A Multicenter, Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (PERIOP-PC)
Despite positive outcomes associated with specialist palliative care (PC) in diverse medical populations, little research has investigated specialist PC in surgical ones. Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortalit...
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| Veröffentlicht in: | Journal of palliative medicine 2019-09, Vol.22 (S1), p.44-S-57 |
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| creator | Aslakson, Rebecca A Chandrashekaran, Shivani V Rickerson, Elizabeth Fahy, Bridget N Johnston, Fabian M Miller, Judith A Conca-Cheng, Alison Wang, Suwei Morris, Arden M Lorenz, Karl Temel, Jennifer S Smith, Thomas J |
| description | Despite positive outcomes associated with specialist palliative care (PC) in diverse medical populations, little research has investigated specialist PC in surgical ones. Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers.
Our objective is to complete a multicenter, randomized controlled trial comparing surgeon-PC co-management with surgeon-alone management among patients pursuing curative-intent surgery for upper GI cancers. We hypothesize that perioperative PC will improve patient postsurgical quality of life. This study and design are based on >8 years of engagement and research with patients, family members, and clinicians surrounding major cancer surgery and advance care planning/PC for surgical patients.
Randomized controlled superiority trial with two study arms (surgeon-PC team co-management and surgeon-alone management) and five data collection points over six months. The principal investigator and analysts are blinded to randomization.
Four, geographically diverse, academic tertiary care hospitals. Data collection began December 20, 2018 and continues to December 2020.
Patients recruited from surgical oncology clinics who are undergoing curative-intent surgery for an upper GI cancer.
In the intervention arm, patients receive care from both their surgical team and a specialist PC team; the PC is provided before surgery, immediately after surgery, and at least monthly until three months postsurgery. Patients randomized to the usual care arm receive care from only the surgical team.
Primary outcome: patient quality of life. Secondary outcomes: patient: symptom experience, spiritual distress, prognostic awareness, health care utilization, and mortality. Caregiver: quality of life, caregiver burden, spiritual distress, and prognostic awareness. Intent-to-treat analysis will be used.
This study has been approved by the institutional review boards of all study sites and is registered on clinicaltrials.gov (NCT03611309, First received: August 2, 2018). |
| doi_str_mv | 10.1089/jpm.2019.0130 |
| format | Article |
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Our objective is to complete a multicenter, randomized controlled trial comparing surgeon-PC co-management with surgeon-alone management among patients pursuing curative-intent surgery for upper GI cancers. We hypothesize that perioperative PC will improve patient postsurgical quality of life. This study and design are based on >8 years of engagement and research with patients, family members, and clinicians surrounding major cancer surgery and advance care planning/PC for surgical patients.
Randomized controlled superiority trial with two study arms (surgeon-PC team co-management and surgeon-alone management) and five data collection points over six months. The principal investigator and analysts are blinded to randomization.
Four, geographically diverse, academic tertiary care hospitals. Data collection began December 20, 2018 and continues to December 2020.
Patients recruited from surgical oncology clinics who are undergoing curative-intent surgery for an upper GI cancer.
In the intervention arm, patients receive care from both their surgical team and a specialist PC team; the PC is provided before surgery, immediately after surgery, and at least monthly until three months postsurgery. Patients randomized to the usual care arm receive care from only the surgical team.
Primary outcome: patient quality of life. Secondary outcomes: patient: symptom experience, spiritual distress, prognostic awareness, health care utilization, and mortality. Caregiver: quality of life, caregiver burden, spiritual distress, and prognostic awareness. Intent-to-treat analysis will be used.
This study has been approved by the institutional review boards of all study sites and is registered on clinicaltrials.gov (NCT03611309, First received: August 2, 2018).</description><identifier>ISSN: 1096-6218</identifier><identifier>EISSN: 1557-7740</identifier><identifier>DOI: 10.1089/jpm.2019.0130</identifier><identifier>PMID: 31486730</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc., publishers</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Baltimore - epidemiology ; Boston - epidemiology ; California - epidemiology ; Digestive System Surgical Procedures - methods ; Digestive System Surgical Procedures - psychology ; Family - psychology ; Female ; Gastrointestinal Neoplasms - psychology ; Gastrointestinal Neoplasms - surgery ; Hospice and Palliative Care Nursing - methods ; Humans ; Male ; Middle Aged ; Models of Care Studies ; New Mexico - epidemiology ; Patient Satisfaction ; Perioperative Care - methods ; Perioperative Care - psychology</subject><ispartof>Journal of palliative medicine, 2019-09, Vol.22 (S1), p.44-S-57</ispartof><rights>Copyright 2019, Mary Ann Liebert, Inc., publishers 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c387t-acb3c6a78a270f663589c56e6a8208b7130c529374138d7314a6c7b97b81636f3</citedby><cites>FETCH-LOGICAL-c387t-acb3c6a78a270f663589c56e6a8208b7130c529374138d7314a6c7b97b81636f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,777,781,882,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31486730$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Aslakson, Rebecca A</creatorcontrib><creatorcontrib>Chandrashekaran, Shivani V</creatorcontrib><creatorcontrib>Rickerson, Elizabeth</creatorcontrib><creatorcontrib>Fahy, Bridget N</creatorcontrib><creatorcontrib>Johnston, Fabian M</creatorcontrib><creatorcontrib>Miller, Judith A</creatorcontrib><creatorcontrib>Conca-Cheng, Alison</creatorcontrib><creatorcontrib>Wang, Suwei</creatorcontrib><creatorcontrib>Morris, Arden M</creatorcontrib><creatorcontrib>Lorenz, Karl</creatorcontrib><creatorcontrib>Temel, Jennifer S</creatorcontrib><creatorcontrib>Smith, Thomas J</creatorcontrib><title>A Multicenter, Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (PERIOP-PC)</title><title>Journal of palliative medicine</title><addtitle>J Palliat Med</addtitle><description>Despite positive outcomes associated with specialist palliative care (PC) in diverse medical populations, little research has investigated specialist PC in surgical ones. Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers.
Our objective is to complete a multicenter, randomized controlled trial comparing surgeon-PC co-management with surgeon-alone management among patients pursuing curative-intent surgery for upper GI cancers. We hypothesize that perioperative PC will improve patient postsurgical quality of life. This study and design are based on >8 years of engagement and research with patients, family members, and clinicians surrounding major cancer surgery and advance care planning/PC for surgical patients.
Randomized controlled superiority trial with two study arms (surgeon-PC team co-management and surgeon-alone management) and five data collection points over six months. The principal investigator and analysts are blinded to randomization.
Four, geographically diverse, academic tertiary care hospitals. Data collection began December 20, 2018 and continues to December 2020.
Patients recruited from surgical oncology clinics who are undergoing curative-intent surgery for an upper GI cancer.
In the intervention arm, patients receive care from both their surgical team and a specialist PC team; the PC is provided before surgery, immediately after surgery, and at least monthly until three months postsurgery. Patients randomized to the usual care arm receive care from only the surgical team.
Primary outcome: patient quality of life. Secondary outcomes: patient: symptom experience, spiritual distress, prognostic awareness, health care utilization, and mortality. Caregiver: quality of life, caregiver burden, spiritual distress, and prognostic awareness. Intent-to-treat analysis will be used.
This study has been approved by the institutional review boards of all study sites and is registered on clinicaltrials.gov (NCT03611309, First received: August 2, 2018).</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Baltimore - epidemiology</subject><subject>Boston - epidemiology</subject><subject>California - epidemiology</subject><subject>Digestive System Surgical Procedures - methods</subject><subject>Digestive System Surgical Procedures - psychology</subject><subject>Family - psychology</subject><subject>Female</subject><subject>Gastrointestinal Neoplasms - psychology</subject><subject>Gastrointestinal Neoplasms - surgery</subject><subject>Hospice and Palliative Care Nursing - methods</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Models of Care Studies</subject><subject>New Mexico - epidemiology</subject><subject>Patient Satisfaction</subject><subject>Perioperative Care - methods</subject><subject>Perioperative Care - psychology</subject><issn>1096-6218</issn><issn>1557-7740</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVUU1v1DAQjRCIfsCRK_KxSGSx443tXJCqqIVKrRqV5Ww5zmTryomXcVJp-SX83DraUsFpnsZv3hvPy7IPjK4YVdWXh92wKiirVpRx-io7ZmUpcynX9HXCtBK5KJg6yk5ifKA0DdDybXbE2VoJyelx9uec3Mx-chbGCfAzuTNjFwb3GzpSh3HC4H2CG3TGk9CTBtCFHaCZ3COQxnjvDrA2COTHjBjmsXPjNjVGC7i0toB70gdM9Mklm0iSB9ncg0NyaQbn9-QGhhYwkrPm4u7qtsmb-tO77E1vfIT3z_U0-3l5sam_59e3367q8-vcciWn3NiWW2GkMoWkvRC8VJUtBQijCqpamY5iy6Lics246mT6uBFWtpVsFRNc9Pw0-3rQ3c3tAN1yBzRe79ANBvc6GKf_fxndvd6GRy25EIVcJ4GzZwEMv2aIkx5ctOC9GSHMUReFKhllBa0SNT9QLYYYEfoXG0b1kqZOaeolTb2kmfgf_93thf03Pv4EHcCcjQ</recordid><startdate>20190901</startdate><enddate>20190901</enddate><creator>Aslakson, Rebecca A</creator><creator>Chandrashekaran, Shivani V</creator><creator>Rickerson, Elizabeth</creator><creator>Fahy, Bridget N</creator><creator>Johnston, Fabian M</creator><creator>Miller, Judith A</creator><creator>Conca-Cheng, Alison</creator><creator>Wang, Suwei</creator><creator>Morris, Arden M</creator><creator>Lorenz, Karl</creator><creator>Temel, Jennifer S</creator><creator>Smith, Thomas J</creator><general>Mary Ann Liebert, Inc., publishers</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>7X8</scope><scope>5PM</scope></search><sort><creationdate>20190901</creationdate><title>A Multicenter, Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (PERIOP-PC)</title><author>Aslakson, Rebecca A ; Chandrashekaran, Shivani V ; Rickerson, Elizabeth ; Fahy, Bridget N ; Johnston, Fabian M ; Miller, Judith A ; Conca-Cheng, Alison ; Wang, Suwei ; Morris, Arden M ; Lorenz, Karl ; Temel, Jennifer S ; Smith, Thomas J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c387t-acb3c6a78a270f663589c56e6a8208b7130c529374138d7314a6c7b97b81636f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Baltimore - epidemiology</topic><topic>Boston - epidemiology</topic><topic>California - epidemiology</topic><topic>Digestive System Surgical Procedures - methods</topic><topic>Digestive System Surgical Procedures - psychology</topic><topic>Family - psychology</topic><topic>Female</topic><topic>Gastrointestinal Neoplasms - psychology</topic><topic>Gastrointestinal Neoplasms - surgery</topic><topic>Hospice and Palliative Care Nursing - methods</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Models of Care Studies</topic><topic>New Mexico - epidemiology</topic><topic>Patient Satisfaction</topic><topic>Perioperative Care - methods</topic><topic>Perioperative Care - psychology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Aslakson, Rebecca A</creatorcontrib><creatorcontrib>Chandrashekaran, Shivani V</creatorcontrib><creatorcontrib>Rickerson, Elizabeth</creatorcontrib><creatorcontrib>Fahy, Bridget N</creatorcontrib><creatorcontrib>Johnston, Fabian M</creatorcontrib><creatorcontrib>Miller, Judith A</creatorcontrib><creatorcontrib>Conca-Cheng, Alison</creatorcontrib><creatorcontrib>Wang, Suwei</creatorcontrib><creatorcontrib>Morris, Arden M</creatorcontrib><creatorcontrib>Lorenz, Karl</creatorcontrib><creatorcontrib>Temel, Jennifer S</creatorcontrib><creatorcontrib>Smith, Thomas J</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of palliative medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Aslakson, Rebecca A</au><au>Chandrashekaran, Shivani V</au><au>Rickerson, Elizabeth</au><au>Fahy, Bridget N</au><au>Johnston, Fabian M</au><au>Miller, Judith A</au><au>Conca-Cheng, Alison</au><au>Wang, Suwei</au><au>Morris, Arden M</au><au>Lorenz, Karl</au><au>Temel, Jennifer S</au><au>Smith, Thomas J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Multicenter, Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (PERIOP-PC)</atitle><jtitle>Journal of palliative medicine</jtitle><addtitle>J Palliat Med</addtitle><date>2019-09-01</date><risdate>2019</risdate><volume>22</volume><issue>S1</issue><spage>44</spage><epage>S-57</epage><pages>44-S-57</pages><issn>1096-6218</issn><eissn>1557-7740</eissn><abstract>Despite positive outcomes associated with specialist palliative care (PC) in diverse medical populations, little research has investigated specialist PC in surgical ones. Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers.
Our objective is to complete a multicenter, randomized controlled trial comparing surgeon-PC co-management with surgeon-alone management among patients pursuing curative-intent surgery for upper GI cancers. We hypothesize that perioperative PC will improve patient postsurgical quality of life. This study and design are based on >8 years of engagement and research with patients, family members, and clinicians surrounding major cancer surgery and advance care planning/PC for surgical patients.
Randomized controlled superiority trial with two study arms (surgeon-PC team co-management and surgeon-alone management) and five data collection points over six months. The principal investigator and analysts are blinded to randomization.
Four, geographically diverse, academic tertiary care hospitals. Data collection began December 20, 2018 and continues to December 2020.
Patients recruited from surgical oncology clinics who are undergoing curative-intent surgery for an upper GI cancer.
In the intervention arm, patients receive care from both their surgical team and a specialist PC team; the PC is provided before surgery, immediately after surgery, and at least monthly until three months postsurgery. Patients randomized to the usual care arm receive care from only the surgical team.
Primary outcome: patient quality of life. Secondary outcomes: patient: symptom experience, spiritual distress, prognostic awareness, health care utilization, and mortality. Caregiver: quality of life, caregiver burden, spiritual distress, and prognostic awareness. Intent-to-treat analysis will be used.
This study has been approved by the institutional review boards of all study sites and is registered on clinicaltrials.gov (NCT03611309, First received: August 2, 2018).</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc., publishers</pub><pmid>31486730</pmid><doi>10.1089/jpm.2019.0130</doi><tpages>14</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of palliative medicine, 2019-09, Vol.22 (S1), p.44-S-57 |
| issn | 1096-6218 1557-7740 |
| language | eng |
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| source | MEDLINE; Alma/SFX Local Collection |
| subjects | Adult Aged Aged, 80 and over Baltimore - epidemiology Boston - epidemiology California - epidemiology Digestive System Surgical Procedures - methods Digestive System Surgical Procedures - psychology Family - psychology Female Gastrointestinal Neoplasms - psychology Gastrointestinal Neoplasms - surgery Hospice and Palliative Care Nursing - methods Humans Male Middle Aged Models of Care Studies New Mexico - epidemiology Patient Satisfaction Perioperative Care - methods Perioperative Care - psychology |
| title | A Multicenter, Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (PERIOP-PC) |
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