Trial Of Early Palliative Care Research Articles

Comparative effectiveness trial of early palliative care delivered via telehealth versus in person among patients with advanced lung cancer.

LBA3 Background: National guidelines recommend the early integration of palliative and oncology care for patients with advanced cancer, given robust evidence showing that this care model improves quality of life (QOL) and other important outcomes. However, most patients do not receive early palliative care (EPC) in the outpatient setting due to limited access and resources. To overcome these barriers, we conducted a large-scale comparative effectiveness trial of EPC delivered via secure video versus in person among patients with advanced non-small cell lung cancer (NSCLC) and their caregivers. Methods: Between 6/14/2018 and 5/4/2023, we enrolled 1250 patients with advanced NSCLC, diagnosed in the past 12 weeks, into a randomized trial of telehealth versus in-person EPC across 22 cancer centers in the US. Patients were randomly assigned to meet with a palliative care clinician every four weeks from enrollment through the course of disease either via video or in the outpatient clinic. Participants completed self-report measures at baseline and weeks 12 and 24. The primary aim was to evaluate the equivalence of the effect of telehealth versus in-person EPC on QOL at week 24, using regression modeling with an equivalence margin of ±4 points on the Functional Assessment of Cancer Therapy-Lung (FACT-L, range = 0-136). We also compared rates of caregiver participation in EPC visits and patient-reported depression and anxiety symptoms (Patient Health Questionnaire-9; Hospital Anxiety and Depression Scale), coping (Brief COPE), and perceptions of prognosis (Perceptions of Treatment and Prognosis Questionnaire) between groups. Study recruitment ceased for two months at the onset of the COVID-19 pandemic. Results: Participants (mean age = 65.5 years; 54.0% female; 82.1% White) had a mean of 4.75 and 4.92 palliative care encounters by week 24 in the telehealth and in-person groups, respectively. Due to the pandemic, the in-person group had 3.9% of visits occur via video. QOL scores at week 24 for patients assigned to the telehealth group were equivalent to those receiving in-person EPC (adjusted means: 99.67 versus 97.67, p < 0.043 for equivalence). The rate of caregiver participation in EPC visits was lower in the telehealth versus in-person group (36.6% versus 49.7%, p < 0.0001). Study groups did not differ in depression and anxiety symptoms, use of coping skills, or perceptions of the goal of treatment and curability of their cancer. Conclusions: The delivery of EPC via video versus in-person visits demonstrated equivalent effects on QOL in patients with advanced NSCLC. The two modalities also did not differ across a range of patient-reported outcomes, though caregivers attended more in-person versus video visits. The findings underscore the considerable potential for improving access to and broader dissemination of this evidence-based care model through telehealth delivery. Clinical trial information: NCT03375489 .

The PaCES Study: Cost effectiveness of an early palliative care intervention in patients with advanced colorectal cancer.

20 Background: An early palliative care (PC) pragmatic trial conducted in outpatient cancer clinics for patients living with advanced colorectal cancer (CRC), led to a 17% increase in early referrals (more than 3 months before death). This study evaluates the cost effectiveness of this trial. A lack of timely palliative care is associated with poorer quality of life, poorer symptom control and fewer days spent at home. Improving on this time toxicity is an important part of early palliative care. Methods: This pragmatic controlled before-and-after study was performed in 18 outpatient cancer clinics in two tertiary cancer centers in neighboring metropolitan cities. Baseline phase was from April 2017 to December 2018 with intervention phase only occurring in 1 of the cities, from April 2019 to December 2020. Intervention consisted of systematically screening patients for unmet PC needs, adding a community-based PC nurse specialist and templated ‘shared care’ letters sent from oncologists to primary care providers. Effectiveness was defined as the number of days spent at home in the last 90 days of life, by subtracting days in hospital, residential hospice, emergency department and clinic. A healthcare system perspective was used to calculate total costs in all sectors including hospital, cancer care, home care, palliative care and physician visits. Healthcare outcomes and costs were analysed using a difference-in-differences (DID) method, while accounting for geographic variations and other covariates. Results: A total of 695 decedents were included. There was a 15% decrease in hospital stay and 18% decrease in chemotherapy days in last 90 days of life. The intervention was cost dominant with an overall DID increase of 2.3 community days with an average cost reduction of C$1,942.17 per patient day in the community. Adjusted analysis showed that this difference was not statistically significant. A non-parametric random resampling of the population with 1,000 reiterations (bootstrapping) showed that the likelihood of the program remaining dominant was 69%. The biggest cost contributors were inpatient acute care (53.6%) and residential hospice (33.6%). Conclusions: Integrating early palliative care services into the care of CRC patients’ shows potential for cost savings and more days spent in the community in the last 90 days of life. Measuring time toxicity is a potentially important outcome in early palliative care trials while examining impact on cost.

Impact of early palliative care according to baseline symptom severity: Secondary analysis of a cluster-randomized controlled trial in patients with advanced cancer.

BackgroundEarly palliative care (EPC) improves the quality of life but may not be feasible for all patients with advanced cancer. Symptom screening has been suggested to triage patients for EPC, but scant evidence exists for this practice.MethodsWe conducted a subgroup analysis of a cluster‐randomized controlled trial of EPC vs. standard oncology care according to patients' baseline symptom scores (high [>23] vs. low [≤23] Edmonton Symptom Assessment System Distress Score [ESAS SDS]). A linear mixed‐effects model was used to account for correlation within clusters, adjusting for the baseline outcome score and all covariates in the original trial.ResultsAmong the 461 participants, baseline symptom scores were high in 229 patients (127 intervention, 102 control) and low in 232 (101 intervention and 131 control). Among those with high baseline symptoms, there was improved quality of life in the EPC arm compared to controls at 4 months (adjusted difference in primary outcome of FACIT‐Sp change score [95% CI], 8.7 [2.8 to 14.5], p = 0.01; adjusted difference in QUAL‐E, 4.2 [0.9–7.5], p = 0.02); there was also improved satisfaction with care (6.9 [3.8–9.9], p = 0.001) and clinician‐patient interactions (−1.7 [−3.4 to −0.1], p = 0.04), but no significant difference in ESAS SDS (−5.6 [−12.7 to 1.4], p = 0.11). In the low baseline symptom group, there were no significant differences between arms for any outcomes.ConclusionEPC improved quality of life, satisfaction with care, and clinician‐patient interactions only in those with high baseline symptoms. Symptom severity may be an appropriate criterion to trigger early referrals to palliative care.

Patient-Reported and End-of-Life Outcomes Among Adults With Lung Cancer Receiving Targeted Therapy in a Clinical Trial of Early Integrated Palliative Care: A Secondary Analysis

ContextTargeted therapy has revolutionized lung cancer treatment and markedly increased survival, though data are lacking on patient-reported and end-of-life (EOL) outcomes among patients receiving targeted therapy. ObjectivesThis study aimed to compare quality of life (QOL), symptoms, prognostic communication, and EOL care between patients receiving targeted therapy and patients with lung cancer without targetable mutations. MethodsIn this secondary analysis of a randomized trial of early palliative care in advanced lung cancer (n=154), we compared change in QOL and symptoms (per the Functional Assessment of Cancer Treatment [FACT]-Lung scale) over 24 weeks among patients with lung cancer receiving targeted therapy versus those without targetable mutations using linear mixed effects models, adjusted for receipt of palliative care, age and gender. We also compared prognostic communication and decedents’ EOL health care utilization using logistic regression, adjusted for palliative care. ResultsCompared to individuals without targetable mutations, patients receiving targeted therapy (n=35) reported greater improvements in QOL (FACT-General B=0.46; 95% CI=0.19, 0.73) and symptoms (FACT-Lung Cancer Subscale B=0.12; 95% CI=0.03, 0.20) over time, independent of palliative care. Patients receiving targeted therapy were also more likely to report they rarely discussed prognosis with their clinicians (OR=2.59, 95% CI=1.01, 6.63) and were more likely to receive cancer-directed therapy in their last 14 days of life (OR=14.98, 95% CI=4.08, 54.96). ConclusionsRelative to patients without targetable mutations, patients with lung cancer who receive targeted therapy experience improved QOL and symptoms, are less likely to discuss prognosis early in their illness course, and more likely to continue treatment until death and die in the hospital.

Early palliative intervention: effects on patient care satisfaction in advanced cancer

ObjectiveIn a cluster-randomised controlled trial of early palliative care (EPC) in advanced cancer, EPC was robustly associated with increased patient satisfaction with care. The present study evaluated mediational mechanisms underlying...

Timing of Palliative Care Referral Before and After Evidence from Trials Supporting Early Palliative Care.

Evidence from randomized controlled trials has demonstrated benefits in quality of life outcomes from early palliative care concurrent with standard oncology care in patients with advanced cancer. We hypothesized that there would be earlier referral to outpatient palliative care at a comprehensive cancer center following this evidence. Administrative databases were reviewed for two cohorts of patients: the pre-evidence cohort was seen in outpatient palliative care between June and November 2006, and the post-evidence cohort was seen between June and November 2015. Timing of referral was categorized, according to time from referral to death, as early (>12 months), intermediate (>6 months to 12 months), and late (≤6 months from referral to death). Univariable and multivariable ordinal logistic regression analyses were used to determine demographic and medical factors associated with timing of referral. Late referrals decreased from 68.8% pre-evidence to 44.8% post-evidence; early referrals increased from 13.4% to 31.1% (p < .0001). The median time from palliative care referral to death increased from 3.5 to 7.0 months (p < .0001); time from diagnosis to referral was also reduced (p < .05). On multivariable regression analysis, earlier referral to palliative care was associated with post-evidence group (p < .0001), adjusting for shorter time since diagnosis (p < .0001), referral for pain and symptom management (p = .002), and patient sex (p = .04). Late referrals were reduced to <50% in the breast, gynecological, genitourinary, lung, and gastrointestinal tumor sites. Following robust evidence from trials supporting early palliative care for patients with advanced cancer, patients were referred substantially earlier to outpatient palliative care. Following published evidence demonstrating the benefit of early referral to palliative care for patients with advanced cancer, there was a substantial increase in early referrals to outpatient palliative care at a comprehensive cancer center. The increase in early referrals occurred mainly in tumor sites that have been included in trials of early palliative care. These results indicate that oncologists' referral practices can change if positive consequences of earlier referral are demonstrated. Future research should focus on demonstrating benefits of early palliative care for tumor sites that have tended to be omitted from early palliative care trials.

Validation of the 7-item Functional Assessment of Cancer Therapy-General (FACT-G7) as a short measure of quality of life in patients with advanced cancer.

Assessing quality of life is essential for individuals with advanced cancer, but lengthy assessments can be burdensome. The authors investigated the psychometric characteristics of the FACT-G7, a 7-item quality-of-life measure derived from the Functional Assessment of Cancer Therapy-General (FACT-G) scale, in advanced cancer. Data were obtained from outpatients with advanced cancer who were enrolled in a randomized controlled trial of early palliative care. At baseline, 228 intervention participants and 233 control participants (N=461) completed the FACT-G and measures of symptom severity, quality of life near the end of life, problematic medical communication, and satisfaction with care. Follow-up measures were administered monthly for 4months. The FACT-G7 showed good internal consistency (Cronbach α=.72-.80), and its single-factor structure was supported. It correlated strongly with the FACT-G total, physical, and functional indices and with symptom severity (absolute r=0.73-0.92); more moderately with the FACT-G emotional index and with symptom impact and preparation for the end of life (r=.40-.71); and least with the FACT-G social/family index and with relationship with health care provider, life completion, problematic medical communication, and care satisfaction measures (absolute r=.26-.44). Eastern Cooperative Oncology Group performance status groups differed on FACT-G7 scores, as expected (all P<.001). Improvements in FACT-G7 scores in the intervention group compared with the control group at 3-month (P=.049) and 4-month (P=.034) follow-up supported responsiveness to change and somewhat greater sensitivity than the FACT-G scores. The FACT-G7 is a valid, brief measure particularly of the physical and functional facets of quality of life. It may enable rapid quality-of-life assessments in patients with advanced cancer.

Rationale and study design: A randomized controlled trial of early palliative care in newly diagnosed cancer patients in Addis Ababa, Ethiopia

Patient-reported outcomes and economic aspects of Palliative Care (PC) provision in low-income countries (LIC) are under-studied. Demonstrating the economic value of PC is key to sustainability and guiding health care policy. Our preliminary data in Ethiopia demonstrated a widespread need for PC, poor access to it, and high out of pocket payments (OOP). We suspect that in this and other LIC, PC may function not only to reduce suffering but also as a poverty reduction strategy.We are conducting a randomized controlled trial of standard Oncology care versus standard Oncology care plus PC in newly diagnosed cancer patients in Addis Ababa. Ninety-seven adults presenting to Oncology Clinic will be randomized in a 1:1 ratio. Subjects receiving PC will meet with a PC provider at time of enrollment and at follow up visits in their homes. All subjects will be assessed via questionnaire at enrollment and follow-up Oncology visits at 8 ± 4 and 12 ± 4 weeks. A cost-consequence analysis will be performed, to include: patient-reported OOP and healthcare utilization, the latter to be assessed through chart adjudication. Outcomes will include change in African Palliative Care Association Palliative Outcome Score, changes in OOP and healthcare utilization.We hypothesize that the cost of home-based PC will be offset by improvements in patient-reported outcomes, decreased OOP and healthcare utilization, rendering PC cost-effective in this LIC. These findings may lead to widespread dissemination of an effective, sustainable and cost-saving public PC delivery strategy that would improve the quality of life and death for millions of people. Trial registrationClinicaltrials.gov NCT03712436.

Depression and anxiety symptoms in bereaved caregivers of patients with advanced cancer.

17 Background: Caregivers of patients with advanced cancer experience substantial caregiving burden and psychological distress during the illness course. However, data on depression and anxiety symptoms in bereaved caregivers and factors associated with their psychological distress are lacking. Methods: We conducted a secondary analysis of 168 caregivers enrolled in a randomized trial of early palliative care integrated with oncology care versus oncology care alone for patients newly-diagnosed with incurable lung and non-colorectal gastrointestinal cancers and their caregivers who completed bereavement assessments at 3 months after their loved one’s death. We used the Hospital Anxiety and Depression Scale (HADS) to assess patients’ and caregivers’ depression and anxiety symptoms at baseline within 8 weeks of diagnosis, and at 3-4 months after the patient’s death (for caregivers). We asked caregivers to rate patient’s physical and psychological distress in the last week of life on a 10-point scale. We used linear regression adjusting for randomization and cancer type to explore associations between patient and caregiver factors and bereaved caregivers’ depression and anxiety. Results: 30.4% (51/168) and 43.4% (73/168) of bereaved caregivers reported clinically significant depression and anxiety symptoms, respectively. Younger patient age (B = -0.06, P = 0.041), higher patient baseline anxiety (B = 0.28, P = 0.002), and caregiver rating of worse physical (B = 0.28, P = 0.035) and psychological (B = 0.41, P &lt; 0.001) distress experienced by the patient at the end of life (EOL) were associated with worse depression symptoms in bereaved caregivers. Only caregiver factors, including age (B = -0.07, P = 0.004), female sex (B = 1.60, P = 0.024), and rating of worse psychological distress experienced by the patient at the EOL (B = 0.42, P &lt; 0.001) were associated with worse bereaved caregivers’ anxiety symptoms. Conclusions: Bereaved caregivers of patients with advanced cancer experience substantial psychological distress which is associated with their perceptions of their loved one’s distress at the EOL. Interventions to optimize EOL care for patients and reduce bereaved caregivers’ psychological distress are needed.

Depression and anxiety symptoms in bereaved caregivers of patients with advanced cancer.

11623 Background: Caregivers of patients with advanced cancer experience substantial caregiving burden and psychological distress during the illness course. However, data on depression and anxiety symptoms in bereaved caregivers and factors associated with their psychological distress are lacking. Methods: We conducted a secondary analysis of 168 caregivers enrolled in a randomized trial of early palliative care integrated with oncology care versus oncology care alone for patients newly-diagnosed with incurable lung and non-colorectal gastrointestinal cancers and their caregivers who completed bereavement assessments at 3 months after their loved one’s death. We used the Hospital Anxiety and Depression Scale (HADS) to assess patients’ and caregivers’ depression and anxiety symptoms at baseline within 8 weeks of diagnosis, and at 3-4 months after the patient’s death (for caregivers). We asked caregivers to rate patient’s physical and psychological distress in the last week of life on a 10-point scale. We used linear regression adjusting for randomization and cancer type to explore associations between patient and caregiver factors and bereaved caregivers’ depression and anxiety. Results: 30.4% (51/168) and 43.4% (73/168) of bereaved caregivers reported clinically significant depression and anxiety symptoms, respectively. Younger patient age (B = -0.06, P = 0.041), higher patient baseline anxiety (B = 0.28, P = 0.002), and caregiver rating of worse physical (B = 0.28, P = 0.035) and psychological (B = 0.41, P &lt; 0.001) distress experienced by the patient at the end of life (EOL) were associated with worse depression symptoms in bereaved caregivers. Only caregiver factors, including age (B = -0.07, P = 0.004), female sex (B = 1.60, P = 0.024), and rating of worse psychological distress experienced by the patient at the EOL (B = 0.42, P &lt; 0.001) were associated with worse bereaved caregivers’ anxiety symptoms. Conclusions: Bereaved caregivers of patients with advanced cancer experience substantial psychological distress which is associated with their perceptions of their loved one’s distress at the EOL. Interventions to optimize EOL care for patients and reduce bereaved caregivers’ psychological distress are needed.

Symptom Assessment in Patients with Advanced Cancer: Are the Most Severe Symptoms the Most Bothersome?

Objective: We investigated correspondence between symptom severity and symptom bothersomeness in patients with advanced cancer. Background: Symptom severity is commonly assessed in clinical cancer settings, but bothersomeness of these symptoms is less often measured. Methods: Participants with advanced cancer enrolled in a cluster-randomized trial of early palliative care completed the Edmonton Symptom Assessment System (ESAS) and the quality of life at the end of life (QUAL-E) measure as part of their baseline assessment. For each symptom, we examined the correspondence between the symptom being indicated as most severe on the ESAS and rated as most bothersome on the QUAL-E. Results: For the 386 patients who completed relevant sections of the ESAS and QUAL-E, tiredness (32.8%), sleep (23.8%), and appetite (20.2%) were most frequently rated as most severe, whereas pain (28.9%) and tiredness (24.3%) were most frequently indicated as most bothersome. The most bothersome and most severe symptom corresponded in 42%. Pain and/or tiredness were consistently among the top three most bothersome symptoms, whereas appetite was frequently rated the most severe symptom but was rarely perceived as the most bothersome. The probability that patients rating a symptom as most severe would also rate it as most bothersome was highest for pain (66%), nausea (58%), and tiredness (40%). Discussion: ESAS symptom severity does not necessarily indicate patients' most bothersome symptom; regardless of severity, pain and tiredness are most frequently perceived as most bothersome. Further research should investigate the clinical benefits of patients also indicating their three most bothersome ESAS symptoms.

Integrating the ENABLE Early Palliative Care Approach in Community Cancer Centers: Results of an Implementation Trial (TH321A)

•Describe the use of ENABLE (Educate, Nurture, Advise, Before Life Ends) model of early, concurrent oncology palliative care.•Describe the findings of an early palliative care (EPC) implementation of ENABLE for individuals with newly diagnosed metastatic cancer in rural-serving community cancer centers. Despite national guidelines recommending early palliative care (EPC) for individuals newly-diagnosed with metastatic cancer, it is rarely available in rural community cancer centers serving underserved populations. We conducted the first implementation trial of EPC in rural cancer centers using the evidence-based ENABLE (Educate, Nurture, Advise, Before Life Ends) model of early, concurrent oncology palliative care. Mixed methods case study of a 4-year American Cancer Society-funded 4-site, implementation trial using a virtual learning collaborative in AL and SC. Guided by the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework, we gathered qualitative and quantitative data via monthly reports and yearly in-person site visits using: 1) a RE-AIM Self-Assessment Tool completed by site staff to measure objectives; 2) EPC General Organizational Index (GOI) to measure capacity for EPC services and implementation progress; and 3) field notes from site interviews and final reports. Baseline patients (n=62) characteristics included: mean age of 58, 70% female, 17% Black or minority, 57% some college, 49% rural dwelling, and 57% non-gynecologic cancer. Sites enrolled at least 58% of the patients they planned to enroll (range: 58%–100%; average: 84%), of which 60% received at least two-thirds of ENABLE content. Reasons for not completing all six sessions included death, unrecorded contacts, or lost to follow up. Longitudinal GOI scores indicated a trend of improved capacity for EPC services at 3 of 4 sites. A 4-site implementation trial found that community cancer centers were able to successfully implement a nurse-led model of early concurrent palliative care facilitated by a virtual learning collaborative that successfully served minorities and rural-dwellers affected by cancer.

Understanding the Barriers to Introducing Early Palliative Care for Patients with Advanced Cancer: A Qualitative Study.

Background: Palliative care is often underutilized or initiated late in the course of life-threatening illness. Randomized clinical Early Palliative Care (EPC) trials provide an opportunity for changing oncologists' perceptions of palliative care and their attitudes to referring patients to palliative care services. Aim: To describe French oncologists' perceptions of EPC and their effects on referral practices before a clinical EPC trial was launched. Design: A qualitative study involving semistructured face-to-face interviews. The data were analyzed using the Grounded Theory coding method. Setting/Participants: Thirteen oncologists and 19 palliative care specialists (PCSs) working at 10 hospitals all over France were interviewed. Most of them were involved in clinical EPC trials. Results: The findings suggest that referral to PCSs shortly after the diagnosis of advanced cancer increases the terminological barriers, induces avoidance patterns, and makes early disclosure of poor prognosis harder for oncologists. This situation is attributable to the widespread idea that palliative care means terminal care. In addition, the fact that the EPC concept is poorly understood increases the confusion between EPC and supportive care. Conclusion: Defining the EPC concept more clearly and explaining to health professionals and patients what EPC consists of and what role it is intended to play, and the potential benefits of palliative care services could help to overcome the wording barriers rooted in the traditional picture of palliative care. In addition, training French oncologists how to disclose "bad news" could help them cope with the emotional issues involved in referring patients to specialized palliative care.

Integrating the ENABLE early palliative care approach in community cancer centers: Results of an implementation trial.

114 Background: Despite national guidelines recommending early palliative care (EPC) for individuals newly-diagnosed with metastatic cancer, it is rarely available in rural community cancer centers serving underserved populations. We conducted the first implementation trial of EPC in rural cancer centers using the evidence-based ENABLE (Educate, Nurture, Advise, Before Life Ends) model of early, concurrent oncology palliative care. Methods: Mixed methods case study of a 4-year American Cancer Society-funded 4-site, implementation trial using a virtual learning collaborative in AL and SC. Guided by the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework, we gathered qualitative and quantitative data via monthly reports and yearly in-person site visits using: 1) a RE-AIM Self-Assessment Tool completed by site staff to measure reach, adoption, implementation, and maintenance; 2) EPC General Organizational Index (GOI) to measure capacity for EPC services and implementation progress; and 3) field notes from site interviews and final reports. Results: Across the 4 sites, 62 patients (range: 4–31; mean: 15) and 46 caregivers (range: 2–22; mean: 12) participated. Baseline patient characteristics included: mean age of 58, 70% female, 17% Black or minority, 57% some college or college, 49% rural dwelling, and 57% non-gynecologic cancer. Sites enrolled at least 58% of the patients they planned to enroll (range: 58%–100%; average: 84%), of which 44% received 100% of ENABLE content and nearly 60% received two-thirds. Reasons for not completing all six sessions included death, unrecorded contacts, or lost to follow up. Longitudinal GOI scores indicated a trend of improved capacity for EPC services at three of the four sites. Qualitative data from site lead interviews revealed administrative (presence or lack of palliative ‘champions’), clinical (having adequate training), and economic (reimbursement) implementation barriers and facilitators. Conclusions: This pilot implementation study demonstrated feasibility and areas to enhance implementation in a larger comparative effectiveness trial to enhance scaling and spreading EPC in community practices.

"I didn't want to be in charge and yet I was": Bereaved caregivers' accounts of providing home care for family members with advanced cancer.

To describe bereaved caregivers' experiences of providing care at home for patients with advanced cancer, while interacting with home care services. Caregivers of patients who had completed a 4-month randomized controlled trial of early palliative care versus standard oncology care were recruited 6months to 5years after the patient's death. All patients except one (control) had eventually received palliative care. In semi-structured interviews, participants were asked about their experiences of caregiving. Grounded theory guided all aspects of the study. Sixty-one bereaved caregivers (30 intervention, 31 control) were interviewed, including spouses (33), adult children (19), and other family (9). There were no differences in themes between control and intervention groups. The core category of Taking charge encompassed caregivers' assumption of active roles in care, often in the face of inadequate formal support. There were 4 interrelated subcategories: (1) Navigating the system-navigating the complexities of the home care system to access resources and supports; (2) Engaging with professional caregivers-interacting with visiting personnel to advocate for consistency and quality of care; (3) Preparing for death-seeking out information about what to expect at the end of life; and (4) Managing after death-managing multiple administrative responsibilities in the emotionally charged period following death. Caregivers were often thrust into assuming control in order to compensate for deficiencies in formal palliative home care services. Policies, quality indicators, and guidelines are needed to ensure the provision of comprehensive, interdisciplinary home palliative care.

A Trial of Early Palliative Care for Serious Illness: Results from the LifeCourse Lay Health Care Worker Intervention (TH300)

A Trial of Early Palliative Care for Serious Illness: Results from the LifeCourse Lay Health Care Worker Intervention (TH300)

A randomised trial of early palliative care for maternal stress in infants prenatally diagnosed with single-ventricle heart disease.

Children with single-ventricle disease experience high mortality and complex care. In other life-limiting childhood illnesses, paediatric palliative care may mitigate maternal stress. We hypothesised that early palliative care in the single-ventricle population may have the same benefit for mothers. In this pilot randomised trial of early palliative care, mothers of infants with prenatal single-ventricle diagnoses completed surveys measuring depression, anxiety, coping, and quality of life at a prenatal visit and neonatal discharge. Infants were randomised to receive early palliative care - structured evaluation, psychosocial/spiritual, and communication support before surgery - or standard care. Among 56 eligible mothers, 40 enrolled and completed baseline surveys; 38 neonates were randomised, 18 early palliative care and 20 standard care; and 34 postnatal surveys were completed. Baseline Beck Depression Inventory-II and State-Trait Anxiety Index scores exceeded normal pregnant sample scores (mean 13.76±8.46 versus 7.0±5.0 and 46.34±12.59 versus 29.8±6.35, respectively; p=0.0001); there were no significant differences between study groups. The early palliative care group had a decrease in prenatal to postnatal State-Trait Anxiety Index scores (-7.6 versus 0.3 in standard care, p=0.02), higher postnatal Brief Cope Inventory positive reframing scores (p=0.03), and a positive change in PedsQL Family Impact Module communication and family relationships scores (effect size 0.46 and 0.41, respectively). In conclusion, these data show that mothers of infants with single-ventricle disease experience significant depression and anxiety prenatally. Early palliative care resulted in decreased maternal anxiety, improved maternal positive reframing, and improved communication and family relationships.

Caregiver quality of life in advanced cancer: Qualitative results from a trial of early palliative care

Background: Early involvement of palliative care improves patient quality of life; however, quantitative studies have not yet demonstrated a similar effect for caregivers, for whom the construct of quality of life is less well developed. Aim: To conceptualise quality of life of caregivers from their own perspective and to explore differences in themes between those who did or did not receive an early palliative care intervention. Design: Qualitative grounded theory study. Setting: Tertiary comprehensive cancer centre. Participants: Following participation in a cluster-randomised trial of early palliative care, 23 caregivers (14 intervention and 9 control) of patients with advanced cancer participated in semi-structured interviews to discuss their quality of life. Results: The core category was ‘living in the patient’s world’. Five related themes were ‘burden of illness and caregiving’, ‘assuming the caregiver role’, ‘renegotiating relationships’, ‘confronting mortality’ and ‘maintaining resilience’. There was thematic consistency between trial arms, except for the last two themes, which had distinct differences. Participants in the intervention group engaged in open discussion about the end of life, balanced hope with realism and had increased confidence from a range of professional supports. Controls tended to engage in ‘deliberate ignorance’ about the future, felt uncertain about how they would cope and lacked knowledge of available supports. Conclusions: Caregiver quality of life is influenced profoundly by the interaction with the patient and should be measured with specific questionnaires that include content related to confronting mortality and professional supports. This would improve delineation of quality of life for caregivers and allow greater sensitivity to change. Registration: clinicaltrials.gov NCT01248624

Overcoming recruitment challenges in a randomized clinical trial of early palliative care.

140 Background: Reasons why clinical trials of early palliative care (ePC) interventions have prolonged patient recruitment time frames have been researched mainly qualitatively. Our objective was to identify major recruitment barriers encountered in our ePC trial, as well as to implement actions to overcome them. The impact of these changes on recruitment was measured. Methods: Data from all patients screened at the main study site (Inselspital, University Hospital Bern) between October 2013 and April 2016 were prospectively analyzed for: date of contact, reporting department, eligibility status, as well as consent status. Data until march 2014 was used to identify the main recruitment barriers. Starting in march 2014 changes to the recruitment process were implemented and all data from then onwards was used to estimate the impact of these adaptations. Results: The three main barriers identified were: Logistic, motivational, or related to eligibility criteria. Logistic barriers were overcome by changing from voluntary referral by the treating physician to systematically screening outpatient clinics of medical oncology, radio-oncology, gyneco-oncology and the internal medicine ward. Motivational barriers were addressed through education and dedicated study staff. Eligibility criteria were widened to include pancreatic and urothelial cancer. The actions implemented increased the accrual rate from one patient during a five month period to 2,8 patients per month. The widening of the eligibility criteria contributed to this result by recruiting 0,5 patients per month. The implementation of a systematic screening procedure increased the number of eligible patients invited to participate from one per month to 4,8 per month. An increase in the study consent rate from 20 % to 58 % can be translated into an increased acceptance of early palliative care. Conclusions: Education and dedicated study staff in order to increase the acceptance of ePC as well as a tool to identify eligible patients in a time-efficient manner improved patient recruitment in our ePC trial. We suggest that these factors can be relevant for the successful integration of ePC in standard oncology care.

Discussions about hospice among patients with advanced cancer.

53 Background: Timely and effective patient-clinician communication about treatment options at the end of life (EOL) is considered essential to quality care. In this study we examined the timing and nature of first discussions about hospice. We hypothesized that earlier initiation of hospice discussions would be associated with longer hospice length of stay. Methods: We analyzed data from a randomized trial of early palliative care integrated with oncology care versus oncology care alone in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer at the Massachusetts General Hospital (n = 350, enrolled 5/11-7/15). Analysis included patients deceased at 1 year after last enrollment (n = 259). Electronic health records were reviewed to identify first documented hospice discussion with a medical oncology or palliative care clinician. Among hospice enrollees, we tested the association of first hospice discussion with hospice length of stay, adjusting for cancer type and randomized group. We used content analysis to explore the nature of first hospice discussions. Results: Prior to death, 79.9% of patients (54% male; M age = 64 yrs [SD = 11 yrs]) enrolled in hospice. Among hospice enrollees, 8.2% had no documented hospice discussion before enrollment. Range of time from first hospice discussion to hospice enrollment was ≤7 days (40.0%), 8-14 days (12.1%), 15-30 days (13.2%) or &gt; 30 days (34.7%). Greater number of days between first hospice discussion and hospice enrollment was associated with more days on hospice (Beta = .14, SE = .04, p &lt; .001). Almost half of first hospice discussions involved initiation of hospice referral. Discussions that occurred early ( &gt; 30 days before enrollment) were varied, reflecting clinician’s provision of information; discussion of future hospice use; and initiation of dialog about patient/family areas of ambivalence or concern. Conclusions: Earlier initiation of hospice discussions was associated with more subsequent days on hospice and reflected attention to patient/family informational needs, perspectives and concerns about hospice and EOL care. Research is needed to help identify and address factors that facilitate earlier discussions with patients/families about EOL care options.