Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer
Purpose Evaluate reliability and validity of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire and its derivative FACT Hepatobiliary Symptom Indexes (FHSI-18 and FHSI-8) in people with metastatic pancreatic cancer. Methods Self-reported questionnaire data from a rand...
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| Veröffentlicht in: | Quality of life research 2013-06, Vol.22 (5), p.1105-1112 |
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| creator | Cella, David Butt, Zeeshan Lee Kindler, Hedy Fuchs, Charles S. Bray, Sarah Barlev, Arie Oglesby, Alan |
| description | Purpose Evaluate reliability and validity of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire and its derivative FACT Hepatobiliary Symptom Indexes (FHSI-18 and FHSI-8) in people with metastatic pancreatic cancer. Methods Self-reported questionnaire data from a randomized controlled Phase II study evaluating the efficacy and safety of conatumumab (AMG 655), ganitumab (AMG 479) or placebo combined with gemcitabine were evaluated. The following were assessed: internal consistency, using Cronbach's α; discriminant validity, comparing baseline patient-reported outcomes (PRO) scores across Eastern Cooperative Oncology Group (ECOG) performance status (PS) levels; and ability to detect change, comparing change from baseline PRO score at each cycle across PS and tumour response groups. Results The analysis included 96 patients. All scale scores demonstrated good internal consistency (Cronbach's α > 0.7) and discriminant validity. Baseline scores were significantly poorer among patients with PS = 1 versus patients with PS = 0 (e.g. difference in FACT-Hep total score −17.27; p < 0.001). Ability to detect change was established for Cycles 2/3 versus baseline; PRO scores reduced in the PS-worsened group versus the PS-stable group (e.g. difference in FACT-Hep total score −24.29; p < 0.001). All PRO scale scores showed significant decline for progressive disease versus stable disease (e.g. difference in FACT-Hep total score −12.58; p = 0.004). Changes on the FHSI-18 and FHSI-8 scales were similar in magnitude whether ECOG improved or worsened. Conclusions FACT-Hep detects change and is a reliable and valid instrument for measuring health-related quality of life in patients with metastatic pancreatic cancer. |
| doi_str_mv | 10.1007/s11136-012-0217-4 |
| format | Article |
| fullrecord | <record><control><sourceid>jstor_proqu</sourceid><recordid>TN_cdi_proquest_miscellaneous_1399049699</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><jstor_id>24724295</jstor_id><sourcerecordid>24724295</sourcerecordid><originalsourceid>FETCH-LOGICAL-c427t-3e49d25e92885027b5dc01ac75824feff7909d3b6b7776448f9da93aec2d1d423</originalsourceid><addsrcrecordid>eNp9kc9u1DAQxiMEotvCA3AAWeJSDgb_Sxwfq1VLkSpxKVwjJ550vUrsrccrtM_FC-JtSkEcOHk085vvs_1V1RvOPnLG9CfknMuGMi4oE1xT9axa8VpLKhplnlcrZhpBjVTypDpF3DLGWsPEy-pEiEa3spar6ud3O3nn84HEkeQNkKuL9S25hp3NsfeTt-lAzo89WnofyP0eMPsYgvUJyBgTsYiA6MMdcR7BItAEk83gCB7mXY4zEhsc2YCd8uZpdr8vtovp5EcgPpDi6CFkJD983pAZssVcWkMZhCHBQzmUEtKr6sVoJ4TXj-dZ9e3q8nZ9TW--fv6yvrihgxI6UwnKOFGDEW1bM6H72g2M20HXrVAjjKM2zDjZN73WulGqHY2zRloYhONOCXlWnS-6uxQfHt7NHgeYJhsg7rHj0himTGNMQd__g27jPoVyu0LVdaNKTk2h-EINKSImGLtd8nP54o6z7photyTalUS7Y6KdKjvvHpX3_QzuaeN3hAUQC4BlFO4g_WX9H9W3y9IWc0x_RJUWSpha_gKL6rd9</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1355641366</pqid></control><display><type>article</type><title>Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer</title><source>MEDLINE</source><source>Jstor Complete Legacy</source><source>Springer Nature - Complete Springer Journals</source><creator>Cella, David ; Butt, Zeeshan ; Lee Kindler, Hedy ; Fuchs, Charles S. ; Bray, Sarah ; Barlev, Arie ; Oglesby, Alan</creator><creatorcontrib>Cella, David ; Butt, Zeeshan ; Lee Kindler, Hedy ; Fuchs, Charles S. ; Bray, Sarah ; Barlev, Arie ; Oglesby, Alan</creatorcontrib><description>Purpose Evaluate reliability and validity of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire and its derivative FACT Hepatobiliary Symptom Indexes (FHSI-18 and FHSI-8) in people with metastatic pancreatic cancer. Methods Self-reported questionnaire data from a randomized controlled Phase II study evaluating the efficacy and safety of conatumumab (AMG 655), ganitumab (AMG 479) or placebo combined with gemcitabine were evaluated. The following were assessed: internal consistency, using Cronbach's α; discriminant validity, comparing baseline patient-reported outcomes (PRO) scores across Eastern Cooperative Oncology Group (ECOG) performance status (PS) levels; and ability to detect change, comparing change from baseline PRO score at each cycle across PS and tumour response groups. Results The analysis included 96 patients. All scale scores demonstrated good internal consistency (Cronbach's α > 0.7) and discriminant validity. Baseline scores were significantly poorer among patients with PS = 1 versus patients with PS = 0 (e.g. difference in FACT-Hep total score −17.27; p < 0.001). Ability to detect change was established for Cycles 2/3 versus baseline; PRO scores reduced in the PS-worsened group versus the PS-stable group (e.g. difference in FACT-Hep total score −24.29; p < 0.001). All PRO scale scores showed significant decline for progressive disease versus stable disease (e.g. difference in FACT-Hep total score −12.58; p = 0.004). Changes on the FHSI-18 and FHSI-8 scales were similar in magnitude whether ECOG improved or worsened. Conclusions FACT-Hep detects change and is a reliable and valid instrument for measuring health-related quality of life in patients with metastatic pancreatic cancer.</description><identifier>ISSN: 0962-9343</identifier><identifier>EISSN: 1573-2649</identifier><identifier>DOI: 10.1007/s11136-012-0217-4</identifier><identifier>PMID: 22678353</identifier><language>eng</language><publisher>Dordrecht: Springer</publisher><subject>Adenocarcinoma - drug therapy ; Adenocarcinoma - psychology ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Bile ducts ; Cancer ; Cancer therapies ; Clinical outcomes ; Deoxycytidine - administration & dosage ; Deoxycytidine - analogs & derivatives ; Disease progression ; Female ; Health outcomes ; Health Status ; Humans ; Male ; Medical prognosis ; Medicine ; Medicine & Public Health ; Metastasis ; Middle Aged ; Neoplasia ; Neoplasm Metastasis - drug therapy ; Oncology ; Pancreatic cancer ; Pancreatic neoplasms ; Pancreatic Neoplasms - drug therapy ; Pancreatic Neoplasms - psychology ; Patient Outcome Assessment ; Patients ; Psychometrics ; Public Health ; Quality of Life ; Quality of Life Research ; Questionnaires ; Randomized Controlled Trials as Topic ; Reproducibility of Results ; Sensitivity and Specificity ; Sociology ; Surveys and Questionnaires ; Symptom Assessment ; Symptoms ; Validation studies ; Validity ; Wellbeing</subject><ispartof>Quality of life research, 2013-06, Vol.22 (5), p.1105-1112</ispartof><rights>Springer Science+Business Media B.V. 2012</rights><rights>Springer Science+Business Media Dordrecht 2013</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c427t-3e49d25e92885027b5dc01ac75824feff7909d3b6b7776448f9da93aec2d1d423</citedby><cites>FETCH-LOGICAL-c427t-3e49d25e92885027b5dc01ac75824feff7909d3b6b7776448f9da93aec2d1d423</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/24724295$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/24724295$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>314,777,781,800,27905,27906,41469,42538,51300,57998,58231</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22678353$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cella, David</creatorcontrib><creatorcontrib>Butt, Zeeshan</creatorcontrib><creatorcontrib>Lee Kindler, Hedy</creatorcontrib><creatorcontrib>Fuchs, Charles S.</creatorcontrib><creatorcontrib>Bray, Sarah</creatorcontrib><creatorcontrib>Barlev, Arie</creatorcontrib><creatorcontrib>Oglesby, Alan</creatorcontrib><title>Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer</title><title>Quality of life research</title><addtitle>Qual Life Res</addtitle><addtitle>Qual Life Res</addtitle><description>Purpose Evaluate reliability and validity of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire and its derivative FACT Hepatobiliary Symptom Indexes (FHSI-18 and FHSI-8) in people with metastatic pancreatic cancer. Methods Self-reported questionnaire data from a randomized controlled Phase II study evaluating the efficacy and safety of conatumumab (AMG 655), ganitumab (AMG 479) or placebo combined with gemcitabine were evaluated. The following were assessed: internal consistency, using Cronbach's α; discriminant validity, comparing baseline patient-reported outcomes (PRO) scores across Eastern Cooperative Oncology Group (ECOG) performance status (PS) levels; and ability to detect change, comparing change from baseline PRO score at each cycle across PS and tumour response groups. Results The analysis included 96 patients. All scale scores demonstrated good internal consistency (Cronbach's α > 0.7) and discriminant validity. Baseline scores were significantly poorer among patients with PS = 1 versus patients with PS = 0 (e.g. difference in FACT-Hep total score −17.27; p < 0.001). Ability to detect change was established for Cycles 2/3 versus baseline; PRO scores reduced in the PS-worsened group versus the PS-stable group (e.g. difference in FACT-Hep total score −24.29; p < 0.001). All PRO scale scores showed significant decline for progressive disease versus stable disease (e.g. difference in FACT-Hep total score −12.58; p = 0.004). Changes on the FHSI-18 and FHSI-8 scales were similar in magnitude whether ECOG improved or worsened. Conclusions FACT-Hep detects change and is a reliable and valid instrument for measuring health-related quality of life in patients with metastatic pancreatic cancer.</description><subject>Adenocarcinoma - drug therapy</subject><subject>Adenocarcinoma - psychology</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Monoclonal - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Bile ducts</subject><subject>Cancer</subject><subject>Cancer therapies</subject><subject>Clinical outcomes</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Disease progression</subject><subject>Female</subject><subject>Health outcomes</subject><subject>Health Status</subject><subject>Humans</subject><subject>Male</subject><subject>Medical prognosis</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Metastasis</subject><subject>Middle Aged</subject><subject>Neoplasia</subject><subject>Neoplasm Metastasis - drug therapy</subject><subject>Oncology</subject><subject>Pancreatic cancer</subject><subject>Pancreatic neoplasms</subject><subject>Pancreatic Neoplasms - drug therapy</subject><subject>Pancreatic Neoplasms - psychology</subject><subject>Patient Outcome Assessment</subject><subject>Patients</subject><subject>Psychometrics</subject><subject>Public Health</subject><subject>Quality of Life</subject><subject>Quality of Life Research</subject><subject>Questionnaires</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Reproducibility of Results</subject><subject>Sensitivity and Specificity</subject><subject>Sociology</subject><subject>Surveys and Questionnaires</subject><subject>Symptom Assessment</subject><subject>Symptoms</subject><subject>Validation studies</subject><subject>Validity</subject><subject>Wellbeing</subject><issn>0962-9343</issn><issn>1573-2649</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp9kc9u1DAQxiMEotvCA3AAWeJSDgb_Sxwfq1VLkSpxKVwjJ550vUrsrccrtM_FC-JtSkEcOHk085vvs_1V1RvOPnLG9CfknMuGMi4oE1xT9axa8VpLKhplnlcrZhpBjVTypDpF3DLGWsPEy-pEiEa3spar6ud3O3nn84HEkeQNkKuL9S25hp3NsfeTt-lAzo89WnofyP0eMPsYgvUJyBgTsYiA6MMdcR7BItAEk83gCB7mXY4zEhsc2YCd8uZpdr8vtovp5EcgPpDi6CFkJD983pAZssVcWkMZhCHBQzmUEtKr6sVoJ4TXj-dZ9e3q8nZ9TW--fv6yvrihgxI6UwnKOFGDEW1bM6H72g2M20HXrVAjjKM2zDjZN73WulGqHY2zRloYhONOCXlWnS-6uxQfHt7NHgeYJhsg7rHj0himTGNMQd__g27jPoVyu0LVdaNKTk2h-EINKSImGLtd8nP54o6z7photyTalUS7Y6KdKjvvHpX3_QzuaeN3hAUQC4BlFO4g_WX9H9W3y9IWc0x_RJUWSpha_gKL6rd9</recordid><startdate>20130601</startdate><enddate>20130601</enddate><creator>Cella, David</creator><creator>Butt, Zeeshan</creator><creator>Lee Kindler, Hedy</creator><creator>Fuchs, Charles S.</creator><creator>Bray, Sarah</creator><creator>Barlev, Arie</creator><creator>Oglesby, Alan</creator><general>Springer</general><general>Springer Netherlands</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7WY</scope><scope>7WZ</scope><scope>7X7</scope><scope>7XB</scope><scope>87Z</scope><scope>88E</scope><scope>88G</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8FL</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BEZIV</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FRNLG</scope><scope>FYUFA</scope><scope>F~G</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K60</scope><scope>K6~</scope><scope>K9.</scope><scope>KB0</scope><scope>L.-</scope><scope>M0C</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PQBIZ</scope><scope>PQBZA</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>ASE</scope><scope>FPQ</scope><scope>K6X</scope></search><sort><creationdate>20130601</creationdate><title>Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer</title><author>Cella, David ; Butt, Zeeshan ; Lee Kindler, Hedy ; Fuchs, Charles S. ; Bray, Sarah ; Barlev, Arie ; Oglesby, Alan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c427t-3e49d25e92885027b5dc01ac75824feff7909d3b6b7776448f9da93aec2d1d423</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adenocarcinoma - drug therapy</topic><topic>Adenocarcinoma - psychology</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antibodies, Monoclonal - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Bile ducts</topic><topic>Cancer</topic><topic>Cancer therapies</topic><topic>Clinical outcomes</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Disease progression</topic><topic>Female</topic><topic>Health outcomes</topic><topic>Health Status</topic><topic>Humans</topic><topic>Male</topic><topic>Medical prognosis</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Metastasis</topic><topic>Middle Aged</topic><topic>Neoplasia</topic><topic>Neoplasm Metastasis - drug therapy</topic><topic>Oncology</topic><topic>Pancreatic cancer</topic><topic>Pancreatic neoplasms</topic><topic>Pancreatic Neoplasms - drug therapy</topic><topic>Pancreatic Neoplasms - psychology</topic><topic>Patient Outcome Assessment</topic><topic>Patients</topic><topic>Psychometrics</topic><topic>Public Health</topic><topic>Quality of Life</topic><topic>Quality of Life Research</topic><topic>Questionnaires</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Reproducibility of Results</topic><topic>Sensitivity and Specificity</topic><topic>Sociology</topic><topic>Surveys and Questionnaires</topic><topic>Symptom Assessment</topic><topic>Symptoms</topic><topic>Validation studies</topic><topic>Validity</topic><topic>Wellbeing</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cella, David</creatorcontrib><creatorcontrib>Butt, Zeeshan</creatorcontrib><creatorcontrib>Lee Kindler, Hedy</creatorcontrib><creatorcontrib>Fuchs, Charles S.</creatorcontrib><creatorcontrib>Bray, Sarah</creatorcontrib><creatorcontrib>Barlev, Arie</creatorcontrib><creatorcontrib>Oglesby, Alan</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>ABI/INFORM Collection</collection><collection>ABI/INFORM Global (PDF only)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ABI/INFORM Global (Alumni Edition)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ABI/INFORM Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Business Premium Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Business Premium Collection (Alumni)</collection><collection>Health Research Premium Collection</collection><collection>ABI/INFORM Global (Corporate)</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>ProQuest Business Collection (Alumni Edition)</collection><collection>ProQuest Business Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ABI/INFORM Professional Advanced</collection><collection>ABI/INFORM Global</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Business</collection><collection>ProQuest One Business (Alumni)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>British Nursing Index</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>British Nursing Index</collection><jtitle>Quality of life research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cella, David</au><au>Butt, Zeeshan</au><au>Lee Kindler, Hedy</au><au>Fuchs, Charles S.</au><au>Bray, Sarah</au><au>Barlev, Arie</au><au>Oglesby, Alan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer</atitle><jtitle>Quality of life research</jtitle><stitle>Qual Life Res</stitle><addtitle>Qual Life Res</addtitle><date>2013-06-01</date><risdate>2013</risdate><volume>22</volume><issue>5</issue><spage>1105</spage><epage>1112</epage><pages>1105-1112</pages><issn>0962-9343</issn><eissn>1573-2649</eissn><abstract>Purpose Evaluate reliability and validity of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire and its derivative FACT Hepatobiliary Symptom Indexes (FHSI-18 and FHSI-8) in people with metastatic pancreatic cancer. Methods Self-reported questionnaire data from a randomized controlled Phase II study evaluating the efficacy and safety of conatumumab (AMG 655), ganitumab (AMG 479) or placebo combined with gemcitabine were evaluated. The following were assessed: internal consistency, using Cronbach's α; discriminant validity, comparing baseline patient-reported outcomes (PRO) scores across Eastern Cooperative Oncology Group (ECOG) performance status (PS) levels; and ability to detect change, comparing change from baseline PRO score at each cycle across PS and tumour response groups. Results The analysis included 96 patients. All scale scores demonstrated good internal consistency (Cronbach's α > 0.7) and discriminant validity. Baseline scores were significantly poorer among patients with PS = 1 versus patients with PS = 0 (e.g. difference in FACT-Hep total score −17.27; p < 0.001). Ability to detect change was established for Cycles 2/3 versus baseline; PRO scores reduced in the PS-worsened group versus the PS-stable group (e.g. difference in FACT-Hep total score −24.29; p < 0.001). All PRO scale scores showed significant decline for progressive disease versus stable disease (e.g. difference in FACT-Hep total score −12.58; p = 0.004). Changes on the FHSI-18 and FHSI-8 scales were similar in magnitude whether ECOG improved or worsened. Conclusions FACT-Hep detects change and is a reliable and valid instrument for measuring health-related quality of life in patients with metastatic pancreatic cancer.</abstract><cop>Dordrecht</cop><pub>Springer</pub><pmid>22678353</pmid><doi>10.1007/s11136-012-0217-4</doi><tpages>8</tpages></addata></record> |
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| subjects | Adenocarcinoma - drug therapy Adenocarcinoma - psychology Adult Aged Aged, 80 and over Antibodies, Monoclonal - administration & dosage Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bile ducts Cancer Cancer therapies Clinical outcomes Deoxycytidine - administration & dosage Deoxycytidine - analogs & derivatives Disease progression Female Health outcomes Health Status Humans Male Medical prognosis Medicine Medicine & Public Health Metastasis Middle Aged Neoplasia Neoplasm Metastasis - drug therapy Oncology Pancreatic cancer Pancreatic neoplasms Pancreatic Neoplasms - drug therapy Pancreatic Neoplasms - psychology Patient Outcome Assessment Patients Psychometrics Public Health Quality of Life Quality of Life Research Questionnaires Randomized Controlled Trials as Topic Reproducibility of Results Sensitivity and Specificity Sociology Surveys and Questionnaires Symptom Assessment Symptoms Validation studies Validity Wellbeing |
| title | Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer |
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