***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE This study was undertaken to prospect ively evaluate the effect of early stage endometrial cancer , age , and obesity on quality of life ( QOL ) . STUDY DESIGN Women undergoing surgery for endometrial cancer or an adnexal mass determined at surgery to be benign ( controls ) were enrolled preoperatively and followed for 6 months . RESULTS Seventy-nine women completed the study .  Functional Assessment of Cancer Therapy ( FACT-G ) scores increased significantly in all women ; however , significant differences by patient weight and age were obtained . Obesity was associated with decreased physical FACT-G and SF-36 scores . Older women had lower SF-36 physical scores , higher emotional scores , and less change over time . CONCLUSION Women with early endometrial cancer had similar changes in QOL as those who received surgery for benign disease . Obese and elderly women had domain alterations . Given the aging population and rising incidence of obesity , these results emphasize the need for QOL interventions in postoperative gynecologic care of these patients OBJECTIVE This study was undertaken to compare the quality of life ( QoL ) in women with early stage endometrial cancer treated with 2 different surgical approaches . STUDY DESIGN Eighty-four women with clinical stage I endometrial cancer were enrolled in a prospect i ve r and omized controlled trial design and treated with laparoscopic or laparotomic approach . Another 40 women matched for demographic characteristics were studied as controls . In patients , before and after surgery , and in their matched controls , QoL was evaluated by using the Short-Form Healthy Survey ( SF-36 ) and the climacteric symptoms using the Kupperman Index ( KI ) . RESULTS After r and omization , no difference was detected in data recorded between the groups . At entry , QoL was similar in both treatment groups but significantly ( P < .05 ) worse in comparison with controls . Throughout the study , QoL was significantly ( P < .05 ) higher in laparoscopic group versus laparotomic group . After KI adjustment our data did not change . CONCLUSION In early stage endometrial cancer , the laparoscopic approach provides significant benefits compared with laparotomy in terms of In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials The objective of this study was to examine and compare two core measures of Quality Of Life ( QOL ) used in cancer clinical trials : the European Organisation for Research and Treatment of Cancer QOL  Core Question naire 30 ( EORTC QLQ-30 ) and the Functional Assessment of Chronic Illness Therapy ( FACIT ) , in order to identify which one patients have the strongest preference for using . 68 patients suffering from Carcinomas of an Unknown Primary site ( CUP ) were recruited in a multicentric study ; all of them completed both question naires , administered in a r and omised manner . The criteria were the percentage of preferences , and four indicators of acceptability . The results indicated that an equal proportion of patients preferred the QLQ-C30 ( 19 % ) and FACIT ( 19 % ) . 54 % of patients felt both question naires were acceptable . All the indicators of acceptability favoured the QLQ-C30 . Analysis of open-ended questions shed light on the difficulties encountered by the patients . As no significant preference was observed for one of the question naires , the QLQ-C30 was chosen on the basis of its significantly better acceptability criteria PURPOSE The value of palliative chemotherapy in women with refractory and recurrent ovarian cancer is difficult to quantify , and little is known about patient expectations from these treatments . We evaluated in the current prospect i ve study patient expectations , palliative outcomes of chemotherapy , and the inherent re source utilization in patients undergoing second- or third-line chemotherapy for recurrent or refractory advanced ovarian cancer . METHODS The European Organization for Research and Treatment of Cancer Quality -of-Life Question naire C30 ( EORTC QLQ C30 ) and Functional Assessment of Cancer Therapy-Ovarian ( FACT-O ) question naires were used to assess palliative benefit and an in-house question naire was used to gauge patient expectations . The minimal clinical ly important difference ( MCID ) was calculated by asking women to make a global rating of change and correlating this to the EORTC QLQ C30 . Re source use was recorded and costs were calculated . RESULTS Twenty-seven patients were accrued . Objective response was documented on seven of 27 . The median survival was 11 months . Sixty-five percent of women expected that chemotherapy would make them live longer and 42 % that it would cure them . After two cycles , quality -of-life ( QL ) improvement was seen particularly in global function ( 11 of 21 ) and emotional function ( 13 of 21 ) with EORTC QLQ C-30 . Improvement was sustained for a median of 2 and 3 months , respectively , in these categories . The MCID was calculated to be 0.39 on a seven-point scale for physical function and 0.13 for global function . The mean total cost per patient for the study period was Can $ 12,500 . CONCLUSION Patient expectations from these treatments are often unrealistic . Although objective responses are low , active palliation with chemotherapy is associated with substantive improvement in patients ' emotional function and global QL , with overall costs that seem relatively modest OBJECTIVES To assess the reliability and validity of the Functional Assessment of Cancer Therapy-Vulvar ( FACT-V ) . METHODS Seventy-seven patients treated between January 1996 and January 2001 for cancer of the vulva completed the FACT-V , the Eastern Cooperative Oncology Group Performance Status Rating ( ECOG-PSR ) and the  Hospital Anxiety and Depression Scale ( HADS ) once , 20 consecutive patients treated between February 2001 and October 2001 completed the question naires twice , once before surgery and at 2 months follow-up . The FACT-V scores were compared by patients ' performance status , FIGO stage , recurrence , and age , and correlated to the HADS scores . Changes in the FACT-V from baseline to 2 months follow-up were evaluated to establish FACT-V 's responsiveness to change . RESULTS The FACT-V 's internal consistency was adequate ( Chronbach 's alpha range , 0.75 to 0.92 ) . Patients with lower performance status , higher FIGO-stage or recurrent disease received lower FACT-V scores , indicating discriminant validity . The correlation between the FACT-V and the HADS were in the expected direction , indicating convergent and divergent validity . From pre- to post-surgery , scores in nine out of fifteen items of the vulvar cancer-specific subscale improved , while those of five items declined , indicating sensitivity of the vulvar cancer specific items to changes in patients ' well-being . CONCLUSIONS The newly developed FACT-V provides a reliable and valid assessment of the quality of life of women with vulvar cancer . It can be used as a short measure of quality of life within research studies , and to facilitate communication about quality of life issues in clinical practice The purpose of this study was to vali date the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group — Neurotoxicity ( FACT/GOG-Ntx ) question naire . The FACT/GOG-Ntx is the FACT-G plus an eleven-item subscale ( Ntx subscale ) that evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy . Two groups of women with ovarian cancer completed the FACT/GOG-Ntx : one group with known neurotoxicities and one group of chemotherapy-naive women newly diagnosed with ovarian cancer .  Levels of patient neuropathy , severity of toxicity , and patient quality of life from diagnosis of ovarian cancer to 12 months post-diagnosis were assessed . The Ntx subscale significantly differentiated the two groups at baseline and 3- and 6-month follow-ups , demonstrating significantly fewer problems among chemotherapy-naive patients than among patients with known neuropathy . The FACT/GOG-Ntx is a reliable and valid instrument for assessing the impact of neuropathy on health-related quality of life . The Ntx subscale demonstrated sensitivity to meaningful clinical distinctions and change over time PURPOSE To compare self-reported quality of life ( QOL ) in patients who did versus did not undergo interval secondary cytoreduction after initial surgery and combination chemotherapy for advanced ovarian cancer and to assess the association between baseline QOL scores and survival . PATIENTS AND METHODS Consenting patients participating in a Gynecologic Oncology Group ( GOG ) phase III treatment trial ( GOG 152 ) completed the Functional Assessment of Cancer Therapy-Ovarian ( FACT-O ) question naire and treatment-specific supplemental questions at the third and sixth chemotherapy cycles and at 6 and 12 months after starting treatment . RESULTS For all patients , QOL decreased approximately 1 unit from the first to second assessment . Significant improvement observed at 6 months ( P < .001 ) was sustained at 12 months , with no appreciable between-group difference . The baseline FACT-O score was associated with overall survival ( P = .048 ) but not progression-free survival . Less neurotoxicity was reported among patients who did ( 38.4 % ) versus did not ( 54.0 % ) undergo interval secondary cytoreduction at the third assessment ( P = .005 ) , and older patients experienced more long-term effects . CONCLUSION This is the first multicenter r and omized trial in ovarian cancer to longitudinally examine self-reported QOL and establish a predictive value of baseline QOL on survival , attributed primarily to the lowest-scoring quartile . Although interval secondary cytoreduction result ed in no notable long-term difference , a clinical ly significant improvement was seen in both arms at 6 and 12 months after starting therapy . Interestingly , there were fewer complaints of neurotoxicity at 6 months among patients who did versus did not undergo interval secondary cytoreduction Objective To prospect ively compare quality of life ( QOL ) outcomes in patients with advanced endometrial cancer treated with whole abdominal irradiation ( WAI ) or doxorubicin-cisplatin ( AP ) chemotherapy .  Methods Using the Fatigue Scale ( FS ) , Assessment of Peripheral Neuropathy ( APN ) , Functional Alterations due to Changes in Elimination ( FACE ) , and Functional Assessment of Cancer Therapy-General ( FACT-G ) , QOL was measured at : pre-treatment , end of treatment ( EOT ) , and 3 and 6 months post-treatment . Results 317 of 396 eligible patients provided a baseline QOL assessment .  The AP arm produced a statistically significant survival benefit along with greater toxicities , including peripheral neuropathy persisting up to 6 months . WAI patients reported worse FS ( p<0.001 ) and FACE ( p<0.001 ) scores at EOT and poorer FACE scores 3 months post-treatment ( p = 0.004 ) compared to AP patients . APN scores were significantly worse among AP patients at EOT , and 3 and 6 months post-treatment ( p<0.001 for all ) . There is no indication that FACT-G scores differed between the two arms at any assessment point . Conclusions The trade-off for increased survival with AP is its potential for clinical ly significant peripheral neuropathy . This should be discussed with patients , particularly those who work with their h and s or on their feet , in weighing therapeutic choices . Further research is needed to manage side effects having an enduring impact on QOL PURPOSE A Gynecologic Oncology Group ( GOG ) r and omized phase III trial ( GOG 172 ) in optimal stage III epithelial ovarian cancer showed that intravenous ( IV ) paclitaxel plus intraperitoneal ( IP ) cisplatin and paclitaxel significantly lengthened progression-free survival and overall survival compared with IV paclitaxel and cisplatin . The purpose of this report is to comprehensively evaluate the patient-reported outcomes associated with IP versus IV therapy . PATIENTS AND METHODS Four hundred fifteen eligible women were enrolled onto GOG 172 at member institutions . The Functional Assessment of Cancer Therapy-Trial Outcome Index ( FACT-TOI ; which includes physical , functional , and ovarian subscales ) and neurotoxicity ( Ntx ) and abdominal discomfort ( AD ) subscales were used to assess patient-reported outcomes . Assessment s were completed before r and om assignment , before cycle 4 , and 3 to 6 weeks and 12 months after treatment . RESULTS Physical and functional well-being and ovarian cancer symptoms were significantly worse in the IP arm before cycle 4 ( P < .001 ) and 3 to 6 weeks after treatment ( P = .001 for FACT-TOI ) . Patients in the IP arm also reported significantly worse AD before cycle 4 ( P < .001 ) and significantly worse Ntx  
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However , we found no evidence for superior performance by the FACT-G compared with the SF-36 or EORTC and FACIT disease-specific modules versus the QLQ-C30 and FACT-G. There was also little evidence to favor EORTC versus FACIT question naires or vice versa .
The evidence we review ed offered little support for the hypothesis that disease- , symptom- , or treatment-specific instruments are more sensitive and responsive than cancer-specific or generic question naires .