A randomized trial of a palliative care intervention for patients on phase I studies.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12001-12001
Author(s):  
Thomas J. Smith ◽  
Vincent Chung ◽  
Mark T. Hughes ◽  
Marianna Koczywas ◽  
Nilofer Saba Azad ◽  
...  
Keyword(s):  
Palliative Care ◽  
Supportive Care ◽  
Phase I ◽  
Usual Care ◽  
Randomized Trial ◽  
Phase 1 ◽  
Quality Care ◽  
Care Plan ◽  
Phase I Clinical Trials ◽  
Care Intervention

12001 Background: The purpose of this study was to test a Palliative Care Intervention for patients with solid tumors enrolled in phase I therapeutic trials. Methods: This randomized trial compared patients accrued to phase I Clinical Trials in groups of Usual Care compared to a Palliative Care Intervention (PCI) in two comprehensive cancer centers. The PCI included assessment of quality of life (QOL) and symptoms, an interdisciplinary meeting to discuss the care plan, including goals of care, and two nurse-delivered teaching sessions. Subjects (n=479) were followed for 24 weeks, with 12 weeks as the primary outcome point. Results: Outcomes revealed that relative to Usual Care, PCI subjects showed less Psychological Distress (1.9 in Intervention and 1.2 in Control pts, p=0.03) and a trend toward improved QOL (3.7 versus 1.6, p=0.07), with differences between sites. We observed high rates of symptom-management admissions (41.3%) and low rates of Advance Directive completion (39%), and use of supportive care services including hospice (30.7%, for only1.2 months duration), despite a median survival for all patients in both groups of 10.1 months from initiating a phase 1 study until death. Patient satisfaction with oncology care was already high at baseline, and we did not see clinically significant changes in those scores by week 12. Conclusions: Palliative care interventions can improve QOL outcomes and distress for patients participating in phase 1 trials. Greater integration of PC is needed to provide quality care to these patients and to support transitions from treatment to supportive care, especially at the end of life. Clinical trial information: NCT01828775 .

Feasibility of a Palliative Care Intervention for Cancer Patients in Phase I Clinical Trials

2014 ◽  
Vol 17 (12) ◽  
pp. 1365-1368 ◽  
Author(s):  
Virginia Sun ◽  
Liz Cooke ◽  
Vincent Chung ◽  
Gwen Uman ◽  
Thomas J. Smith ◽  
...  
Keyword(s):  
Palliative Care ◽  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Clinical Trials ◽  
Care Intervention

Integration of supportive care in immuno-oncology trials: Investigating the incidence and severity of immune-related toxicities among older adults versus mid-age patients on immunotherapy-based phase I clinical trials.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 152-152
Author(s):  
Ishwaria Mohan Subbiah ◽  
Kenneth R. Hess ◽  
Takeo Fujii ◽  
Anna Lui ◽  
Vivek Subbiah ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trials ◽  
Adverse Events ◽  
Supportive Care ◽  
Phase I ◽  
Phase 1 ◽  
Low Grade ◽  
Phase I Trials ◽  
High Grade ◽  
Phase I Clinical Trials

152 Background: Older adults (65y+) with cancer are underrepresented in trials of novel drugs notably in phase I clinical trials with immunotherapies. The trepidation over immune-related toxicities in the context of older age and associated comorbidities may function as a barrier to participation. To that end, we investigated the enrollment and incidence of immune related adverse events of older adults enrolled in phase 1 immunotherapy trials. Methods: We identified 422 consecutive pts w advanced cancer treated on immunotherapy-based phase I trials bw 04/2009-09/2015, and collected pt/disease characteristics and immune-related adverse events (irAE) such as endocrinopathies, diarrhea/colitis, pneumonitis, constitutional (fatigue, fever, anorexia), myalgia, and dermatitis. Results: Older adults comprised 27% of trial participants (116 of 422 pts, median age 70y) while 256 pts were mid age (61%, median 56y). Most common cancers were GI (n = 108, 26%), thoracic/head/neck (n = 84, 20%), GU (n = 54, 13%), and GYN (n = 47, 11%). Median PFS was comparable among older pts (2.4m) and mid age (2.1m). Older adults had a higher incidence of irAE than mid age (low grade [G1/2] 49% vs 34%, p 0.02; high grade [G3/4] 19% vs 11%. p 0.14). The odds ratio of high grade events among older adults vs mid age pts was 1.81 (95% CI 1.01, 3.24; p 0.05) and low grade events was 1.85 (95% CI 1.20, 2.85; p 0.0055). Most common G1/2 irAE among all patients was fatigue (n = 76, 18%), dermatitis (n = 59, 14%), fever (n = 29, 7%) and anorexia (n = 28, 7%) with older adults having a greater incidence of low grade fatigue (25% vs 15%, OR 1.84, 95% CI 1.09, 3.10, p 0.025). Conclusions: Older adult participation remained under 30% for immunotherapy-based phase I trials. This early analysis suggests a higher incidence of toxicities among older adults, which calls for the urgent integration of comprehensive supportive care strategy to guide seniors through therapy. This work lays the foundation for future studies investigating the early involvement of supportive care through treatment on early phase clinical trials with immunotherapeutic agents.

A randomized, controlled trial of structured palliative care versus standard supportive care for patients enrolled on phase I clinical trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 3634-3634
Author(s):  
Michelle Elizabeth Treasure ◽  
Barbara J. Daly ◽  
PingFu Fu ◽  
Shufen Cao ◽  
Neal J. Meropol ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Palliative Care ◽  
Clinical Trials ◽  
Supportive Care ◽  
Usual Care ◽  
Phase 1 ◽  
Symptom Burden ◽  
Care Services

3634 Background: Phase 1 clinical trials are the first step in developing new cancer therapeutics. Patients enrolled in these studies have typically exhausted standard therapies and are at a point in their disease trajectory where they often are choosing between a phase 1 clinical trial and hospice care. These patients may have significant symptom burden, which can result in early trial discontinuation and confound phase 1 trial outcomes, including toxicity profiles, which may influence further drug development. This study aimed to determine the palliative care needs of patients enrolled on phase 1 clinical trials and their caregivers (CGs), along with differences in study duration, adverse event (AE) and symptom profiles, and quality of life (QOL) between those receiving structured palliative care vs usual supportive care. Methods: 68 patients enrolled on phase 1 clinical trials were randomly assigned to receive structured palliative care or usual supportive care. 39 of their CGs were enrolled and assigned to the same arm as the patient. Quality of life metrics were obtained monthly: the Functional Assessment of Cancer Therapy-General and Memorial Symptom Assessment Scale -Short Form for patients, and The Quality of Life in Life Threatening Illness - Family Carer Version and Caregiver Reaction Assessment for CGs. Palliative care resources utilized were assessed for those in the palliative care arm, and referrals to supportive care services assessed in those in the usual care arm. AEs recorded on the Phase 1 trials were evaluated & compared between arms. Results: Mean duration on phase 1 study was 132 days in the palliative care arm vs 114 days in the usual care arm (p = 0.55). Total weighted AE rate (# of AE [x] AE grade per month) was 26.9 in the palliative care arm vs 34.0 in the usual care arm (p = 0.53). Patients in the palliative care arm experienced better QOL and lower symptom burden, as did their CGs, compared to those in the usual care arm. While the differences in outcomes were not statistically significant, all results favored structured palliative care. Conclusions: Phase 1 patients and their CGs have physical and psychosocial needs which warrant palliative care services. Preliminary results suggest structured palliative care is associated with increased duration on study (by nearly 3 weeks), improved patient and CG QOL, and reduced patient symptom and CG burden. A larger study is warranted to confirm these results and further develop the ideal palliative care intervention in these populations. Clinical trial information: NCT02543541 .

scholarly journals Pilot Randomized Trial of a Transdisciplinary Geriatric and Palliative Care Intervention for Older Adults With Cancer

2020 ◽  
Vol 18 (5) ◽  
pp. 591-598
Author(s):  
Ryan D. Nipp ◽  
Brandon Temel ◽  
Charn-Xin Fuh ◽  
Paul Kay ◽  
Sophia Landay ◽  
...  
Keyword(s):  
Older Adults ◽  
Palliative Care ◽  
Usual Care ◽  
Pilot Trial ◽  
Symptom Burden ◽  
Medium Effect ◽  
Care Needs ◽  
Care Intervention ◽  
Cancer Types

Background: Oncologists often struggle with managing the unique care needs of older adults with cancer. This study sought to determine the feasibility of delivering a transdisciplinary intervention targeting the geriatric-specific (physical function and comorbidity) and palliative care (symptoms and prognostic understanding) needs of older adults with advanced cancer. Methods: Patients aged ≥65 years with incurable gastrointestinal or lung cancer were randomly assigned to a transdisciplinary intervention or usual care. Those in the intervention arm received 2 visits with a geriatrician, who addressed patients’ palliative care needs and conducted a geriatric assessment. We predefined the intervention as feasible if >70% of eligible patients enrolled in the study and >75% of eligible patients completed study visits and surveys. At baseline and week 12, we assessed patients’ quality of life (QoL), symptoms, and communication confidence. We calculated mean change scores in outcomes and estimated intervention effect sizes (ES; Cohen’s d) for changes from baseline to week 12, with 0.2 indicating a small effect, 0.5 a medium effect, and 0.8 a large effect. Results: From February 2017 through June 2018, we randomized 62 patients (55.9% enrollment rate [most common reason for refusal was feeling too ill]; median age, 72.3 years; cancer types: 56.5% gastrointestinal, 43.5% lung). Among intervention patients, 82.1% attended the first visit and 79.6% attended both. Overall, 89.7% completed all study surveys. Compared with usual care, intervention patients had less QoL decrement (–0.77 vs –3.84; ES = 0.21), reduced number of moderate/severe symptoms (–0.69 vs +1.04; ES = 0.58), and improved communication confidence (+1.06 vs –0.80; ES = 0.38). Conclusions: In this pilot trial, enrollment exceeded 55%, and >75% of enrollees completed all study visits and surveys. The transdisciplinary intervention targeting older patients’ unique care needs showed encouraging ES estimates for enhancing patients’ QoL, symptom burden, and communication confidence.

Characteristics and outcomes of patients with gallbladder cancer and cholangiocarcinoma referred to a phase I clinic.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 364-364 ◽  
Author(s):  
Ishwaria Mohan Subbiah ◽  
Vivek Subbiah ◽  
Ahmed Omar Kaseb ◽  
Filip Janku ◽  
Jennifer J. Wheler ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Phase I ◽  
Median Time ◽  
Median Survival ◽  
Phase I Trial ◽  
Mutational Analysis ◽  
Phase 1 ◽  
Cancer Center ◽  
Phase I Clinical Trials

364 Background: The prognosis of cholangiocarcinoma (CC) and gallbladder carcinoma (GC) remains grim. The purpose of this study was to report the presenting characteristics and outcomes of patients with CC and GC treated on phase 1 clinical trials focused on targeted agents at a major cancer center. Methods: We reviewed the records of consecutive patients with GC and CC in the Phase I Clinical Trials Program at the M. D. Anderson Cancer Center from Nov 2004. We assessed the relationship between overall survival, patients' tumor types, and mutations, demographic and clinical characteristics. Results: Fifty-two patients were identified (7 with GC, 45 with CC). The median age was 58 yrs (range, 20-75 yrs). ECOG performance status (PS) was 0, 1, 2, and 3 in 9 (17%), 30 (58%), 7 (13%), and 6 (12%) pts, respectively. Median number of prior therapies was 3 (range 0-17). The median time from diagnosis of metastatic disease to primary Phase I clinic evaluation was 14.6 months. Of 52 patients, 17 (33%) were not enrolled on a Phase I trial due to decline in PS (n=13) or decision to pursue other treatments (n=4). Of 35 patients evaluable for response, 2 (6%) had a partial response (PR), and 3 (9%) had stable disease > 4 months. Prognostic factors analyzed include Hg < 10.5 g/dL, elevated CA 19-9 (>47 ng/mL), ECOG PS > 3, LDH > 618 IU/L, albumin < 3.5 g/dL, platelets < 150 K/UL, and number of metastatic sites. Full analysis including the mutational analysis for PIK3CA, KRAS, BRAF, TP53 is in progress. Median survival since presentation to the Phase I clinic was 4.1 months (range 2.3 - 30.8 months). Median overall survival from diagnosis was 23.9 months. The median survival since enrollment in a Phase I trial was 4.6 months w the median time to disease progression on Phase I treatment was 2.2 months (range 0.6 - 25.6 months). Conclusions: Prognosis of pts with CC and GC referred for phase I studies remains poor. Further analysis including complete mutational profiles of CC and GC patients will be reported.

Interdisciplinary palliative care for patients with lung cancer.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 130-130
Author(s):  
Betty R. Ferrell ◽  
Virginia Sun ◽  
Arti Hurria ◽  
Mihaela C. Cristea ◽  
Dan Raz ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Palliative Care ◽  
Psychological Distress ◽  
Supportive Care ◽  
Usual Care ◽  
Usual Care Group ◽  
Intervention Group ◽  
Well Being ◽  
Care Group ◽  
Ambulatory Care Setting

130 Background: Palliative care, including symptom management and attention to quality of life (QOL) concerns, should be addressed throughout the trajectory of a serious illness such as lung cancer. This study tested the effectiveness on an interdisciplinary palliative care intervention for patients with stage I-IV non-small cell lung cancer (NSCLC). Methods: Patients undergoing treatments for NSCLC were enrolled in a prospective, quasi-experimental study whereby the usual care group was accrued first followed by the intervention group. Patients in the intervention group were presented at interdisciplinary care meetings and appropriate supportive care referrals were made. They also received four educational sessions. In both groups, QOL, symptoms, and psychological distress were assessed at baseline and 12 weeks using surveys which included the FACT-L, FACIT-Sp-12, LCS, and the Distress Thermometer. Results: A total of 491 patients were included in the primary analysis. Patients who received the intervention had significantly better scores for QOL (109.1 vs. 101.4; p < .001), symptoms (25.8 vs. 23.9; p < .001), spiritual well-being (38.1 vs. 36.2; p < .001), and lower psychological distress (2.2 vs. 3.3; p < .001) at 12 weeks, after controlling for baseline scores, compared to patients in the usual care group. Patients in the intervention group also had significantly higher numbers of completed advance care directives (44% vs. 9%; p < .001), and overall supportive care referrals (61% vs. 28%; p < .001). Conclusions: Interdisciplinary palliative care in the ambulatory care setting resulted in significant improvements in QOL, symptoms, and distress for NSCLC patients.

Integration of specialty palliative care in a phase I ovarian cancer population.

2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 75-75
Author(s):  
Marisa R Moroney ◽  
Breana Hill ◽  
Jeanelle Sheeder ◽  
Jennifer Robinson Diamond ◽  
Melony Avella-Howell ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Palliative Care ◽  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Disease Stage ◽  
Phase I Clinical Trials ◽  
Care Services ◽  
Palliative Care Services

75 Background: ASCO guidelines recommend patients with advanced cancer receive early integrated specialty palliative care based on evidence of multiple clinical benefits. To our knowledge, there is no literature evaluating utilization of specialty palliative care in Phase I clinical trial patients, but there is limited data demonstrating underutilization of palliative care services in patients with life-threatening diseases including advanced cancer. Methods: A retrospective review of ovarian cancer patients enrolled in Phase I clinical trials at one institution from 2008 to 2018. Charts were reviewed for patient and disease characteristics including age, disease stage, number of chemotherapy regimens and date of death. Charts were also reviewed to determine if and when patients received specialty palliative care services. Results: A total of 121 patients with ovarian cancer were enrolled in Phase I clinical trials. Median age at time of Phase I enrollment was 59 years (range 33-88). 87% of patients had advanced stage disease: 60% Stage III and 27% Stage IV. Median number of chemotherapy regimens received prior to Phase I enrollment was 5 (range 1-13). Median survival was 311 days (95%CI 225.9-396.1). Of the 121 patients, 4 (3.3%) received specialty palliative care prior to Phase I enrollment, 7 (5.8%) within 30 days after enrollment, and 53 (43.8%) more than 30 days after enrollment. 57 patients (47.1%) never received specialty palliative care. Conclusions: Ovarian cancer patients enrolled in Phase I clinical trials have advanced cancer – defined by ASCO as disease that is late-stage and life limiting with a prognosis less than 24 months – and should therefore receive early integrated specialty palliative care. This study demonstrates that a significant portion of Phase I ovarian cancer patients are either receiving no or late integration of specialty palliative care. Further work needs to focus on increasing early integration of specialty palliative care in this population.

Palliative Care in Nephrology

2020 ◽  
Keyword(s):  
Palliative Care ◽  
Kidney Disease ◽  
Supportive Care ◽  
Nurse Practitioners ◽  
Quality Care ◽  
Physician Assistants ◽  
Care Needs ◽  
Patient Centered ◽  
Medical Practitioners ◽  
Seriously Ill Patients

Palliative care has become increasingly important across the spectrum of healthcare, and with it, the need for education and training of a broad range of medical practitioners not previously associated with this field of care. As part of the Integrating Palliative Care series, this volume on palliative care in nephrology guides readers through the core palliative knowledge and skills needed to deliver high value, high quality care for seriously ill patients with chronic and end-stage kidney disease. Chapters are written by a team of international leaders in kidney palliative care and are organized into sections exploring unmet supportive care needs, palliative care capacity, patient-centered care, enhanced support at the end of life, and more. Chapter topics are based on the Coalition for Supportive Care of Kidney Patients Pathways Project change package of 14 evidence-based best practices to improve the delivery of palliative care to patients with kidney disease. An overview of the future of palliative care nephrology with attention to needed policy changes rounds out the text. Palliative Care in Nephrology is an ideal resource for nephrologists, nurses, nurse practitioners, physician assistants, social workers, primary care clinicians, and other practitioners who wish to learn more about integrating individualized, patient-centered palliative care into treatment of their patients with kidney disease.

Supportive care day hospital: A new tool for palliative care in cancer centers.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 170-170
Author(s):  
Carole Bouleuc
Keyword(s):  
Palliative Care ◽  
Home Care ◽  
Supportive Care ◽  
Palliative Care Team ◽  
Care Team ◽  
Care Plan ◽  
Day Hospital ◽  
Cancer Centers ◽  
Advance Care ◽  
At Home

170 Background: In May 2005, the Curie Institute in Paris opened the first supportive care day hospital in France. This type of new ward is now very frequent in the French comprehensive cancer centers. Methods: Patients are managed by the palliative care team with a two-part team of a physician and a nurse in order to address their supportive care needs: advanced-care symptoms, psychosocial distress, medical questions and concerns, support need in decision making, end of life care preference and advance care plan when patients or caregivers when needed. Depending of the needs identified by the palliative care team assess, at least 2 of the following healthcare professionals will intervene: oncologist, pain physician, psycho-oncologist, dietitician, social worker, physiotherapist. Coordination with the home care team takes systematically place (with general practitioner, nurse and home palliative care team). New symptoms occurrence are explored with biological test or radiographic examination when necessary. Medical procedures are sometimes performed like venous perfusion therapy, blood transfusions, or draining effusion after ultrasonic tracking. It is possible to offer the patient hypnosis, relaxation or sophrology consultation. Eventually at the end of the in-patient stay, the patient is given a medical synthesis with therapeutic recommendations and personalized care plan. 1 Physician and two nurses are needed to manage 4 patients every day. Results: In 2016 we have admitted 350 patients and performed 948 stays in our supportive rand 55% of them have breast cancer. Median survival since the first day at supportive care day hospital is 65 days. Death at home occurred in 15% of patients and in hospice for 62%. Home death is more often when patients don’t have any dyspnea are included in a home palliative care network and when they receive the last chemotherapy more than 30 days before death. More date will be shown. Conclusions: Supportive care day hospital is really a good tool for integrated palliative care, promoting collaboration with oncologists, coordination with home care teams, and advance care planning, so that patients can longer stay at home as they often hope so.

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