Functional Assessment Of Cancer Therapy-General Questionnaire Research Articles

Quality of Life and Global Response Score in Cutaneous T-Cell Lymphoma

Background: Cutaneous T-cell lymphoma (CTCL) encompasses a heterogenous group of conditions that are typically incurable and managed as chronic, life-long diseases. Clinically, CTCL is associated with pruritus, and skin lesions that can cause pain and cosmetic discomfort, resulting in reduced health-related quality of life (HRQoL) for patients. As these patients often receive life-long therapy, any proposed therapy should maximize therapeutic safety and efficacy as well as patient HRQoL. Improvement in HRQoL may provide an indication to continue therapy, even for patients with partial response. Clinical trial response assessments for CTCL utilize a global response score, which includes skin, nodal and blood assessments (Olsen et al, JCO 2011). Dermatology-specific instruments, such as Skindex-29 (Chren 2012, Dermatol Clin 30), and oncology-specific instruments such as the Functional Assessment of Cancer Therapy - General (FACT-G) (Cella et al, JCO 1993), have been used to assess quality of life in this population. Disease entity, stage, age, sex, education, and treatment regimen are related to the extent of HRQOL impairment in patients with CTCL (Porkert et al, EJC 2018). Correlation between clinical response and HRQoL response has been reported in other cancers, such as renal cell carcinoma (Grimm Oncol Ther 2017) and other dermatologic conditions such as psoriasis (Acta Derm Venereol 2017), but has not been reported in CTCL. We evaluated changes in HRQoL in relation to the global response score in CTCL. Methods: Global response data, as well as Skindex-29 and FACT-G scores, were obtained from the phase III MAVORIC study (Kim et al, Lancet Oncol 2018). Patients with stage IB-IVB mycosis fungoides or S ézary syndrome were prospectively enrolled. Global response score was assessed every 8 weeks. Skindex-29 and FACT-G questionnaires were administered every 8 weeks. Patients with at least a baseline value for Skindex-29 or FACT-G score, at least one subsequent visit with both Skindex-29 or FACT-G value, and an overall response value were included. Changes in scores were calculated from baseline to the first visit with best overall response. A higher score in Skindex-29 indicated worse HRQoL. A higher score on FACT-G indicated improvement in HRQoL. Wilcoxon rank-sum test was performed. Correlation was calculated by Pearson coefficient. Results: 324 patients were evaluable for total Skindex-29 analysis. First visit with best overall response for patients with PD/SD occurred at a median of 1.26 cycles (IQR; 1.26, 14.26); 5.98 cycles (IQR; 1.26, 48.98) for PR; and 10.98 cycles (IQR; 3.98, 36.98) for CR. Patients with CR/PR as best response (n=121) had median change in Skindex-29 of -16 (IQR; -31, -8) and patients with SD/PD as best response rate had median change in Skindex-29 of -4 (IQR; -12, 3) (p <0.001) (Table 1). 333 patients were evaluable for total FACT-G analysis. Patients with CR/PR as best response rate had median change in FACT-G of 6 (IQR; -2, 16) and patients with SD/PD as best response rate had median change in FACT-G of 2 (IQR; -6, 8) (p <0.001) (Table 1). Skindex-29 correlates with global response score overall and across all domains. FACT-G correlates with global response score overall and across all domains, with the exception of social well-being. There was a moderate reverse correlation between change in total Skindex-29 and change in total FACT-G score (R=-0.61, p<0.001) (Figure 1). Conclusion: HRQoL as measured by the Skindex-29 and FACT-G correlate with complete or partial response to therapy in the global response score in patients with CTCL. There is moderate correlation between skin-specific quality of life and general quality of life in this population. Further exploration of factors affecting social well-being in patients with CTCL is warranted. Incorporation of QOL scales in global response score criteria should be considered.

Validation of the Tagalog and Ilokano translations of the Functional Assessment of Cancer Therapy-General (FACT-G) scale for adult cancer center patients in a state-funded tertiary hospital.

e18524 Background: Patient reported outcomes such as the health related quality of life (HRQOL) is a significant variable that should be used in clinical decision making and health policy. The Functional Assessment of Cancer Therapy - General (FACT-G), is one of the most widely used HRQOL questionnaires and to make it more accessible globally translation to local dialects are imperative for inclusive service delivery. Prior to use, the validity and reliability of these tools should be established for the population it is intended to cater. Consistent with the mission statement of the hospital the researcher wanted this service to be more accessible and equitable by addressing language differences for our non english speaking end-users. Hence, the study aimed to document validity and reliability of translated Tagalog and Ilokano versions of the FACT-G questionnaire for use in patients catered upon by the Baguio General Hospital and Medical Center (BGHMC). Methods: Psychometric evaluation of the above tools was done involving 384 adult cancer patients of BGHMC. Data management and analysis using SPSS software was used to evaluate reliability, face validity, content validity, and construct validity. An addition of cognitive interviews was done with end-users and subsequent thematic analysis aimed to improve questionnaire quality. Results: Both the Tagalog and Ilokano questionnaires had indices above the set value for reliability measured as Chronbach’s alpha of 0.968 and 0.974, content validity indices of 0.95 and 0.95, and face validity indices of 0.98 and 0.98, respectively. Construct validity was established through an exploratory factor analysis comprised of a principal components analysis and Varimax factor rotation with Kaiser normalization. Conclusions: The Tagalog and Ilokano questionnaires are reliable and valid tools for use of approximation of HRQOL of cancer patients catered by the BGHMC. With the results of the validation study it is recommended to incorporate the use of these translated questionnaires to the day to day health service provision to approximate the health-related quality of life of cancer patients. These can also be used as measures to evaluate interventions and policies that are directed towards cancer patients catered in Northern Luzon. To better these questionnaires the revised questionnaires includes the omission of the 7th item in the scale of general social and family well-being to minimize disruptions in rapport due to nature of the question. Another is the reversion of the 2nd item in the scale of general emotional well-being so that it would have the same direction on the approximation of HRQOL with the other items in the scale.

Gonadal Function in Male Patients With Metastatic Renal Cell Cancer Treated With Sunitinib.

Single-agent tyrosine kinase inhibitors are still prescribed as first-line treatment to a relevant subgroup of patients with metastatic renal cell carcinoma (mRCC). These agents are known to cause disfunction of many endocrine glands (e.g., thyroid). In this two-step trial, we aimed to assess gonadal function among male patients with mRCC treated with sunitinib. We enrolled a first cross-sectional cohort of pre-treated (>6 months) patients and a subsequent cohort of treatment-naïve patients who were prospectively followed-up. All patients were screened for hypogonadism and received a Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire at study entry and after 6 months of therapy. Patients who were candidates for testosterone replacement therapy (TRT) also received a FACT-G questionnaire at baseline and 3 months after supplementation. Among the 30 enrolled patients, the prevalence of hypogonadism was found to be higher in those receiving sunitinib for a longer period (27.3% at baseline, 41.7% in the first 6 months, and 68.4% after 9 months of therapy). The testosterone level of patients correlated with quality of life (R=0.32). A total of six patients received TRT, with a significant improvement in their global quality of life after the first 3 months of treatment. An increasing prevalence of hypogonadism was seen among male patients who received long-term treatment with sunitinib. TRT was associated with relevant improvements in quality of life. These findings corroborate similar published observations and encourage the assessment of gonadal function in male patients with mRCC under treatment with sunitinib.

MP19-03 COMPARISON OF FACT-G SCORES WITH CANCER AND GENERAL POPULATION NORMS IN CANADIAN PATIENTS UNDERGOING RADICAL CYSTECTOMY

You have accessJournal of UrologyHealth Services Research: Practice Patterns, Quality of Life and Shared Decision Making II (MP19)1 Sep 2021MP19-03 COMPARISON OF FACT-G SCORES WITH CANCER AND GENERAL POPULATION NORMS IN CANADIAN PATIENTS UNDERGOING RADICAL CYSTECTOMY Julie Trudel, Ryan McLarty, and Conrad Maciejewski Julie TrudelJulie Trudel More articles by this author , Ryan McLartyRyan McLarty More articles by this author , and Conrad MaciejewskiConrad Maciejewski More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002004.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The Functional Assessment of Cancer Therapy-General (FACT-G) is often used as a generic measure in Health-Related Quality of Life (HRQOL) assessment among cancer patients. Its reference values relating to the general population and patients with different diseases are useful for the interpretation of HRQOL scores and allow a better understanding of the patients needs and HRQOL. No study to date has yet compared FACT-G normative data scores to those of Canadian patients undergoing radical cystectomy (RC) for bladder cancer. The objective of this study was to compare our patients pre-cystectomy FACT-G scores with US cancer and general population norms. METHODS: Patients were recruited from the Diana Wood Cancer Survivorship Clinic at The Ottawa Hospital between January 2019 and August 2020. HRQOL was evaluated by the FACT-G and raw scores were obtained for each FACT-G subscale, higher scores indicating better HRQOL. Effect sizes (ES-Hedge's g statistics), confidence intervals and minimal clinical significant differences (MCIDs) were used to compare pre FACT-G subscale scores with normative data. As suggested by current literature, a change of at least 5% to 10% within the instrument range was used as an estimate calculation of the MCID. RESULTS: 55 patients completed the FACT-G questionnaire before RC. The mean age was 67 years (SD: 10 years), 71% were male, 80% were in a married/common law partnership and 84% lived with someone. Overall, ES between pre-surgery FACT-G subscale scores and US cancer norms were small (ES≤0.2) and the MCIDs were less than 5% of change in the FACT-G measurement scale except for the dimension “Physical Well-Being” (ES=0.3, reported MCID value of 1.77, 6% of change). ES calculated between FACT-G scores and those from the US general population showed small effect sizes (ES≤0.2) for all FACT-G subscales except for the dimensions “Emotional Well-Being” (Medium ES=-0.56, reported MCID value of 2.7, 11% of change) and “Social Well-Being” (Medium ES=0.37, reported MCID value of 2.5, 9% of change). CONCLUSIONS: In our survivorship clinic, patients undergoing RC reported broadly similar FACT-G scores to US cancer population norms, with a notable exception of increased perceived “Physical Well-Being”. When comparing our data to US population norms, we once again showed similar scores on FACT-G subscales with the exception of decreased “Emotional Well-Being” and higher “Social Well-Being”. These results emphasize unique aspects of the bladder cancer survivorship experience, and highlight the value of patient reported assessment of HRQOL in RC patients. Source of Funding: The Diana Wood Bladder Cancer Survivorship Program © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e328-e328 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Julie Trudel More articles by this author Ryan McLarty More articles by this author Conrad Maciejewski More articles by this author Expand All Advertisement Loading ...

Effect of palliative care services on quality of life over time among gynecologic oncology patients

<h3>Objectives:</h3> Palliative Care (PC) has been shown to be a beneficial adjunct to cancer therapy. This study aimed to compare the impact on the quality of life in attending a PC appointment among gynecologic oncology patients utilizing the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire over time. <h3>Methods:</h3> A longitudinal analysis was conducted utilizing data obtained from a previous randomized control trial that evaluated the effect of an interventional video on improving PC knowledge and attendance at outpatient PC appointments in gynecologic oncology patients receiving active treatment at a single academic tertiary care center. Women were divided into two groups: those that attended PC appointments (PC group) and those that did not (no PC group). All participants completed the FACT-G questionnaire at initial enrollment and were asked to repeat the same questionnaire at 3 and 6 months electronically. Data with complete questionnaires at the 3 and 6 month time point were utilized in analysis separately. Measurement data included demographics, FACT-G, and FACT-G sub-score results. Data analyses were performed using descriptive statistics, ANOVA, and Mann Whitney rank sums tests with a significance level of α = 0.05 <h3>Results:</h3> The initial cohort included 111 patients completing the FACT-G questionnaire: 68 (61.2%) of those completed the 3-month FACT-G questionnaire (20 PC, 48 no PC), while 30 (27%) completed the 6-month questionnaire (8 PC, 22 no PC). Baseline demographics were not significantly different between the entire cohort and respondents. The majority of patients were Caucasian, never smoked, were married, had stage III disease, had ovarian cancer, were platinum-sensitive, and were treated with primary cytoreduction. There was no statistical change in longitudinal FACT-G score at 3 months [(n=68) = 0.76, p=0.39], and 6 months [(n=30) = 0.43, p=0.66] (Table 1). Secondary analysis compared PC vs no PC group FACT-G sub-scores at baseline, 3 month and 6 months: physical well-being (GP) [(n=111, p=0.02) (n=68, p=0.11) (n=30, p=0.60)], social/family well-being (GS) [(n=111, p=0.20) (n=68, p=0.40) (n=30, p=0.38, emotional well-being (GE) [(n=111, p=0.10) (n=68, p=0.07) (n=30, p=0.85)], and functional well-being (GF) [(n=111, p=0.003) (n=68, p=0.001) (n=30, p=0.73)]. There was a statistically significant difference in GF (p=0.003) and GP (0.02) sub-scores at the initial survey, with no PC group having higher scores. By the 6-month survey, the statistical significance between groups was lost in the GF (p=0.73) and GP (p=0.60) sub-scores; noting the minimal change in the no PC scores (GF 21.5 to 20.4, GP 23 to 23.5) but with improvement in the PC scores (GF 16 to 19.8, GP 18 to 20). This suggests a potential positive impact of PC on these sub-score outcomes and quality of life. <h3>Conclusions:</h3> Attending a PC appointment did not significantly improve the quality of life as assessed by FACT-G at 3 or 6-month intervals for this small cohort. However, the differences at the initial survey in the GP and GF sub-scores were no longer significant by 6 months, suggesting a positive impact of PC on these aspects. Further research should focus on investigating the effect of PC over time in a larger population as well as explore other metrics that may better identify the effect of PC on quality of life.

Kanser Tedavisinin İşlevsel Değerlendirmesi Ölçeği FACT-G Türkçe Versiyonunun Geçerlik ve Güvenilirliği

Objective: Many of the cancer-specific quality of life (QOL) questionnaires improved over the last 20 years, can be contemplated as reference measures. The Functional Assessment of Chronic Illness Therapy (FACIT) system is an based and generic health-related quality of life measures. The aim of this study was conducted to test the reliability and construct validity of the Functional Assessment of Cancer Therapy General (FACT-G) for Turkish cancer patients. Material and Methods: This research is a methodological study. The data were obtained by using the sociodemographic and the FACT-G questionnaire. The sample comprised 148 cancer pa¬tients. Data were analysed by using the SPSS package program, descriptive statistics and to assess the reliability of the scales, cronbach alpha coefficient, item total score analysis, and, item total correlation coefficient (Pearson's correlation). For the construct validity of the instrument; exploratory factor analysis and confirmatory factor analysis were used. Results: The mean total score of FACT-G was 60.71±14.42, and for the physical, social/ family, emotional and functional well-being subscales 15.83±5.48, 13.91±4.90, 13.45±5.03 and 17.51± 5.04, respectively. The alpha coefficient was 0.88 for the global scale of the FACT-G questionnaire and ranged from 0.70 to 0.79 across subscales. A statistically significant positive correlation was found between FACT-G and test-retest scores of the four sub-dimensions (p=0.001). Conclusion: In this study, as a result of evaluating the psychometric properties of the FACT-G scale, the scale is a valid and reliable tool for use in Turkish patients with cancer.

Effect of postoperative rehabilitation on quality of life in patients with vulvar cancer

Aim: to evaluate the quality of life parameters dynamics in patients with vulvar cancer I and II stages during postoperative rehabilitation.Materials and Methods. A prospective comparative randomized study included 47 women with vulvar cancer I–II stages, aged 38 to 70 years, with an average age of 56.3 ± 3.9 years. Patients were randomized into 2 groups: 24 of them underwent postoperative rehabilitation and 23 were included in the comparison group. Quality of life and sexual function, as well as psycho-emotional state were assessed using a set of questionnaires: quality of life of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, Functional Assessment of Cancer Therapy-General (FACT-G) with an extension for vulvar cancer, Female Sexuality Index (FSFI) and WAM (well-being, activity, mood).Results. Patient who receiving postoperative rehabilitation even during the first three months, a reliable positive dynamics of all parameters of FSFI and EORTC, except cognitive function, was noted. At the same time, in the patients not undergoing postoperative rehabilitation program there was no reliable difference in the results of the questionnaires, except for FSFI, but the severity of changes was significantly less than in the patients of the research group. Dynamics in the EORTC parameters in women in postoperative rehabilitation averaged 14.8 points with 7.8 points in the comparison group. In the FACT-G questionnaire, the dynamics were even more pronounced with 19.9 and 6.8 points respectively. There was a reliable positive trend in improving the quality of sexual life and a decrease in the percentage of women suffer from pain and discomfort during sexual intercourse: from 25,0 % (n = 6) to 4,2 % (n = 1) in the study group and from 21,7 % (n = 5) to 13,0 % (n = 3) in the comparison group. Improvement in sexual desire and satisfaction during the year was noted in 5 (20.8 %) women in the study group and only 2 (8.7 %) in the comparison group.Conclusion. The developed program of postoperative rehabilitation of patients with vulvar cancer, which includes individual and group psychotherapy, "anti-cancer diet therapy", dosed physical activity, dynamic correction of vaginal biocoenosis showed high efficiency already during the first 6 months. All patients with vulvar cancer in the postoperative period should receive active rehabilitation aimed at correction of psycho-emotional state and sexual function, which will improve the quality of life and improve further prognosis.

CN84 - Health-related quality of life in Greek haematological malignancies patients undergoing chemotherapy

BackgroundRecent studies indicate that quality of life plays crucial role in cancer patients’ outcome. In order to obtain a more comprehensive view into this option, we applied three different questionnaires, the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30), the Functional Assessment of Cancer Therapy-general (FACT-G) and the generic Short –Form 36 (SF-36) for registering the haematological malignancies patients’ point of view. MethodsA cross- sectional study was established involving 67 patients, treated in a large hospital in a major Northern Greek city, with haematological malignancies undergoing chemotherapy in cycle 3. Data was collected using the three aforementioned scales in addition with a questionnaire with demographic and clinical characteristics. ResultsThe vast majority of patients were men (n=42, 62.7%) and married ( 65.7 %, n=44). Ten out of sixty-seven were multiple myeloma patients (n=10, 14.9%). The mean scores of overall scales were: SF-36: 47.93±18.84, FACT-G: 73.68±18.25, EORTC-QLQ: 70,70±17.93. Cronbach’s a was >0.70 for all of the subscales of the questionnaires. There is an exception in emotional well being subscale of FACT-G and in physical functional subscale of EORTC QLQ-C30. Also, there was a strong correlation (>0.50) between physical functional subscale and emotional function subscale of the FACT-G, EORTC QLQ-C30 and SF-36 instruments (p<0.001) and generally between the overall scores of three questionnaires (r=0.771, p<0.001 between FACT-G, EORTC QLQ-C30; r=0.771, p<0.001 between SF-36 and FACT-G; r=0.842 p<0.001 between SF-36 and EORTC QLQ-C30). ConclusionsThe Greek versions of FACT-G, EORTC QLQ-C30 and SF-36 questionnaires are valuable tools that could be easily applied in a daily practical routine for assessing quality of life in patients with hematological malignancies. Additionally, the above procedure provides valid information to the nursing staff in order to help their patients to improve their quality of life having possible influence in the disease outcome. Legal entity responsible for the studyThe authors. FundingHas not received any funding. DisclosureAll authors have declared no conflicts of interest.

Utility Estimation of Health Status of Cancer Patients by Mapping for Cost-Utility Analysis

Background: It is important to obtain accurate information about the preferences of people for measuring quality-adjusted life years (QALYs), because it is necessary for cost-utility analysis. In this regard, mapping is a method to access this information. Therefore, the purpose of this study was to map Functional Assessment of Cancer Therapy – General (FACT-G) onto Short Form Six Dimension (SF-6D) in breast cancer patients to provide appropriate conditions for a detailed cost-utility analysis. Methods: This descriptive analytical study was conducted on 416 patients with breast cancer. The SF-6D and FACT-G questionnaires were completed for patients selected by consecutive sampling from the Imam Khomeini Cancer Institute in Tehran in 2018. The Ordinary Least Squares model was used to estimate the value of utility and the models' goodness of fit was evaluated using R2. In addition, models' predictive performance was assessed by Mean Absolute Error (MAE), Root Mean Square Error (RMSE), and Minimal Important Difference (MID) conducted between the observed and predicted SF-6D values. Models were validated using a 10-fold cross validation method. Results: Given the criteria of goodness of fit, model 2 was the best (R2 = 41.19 %). Moreover, findings of the predictive performance of models showed that model 2 was the best (MAE = 0.06943, RMSE = 0.09031, and MID = 0.0003). Conclusions: Findings showed that the developed algorithm had a good predictive ability. So, it can enable the policymakers and researchers to convert cancer-specific health-related quality of life instruments to preference-based instruments.

A Double Priming Induction Regimen for Acute Myeloid Leukemia with Inferior PS Among Resource Limited Areas

The treatment options for patients with acute myeloid leukemia (AML) under inferior performance status (i.e. senior patients, MDS transformed AML, and patients with proven invasive fungal disease) are limited. The conventional “3+7” (idarubicin plus cytarabine) induction for those patients can be either too toxic, which leads to higher mortality rate, or requires prolonged recovery time thus raise medical cost. And the delay of consolidation may compromise outcome thus cause early relapse in such patients.Giving the rationale from the designing art of CPX-351, the prolonged IV time requirement for cytarabine, as well as mini-transplantation for AML treatment, at least in part, reflects the philosophy of a longer exposure to the chemo agent can be a more effective treatment approach for leukemia. On the other hand, the D-CAG protocol, which indicated an encouraging result for elderly patients with AML, indicated effectiveness of the strategy with reduced intensity. However, the cyto-toxic effect of decitabine with standard dose (20mg/m2) could still lead to severe treatment adverse events (AEs) thus raise the need of optimization of D-CAG regimen for patients with inferior PS.When considering the low dose hypo-methylation agent (HMA) can trigger the innate immunity response, the unique effect of homoharringtonine, as well as the effectiveness of CAG, we designed this DHCAG protocol following the principle of “longer exposure, lower intensity preceded by priming” and observed an unexpected excellent outcome with high CR rate, low induction failure and treatment mortality, as well as a higher cost effective value for patients with AML, when compared to “3+7” protocol, whom under inferior PS.From March 2016 - January 2018, we initiated this pilot study and investigated the safety and efficiency of this DHCAG protocol in patients with AML under poor PS. We enrolled 25 patients and administer the regimen as followings: i) G-CSF: 5μg/kg used when WBC <20×10^9/L at day 0-14 subcutaneous injection; ii) Decitabine: 6mg/m2 at day 0, 3, 6, 9, 12 iv drip; iii) Aclarubicin: 6mg/m2 at day 1-8 iv drip; iv) Homoharringtonine: 1mg/m2 at day 9-14 iv drip ( at day 9, if WBC >1*10^9/L then increase the dosage of homoharringtonine to 2mg/m2); iv) Cytarabine:10mg/m2 q12h at day 1-14 subcutaneous injection (if WBC >20*10^9/L then increase to 100mg/m2 by 24h CIV, or 50mg/m2 q12h by subcutaneous injection).The primary end point was complete hematologic remission, defined as a bone marrow blast cells ≤5%, Neutrophils in peripheral blood ≥1.0X109 /L, hemoglobin≥90g/L, and platelets ≥100X109/L and no any evidence of extramedullary leukemic infiltration; Secondary end points included numbers of adverse events, length of hospital stay, medical costs, and quality of life as measured with the use of the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. Among the 25 patients in the study, 23 completed the induction therapy. And 21/25 patients had a hematologic complete remission after a median time of 19 days. Once complete remission had occurred, all 21 patients received post-remission treatment for another 5 cycles of DHCAG. Median follow-up was 14 months (range, 8 to 19) by June 2018. Interestingly, regardless of grade 3-4 myelo-suppression occurred all of our patients during induction, eight patients did not experienced grade 3-4 myelo-suppression during the following cycles. The median hospital stay is 22 days. The median of total medical costs for induction was $9,815 (range, $5,053 to $16,336) vs $14,705 for “3+7” induction protocol (history control. Data unpublished). Patients resumed their usual lifestyle during post-remission therapy, and their quality of life was rated as nearly normal on the FACT-G questionnaire. At the time of the last follow-up, seven patients had had a hematologic relapse. The results of our pilot study, in which we tested a priming based, low dose and longer exposure in 25 patients with AML under poor PS, showed that the treatment was safe, effective, and economical. A prospective multicenter, randomized trial comparing DHCAG with IA is now under way in China. DisclosuresNo relevant conflicts of interest to declare.

The impact of muscle relaxation techniques on the quality of life of cancer patients, as measured by the FACT-G questionnaire

IntroductionPatients with cancer frequently suffer from emotional distress, characterized by psychological symptoms such as anxiety or depression. The presence of psychological symptoms combined with the complex nature of oncology processes can negatively impact patients’ quality of life. We aimed to determine the impact of a relaxation protocol on improving quality of life in a sample of oncological patients treated in the Spanish National Public Health System.Materials and methodsWe conducted a multicenter interventional study without a control group. In total, 272 patients with different oncologic pathologies and showing symptoms of anxiety were recruited from 10 Spanish public hospitals. The intervention comprised abbreviated progressive muscle relaxation training, according to Bernstein and Borkovec. This was followed by weekly telephone calls to each patient over a 1-month period. We collected sociodemographic variables related to the disease process, including information about mental health and the intervention. Patients’ quality of life was assessed using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. Bivariate and univariate analyses were performed, along with an analysis of multiple correspondences to identify subgroups of patients with similar variations on the FACT-G.ResultsPatients showed statistically significant improvements on the FACT-G overall score (W = 16806; p<0.001), with an initial mean score of 55.33±10.42 and a final mean score of 64.49±7.70. We also found significant improvements for all subscales: emotional wellbeing (W = 13118; p<0.001), functional wellbeing (W = 16155.5; p<0.001), physical wellbeing (W = 8885.5; p<0.001), and social and family context (W = −1840; p = 0.037).ConclusionsPatients with cancer who learned and practiced abbreviated progressive muscle relaxation experienced improvement in their perceived quality of life as measured by the FACT-G. Our findings support a previous assumption that complementary techniques (including relaxation techniques) are effective in improving the quality of life of patients with cancer.

Quality of Life of Patients with Spinal Metastasis from Cancer of Unknown Primary Origin: A Longitudinal Study of Surgical Management Combined with Postoperative Radiation Therapy.

Patients with spinal metastasis from cancer of unknown primary origin have limited life expectancy and poor quality of life. Surgery and radiation therapy remain the main treatment options, but, to our knowledge, there are limited data concerning quality-of-life improvement after surgery and radiation therapy and even fewer data on whether surgical intervention would affect quality of life. Patients were enrolled between January 2009 and January 2014 at the Changzheng Hospital, Shanghai, People's Republic of China. The quality of life of 2 patient groups (one group that underwent surgery followed by postoperative radiation therapy and one group that underwent radiation therapy only) was assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire during a 6-month period. A subgroup analysis of quality of life was performed to compare different surgical strategies in the surgical group. A total of 287 patients, including 191 patients in the group that underwent surgery and 96 patients in the group that underwent radiation therapy only, were enrolled in the prospective study; 177 patients completed all 5 checkpoints and 110 patients had died by the final checkpoint. The surgery group had significantly higher adjusted quality-of-life scores than the radiation therapy group in each domain of the FACT-G questionnaire (all p < 0.05). Subgroup analysis showed that adjusted functional and physical well-being scores were higher in the circumferential surgical decompression group. Surgery followed by postoperative radiation therapy improved and maintained quality of life in patients with spinal metastasis from cancer of unknown primary origin in the 6-month assessment. In terms of surgical strategies, circumferential decompression seems better than laminectomy alone in quality-of-life improvement. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Health-related quality of life for everolimus versus placebo in patients with advanced, non-functional, well-differentiated gastrointestinal or lung neuroendocrine tumours (RADIANT-4): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

In the phase 3 RADIANT-4 trial, everolimus increased progression-free survival compared with placebo in patients with advanced, progressive, non-functional, well-differentiated gastrointestinal or lung neuroendocrine tumours (NETs). We now report the health-related quality of life (HRQOL) secondary endpoint. RADIANT-4 is a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial done in 97 centres in 25 countries worldwide. Adults (aged ≥18 years) were eligible for the study if they had pathologically confirmed, advanced (unresectable or metastatic), non-functional, well-differentiated (grade 1 or 2) NETs of lung or gastrointestinal origin. Patients were randomly allocated (2:1) using block randomisation (block size of three) by an interactive voice response system to receive oral everolimus (10 mg per day) or placebo, both with best supportive care, with stratification by tumour origin, WHO performance status, and previous somatostatin analogue treatment. HRQOL was assessed with the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire at baseline (visit 2, day 1), every 8 weeks (± 1 week) during the study for the first 12 months after randomisation, and every 12 weeks thereafter until study drug discontinuation. The primary endpoint, reported previously, was progression-free survival assessed by central review; HRQOL was a prespecified secondary endpoint. The prespecified secondary outcome measure was time to definitive deterioration (≥7 points) in FACT-G total score. Analyses were done on the full analysis set, consisting of all randomised patients, by intention to treat. Only data obtained while receiving the randomly allocated treatment were included in this analysis. Enrolment for RADIANT-4 was completed on Aug 23, 2013, but the trial is ongoing pending final analysis of the key secondary endpoint of overall survival. This trial is registered with ClinicalTrials.gov, number NCT01524783. Between April 3, 2012, and Aug 23, 2013, 302 patients were enrolled; 205 were randomly allocated everolimus and 97 were assigned placebo. At baseline, 193 (94%) of 205 patients assigned everolimus and 95 (98%) of 97 allocated placebo had completed either fully or partly the FACT-G questionnaire; at week 48, 70 (83%) of 84 patients assigned everolimus and 22 (85%) of 26 allocated placebo completed FACT-G. Median time to definitive deterioration in FACT-G total score was 11·27 months (95% CI 9·27-19·35) with everolimus and 9·23 months (5·52-not estimable) with placebo (adjusted hazard ratio 0·81, 95% CI 0·55-1·21; log-rank p=0·31). HRQOL was maintained for patients with advanced, non-functional, gastrointestinal or lung NETs, with no relevant differences noted between the everolimus and placebo groups. In view of the previous RADIANT-4 findings of longer progression-free survival with everolimus, our findings suggest that everolimus delays disease progression while preserving overall HRQOL, even with the usual toxic effects related to active targeted drug treatment for cancer. Novartis Pharmaceuticals.

Can patient reported outcomes help identify the optimal outcome in palliative surgery?

The purpose of this pilot study was to determine whether an open-ended questionnaire captures severe symptoms in cancer patients undergoing palliative surgical consultation that a structured, validated quality-of-life assessment does not capture. We prospectively used the Functional Assessment of Cancer Therapy-General (FACT-G) and an open-ended questionnaire to assess the symptoms of patients with incurable malignancies who underwent palliative surgical consultation at our institution between January 2011 and September 2012. Of the 69 patients enrolled, the most common indications for consultation were bowel obstruction (54%), jaundice (13%), wound problems (10%), and gastrointestinal bleeding (7%). Of the severe symptoms patients reported, 76% were identified with the FACT-G alone, 22% were identified with the open-ended questionnaire alone, and 2% were duplicate responses captured with both the FACT-G and open-ended questionnaire. The open-ended questionnaire captured 68 instances of severe symptoms in 47 patients that the FACT-G did not capture; of these symptoms, 52 were considered to be highly relevant to surgery and potential outcome measures. An open-ended questionnaire can identify severe symptoms that a global quality of life survey cannot capture and could be used in conjunction with a global survey to reassess symptoms after palliative surgical consultation.

Meta-analysis provides evidence-based effect sizes for a cancer-specific quality-of-life questionnaire, the FACT-G

Objective To compare Cohen's guidelines for small (0.2), medium (0.5), and large (0.8) effect sizes with empirical estimates for a cancer-specific health-related quality-of-life questionnaire (HRQOL), the Functional Assessment of Cancer Therapy - General (FACT-G). Methods Seventy-one papers satisfied inclusion criteria for meta-analysis. Blinded to the HRQOL results, three “experts” (with expertise in interpreting the FACT-G questionnaire and managing cancer patients), predicted the relative magnitude of HRQOL mean differences. Size classes (small, medium, large) were defined in terms of relevance to clinical decision making. The experts worked independently and based their predictions on patient characteristics and clinical circumstances. Their judgments were linked with FACT-G results and inverse-variance–weighted mean effect sizes calculated for each size class. Results At least two experts were perfectly concordant and up to one was discordant by at most one size category for 833 of the mean differences; for these, weighted kappas were generally in the “substantial” range (0.60–0.79). Of these mean differences, 617 were cross-sectional; small, medium, and large mean effect sizes were physical well-being 0.42, 0.87, 1.6; functional well-being 0.37, 0.71, 1.6; emotional well-being 0.32, 0.40, no large differences; and social well-being 0.14, 0.23, no large differences. Two hundred and sixteen longitudinal mean differences yielded small and medium effect sizes: physical well-being 0.26, 0.34; functional well-being 0.14, 0.28; emotional well-being 0.27, 0.23; and social well-being 0.08, 0.01. There was virtually no evidence for large longitudinal effects. Conclusion These results provide specific, evidence-based alternatives to Cohen's generic guidelines, for use in sample-size calculations for the FACT-G and interpretation of the clinical significance of effects measured with FACT-G.

Comprehensiveness of Quality of Life Instruments in Capturing Concerns Related to Chemotherapy-Induced Neutropenia

Neutropenia is a serious hematologic consequence of cancer chemotherapy that can lead to further complications such as febrile neutropenia (FN). FN is potentially life threatening and often requires hospitalization. Few studies have evaluated the impact of neutropenia on quality of life (QoL). This study quantified QoL using two nonneutropenia-specific instruments, the EQ-5D questionnaire, a generic tool used to measure health-related QoL, and the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, and a neutropenia-specific instrument, the Functional Assessment of Cancer Therapy - Neutropenia (FACT-N) questionnaire. The FACT-G is a 27-item questionnaire that examines QoL in patients with cancer using four subscales. A neutropenia-specific subscale (NSS) has been developed for use with the FACT-G; this combined questionnaire is the FACT-N. Data were collected from patients, who provided informed consent, and who were admitted to Sunnybrook Health Sciences Centre, Toronto, Canada, for the treatment of chemotherapy-induced FN. Linear regression models were fitted to examine the relationship of scores from the neutropenia-specific instrument with those obtained from the other instruments. Two models were fitted using the NSS as the response variable. Predictors for the regression models were the FACT-G scores for each of the subscales (physical, emotional, social and functional wellbeing) and the five domains of the EQ-5D (mobility, self-care, usual activity, pain/discomfort and anxiety/depression) along with the visual analog scale (VAS) component of this tool. The physical and emotional wellbeing subscales of the FACT-G had a strong relationship to the NSS (p < 0.05); the social and functional well-being subscales had a much weaker relationship (p > 0.5). For the EQ-5D, the pain/discomfort domain had the strongest relationship to the NSS (p=0.18); the remaining domains, with or without the VAS, all demonstrated a weaker relationship (p > 0.5). Model fit was assessed by the adjusted R2 statistic; it was 0.54 when FACT-G subscales were used as the predictors compared to −0.04 for the EQ-5D domains indicating that the FACT-G was a better predictor of neutropenia-related concerns. Neutropenia concerns appear to be more closely related to cancer specific QoL compared to general quality of life as demonstrated by the stronger relationship of the NSS to the FACT-G than to the EQ-5D. This may be due to the comprehensiveness of the FACT-G questionnaire where a possible score anywhere from 0 to 24 or 28 can be obtained in each of the subscales, compared to three-point descriptive system for each of the domains of the EQ-5D.

Management of pain in elderly patients receiving infusion of zoledronic acid for bone metastasis: a single-institution report

Bone metastases are a common cause of morbidity in elderly patients with solid tumors and myeloma. We studied the safety and the effect of a new bisphosphonate, zoledronic acid (ZA), on pain and on quality of life (QoL) in elderly patients with bone metastases. From January 2004 to December 2005, we have enrolled elderly patients with bone metastasis for receiving ZA administration. Visual analog scale (VAS) and Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire were used to assess potential benefits of ZA therapy. Eighty-six patients were included; the median age was 75.5 years. Before starting treatment, the mean VAS was 6.8 (+/-0.24), after three infusions 5.4 (+/-0.3), and after six courses 4.5 (+/-0.3) with a significant improvement of bone pain. Moreover, we found a statistically significant improvement of QoL measured by FACT-G questionnaire after six courses (p = 0.010). Median baseline and final value of serum creatinine were 0.73 and 0.72 mg/dl, respectively (p = 0.11); creatinine clearance was also normal for most patients. Osteonecrosis of the jaw was diagnosed in one patient who received a prolonged ZA treatment. These data confirm the benefits of ZA on pain and QoL also in elderly patients with bone metastasis from solid tumors.

French version of FACT-G: validation and comparison with other cancer-specific instruments

The aim of this study was to assess the validity of the French version of the Functional Assessment of Cancer Therapy – General (FACT-G), and to compare its psychometric properties with those of two other cancer-specific quality of life questionnaires, European Organisation for Research and Treatment of Cancer Quality of Life – Core 30 (EORTC QLQ-C30) and Functional Living Index – Cancer (FLIC). Two hundred and twenty three patients with breast or colorectal cancer completed the FACT-G questionnaire in French followed by (in random order) the QLQ-C30 and FLIC. An additional 87 patients with head and neck (H&N) cancer completed the FACT-H&N followed by the QLQ-C30 and H&N-Besançon. The French version of FACT-G was internally consistent, and its reproducibility was excellent. FACT-G Physical Well-Being and global scores correlated with all QLQ-C30 subscales. There was evidence of discriminant validity. Compared with the other tools, FACT-G included a statistically significantly higher proportion of items patients considered to be confusing or upsetting. Patients with breast or colorectal cancer expressed a preference for QLQ-C30. Use of the specific H&N additional items increased the responsiveness to change of FACT-G. The French version of FACT-G is valid and has psychometric properties similar to those of FLIC and QLQ-C30.