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A Multicenter, Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (PERIOP-PC).
- Source :
- Journal of Palliative Medicine; 2019 Supplement1, Vol. 22, p44-57, 14p, 3 Diagrams, 4 Charts
- Publication Year :
- 2019
-
Abstract
- Background: 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. Objectives and Hypotheses: 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. Methods: 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. Setting: Four, geographically diverse, academic tertiary care hospitals. Data collection began December 20, 2018 and continues to December 2020. Participants: Patients recruited from surgical oncology clinics who are undergoing curative-intent surgery for an upper GI cancer. Interventions: 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. Main Outcomes and Measures: 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. Ethics and Dissemination: 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 FROM AUTHOR]
- Subjects :
- TUMOR surgery
CANCER patient psychology
MEDICAL care use
MEDICAL cooperation
PALLIATIVE treatment
PATIENTS
QUALITY of life
RESEARCH
STATISTICAL sampling
SPIRITUALITY
SURGERY
GASTROINTESTINAL tumors
EXTENDED families
PSYCHOSOCIAL factors
RANDOMIZED controlled trials
BURDEN of care
PERIOPERATIVE care
TERTIARY care
Subjects
Details
- Language :
- English
- ISSN :
- 10966218
- Volume :
- 22
- Database :
- Complementary Index
- Journal :
- Journal of Palliative Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 138463592
- Full Text :
- https://doi.org/10.1089/jpm.2019.0130