Identifying early-phase clinical trial (EP-CT) participants at risk for poor outcomes.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 301-301
Author(s):  
Debra Lundquist ◽  
Rachel Jimenez ◽  
Megan Healy ◽  
Andrew Johnson ◽  
Sienna Durbin ◽  
...  
Keyword(s):  
At Risk ◽  
Palliative Care ◽  
Social Work ◽  
Supportive Care ◽  
Clinical Outcomes ◽  
Poor Prognosis ◽  
Metastatic Cancer ◽  
Care Services ◽  
Poor Outcomes ◽  
Prognosis Score

301 Background: EP-CTs investigate novel treatment options, with recent advances in personalized therapy leading to increased response rates, decreased toxicity, and improved survival. Identifying EP-CT participants at risk for poor outcomes could help identify those who may benefit most from targeted supportive care efforts. Methods: We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs from 2017-2019 to obtain baseline characteristics (demographics and clinical factors), clinical outcomes (survival, time on trial, completion of dose-limiting toxicity [DLT] period, emergency room [ER] visits, hospitalizations, and hospice use), and receipt of supportive care services before/during trial (palliative care, social work, physical therapy [PT], and nutrition). We calculated the validated Royal Marsden Hospital (RMH) prognosis score using data at the time of EP-CT enrollment based on patients’ lactate dehydrogenase, serum albumin, and number of sites of metastasis. RMH scores range from 0-3, with scores of 2+ indicating a poor prognosis. We examined differences in patient characteristics, clinical outcomes, and receipt of supportive care services based on the RMH prognosis score. Results: Among 350 patients (median age = 63.2 years [range 23.0-84.3]; 57.1% female, 98.0% metastatic cancer), the most common cancer types were lung (23.4%), gastrointestinal (20.3%), and breast (12.0%). Nearly one-third (31.7%) had an RMH score indicating a poor prognosis. Patients with a poor prognosis RMH score had a worse performance status (ECOG ≥1: 80.2% vs 58.1%, p <.001) and more prior treatment (3+ prior lines: 48.6% vs 34.7%, p =.001) than those with a better prognosis score. Those with a poor prognosis RMH score had worse survival (median: 147 vs 402 days, p <.001) and shorter time on trial (median: 49 vs 84 days, HR = 1.53, p <.001), as well as a lower likelihood of completing the DLT period (72.1% vs 80.8%, p =.015). Patients with a poor prognosis score had a higher risk for ER visits (HR 1.66; p =.037) and hospitalizations (HR 1.69; p =.016) while on trial, with earlier hospice enrollment (HR 2.22; p =.006) following the trial. Patients with a poor prognosis score were significantly more likely to receive palliative care before/during trial (46.8% vs 27.6% p =.001), but not social work (41.4% vs 41.4% p = 1.00), PT (44.1% vs 34.7%; p =.098), or nutrition (40.5% vs 37.2%; p =.557). Conclusions: EP-CT participants represent a unique population of patients with advanced cancer, and we identified a group at risk for particularly poor outcomes, including worse survival, shorter time on trial, and greater use of healthcare services. Although patients with a poor prognosis score had higher rates of palliative care use, under half received supportive care services, underscoring the need for efforts to prospectively target these patients with interventions that address their supportive care needs.

Understanding the supportive care needs of early-phase cancer clinical trial (CT) participants.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 26-26
Author(s):  
Debra Lundquist ◽  
Dejan Juric ◽  
Rachel Jimenez ◽  
Virginia Capasso ◽  
Casandra McIntyre ◽  
...  
Keyword(s):  
Supportive Care ◽  
Early Phase ◽  
Poor Prognosis ◽  
Phase 1 ◽  
Supportive Care Needs ◽  
Care Needs ◽  
Targeted Interventions ◽  
Care Services ◽  
Patient Reported ◽  
Prognosis Score

26 Background: Early phase CTs investigate novel therapeutic approaches for patients with cancer, but little is known about the use of supportive care services among participants in early phase CTs. Methods: We conducted a retrospective chart review of consecutive patients enrolled in Phase 1 CTs from 2017-2019, capturing sociodemographics, clinical data, and use of supportive care services from the electronic health record. We calculated the Royal Marsden Hospital (RMH) prognostic score using data at the time of CT trial enrollment based on patients’ lactate dehydrogenase, albumin, and number of sites of metastasis. The RMH score ranges from 0-3, with scores of 2+ indicating a poor prognosis. We explored differences in patient characteristics, supportive care use, and clinical outcomes based on the RMH prognosis score. Results: Among 426 patients treated on Phase 1 CTs during the study period, the median age was 63.0 years (range 20.5-85.2 years), and most were female (56.1%), white race (85.1%), and had metastatic cancer (97.7%). The most common cancer types were gastrointestinal (22.1%), lung (20.0%), and breast (10.6%) cancer. Under half (31.6%) had an RMH score indicating a poor prognosis. Patients with a poor prognosis score had a worse performance status (ECOG ≥1: 80.2% v 58.3%, p < .001) and more prior treatment (3+ prior lines: 49.5% v 35.0%, p = .001) compared to those without a poor prognosis score. Those with a poor prognosis score were more likely to receive palliative care before or during CT participation (40.5% v 27.1%, p = .011). We observed no significant differences in the rates of nutrition (69.1% v 64.0%), social work (62.2% v 63.8%), or physical therapy (64.5% v 61.7%) consults between those with and without a poor prognosis score. We found that those with an RMH score indicating a poor prognosis had a shorter time on trial (median: 49 vs 87 days, p < .001) and worse survival (median: 139 v 379 days, p < .001). Conclusions: Early phase CT participants represent an advanced cancer population with unique supportive care needs, and we identified a group with a particularly poor prognosis for whom earlier intervention with supportive care services may be needed. Our findings highlight the need to prospectively examine these characteristics along with patient-reported outcomes to better understand the distinct supportive care needs of this population and guide the development of targeted interventions.

American Society of Clinical Oncology Provisional Clinical Opinion: The Integration of Palliative Care Into Standard Oncology Care

2012 ◽  
Vol 30 (8) ◽  
pp. 880-887 ◽  
Author(s):  
Thomas J. Smith ◽  
Sarah Temin ◽  
Erin R. Alesi ◽  
Amy P. Abernethy ◽  
Tracy A. Balboni ◽  
...  
Keyword(s):  
Health Care ◽  
Palliative Care ◽  
End Of Life ◽  
Clinical Oncology ◽  
Metastatic Cancer ◽  
Expert Consensus ◽  
Care Services ◽  
Palliative Care Services ◽  
Oncology Care ◽  
American Society

Purpose An American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) offers timely clinical direction to ASCO's membership following publication or presentation of potentially practice-changing data from major studies. This PCO addresses the integration of palliative care services into standard oncology practice at the time a person is diagnosed with metastatic or advanced cancer. Clinical Context Palliative care is frequently misconstrued as synonymous with end-of-life care. Palliative care is focused on the relief of suffering, in all of its dimensions, throughout the course of a patient's illness. Although the use of hospice and other palliative care services at the end of life has increased, many patients are enrolled in hospice less than 3 weeks before their death, which limits the benefit they may gain from these services. By potentially improving quality of life (QOL), cost of care, and even survival in patients with metastatic cancer, palliative care has increasing relevance for the care of patients with cancer. Until recently, data from randomized controlled trials (RCTs) demonstrating the benefits of palliative care in patients with metastatic cancer who are also receiving standard oncology care have not been available. Recent Data Seven published RCTs form the basis of this PCO. Provisional Clinical Opinion Based on strong evidence from a phase III RCT, patients with metastatic non–small-cell lung cancer should be offered concurrent palliative care and standard oncologic care at initial diagnosis. While a survival benefit from early involvement of palliative care has not yet been demonstrated in other oncology settings, substantial evidence demonstrates that palliative care—when combined with standard cancer care or as the main focus of care—leads to better patient and caregiver outcomes. These include improvement in symptoms, QOL, and patient satisfaction, with reduced caregiver burden. Earlier involvement of palliative care also leads to more appropriate referral to and use of hospice, and reduced use of futile intensive care. While evidence clarifying optimal delivery of palliative care to improve patient outcomes is evolving, no trials to date have demonstrated harm to patients and caregivers, or excessive costs, from early involvement of palliative care. Therefore, it is the Panel's expert consensus that combined standard oncology care and palliative care should be considered early in the course of illness for any patient with metastatic cancer and/or high symptom burden. Strategies to optimize concurrent palliative care and standard oncology care, with evaluation of its impact on important patient and caregiver outcomes (eg, QOL, survival, health care services utilization, and costs) and on society, should be an area of intense research. NOTE. ASCO's provisional clinical opinions (PCOs) reflect expert consensus based on clinical evidence and literature available at the time they are written and are intended to assist physicians in clinical decision making and identify questions and settings for further research. Because of the rapid flow of scientific information in oncology, new evidence may have emerged since the time a PCO was submitted for publication. PCOs are not continually updated and may not reflect the most recent evidence. PCOs cannot account for individual variation among patients and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It is the responsibility of the treating physician or other health care provider, relying on independent experience and knowledge of the patient, to determine the best course of treatment for the patient. Accordingly, adherence to any PCO is voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances. ASCO PCOs describe the use of procedures and therapies in clinical trials and cannot be assumed to apply to the use of these interventions in the context of clinical practice. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of ASCO's PCOs, or for any errors or omissions.

Symptom Assessment and Early Access to Supportive and Palliative Care for Patients With Advanced Solid Tumors in Mexico

2019 ◽  
Vol 35 (1) ◽  
pp. 40-45 ◽  
Author(s):  
Mirza Jacqueline Alcalde-Castro ◽  
Enrique Soto-Perez-de-Celis ◽  
Alfredo Covarrubias-Gómez ◽  
Sofía Sánchez-Román ◽  
Paulina Quiróz-Friedman ◽  
...  
Keyword(s):  
Palliative Care ◽  
Supportive Care ◽  
Solid Tumors ◽  
Advanced Cancer ◽  
Symptom Assessment ◽  
First Year ◽  
Advanced Solid Tumors ◽  
Care Clinic ◽  
Care Services ◽  
Oncology Care

Background: Early specialized palliative care improves quality of life of patients with advanced cancer, and guidelines encourage its integration into standard oncology care. However, many patients fail to obtain timely palliative/supportive care evaluations, particularly in limited-resource settings. We aimed to determine the proportion of patients with advanced cancer who received an assessment of symptoms and were referred to supportive and palliative care services during the first year after diagnosis in a Mexican hospital. Methods: Individuals with newly diagnosed advanced solid tumors and 1 year of follow-up at the oncology clinics in the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran in Mexico City from October 2015 to April 2016 were included in this retrospective study. Results: Seventy-seven patients were included. Forty-two (54.5%) were referred to the various supportive care services during the first year after diagnosis, and 23 (29.8%) were referred to the palliative care clinic. The most commonly assessed symptoms by oncologists were pain (77.9%), anorexia (74.0%), fatigue (68.8%), and nausea (55.8%), while depression/anxiety were evaluated in 10 (12.9%) patients. The oncologist offered to clarify treatment goals in 39 (50.6%) cases and evaluated the understanding of diagnosis/illness and prognosis in 22 (28.5%). Conclusion: Palliative and supportive care services were widely underutilized, which may be related to a lack of standardized symptom assessments and poor end-of-life communication. Novel strategies are needed to improve the implementation of tools for systematic symptom assessment and to optimize the integration of supportive care interventions into oncology care in developing countries.

scholarly journals Barriers to Early Utilization of Palliative Care in Heart Failure: A Narrative Review

Healthcare ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 36
Author(s):  
Massimo Romanò
Keyword(s):  
Heart Failure ◽  
Palliative Care ◽  
Clinical Practice ◽  
Supportive Care ◽  
Poor Prognosis ◽  
Substantial Variation ◽  
Main Indication ◽  
Patients With Heart Failure ◽  
Near Future ◽  
Early Phases

Palliative care is indicated in patients with heart failure since the early phases of the disease, as suggested by international guidelines. However, patients are referred to palliative care very late. Many barriers could explain the gap between the guidelines’ indications and clinical practice. The term palliative is perceived as a stigma by doctors, patients, and family members because it is charged with negative meanings, a poor prognosis, and no hope for improvement. Many authors prefer the term supportive care, which could facilitate a discussion between doctors, patients, and caregivers. There is substantial variation and overlap in the meanings assigned to these two terms in the literature. Prognosis, as the main indication to palliative care, delays its implementation. It is necessary to modify this paradigm, moving from prognosis to patients’ needs. The lack of access to palliative care programs is often due to a lack of palliative care specialists and this shortage will be greater in the near future. In this study, a new model is proposed to integrate early over the course of the disease the palliative care (PC) specialist in the heart failure team, allowing to overcome the barriers and to achieve truly simultaneous care in the treatment of heart failure (HF) patients.

In-hospital cancer care: Are we missing an opportunity for end of life care?

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9039-9039
Author(s):  
Gabrielle Betty Rocque ◽  
Anne Elizabeth Barnett ◽  
Lisa Illig ◽  
Howard Harry Bailey ◽  
Toby Christopher Campbell ◽  
...  
Keyword(s):  
Palliative Care ◽  
Overall Survival ◽  
Hospital Admission ◽  
End Of Life ◽  
Poor Prognosis ◽  
Metastatic Cancer ◽  
Academic Medical Center ◽  
Imaging Studies ◽  
Improvement Project ◽  
Palliative Care Consultation

9039 Background: Little data exists on the estimated survival of patients with metastatic cancer after hospitalization. As part of a prospective quality improvement project, we characterized the population of patients admitted to an inpatient oncology service in an academic medical center with emphasis on the disposition at discharge and overall survival. Methods: We collected data over a 4 month period (9/1/10-12/23/10) representing 149 admissions of 119 unique patients. We measured patient characteristics, disease evaluation, procedures, consults, imaging studies performed, disposition, length of stay, and overall survival. These data were compared to a similar study conducted in our center in 2000. Results: Uncontrolled symptoms were the most common reason for admission (pain 28%, dyspnea 9%, nausea 9%). Imaging studies were more common than in 2000 (415 vs. 196 total procedures). Eighty-five percent of patients had progressive disease. Seventy percent of patients were discharged home without additional services such as home health or hospice. The overall median survival was poor in 2000 and in 2010, 100 days and 60 days from discharge, respectively. Despite an overall poor prognosis, palliative care consultation was obtained only 13 times (8% of admissions) and 18% of patients were enrolled in hospice at discharge. Conclusions: An unscheduled hospital admission portends a poor prognosis. Cancer patients in the hospital are nearing the end-of-life with a median life expectancy of approximately 3 months and could be considered hospice-eligible and appropriate for a palliative care consult. We believe that hospital admission represents a missed opportunity to provide palliative care services and end-of-life counseling to this patient population.

Reducing patient suffering and preventing readmissions via supportive care screening: The James Cancer Hospital supportive-care screening model.

2014 ◽  
Vol 32 (31_suppl) ◽  
pp. 33-33
Author(s):  
Sharla Wells-Di Gregorio ◽  
Alexandra Zaleta ◽  
Emily Porensky ◽  
Lisa Graham ◽  
Kelly McDowell ◽  
...  
Keyword(s):  
Palliative Care ◽  
Supportive Care ◽  
Phase Ii ◽  
Hospital Admissions ◽  
Physical Symptoms ◽  
Distress Screening ◽  
Care Clinic ◽  
Screening Model ◽  
Care Services ◽  
Cancer Hospital

33 Background: Hospital admissions create physical, financial and emotional stress for oncology patients. Hospital avoidable readmissions are considered a marker of poorer quality patient care. To reduce readmissions, cancer hospitals must understand modifiable readmission risk factors AND establish screening systems to triage at-risk patients to outpatient palliative/supportive care services. The James Cancer Hospital is in Phase II development of a model to reduce patient suffering and readmission via the James Supportive Care Screening (JSCS), a 48-item validated clinical-research instrument. Methods: In 2013, the James Cancer Hospital began implementation of Supportive Care Screening to meet Standard 3.2 (Psychosocial Distress Screening) of the Commission on Cancer. The JSCS asks patients to rate distress in six palliative care domains including emotional concerns, physical symptoms, social/practical problems, spiritual problems, cognitive concerns, and healthcare decision-making/communication issues. Between January 2011 and December 2013, one-thousand and one patients completed the JSCS in the Outpatient Palliative Care clinic. During this period, 57 patients had at least one readmission. Hierarchical linear regression was used to predict the number of future readmissions with JSCS subscales as independent variables. Results: The overall model predicting readmissions was significant, F(7,959) = 37.074, p<.001. Time to readmission, physical symptoms, emotional concerns, spiritual concerns, and social concerns were significant predictors of patient readmission. We are currently examining palliative care outcomes in these domains and have found that outpatient palliative care significantly reduces suffering related to physical and emotional distress. Conclusions: Supportive care screening, can serve to reduce oncology readmissions and prevent patient suffering in six key palliative domains. During Phase II of the James Supportive Care Screening Model, we have identified several problem areas targeted to reduce readmissions and improve patient self-reported outcomes.

Comparability of the Cancer Supportive Care Clinical Studies Collaborative (CSCCSC) study population to national referrals to other specialist palliative care services.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 63-63
Author(s):  
David Christopher Currow ◽  
Hiromichi Matsuoka ◽  
Samuel Allingham ◽  
Belinda Fazekas ◽  
Linda Brown ◽  
...  
Keyword(s):  
Palliative Care ◽  
Supportive Care ◽  
Clinical Studies ◽  
Symptom Control ◽  
Population Characteristics ◽  
Phase Iii ◽  
Trial Participation ◽  
Care Services ◽  
Significant Difference ◽  
Palliative Care Services

63 Background: There are no agreed national nor international criteria for referral to palliative care. Key population characteristics have been defined to aid the generalizability of research findings in palliative care clinical studies. To codify differences in key demographic factors between patients with cancer participating in the Australian national Cancer Supportive Care Clinical Studies Collaborative (CSCCSC) phase III symptom control studies and the population referred to other Australian palliative care services. Methods: This study compares two contemporaneous consecutive cohorts generated through clinical trial participation and the national palliative care clinical quality improvement registry in Australia. Age, sex, cancer diagnosis, language, and socio-economic status were compared. Results: Cohorts were people with cancer: enrolled in CSCCSC phase III clinical studies (n=902; 17 sites); and registered by the Australian national Palliative Care Outcomes Collaboration (PCOC; n=75,240; 117 sites). Participants in CSCCSC studies were younger than those of PCOC (median 71 (IQR 62, 79) versus median 73 (IQR 63, 81); p=0.003 respectively). There was no significant difference in sex (p=0.483). Patients who spoke English accounted 95.0% of enrollees in the CSCCSC group and 92.2% in the PCOC group (p = 0.004). Clinical study participants had higher socioeconomic status that the PCOC group (p=0.022). Conclusions: Overall, the slightly different demographic patterns are reflective of the differences often seen between phase III trials and the populations to whom the results will be applied. Age differences particularly need to be taken into account when considering the best way to apply each study’s findings.

Using a supportive care framework to understand and improve palliative care among cancer patients in Africa

2015 ◽  
Vol 14 (3) ◽  
pp. 284-301 ◽  
Author(s):  
David S. Busolo ◽  
Roberta L. Woodgate
Keyword(s):  
Palliative Care ◽  
Supportive Care ◽  
Cancer Patients ◽  
Care Needs ◽  
African Countries ◽  
Research Education ◽  
Patients With Cancer ◽  
Care Services ◽  
Incidence And Mortality ◽  
Palliative Care Services

ABSTRACTObjective:Cancer incidence and mortality are increasing in Africa, which is leading to greater demands for palliative care. There has been little progress in terms of research, pain management, and policies related to palliative care. Palliative care in Africa is scarce and scattered, with most African nations lacking the basic services. To address these needs, a guiding framework that identifies care needs and directs palliative care services could be utilized. Therefore, using the supportive care framework developed by Fitch (Fitch, 2009), we here review the literature on palliative care for patients diagnosed with cancer in Africa and make recommendations for improvement.Method:The PubMed, Scopus, CINAHL, Web of Science, Embase, PsycINFO, Social Sciences Citation Index, and Medline databases were searched. Some 25 English articles on research from African countries published between 2004 and 2014 were selected and reviewed. The reviewed literature was analyzed and presented using the domains of the supportive care framework.Results:Palliative care patients with cancer in Africa, their families, and caregivers experience increasing psychological, physical, social, spiritual, emotional, informational, and practical needs. Care needs are often inadequately addressed because of a lack of awareness as well as deficient and scattered palliative care services and resources. In addition, there is sparse research, education, and policies that address the dire situation in palliative care.Significance of Results:Our review findings add to the existing body of knowledge demonstrating that palliative care patients with cancer in Africa experience disturbing care needs in all domains of the supportive care framework. To better assess and address these needs, holistic palliative care that is multidomain and multi-professional could be utilized. This approach needs to be individualized and to offer better access to services and information. In addition, research, education, and policies around palliative care for cancer patients in Africa could be more comprehensive if they were based on the domains of the supportive care framework.

scholarly journals Patients' experiences of attending an adapted cardiac rehabilitation programme for heart failure in a day hospice

2020 ◽  
Vol 26 (6) ◽  
pp. 292-300
Author(s):  
Helen Walthall ◽  
Christie Roberts ◽  
Dan Butcher ◽  
Sue Schutz
Keyword(s):  
Heart Failure ◽  
Palliative Care ◽  
Hospice Care ◽  
Positive Impact ◽  
Post Intervention ◽  
Cardiac Rehabilitation Programme ◽  
Care Services ◽  
Final Sample ◽  
Palliative Care Services ◽  
Poor Outcomes

Background: Heart failure is highly prevalent with poor outcomes, yet only a small proportion of patients receive specialist palliative care services. Aim: To explore if a programme focusing on support and symptom management of people with heart failure in a hospice environment would be acceptable and of benefit to patients. Methods: A pre/post intervention study design using mixed methods was used to evaluate the programme. The programme was delivered in 2-hour time slots over a period of 8 weeks. Participants completed three questionnaires pre- and post- and were interviewed within 1 week of completion. The study was conducted between June 2014 and January 2015. Findings: A response rate of 51.7% (n=15) was narrowed to a final sample size of 12 patients. The questionnaire results showed a positive impact on participants' wellbeing and views regarding the use of a hospice, but a desire for greater focus on emotional support. Four key themes emerged from inductive qualitative analysis: demystifying perceptions about hospice care; positivity about wellbeing; learning together; and consideration of end-of-life preparation. Conclusion: This adapted programme provides a useful model for the increased integration of palliative care into provision for those living with advancing heart failure.

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