiency can, therefore, negatively impact patients' health-related quality of life (HRQOL) and requires treatment to replete iron stores. Although oral iron is a common initial treatment, some patients do not tolerate it or fail to adequately respond, and many of these patients live with chronic anemia and the related negative effects on their HRQOL. A Phase 3 double-blind, placebo-controlled trial (NCT01114139) had previously found that patients with iron deficiency anemia (IDA), unsuccessfully treated with oral iron, had very poor baseline HRQOL scores associated with fatigue, and that IV iron treatment with ferumoxytol resulted in clinically meaningful improvements, significantly greater than placebo, over the 5-week study period. To explore the durability of this treatment effect, this analysis reports on the impact on patient-reported outcomes (PRO) of a single course of ferumoxytol therapy over the course of the subsequent 6-month extension study.Methods: A 6-month Phase 3, open-label extension study (NCT01114217) was conducted in patients who had completed the double-blind, placebo-controlled Phase 3 trial. Enrolled patients were evaluated for IDA monthly throughout the study period. Those with persistent or recurrent IDA (Hgb <11.0 g/dL and TSAT <20%) at any evaluation visit, received a course of ferumoxytol (2 x 510 mg, 3-8 days apart). The same validated PRO instruments were administered in this extension study as in the preceding double-blind trial: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue), Short Form Health Survey (SF-36), and Linear Analogue Scale Assessment (LASA) of Energy, Activities of Daily Living (ADL) and HRQOL. This analysis reports results for the subgroup of patients who did not receive any additional doses of ferumoxytol during the entire 6-month period of the extension study.Results: The majority of patients enrolled in the extension study who had received ferumoxytol in the previous Phase 3 trial (285/471; 61%) did not meet the above-noted re-treatment criteria during the 6-month extension, and did not receive any further doses of ferumoxytol. Reflecting the overall enrollment in the extension study, these patients were predominantly female (90.0%) and white (63.5%), with mean age of 43.6±13.3 years (range 19-88). The most common primary underlying conditions were abnormal uterine bleeding (41.8%), GI disorder (33.0%), and cancer (10%). Their mean Hgb had increased from 9.0±0.8 g/dL at Baseline to 12.1±1.1 at Week 5 of the double-blind trial and remained above 12.0 throughout the 6-month extension study visits (Month 7 Hgb 12.1±1.2) despite receiving no further ferumoxytol.At Baseline of the double-blind trial, their FACIT-Fatigue scores were lower (24.3±12.3) than general (non-anemic) US population norms (40.1-43.6), and comparable to anemic cancer patients receiving chemotherapy (23.9, Cella 2002). By Week 5 following ferumoxytol treatment, their FACIT-Fatigue scores had increased significantly (36.1±11.2), approaching general population norms. This improvement was sustained over the following 6 months (Month 7 score 38.8±11.5).Their SF-36 Vitality scores increased from 37.6 ±11.8 at Baseline of the double-blind trial to 47.7±12.0 at Week 5, approaching the general US population norm (50.0, McHorney 1993) and continued to increase slightly over the next 6 months (Month 4, 50.0±12.0; Month 7, 50.9±11.5). Similarly, the significant improvements in LASA Energy, ADL and HRQOL scores that were observed in the double-blind study were also maintained over the next 6 months.Conclusions:These data suggest that ferumoxytol may provide important clinical benefits to IDA patients with a history of unsatisfactory oral iron therapy; these benefits include reductions in fatigue, increased energy, vitality, and ability to perform ADL and improved HRQOL. This is important especially in light of the poor baseline energy and HRQOL scores of patients who cannot take oral iron. This study found that for the majority of patients, these improvements were sustained for at least 6 months after a single course of therapy. [Display omitted] DisclosuresVadhan-Raj:AMAG Pharmaceuticals, Inc: Other: received funding from Amag to support clinical trial. Dahl:AMAG Pharmaceuticals, Inc: Employment, Equity Ownership. Jiang:AMAG Pharmaceuticals, Inc: Employment, Equity Ownership. Strauss:AMAG Pharmaceuticals, Inc: Employment, Equity Ownership.

Feasibility of a patient-reported outcomes quality-of-life instrument to improve care in underserved, ethnic minority patients with cancer.

65 Background: We need better methods to understand the social determinants of health and integrate psychosocial and economic sequelae of cancer and its treatment into healthcare delivery for ethnoculturally diverse population. A Patient-Reported Outcomes Quality of Life (PROQOL) instrument has been developed to capture less commonly discussed patient concerns (Personal Relationships, Emotional health, Physical health, Cancer diagnosis and treatment, Money and Care planning) and improve patient-provider communication. We sought to adapt this instrument and pilot it in underserved, ethnically diverse solid tumor and hematological malignancies patients at Maricopa Integrated Health System (MIHS) in Phoenix, AZ. Methods: Two focus groups (FG) were conducted to understand patient perspectives of an adapted Spanish version of PROQOL. This version was then piloted among patients on active cancer treatment. Patients also completed a Linear Analog Scale Assessment (from 1-10) for quality of life (QOL) and its domains (higher scores indicate better QOL). Results: All participants in both FG (11/12 female) were Hispanics, with a median age of 53 years. Participants agreed that the domains covered in the PROQOL represented the most important psychosocial needs in their cancer continuum. No difficulty in understanding the individual domains or questions for delving deeper into each domain was noted. Median age of 34 pilot study participants (74% female) was 48 years, 79% were Hispanic, 10% were African Americans and median household income was $ 43,924 (range 23,002-98,382). 28/34 completed the Spanish version. Most common concerns were ‘Money’ (32%): difficulty paying medical bills and non-medical expenses and ‘Cancer Diagnosis, Treatment and Survivorship’ (32%): type of cancer and treatment concerns. Median overall QOL was 8 (range 3-10). Conclusions: PROQOL is feasible for systematic capture of patient concerns in underserved, ethnic minority cancer patients. A better understanding of these challenges can help design interventions to improve psychosocial and financial outcomes for the vulnerable groups and decrease disparities in care delivery.

Mindfulness for Healthcare Providers: The Role of Non-Reactivity in Reducing Stress

There is strong evidence in the literature that the cultivation of mindfulness through programs such as Mindfulness-Based Stress Reduction (MBSR) has a profound impact on perceived stress for healthcare providers. The mechanism of the latter association is still being studied. However, it has been hypothesized that in particular, the cultivation of non-reactivity as a mindfulness skill may be particularly associated with the salutary effect of MBSR to reduce stress in health care providers even if adjusted for the benefit on quality of life gained after MBSR. The latter may represent important mechanistic information to build customized mindfulness interventions for health care providers. Determine whether the change in non-reactivity to inner experience after MBSR is associated with the adjusted changes in perceived stress after MBSR. a Cross-sectional study. A large, Midwestern teaching hospital. 100 health care providers. 8-week standard MBSR course. Perceived Stress Scale-10, Linear Analog Scale Assessment to measure Quality of life, and the mindfulness domain non-reactivity to inner experience was assessed by the non-reactivity subscale of the Five Facet Mindfulness Questionnaire. All measures were administered at baseline and completion of the intervention. The change from baseline to completion of MBSR was significant for all variables, with moderate-to-robust effect sizes. There was a significant negative correlation between non-reactivity and perceived stress both at baseline (p<0.0001) and when comparing changes in scores from baseline to post-intervention (p<0.0001). Change in non-reactivity to inner experience was robustly associated with the change in perceived stress (p<0.0001) after MBSR (97% in 5000 bootstrapped models). Non-reactivity to inner experience is a key aspect of MBSR that is independently associated with a change in perceived stress in health care providers.

Patient-reported outcomes of catheter-based accelerated partial breast brachytherapy and whole breast irradiation, a single institution experience.

Accelerated partial breast irradiation (APBI) and whole breast irradiation (WBI) are treatment options for early-stage breast cancer. The purpose of this study was to compare patient-reported-outcomes (PRO) between patients receiving multi-channel intra-cavitary brachytherapy APBI or WBI. Between 2012 and 2015, 131 patients with ductal carcinoma in situ (DCIS) or early stage invasive breast cancer were treated with adjuvant APBI (64) or WBI (67) and participated in a PRO questionnaire. The linear analog scale assessment (LASA), harvard breast cosmesis scale (HBCS), PRO-common terminology criteria for adverse events- PRO (PRO-CTCAE), and breast cancer treatment outcome scale (BCTOS) were used to assess quality of life (QoL), pain, fatigue, aesthetic and functional status, and breast cosmesis. Comparisons of PROs were performed using t-tests, Wilcoxon rank-sum, Chi square, Fisher exact test, and regression methods. Median follow-up from completion of radiotherapy and questionnaire completion was 13.3months. There was no significant difference in QoL, pain, or fatigue severity, as assessed by the LASA, between treatment groups (p>0.05). No factors were found to be predictive of overall QoL on regression analysis. BCTOS health-related QoL scores were similar between treatment groups (p=0.52).The majority of APBI and WBI patients reported excellent/good breast cosmesis, 88.5% versus 93.7% (p=0.37). Skin color change (p=0.011) and breast elevation (p=0.01) relative to baseline were more common in the group receiving WBI. APBI and WBI were both associated with favorable patient-reported outcomes in early follow-up. APBI resulted in a lesser degree of patient-reported skin color change and breast elevation relative to baseline.

Impact of anaemia on health-related quality of life and cardiac remodelling in patients with lower risk myelodysplastic syndromes. Results of GlobQoL study

The aim of this study was to analyse the eventual changes in health-related quality of life (HRQoL) and left ventricular function (LVF) over a 1-year follow-up period in a cohort of patients with lower risk myelodysplastic syndromes (MDS) receiving standard supportive treatment, in order to identify potential clues for early clinical intervention, as well as to analyse how they relate to haemoglobin levels and other aspects of the disease. A total of 39 adult anaemic patients with lower risk MDS were included in a prospective, observational, multi-centre study. Changes in performance status, functional capacity and HRQoL were collected by using standardised measures (ECOG scale; SPPB, Short Physical Performance Battery; SF-36, Short-Form 36 questionnaire; QLQ-C30, Quality of Life Core Questionnaire; FACT-An, Functional Assessment of Cancer Therapy-Anaemia scale questionnaires respectively). Need for transfusion (Linear Analogue Scale Assessment), as perceived independently by the patient and the haematologist, was also recorded. No changes in HRQoL (or LVF) were found, except for slight reductions in SF-36 physical function (P=0.034), SPPB gait speed (P=0.038) and FACT-An score (P=0.029), all without apparent immediate clinical relevance for HRQoL, that were unrelated to changes in haemoglobin level. Periodical evaluation of gait speed may assist the clinician in early detection of patient's occult functional decline before it becomes clinically relevant.

Quality of Life of Surgical Oncology Residents and Fellows Across Europe

Data are currently lacking regarding the quality of life of surgical oncology (SO) trainees. We sought to assess the training conditions and quality of life of SO residents and fellows across Europe. Members of the European Society for Surgical Oncology were invited to complete a Web-based survey that included a questionnaire specifically designed for SO trainees. Demographics, timing, and incentive to choose for SO, quality of life, and symptoms of fatigue, sleepiness, depression, and burnout, as well as self-reported medical errors, were assessed using validated instruments. The survey was completed by 109 residents and 53 fellows (mean age 34.6 ± 8.2). The mean Linear Analog Scale Assessment score for quality of life was 34.8 ± 8.6 out of a possible 50. A low level of fatigue was declared by 60% of the trainees. However, 44% scored an abnormal Epworth Sleepiness score, which was mostly related to in-hospital work time and lack of educational programs. High positive screenings regarding depression (51%) and burnout (25%) were associated with resident status and lack of mentorship, respectively. Major medical errors during the last 3 months were self-reported by 20% of the trainees. In Europe, the perceived quality of life is overall acceptable among trainees in SO. However, the present study demonstrated a high level of sleepiness, depression, and burnout symptoms. Additional work is required to identify and overcome the underlying causes of these symptoms.

P-0186 - Relation of General Self-Efficacy with Stress, Symptoms and Quality of Life in Colorectal Cancer Patients

Background: Symptoms related with colorectal cancer (cc), may increase the psychological and physical status and deteriorate patients quality of life. The purpose of this study was to evaluate symptoms, general self-efficacy, stress and quality of life of cc patients. In addition, our purpose was to investigate correlation between general self-efficacy and other parameters, at baseline and actual modification one year after adjuvant chemotherapy. Conclusions: One year after adjuvant chemotherapy, impairment was observed in all evaluated parameters. Change of general self-efficacy was mainly related to change of stress levels, moderate but equally important related to severity and intervention of symptoms in quality of life and at a minor extent to energy (subscale of LASA) of patients. The results of this study show that general self-efficacy, stress, physical symptoms and energy of patients are crucial factors for cc patients and therefore, physicians should consider these psychological and physical dimensions. Methods: 90 cc patients were included in our study. General self-efficacγ was evaluated with « General Perceived Self-Efficacy scale » (GSE), quality of life was measured with « Linear Analogue Scale Assessment» (LASA), stress was evaluated with the (HAD) scale, impairment and involvement of symptoms were measured with «MD Anderson Symptom Inventory» (MDASI) questionnaire, at the time of diagnosis and one year after adjuvant chemotherapy. Results: Measurements one year after adjuvant chemotherapy showed that general self-efficacy decreased (28.86 + /- 6.42), stress increased (9.56 + /- 4.42), quality of life impairment (6.74 + /- 1.81) following the severity of symptoms (3.24 + /- 2.62). Actual modification at the time of diagnosis and one year after adjuvant chemotherapy showed important negative correlation between general self-efficacy and stress (p < 0.0005). Moderate negative correlation was observed between general self-efficacy and symptoms (MDASI severity of symptoms: p = 0.003, intervention of symptoms: p = 0.002), while low positive correlation was found between self-efficacy and energy LASA scale (p = 0.048). Results: Measurements one year after adjuvant chemotherapy showed that general self-efficacy decreased (28.86 + /- 6.42), stress increased (9.56 + /- 4.42), quality of life impairment (6.74 + /- 1.81) following the severity of symptoms (3.24 + /- 2.62). Actual modification at the time of diagnosis and one year after adjuvant chemotherapy showed important negative correlation between general self-efficacy and stress (p < 0.0005). Moderate negative correlation was observed between general self-efficacy and symptoms (MDASI severity of symptoms: p = 0.003, intervention of symptoms: p = 0.002), while low positive correlation was found between self-efficacy and energy LASA scale (p = 0.048). Conclusion: One year after adjuvant chemotherapy, impairment was observed in all evaluated parameters. Change of general self-efficacy was mainly related to change of stress levels, moderate but equally important related to severity and intervention of symptoms in quality of life and at a minor extent to energy (subscale of LASA) of patients. The results of this study show that general self-efficacy, stress, physical symptoms and energy of patients are crucial factors for cc patients and therefore, physicians should consider these psychological and physical dimensions.

Evaluation of instrumental activities of daily living in Greek patients with advanced cancer

Translation of the instrumental activities of daily living (IADL) was carried out and its psychometric properties were assessed in a Greek sample of patients with advanced cancer. The scale was translated with the forward-backward procedure into the Greek language. It was initially administered to 136 advanced cancer patients. To assess reliability, it was administered to 45 patients 3 days later. To assess the effect of treatment, 75 patients were studied. The patients also completed the Eastern Cooperative Oncology Group (ECOG) performance status and the linear analogue scale assessment (LASA) quality of life (QoL) scale. Confirmatory factor analysis of the IADL was carried out. Reliability was assessed in terms of internal consistency (Cronbach's α) and test-retest correlation (Pearson and ICC) of the IADL scale. Construct validity was assessed through correlation of IADL with ECOG and LASA QoL scores. Confirmatory factor analysis yielded a single-factor model. The homogeneity of the instrument proved to be satisfactory (α was 0.88 for men and 0.83 for women). Test-retest reliability was also satisfactory (P<0.0005). High correlation with ECOG (men, r=-0.87; women, r=-0.85) and LASA QoL (men, r=0.55; women, r=0.53) was observed. The Greek version of the IADL in cancer patients treated in a palliative care unit is a reliable and valid clinical instrument.

Spiritual well-being in lung cancer survivors

Spiritual well-being (SWB) among lung cancer survivors has not been well-delineated. Additionally, little is known about how SWB is affected over the trajectory of the disease process. The aims of this study were to examine the SWB of individuals with a diagnosis of lung cancer, to assess the stability of SWB over time, and to identify the factors associated with SWB. A prospective cohort of patients with lung cancer first seen at the Mayo Clinic over a 10-year period of time was included in this study. Study entry was at the time of diagnosis or referral to the Mayo Clinic, and participation involved annual survey using the Functional Assessment in Chronic Illness Therapy-Spiritual Well-being, Medical Outcome Short Form 8, and Quality of Life (QOL) Linear Analog Scale Assessment. Associations were explored using Fisher's exact test, chi-squared test, Kruskal-Wallis test, and Spearman correlations. Linear regression was used to explore multivariate relationships. There were 1,578 participants over a 10-year period of time. Group SWB scores were relatively high and stable over a 10-year period of time ([Formula: see text], standard deviation = 14.47-18.46, possible scale of 0-100). However, individual scores varied widely across almost the entire scale (2.1-100) and revealed a chaotic trajectory for SWB. Males, current smokers, and those with higher pack-years experienced lower SWB compared to females, nonsmokers, and those with lower pack-years (p < 0.0001, 0.0455, and 0.0004, respectively). SWB was strongly associated with overall QOL. SWB is an individualistic experience that can change dramatically over time for cancer survivors. Ongoing assessments are important.