Dataset Information

Effect of Perioperative Palliative Care on Health-Related Quality of Life Among Patients Undergoing Surgery for Cancer: A Randomized Clinical Trial.

ABSTRACT:

Importance

Involvement of palliative care specialists in the care of medical oncology patients has been repeatedly observed to improve patient-reported outcomes, but there is no analogous research in surgical oncology populations.

Objective

To determine whether surgeon-palliative care team comanagement, compared with surgeon team alone management, improves patient-reported perioperative outcomes among patients pursuing curative-intent surgery for high morbidity and mortality upper gastrointestinal (GI) cancers.

Design, setting, and participants

From October 20, 2018, to March 31, 2022, a patient-randomized clinical trial was conducted with patients and clinicians nonblinded but the analysis team blinded to allocation. The trial was conducted in 5 geographically diverse academic medical centers in the US. Individuals pursuing curative-intent surgery for an upper GI cancer who had received no previous specialist palliative care were eligible. Surgeons were encouraged to offer participation to all eligible patients.

Intervention

Surgeon-palliative care comanagement patients met with palliative care either in person or via telephone before surgery, 1 week after surgery, and 1, 2, and 3 months after surgery. For patients in the surgeon-alone group, surgeons were encouraged to follow National Comprehensive Cancer Network-recommended triggers for palliative care consultation.

Main outcomes and measures

The primary outcome of the trial was patient-reported health-related quality of life at 3 months following the operation. Secondary outcomes were patient-reported mental and physical distress. Intention-to-treat analysis was performed.

Results

In total, 359 patients (175 [48.7%] men; mean [SD] age, 64.6 [10.7] years) were randomized to surgeon-alone (n = 177) or surgeon-palliative care comanagement (n = 182), with most patients (206 [57.4%]) undergoing pancreatic cancer surgery. No adverse events were associated with the intervention, and 11% of patients in the surgeon-alone and 90% in the surgeon-palliative care comanagement groups received palliative care consultation. There was no significant difference between study arms in outcomes at 3 months following the operation in patient-reported health-related quality of life (mean [SD], 138.54 [28.28] vs 136.90 [28.96]; P = .62), mental health (mean [SD], -0.07 [0.87] vs -0.07 [0.84]; P = .98), or overall number of deaths (6 [3.7%] vs 7 [4.1%]; P > .99).

Conclusions and relevance

To date, this is the first multisite randomized clinical trial to evaluate perioperative palliative care and the earliest integration of palliative care into cancer care. Unlike in medical oncology practice, the data from this trial do not suggest palliative care-associated improvements in patient-reported outcomes among patients pursuing curative-intent surgeries for upper GI cancers.

Trial registration

ClinicalTrials.gov Identifier: NCT03611309.

SUBMITTER: Aslakson RA

PROVIDER: S-EPMC10233417 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

Effect of Perioperative Palliative Care on Health-Related Quality of Life Among Patients Undergoing Surgery for Cancer: A Randomized Clinical Trial.

Aslakson Rebecca A RA Rickerson Elizabeth E Fahy Bridget B Waterman Brittany B Siden Rachel R Colborn Kathryn K Smith Shelby S Verano Mae M Lira Isaac I Hollahan Caroline C Siddiqi Amn A Johnson Kemba K Chandrashekaran Shivani S Harris Elizabeth E Nudotor Richard R Baker Joshua J Heidari Shireen N SN Poultsides George G Conca-Cheng Alison M AM Cook Chapman Allyson A Lessios Anna Sophia AS Holdsworth Laura M LM Gustin Jillian J Ejaz Aslam A Pawlik Timothy T Miller Judi J Morris Arden M AM Tulsky James A JA Lorenz Karl K Temel Jennifer S JS Smith Thomas J TJ Johnston Fabian F

JAMA network open 20230501 5

<h4>Importance</h4>Involvement of palliative care specialists in the care of medical oncology patients has been repeatedly observed to improve patient-reported outcomes, but there is no analogous research in surgical oncology populations.<h4>Objective</h4>To determine whether surgeon-palliative care team comanagement, compared with surgeon team alone management, improves patient-reported perioperative outcomes among patients pursuing curative-intent surgery for high morbidity and mortality upper ...[more]

PMID: 37256623

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Project description:ImportanceDuring hospitalization for hematopoietic stem cell transplantation (HCT), patients receive high-dose chemotherapy before transplantation and experience significant physical and psychological symptoms and poor quality of life (QOL).ObjectiveTo assess the effect of inpatient palliative care on patient- and caregiver-reported outcomes during hospitalization for HCT and 3 months after transplantation.Design, setting, and participantsNonblinded randomized clinical trial among 160 adults with hematologic malignancies undergoing autologous/allogeneic HCT and their caregivers (n = 94). The study was conducted from August 2014 to January 2016 in a Boston hospital; follow-up was completed in May 2016.InterventionsPatients assigned to the intervention (n=81) were seen by palliative care clinicians at least twice a week during HCT hospitalization; the palliative intervention was focused on management of physical and psychological symptoms. Patients assigned to standard transplant care (n=79) could be seen by palliative care clinicians on request.Main outcomes and measuresPrimary: change in patient QOL from baseline to week 2; secondary: patient-assessed mood, fatigue, and symptom burden scores at baseline, 2 weeks, and 3 months after HCT and caregiver-assessed QOL and mood at baseline and 2 weeks after HCT.ResultsAmong 160 enrolled patients (mean age, 60 [SD, 13.3] years; 91 women [56.9%]; median hospital stay, 21 days) and 94 caregivers, 157 (98.1%) and 89 (94.7%), respectively, completed 2-week follow-up, and 149 patients (93.1%) completed 3-month follow-up. Patients in the intervention group reported a smaller decrease in QOL from baseline to week 2 (mean baseline score, 110.26; week 2 score, 95.46; mean change, -14.72) compared with patients in the control group (mean baseline score, 106.83; week 2 score, 85.42; mean change, -21.54; difference between groups, -6.82; 95% CI, -13.48 to -0.16; P = .045). Among the secondary outcomes, from baseline to week 2, patients in the intervention group vs those in the control group had less increase in depression (mean, 2.43 vs 3.94; mean difference, 1.52; 95% CI, 0.23-2.81; P = .02), lower anxiety (mean, -0.80 vs 1.12; mean difference, 1.92; 95% CI, 0.83-3.01; P < .001), no difference in fatigue (mean, -10.30 vs -13.65; mean difference, -3.34; 95% CI, -7.25 to 0.56; P = .09), and less increase in symptom burden (mean, 17.35 vs 23.14; mean difference, 5.80; 95% CI, 0.49-11.10; P = .03). At 3 months after HCT, intervention patients vs control patients had higher QOL scores (mean, 112.00 vs 106.66; mean difference, 5.34; 95% CI, 0.04-10.65; P = .048) and less depression symptoms (mean, 3.49 vs 5.19; mean difference, -1.70; 95% CI, -2.75 to -0.65; P = .002) but no significant differences in anxiety, fatigue, or symptom burden. From baseline to week 2 after HCT, caregivers of patients in the intervention group vs caregivers of patients in the control group reported no significant differences in QOL or anxiety but had a smaller increase in depression (mean, 0.25 vs 1.80; mean difference, 1.55; 95% CI, 0.14-2.96; P = .03).Conclusions and relevanceAmong adults at a single institution undergoing HCT for hematologic malignancy, the use of inpatient palliative care compared with standard transplant care resulted in a smaller decrease in QOL 2 weeks after transplantation. Further research is needed for replication and to assess longer-term outcomes and cost implications.Trial registrationclinicaltrials.gov Identifier: NCT02207322.

Project description: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).

Project description:Importance:Day surgery puts demands on the patients to manage their own recovery at home according to given instructions. Low health literacy levels are shown to be associated with poorer health outcomes. Objective:To describe functional health literacy levels among patients in Sweden undergoing day surgery and to describe the association between functional health literacy (FHL) and health care contacts, quality of recovery (SwQoR), and health-related quality of life. Design, Setting, and Participants:This observational study was part of a secondary analysis of a randomized clinical trial of patients undergoing day surgery and was performed in multiple centers from October 2015 to July 2016 and included 704 patients. Main Outcomes and Measures:The primary end point was SwQoR in the FHL groups 14 days after surgery. Secondary end points were health care contacts, EuroQol-visual analog scales, and the Short Form (36) Health Survey in the FHL groups. Results:Of 704 patients (418 [59.4%] women; mean [SD] age with inadequate or problematic FHL levels, 47 [16] years and 49 [15.1], respectively), 427 (60.7%) reported sufficient FHL, 223 (31.7%) problematic FHL, and 54 (7.7%) inadequate FHL. The global score of SwQoR indicated poor recovery in both inadequate (37.4) and problematic (22.9) FHL. There was a statistically significant difference in the global score of SwQoR (SD) between inadequate (37.4 [34.7]) and sufficient FHL (17.7 [21.0]) (P < .001). The patients with inadequate or problematic FHL had a lower health-related quality of life than the patients with sufficient FHL in terms of EuroQol-visual analog scale scores (mean [SD], 73 [19.1], 73 [19.1], and 78 [17.4], respectively; P = .008), physical function (mean [SD], 72 [22.7], 75 [23.8], and 81 [21.9], respectively; P < .001), bodily pain (mean [SD], 51 [28.7], 53 [27.4], and 61 [27.0], respectively; P = .001), vitality (mean [SD], 50 [26.7], 56 [23.5], and 62 [25.4], respectively; P < .001), social functioning (mean [SD], 73 [28.2], 81 [21.8], and 84 [23.3], respectively; P = .004), mental health (mean [SD], 65 [25.4], 73 [21.2], and 77 [21.2], respectively; P < .001), and physical component summary (mean [SD], 41 [11.2], 42 [11.3], and 45 [10.1], respectively; P = .004). There were no differences between the FHL groups regarding health care contacts. Conclusions and Relevance:Inadequate FHL in patients undergoing day surgery was associated with poorer postoperative recovery and a lower health-related quality of life. Health literacy is a relevant factor to consider for optimizing the postoperative recovery in patients undergoing day surgery. Trial Registration:ClinicalTrials.gov Identifier: NCT02492191.

Project description:ImportancePalliative care has the potential to improve care for patients and families undergoing high-risk surgery.ObjectiveTo characterize the use of perioperative palliative care and its association with family-reported end-of-life experiences of patients who died within 90 days of a high-risk surgical operation.Design, setting, and participantsThis secondary analysis of administrative data from a retrospective cross-sectional patient cohort was conducted in the Department of Veterans Affairs (VA) Healthcare System. Patients who underwent any of 227 high-risk operations between January 1, 2012, and December 31, 2015, were included.ExposuresPalliative-care consultation within 30 days before or 90 days after surgery.Main outcomes and measuresThe outcomes were family-reported ratings of overall care, communication, and support in the patient's last month of life. The VA surveyed all families of inpatient decedents using the Bereaved Family Survey, a valid and reliable tool that measures patient and family-centered end-of-life outcomes.ResultsA total of 95 204 patients underwent high-risk operations in 129 inpatient VA Medical Centers. Most patients were 65 years or older (69 278 [72.8%]), and the most common procedures were cardiothoracic (31 157 [32.7%]) or vascular (23 517 [24.7%]). The 90-day mortality rate was 6.0% (5740 patients) and varied by surgical subspecialty (ranging from 278 of 7226 [3.8%] in urologic surgery to 875 of 6223 patients [14.1%] in neurosurgery). A multivariate mixed model revealed that families of decedents who received palliative care were 47% more likely to rate overall care in the last month of life as excellent than those who did not (odds ratio [OR], 1.47 [95% CI, 1.14-1.88]; P = .007), after adjusting for patient's characteristics, surgical subspecialty of the high-risk operation, and survey nonresponse. Similarly, families of decedents who received palliative care were more likely to rate end-of-life communication (OR, 1.43 [95% CI, 1.09-1.87]; P = .004) and support (OR, 1.31 [95% CI, 1.01-1.71]; P = .05) components of medical care as excellent. Of the entire cohort, 3374 patients (3.75%) had a palliative care consultation, and 770 patients (0.8%) received it before surgery. Of all decedents, 1632 (29.9%) had a palliative care consultation, with 319 (5.6%) receiving it before surgery.Conclusions and relevanceReceipt of a palliative consultation was associated with better ratings of overall end-of-life care, communication, and support, as reported by families of patients who died within 90 days of high-risk surgery. Yet only one-third of decedents was exposed to palliative care. Expanding integration of perioperative palliative care may benefit patients undergoing high-risk operations and their families.

Project description:ImportancePatient education and engagement is a pivotal component of surgical recovery. Ensuring proper patient education involves a thorough understanding of one's diagnosis and recovery plan, while reducing language and learning barriers to help patients make informed decisions and improve their hospital experience.ObjectiveTo assess whether using an animated surgical guide will help patients who are undergoing head and neck surgery feel more satisfied with their surgery and recovery process.Design, setting, and participantsA randomized clinical trial was conducted between January and August 2020 at a single tertiary care academic center in Montreal, Canada. A consecutive sample of individuals who were undergoing any of the following surgical procedures was recruited: head and neck cancer resection with or without reconstruction, parotidectomy, thyroidectomy, parathyroidectomy, laryngectomy, or transoral robotic resection. The treating team was masked to group allocation, while study participants in the nonintervention group were unaware of the multimedia platform to avoid introducing bias in their survey responses.InterventionsPatients were randomly allocated to either the treatment arm, in which they obtained access to a multimedia patient education platform, or the control arm, in which they received traditional patient education methods via clinical visits.Main outcomes and measuresPrimary analysis compared patient satisfaction scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire INFO 25, a validated questionnaire on the perceived quality of information received by patients with cancer (possible scores ranging from 20 to 80).ResultsA total of 100 patients (50 in each arm; 63 women [63%]; 6 African American [6%, 12 Hispanic/Latino [12%], 11 Middle Eastern [11%], and 78 White [78%] individuals) completed the preintervention and postintervention questionnaires. In those who received access to the patient education platform, there was an 11.3-point (Cohen d = 1.02; control group score, 61.1 of 80; treatment group score, 72.4 of 80) difference of greater postoperative satisfaction scores at 1 month. While both groups felt that they received an adequate amount of information concerning their disease process, patients in the treatment arm had significantly better satisfaction with information concerning their medical tests, treatments, and other services.Conclusions and relevanceThis randomized clinical trial of patients undergoing head and neck cancer treatment demonstrates that multimedia patient education platforms may enhance current traditional methods, providing complementary information on patients' treatment plans and recovery process, mental health, family life, and supplementary services. Further research is currently underway to confirm whether this platform will lead to decreased hospital stay, shorter complication rates, and long-term effects.Trial registrationClinicalTrials.gov Identifier: NCT04048538.

Project description:ImportanceBoth augmented reality (AR) and virtual reality (VR) have had increasing applications in medicine, including medical training, psychology, physical medicine, rehabilitation, and surgical specialties, such as neurosurgery and orthopedic surgery. There are little data on AR's effect on patients' anxiety and experiences.ObjectiveTo determine whether the use of an AR walkthrough effects patient perioperative anxiety.Design, setting, and participantsThis randomized clinical trial was conducted at an outpatient surgery center in 2021 to 2022. All patients undergoing elective orthopedic surgery with the senior author were randomized to the treatment or control group. Analyses were conducted per protocol. Data analysis was performed in November 2022.InterventionAR experience explaining to patients what to expect on their day of surgery and walking them through the surgery space. The control group received the standard educational packet.Main outcomes and measuresThe main outcome was change in State-Trait Anxiety Inventory (STAI) from the screening survey to the preoperative survey.ResultsA total of 140 patients were eligible, and 45 patients either declined or were excluded. Therefore, 95 patients (63 [66.3%] male; mean [SD] age, 38 [16] years) were recruited for the study and included in the final analysis; 46 patients received the AR intervention, and 49 patients received standard instructions. The AR group experienced a decrease in anxiety from the screening to preoperative survey (mean score change, -2.4 [95% CI, -4.6 to -0.3]), while the standard care group experienced an increase (mean score change, 2.6 [95% CI, 0.2 to 4.9]; P = .01). All patients postoperatively experienced a mean decrease in anxiety score compared with both the screening survey (mean change: AR, -5.4 [95% CI, -7.9 to -2.9]; standard care, -6.9 [95% CI, -11.5 to -2.2]; P = .32) and preoperative survey (mean change: AR, -8.0 [95% CI, -10.3 to -5.7]; standard care, -4.2 [95% CI, -8.6 to 0.2]; P = .19). Of 42 patients in the AR group who completed the postoperative follow-up survey, 30 (71.4%) agreed or strongly agreed that they enjoyed the experience, 29 (69.0%) agreed or strongly agreed that they would recommend the experience, and 28 (66.7%) agreed or strongly agreed that they would use the experience again. No differences were observed in postoperative pain levels or narcotic use.Conclusions and relevanceIn this randomized clinical trial, the use of AR decreased preoperative anxiety compared with traditional perioperative education and handouts, but there was no significant effect on postoperative anxiety, pain levels, or narcotic use. These findings suggest that AR may serve as an effective means of decreasing preoperative patient anxiety.Trial registrationClinicalTrials.gov Identifier: NCT04727697.

Dataset Information

Effect of Perioperative Palliative Care on Health-Related Quality of Life Among Patients Undergoing Surgery for Cancer: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Intervention

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Effect of Perioperative Palliative Care on Health-Related Quality of Life Among Patients Undergoing Surgery for Cancer: A Randomized Clinical Trial.

Similar Datasets

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