An IRT-constructed Brief Physical Functioning Scale and Its Association with Health Status

9057 Background: In the registrational phase 2 CodeBreaK 100 trial, sotorasib demonstrated a response rate of 37.1% with median duration of 10.0 months, a median progression-free survival of 6.8 months, and a tolerable safety profile in patients with pretreated KRAS p.G12C mutated NSCLC. Patients received a median of 2 prior lines of therapy. Here, we report PRO measures of health-related quality of life (QoL), physical functioning, and key lung cancer symptoms from this trial. Methods: Eligible patients had KRAS p.G12C mutated advanced NSCLC and received prior standard therapies. Sotorasib was given at an oral daily dose of 960 mg with 21-day treatment cycles until disease progression. Disease-related symptoms and health-related QoL were evaluated as exploratory endpoints on day 1 of each cycle from baseline to discontinuation, using the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and its lung cancer module, EORTC QLQ-LC13. The single item, 5-point scale GP5, of the Functional Assessment of Cancer Therapy-General version was used to evaluate the impact of side effects. Predefined analyses included change from baseline using descriptive statistics and mixed model for repeated measures for global health status/QoL, physical functioning, and key lung cancer symptoms of cough, dyspnea and chest pain. Results: Of 126 patients enrolled, compliance rates for each of the questionnaires were high throughout the study ( > 70%). Data up to cycle 11 (where n > 20) are presented. EORTC QLQ-C30 global health status/QoL and physical functioning were maintained over time (least-square mean changes ranged from -3.5 to 0.2 and 0.1 to 3.9, respectively). EORTC QLQ-C30 symptoms of fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, and constipation were stable or improved. Similarly, key lung cancer-related symptoms, as measured by EORTC QLQ-LC13, remained stable or improved from baseline, with the greatest least-square mean change of -11.2 (95% Cl: -16.2, -6.1) for cough, -4.9 (95% Cl: -10.3, 0.4) for chest pain, and -3.4 (95% Cl: -7.8, 1.0) for dyspnea. Most patients reported on the GP5 that they were “not at all” (54.2%-79.2%) or “a little bit” (8.3%-33.3%) bothered by side effects from sotorasib, with 0%-7.4% reporting being bothered as “quite a bit” and 0% as “very much”. Conclusions: In patients from the single-arm phase 2 trial of sotorasib, PRO measures suggested maintenance or improvement of global health status/QoL, physical functioning, and the severity of key lung cancer-related symptoms, including cough, dyspnea, and chest pain. Self-reported side effect bother was minimal. These data, together with the encouraging efficacy and safety profiles, strongly support the use of sotorasib in this population. Clinical trial information: NCT03600883.

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Taxane-induced peripheral neuropathy and quality of life in breast cancer patients

Journal of Oncology Pharmacy Practice ◽

10.1177/1078155219898511 ◽

2020 ◽

Vol 26 (6) ◽

pp. 1421-1428

Author(s):

Ebrahim Salehifar ◽

Ghasem Janbabaei ◽

Abbas Alipour ◽

Nasim Tabrizi ◽

Razieh Avan

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Health Status ◽

Peripheral Neuropathy ◽

Global Health ◽

Cancer Patients ◽

Physical Functioning ◽

Role Functioning ◽

Breast Cancer Patients

Purpose Taxane-induced peripheral neuropathy (TIPN) is a common and bothersome toxicity. This study aimed to determine the incidence and severity of TIPN in patients with breast cancer and to investigate the relationship between TIPN and quality of life. Methods A total of 82 breast cancer patients with TIPN symptoms were included in this study. The criteria of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03) and the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) were used to evaluate grading of sensory neuropathy and quality of life, respectively. Analysis of the data was done by IBM SPSS statistics version 23. Results A total of 346 patients received taxane-based chemotherapy and 82 patients (23.7%) experience TIPN. The mean (SD) global health status/quality of life, physical functioning, role functioning, and pain subscales were 60.63 (5.26), 80.64 (9.05), 81.77 (10.41), and 43.88 (11.27), respectively. There were significant negative correlations between global health status/quality of life, physical functioning, and role functioning subscales with the grade of neuropathy (r = −0.33, −0.80, and −0.61, respectively) and positive correlation between pain subscale and the grade of neuropathy (r = 0.70). Conclusion This study shows a clear association between TIPN and worsened quality of life. These findings emphasize on detecting and management of TIPN in an effort to improve the quality of life of breast cancer patients.

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High-Dose Therapy and Autologous Hematopoietic Stem Cell Transplantation (ASCT) Has a Significant but Transient Impact on Quality of Life: Lessons From the Chronic Lymphocytic Leukemia (CLL) ASCT Study by the CLL Subcommittee of the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation

Blood ◽

10.1182/blood.v118.21.1989.1989 ◽

2011 ◽

Vol 118 (21) ◽

pp. 1989-1989

Author(s):

Liesbeth C. de Wreede ◽

Maggie Watson ◽

Donald Milligan ◽

Mauricette Michallet ◽

Peter Dreger ◽

...

Keyword(s):

Quality Of Life ◽

Health Status ◽

Global Health ◽

Social Functioning ◽

Physical Functioning ◽

Global Health Status ◽

First Year ◽

High Dose ◽

High Dose Therapy

Abstract Abstract 1989 Objective: High-dose therapy (HDT) and ASCT is the standard of care in a variety of hematologic malignancies. Whereas for some indications a survival advantage for HDT and ASCT has been demonstrated, a benefit only in terms of better progression-free survival has been shown for CLL. Because of this the quality of life (QoL) deserves particular attention. QoL assessment was a major focus of a randomized controlled EBMT-Intergroup trial on the value of HDT compared to observation in first or second remission of CLL (Michallet, Blood, 2011). Methods: 222 patients were enrolled into the study and allocated to either ASCT or observation. In the transplant arm, 72% received HDT and ASCT (for those median time from randomization to transplant was 3.01 months); in the observation arm 9% received ASCT. QoL was assessed with the EORTC QLQ C30 version 3.0, a questionnaire that has to be filled in by the patients. The answers to the questions yielded 15 scores, each on a scale from 0 to 100. The scores represent 15 domains: global health status/QoL, 5 functional scales (100 representing perfect health) and 9 symptom scales (0 representing no complaints). QoL forms had to be completed at randomization and at months 4, 8, 12, and 24. Data on 56%, 53%, 54%, 61%, and 50% of the baseline patients are available for the respective periods. Missing forms were not systematically related to baseline variables or relapse. The numbers of drop out due to death at 2 years were 5 patients in the HDT arm and 4 patients in the control arm. All QoL outcomes were analyzed with mixed models according to the intent to treat principle. Time (as factor), age, gender, treatment arm and the interaction of time and treatment arm were modelled as fixed effects, whereas individual random effects were added for the intercept. Results: The mean values for global health status/QoL, physical functioning, role functioning and social functioning over time for the transplant and the observation group are shown in Figure 1. Global health status/QoL at 4 months (estimated effect from the multivariate model −7.15, p=0.034) was significantly inferior in the transplant cohort compared to the control group. At 8 months the estimated effect of HDT on global health status/QoL was −3.06 (p=0.36). This difference further diminished over the first year (estimate at 1 year −0.53, p=0.87). QoL did not decrease independently from the treatment during the first 2 years. The same global pattern of change over time was observed for physical functioning, role functioning and social functioning; however, the treatment impact was still significant at 8 months for physical functioning (-6.58; p=0.025) and social functioning (-11.18; p=0.014). No significant covariate effects could be delineated for either of these scales apart from age having a beneficial effect on social functioning. Conclusions: Quality of life is affected multi-dimensionally in the first year after high-dose therapy and autologous stem cell support. The negative impact of HDT on QoL has disappeared after two years. Patients should be informed that HDT followed by ASCT impairs quality of life in the first year after transplantation. Disclosures: No relevant conflicts of interest to declare.

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Functional health status in children and adolescents after Fontan: comparison of generic and disease-specific assessments

Cardiology in the Young ◽

10.1017/s1047951113000632 ◽

2013 ◽

Vol 24 (3) ◽

pp. 469-477 ◽

Cited By ~ 11

Author(s):

Brian W. McCrindle ◽

Victor Zak ◽

Victoria L. Pemberton ◽

Linda M. Lambert ◽

Victoria L. Vetter ◽

...

Keyword(s):

Health Status ◽

Medical History ◽

Physical Functioning ◽

Clinical Characteristics ◽

Congenital Heart ◽

Fontan Procedure ◽

Bodily Pain ◽

Functional Health ◽

Functional Health Status ◽

Disease Specific

AbstractPurpose: The aim of this study was to compare associations between generic versus disease-specific functional health status assessments and patient and clinical characteristics for patients with severe congenital heart disease. Methods: This was a cross-sectional observational study involving 325 single ventricle patients, aged 10–18 years, after Fontan procedure. Enrolled patients underwent a medical history review, laboratory testing, and assessment of the functional health status by completion of the generic Child Report Child Health Questionnaire and the disease-specific Congenital Heart Adolescent and Teenage questionnaire. Correlated conceptually equivalent domains from both questionnaires were identified and their associations with patient and clinical variables were compared. Results: From the generic assessment, patients perceived marginally lower physical functioning (p = 0.05) but greater freedom from bodily pain compared with a normal population (p < 0.001). The equivalent physical functioning/limitations domain of the generic instrument, compared with the disease-specific instrument, had similar associations (higher multi-variable model R2) with medical history variables (R2 = 0.14 versus R2 = 0.12, respectively) and stronger associations with exercise testing variables (R2 = 0.22 versus R2 = 0.06). Similarly, the corresponding freedom from bodily pain/symptoms domains from both questionnaires showed a greater association for the generic instrument with medical history variables (R2 = 0.15 versus R2 = 0.09, respectively) and non-cardiac conditions (R2 = 0.13 versus R2 = 0.06). The associations of each questionnaire with echocardiographic results, cardiac magnetic resonance imaging results, and serum brain natriuretic peptide levels were uniformly weak (R2 range <0.01 to 0.04). Conclusions: Assessment of the physical functional health status using generic and disease-specific instruments yields few differences with regard to associations between conceptually similar domains and patient and clinical characteristics for adolescents after Fontan procedure.

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Long-term Effects of 1-Year Maintenance Training on Physical Functioning and Health Status in Patients With COPD

Journal of Cardiopulmonary Rehabilitation and Prevention ◽

10.1097/hcr.0b013e3181c9c985 ◽

2010 ◽

Vol 30 (1) ◽

pp. 47-52 ◽

Cited By ~ 35

Author(s):

Thomas Ringbaek ◽

Eva Brøndum ◽

Gerd Martinez ◽

Jane Thøgersen ◽

Peter Lange

Keyword(s):

Health Status ◽

Physical Functioning ◽

Long Term Effects

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Physical functioning and perceived health status after surviving the first COVID-19 wave. A long-term observational perspective

10.21203/rs.3.rs-421937/v1 ◽

2021 ◽

Author(s):

Francesco Ferrarello ◽

Carmela Iacopino ◽

Catia Pierinelli

Keyword(s):

Health Status ◽

Activities Of Daily Living ◽

Physical Functioning ◽

Daily Living ◽

Perceived Health ◽

Mobility Limitations ◽

Perceived Health Status ◽

Health Status Measures ◽

Time Limitations

Abstract After the COVID-19 infection, individuals can experience impairment, activity limitation and participation restriction. Little information is available on range and frequency of individual problems arising after COVID-19 and its sequelae and long-term outcomes. In June and July 2020, nineteen individuals previously hospitalized with COVID-19 were referred to our outpatient physiotherapy unit. We monitored their level of independence in activities of daily living, mobility, and perceived health status for 7.4–9.5 months (median, 8.6) after healing. At baseline, our cohort showed substantial independence in activities of daily living, some mobility limitations, and below average perceived health status. Measures improved over time. Limitations of physical functioning were mostly moderate to slight and tending to improve; if present, severe limitations were probably related to pre- COVID-19 conditions. However, individuals in some cases may not have fully recovered their premorbid functioning seven to nine months after healing.

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Physical activity measures in patients with myalgic encephalomyelitis/chronic fatigue syndrome: correlations between peak oxygen consumption, the physical functioning scale of the SF-36 questionnaire, and the number of steps from an activity meter

10.21203/rs.3.rs-21479/v2 ◽

2020 ◽

Author(s):

C (Linda) MC van Campen ◽

Peter C Rowe ◽

Freek WA Verheugt ◽

Frans C Visser

Keyword(s):

Physical Activity ◽

Chronic Fatigue Syndrome ◽

Physical Functioning ◽

Stress Test ◽

Chronic Fatigue ◽

Myalgic Encephalomyelitis ◽

Peak Oxygen Consumption ◽

Physical Functioning Scale ◽

Fatigue Syndrome ◽

Sf 36

Abstract Background most studies to assess effort intolerance in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) have used questionnaires. Few studies have compared questionnaires with objective measures like an actometer or an exercise test. Therefore three measures of physical activity in ME/CFS patients, being the physical functioning scale (PFS) of the SF-36, the number of steps/day (Steps) of an actometer and the %peak VO 2 of a cardiopulmonary stress test were compared. Methods female ME/CFS patients were selected from a clinical database if the three types of measurements were available, and the interval between measurements was ≤ three months. Data of the three measures were compared by linear regression. Results in 99 female patients the three different measures were linearly, significantly and positively correlated (PFS vs Steps, PFS vs %peak VO 2 and Steps vs %peak VO 2 : all P<0.001). Subgroup analysis showed that the relations between the three measures were not different in patients with versus without fibromyalgia and with versus without a maximal exercise effort (RER≥1.1). In 20 patients re-evaluated for symptom worsening, the mean of all three measures was significantly lower (P<0.0001), strengthening the observation of the relations between them. Despite the close correlation a large variation was observed between the three measures in individual patients. Conclusions given the large variation in ME/CFS patients, the use of only one type of measurement is inadequate. Integrating the three modalities may be useful for patient care by detecting overt discrepancies and may aid study designs aimed at improving exercise capacity.

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Association between health status and social integration/loneliness in survivors of adolescent and young adult (AYA) cancers.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e21563 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e21563-e21563

Author(s):

I-Chan Huang ◽

Conor Jones ◽

Deo Kumar Srivastava ◽

Melissa M. Hudson ◽

Leslie L. Robison ◽

...

Keyword(s):

Social Support ◽

Social Network ◽

Health Status ◽

Health Outcomes ◽

Social Integration ◽

Solid Tumors ◽

Physical Functioning ◽

Adolescent And Young Adult ◽

Contact Frequency ◽

Health Related

e21563 Background: AYA cancer survivors are at risk of various adverse health outcomes, but the relation between health status, social integration (i.e., social network and support) and loneliness is understudied. Methods: 102 AYA survivors (mean age = 25 years; diagnoses = leukemia 27%; lymphoma 24%; brain tumors 9%; solid tumors 41%) and 102 age-sex-matched controls were recruited from a community-based online panel. Participants reported social network information (e.g., contact frequency, resources for health counseling) for up to 25 of closest friends/relatives, which was used to create a functional social network index. UCLA Loneliness Scale, Duke-UNC Functional Social Support Questionnaire and PROMIS Health Profile were used to measure loneliness, social support and health-related outcomes (physical functioning, depression, anxiety, fatigue and pain), respectively. Multiple linear regression was used to compare functional social network, social support and loneliness between survivors and controls, and to assess the relation between health outcomes and perceived loneliness. Results: Compared to controls, survivors of lymphoma (b = 1.98; p = 0.005), leukemia (b = 1.67; p = 0.012) and solid tumors (b = 1.22; p = 0.030) had a higher functional social network index. However, social support did not differ between survivors and controls (p’s > 0.05). Brain tumor survivors (b = 15.65; p = 0.006) and solid tumor survivors (b = 10.83; p < 0.001) had more loneliness than controls. Compared to low loneliness controls, high loneliness survivors had significantly lower physical functioning (b = -7.72; p < 0.001) and higher anxiety (b = 8.35; p < 0.001), depression (b = 10.57; p < 0.001), fatigue (b = 5.52; p = 0.011) and pain (b = 6.37; p < 0.001) after adjusting for age, sex, education, social integration, and number of self-reported chronic health conditions. Conclusions: Loneliness is significantly associated with poor health-related outcomes in AYA survivors, which is independent of the influence of social integration. Future research is warranted to understand the relation between health status and social interactions among AYA survivors to inform intervention-based strategies.

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Abstract 2983: Sex Differences in Quality of Life and Health Status in the COURAGE Trial

Circulation ◽

10.1161/circ.116.suppl_16.ii_666-d ◽

2007 ◽

Vol 116 (suppl_16) ◽

Author(s):

Paul Kolm ◽

William E Boden ◽

John A Spertus ◽

David J Maron ◽

Robert O’Rourke ◽

...

Keyword(s):

Quality Of Life ◽

Sex Differences ◽

Health Status ◽

Physical Functioning ◽

Drug Evaluation ◽

Management Strategies ◽

Coronary Intervention ◽

Percutaneous Coronary

Purpose: The Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial randomized 2,287 patients to percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) or OMT alone. The purpose of this study was to assess sex differences in quality of life (QOL) and health status between randomized initial management strategies over the trial follow-up period. Methods: Of the 2,287 patients, 979 males and 169 females were randomized to PCI, and 968 males and 169 females were randomized to OMT. Quality of life was assessed with the Seattle Angina Questionnaire (SAQ) and health status with the RAND-36 at baseline, 1, 3, 6, 12 months and annually thereafter. SAQ and RAND-36 scores were assessed by analysis of variance (ANOVA), and linear mixed effects models. Results: There were no significant sex by treatment group interactions indicating PCI vs. OMT differences were similar for the 1,947 men (85%) and 338 women (15%). Men had significantly higher SAQ Physical Functioning scores at baseline and 1 month post-treatment (p < 0.004) and a trend of higher means thereafter (Figure 1A ) and significantly higher RAND-36 Physical Functioning scores over 3 years of follow-up (p < 0.001, Figure 1B ). Men also had significantly higher RAND-36 Energy/Fatigue means scores (p < 0.05, Figure 1C ). RAND-36 scores for the other domains were similar fbetween the two groups (Figure 1D ). Conclusions: Men and women in both arms experienced improvement in quality of life and health status over time. Men had significantly higher physical functioning as well as energy/fatigue scores, but were similar to women in other quality of life and health status domains.

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