Standard Oncology Care Research Articles

Abstract P4-12-13: Psychosocial aspects in relation to clinical status of breast cancer patients after prolonged COVID pandemic in south India: A observational survey study

Abstract BACKGROUND:The prolonged global threat imposed by covid 19 pandemic’s first and second wave has created immense stress among the breast cancer due to interruptions of standard oncological care. The frequent lockdown imposed had tremendous impact on the patients’ financial status and posed hinderance in transportation to oncological centre. In our hospital, majority of the treatment population are from distant places and below poverty line. We conducted a questionnaire based study to assess the psychological impact in this situation affecting their quality of life(QOL) and their perspective in this current situation. MATERIALS AND METHODS:Breast cancer patients who had been diagnosed and registered in our department from 1st January to 1stApril 2020 before the covid out break were tracked from the medical records. The patients details, disease status dates of follow up and the treatment details were collected.Defaulted patients were contacted.Post one year, in April 2021, these patients were assessed clinically and questioned regarding the treatment perspective. Psychological status and health related quality of life were analysed with GAD-7 (Generalised anxiety disorder questionnaire), PHQ-9 (patient health questionnaire) and EORTC QLQ-C30 questionnaire.RESULTS:A total of 202 breast cancer patients were included. 83 patients(41%) were diagnosed with early breast cancer of which 67(33%) patients were started on adjuvant chemotherapy after surgery,16 (8%)were registered for hormonal therapy. 54(27%) patients with locally advanced, were on neoadjuvant chemotherapy. 65(32%)had metastatic disease at presentation. 23 of 65 metastatic patients were in visceral crisis and were on supportive management for the same. 35 patients had been started on palliative chemotherapy. Out of the 156 patients who had been in initiated with various chemotherapy, only 62(31%) patients were able to review at correct interval for the scheduled chemotherapy. 45 patients(22%) reviewed in the day care irregularly. Among the 45, 28 patients had locally advanced breast cancer and 22 patients had clinical progression due to prolonged gap. 38 patients(19%) had defaulted completely.Of the 38,16 had advanced disease and presented with clinical progression of disease and switched to second line chemotherapy. 15 patients progressed to have distant metastases and are started on palliative chemotherapy or supportive care. 7 patients who were on adjuvant chemotherapy are kept under close follow up. 11 patients with metastatic breast cancer had died during the past one year. 3 patients had committed suicide.112(55 %) patients were within the city. 71 patients(35%) were from suburban areas. 19 patients(10%) were from adjacent rural areas. 113(56%) were educated.176 (87 %) were desperate to continue treatment inspite of pandemic, while remaining patients main concern was to avoid infection than to get oncological management. While the most common reason for defaulting was travel restrictions, few also documented financial issues and ignorance about progression of cancer. 46 (22%)of patients who had been visiting the day care had turned covid positive. Except for 2 patients who succumbed to the infection, none had major complications. 51%, 42%, 7% had mild, moderate and severe anxiety. 69%, 25%, 6% had mild, moderate and severe depression. The severe anxiety and depression was significant with metastatic breast cancer and educated patients. There were 3 suicides. The overall heath score had a mean of 4. The overall QOL had a mean score of 3 (1- very poor to 7- excellent).CONCLUSION: In patients who were already psychologically affected by onset of cancer, the chaos created by the pandemic added to it further. Hence the patients also need counseling appropriately during oncological treatment Citation Format: Chandralekha Krishnan. Psychosocial aspects in relation to clinical status of breast cancer patients after prolonged COVID pandemic in south India: A observational survey study [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-12-13.

Effect of a Symptom Monitoring Intervention for Patients Hospitalized With Advanced Cancer

Symptom monitoring interventions are increasingly becoming the standard of care in oncology, but studies assessing these interventions in the hospital setting are lacking. To evaluate the effect of a symptom monitoring intervention on symptom burden and health care use among hospitalized patients with advanced cancer. This nonblinded randomized clinical trial conducted from February 12, 2018, to October 30, 2019, assessed 321 hospitalized adult patients with advanced cancer and admitted to the inpatient oncology services of an academic hospital. Data obtained through November 13, 2020, were included in analyses, and all analyses assessed the intent-to-treat population. Patients in both the intervention and usual care groups reported their symptoms using the Edmonton Symptom Assessment System (ESAS) and the 4-item Patient Health Questionnaire-4 (PHQ-4) daily via tablet computers. Patients assigned to the intervention had their symptom reports displayed during daily oncology rounds, with alerts for moderate, severe, or worsening symptoms. Patients assigned to usual care did not have their symptom reports displayed to their clinical teams. The primary outcome was the proportion of days with improved symptoms, and the secondary outcomes were hospital length of stay and readmission rates. Linear regression was used to evaluate differences in hospital length of stay. Competing-risk regression (with death treated as a competing event) was used to compare differences in time to first unplanned readmission within 30 days. From February 12, 2018, to October 30, 2019, 390 patients (76.2% enrollment rate) were randomized. Study analyses to assess change in symptom burden included 321 of 390 patients (82.3%) who had 2 or more days of symptom reports completed (usual care, 161 of 193; intervention, 160 of 197). Participants had a mean (SD) age of 63.6 (12.8) years and were mostly male (180; 56.1%), self-reported as White (291; 90.7%), and married (230; 71.7%). The most common cancer type was gastrointestinal (118 patients; 36.8%), followed by lung (60 patients; 18.7%), genitourinary (39 patients; 12.1%), and breast (29 patients; 9.0%). No significant differences were detected between the intervention and usual care for the proportion of days with improved ESAS-physical (unstandardized coefficient [B] = -0.02; 95% CI, -0.10 to 0.05; P = .56), ESAS-total (B = -0.05; 95% CI, -0.12 to 0.02; P = .17), PHQ-4-depression (B = -0.02; 95% CI, -0.08 to 0.04; P = .55), and PHQ-4-anxiety (B = -0.04; 95% CI, -0.10 to 0.03; P = .29) symptoms. Intervention patients also did not differ significantly from patients receiving usual care for the secondary end points of hospital length of stay (7.59 vs 7.47 days; B = 0.13; 95% CI, -1.04 to 1.29; P = .83) and 30-day readmission rates (26.5% vs 33.8%; hazard ratio, 0.73; 95% CI, 0.48-1.09; P = .12). This randomized clinical trial found that for hospitalized patients with advanced cancer, the assessed symptom monitoring intervention did not have a significant effect on patients' symptom burden or health care use. These findings do not support the routine integration of this type of symptom monitoring intervention for hospitalized patients with advanced cancer. ClinicalTrials.gov Identifier: NCT03396510.

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.

Early Palliative Care in Patients With Non-Small-Cell Lung Cancer: A Randomized Controlled Trial in Southwest China.

Effective interventions to improve prognosis in non-small-cell lung cancer (NSCLC) are urgently needed. We assessed the effect of the early integration of interdisciplinary palliative care (based on WARM model) for patients with NSCLC on the quality of life (QoL), psychological state, cancer pain and nutritional status. In this randomized controlled trial, 120 newly diagnosed NSCLC patients were enrolled and randomly assigned (1:1) to the combined early palliative care (CEPC) group integrated with standard oncologic care or standard oncological care (SC) group. QoL and psychological state were assessed at baseline and at 24weeks by Functional Assessment of Cancer Therapy-Lung (FACT-L) scale, the Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire-9 (PHQ-9), respectively. Cancer nutritional and pain status were assessed with the use of the Patient-Generated Subjective Global Assessment (PG-SGA) and Numerical Rating Scale (NRS), respectively. The primary outcome was the change in the quality of life, psychological state and nutritional status at 24weeks. Analysis was by intention to treat. 120 patients were enrolled: 60 in CEPC group (38 completed) and 60 in the SC group (32 completed). CEPC group had a better QoL than SC group (P < .05). In addition, fewer patients in the CEPC group than in the SC group had depressive (P = .005) symptoms. Furthermore, patients in CEPC group had a better nutritional status than SC group (P = .001). Among patients with non-small-cell lung cancer, early palliative care led to significant improvements in quality of life, psychological state and nutritional status.

Early Palliative Care in Acute Myeloid Leukemia.

Simple SummarySeveral new targeted drugs for the treatment of acute myeloid leukemia (AML) have been developed in recent years. However, their potential efficacy should be balanced with the possibility of a poor outcome. For patients with solid tumors, the integration of palliative care (PC) with standard oncologic care, eight weeks after the diagnosis of advanced cancer, has demonstrated many benefits. In patients with hematologic malignancies, this model is underutilized. Here, we review the PC needs and the evidence in the literature supporting the early integration of PC in the disease trajectory of patients with AML. Early PC should be the standard of care for patients with AML. Efforts should also be made to extend the integrated PC model to patients with other hematologic malignancies.Background: Several novel targeted therapies seem to improve the outcome of acute myeloid leukemia (AML) patients. Nonetheless, the 5-year survival rate remains below 40%, and the trajectory of the disease remains physically and emotionally challenging, with little time to make relevant decisions. For patients with advanced solid tumors, the integration of early palliative care (EPC) with standard oncologic care a few weeks after diagnosis has demonstrated several benefits. However, this model is underutilized in patients with hematologic malignancies. Methods: In this article, we analyze the palliative care (PC) needs of AML patients, examine the operational aspects of an integrated model, and review the evidence in favor of EPC integration in the AML course. Results: AML patients have a high burden of physical and psychological symptoms and high use of avoidant coping strategies. Emerging studies, including a phase III randomized controlled trial, have reported that EPC is feasible for inpatients and outpatients, improves quality of life (QoL), promotes adaptive coping, reduces psychological symptoms, and enhances the quality of end-of-life care. Conclusions: EPC should become the new standard of care for AML patients. However, this raises issues about the urgent development of adequate programs of education to increase timely access to PC.

The early integration of palliative care into oncology care: A rapid review.

With the number of cancer diagnoses and cancer-related deaths on the rise, palliative care is becoming a more important consideration for helping to improve the quality of life of patients and families and the support they receive during their healthcare journey. Accordingly, the early integration of palliative care into standard oncology care would appear to be an underutilized and novel approach that could be used to address the specific needs of palliative oncology patients. Oncology nurses play a central role in this process, delivering care throughout the health continuum, including palliative care. The purpose of this rapid review is to outline the benefits of early palliative care interventions and describe their characteristics. A literature search on CINAHL and PubMed returned five randomized trials conducted between 2010 and 2018. An analysis of these papers showed that the majority of the selected studies concluded that the early integration of palliative care into standard oncology care, which includes such treatments as chemotherapy and radiation therapy, can lead to improvements in quality of life, symptoms of anxiety and depression, and overall survival rate.

The Effects of Integrative Palliative Oncology on Hospital Time, Hospice Referrals, and Advanced Care Planning

Background: &#x0D; Integrative palliative oncology incorporates mental, physical, and familial aspects of care into standard cancer treatment. Patients in these programs have access to a doctor, nurse, psychologist, social worker, and chaplain who are all trained in palliative oncology whereas standard oncology does not have this team. Integrative programs improve well-being while reducing futile treatments. We hypothesize that emergency department (ED) visits, inpatient admissions, intensive care unit (ICU) stays, hospital deaths, hospice referrals, and advanced care planning (ACP) are affected by these programs.&#x0D; &#x0D; Methods: &#x0D; A retrospective chart review analyzed patients from Parkview Regional Medical Center. Cohort A included 100 patients from a palliative oncology program. Cohort B included 100 patients who received standard oncology care. Cohorts were matched on gender, age, cancer type, and stage. Number of ED visits, ICU admissions, and inpatient stays were analyzed. Hospice referrals, hospital deaths, and ACP documents were also compared.&#x0D; &#x0D; Results:&#x0D; A T-test showed no difference between ED visits, ICU stays, or inpatient admissions between cohorts. A chi-square analysis also showed no difference in hospice referrals or hospital deaths. However, there were significantly more ACP documents on file for cohort A (p = 0.000132). This suggests that palliative oncology programs do not strongly affect hospital time or hospice referrals but may impact advanced care planning.&#x0D; &#x0D; Conclusion:&#x0D; Since the benefits of palliative oncology programs do not seem related to hospital time or hospice care, another factor must be responsible for improving patients’ quality of life. These programs emphasize family involvement and planning thus explaining the significant increase in ACP documents. Perhaps this extra support and preparedness also improves patients’ moods and well-being.&#x0D; &#x0D; Impact:&#x0D; Future studies should involve a larger sample size and focus on psychological aspects of these programs to determine why they benefit patient health, specifically mental health, and what improvements can be made.

Efficacy of early interdisciplinary palliative care based on WARM model in non-small-cell lung cancer

Objective: To assess the therapeutic effect of the early interdisciplinary palliative care based on WARM model (whole, assessment, revaluation, management) on the quality of life, psychological state, pain and nutritional status in patients with non-small-cell lung cancer (NSCLC). Methods: A total of 60 patients from Chongqing University Cancer Hospital with newly diagnosed advanced NSCLC from Oct 15, 2019 to Jun 12, 2020 were enrolled. According to the method of random number table, the patients were divided into two groups: standard oncologic care group (SC, n=30) and early palliative care group (EPC, n=30). SC group only received standard oncological care, while EPC group received standard oncological care and additional comprehensive treatment from a MDT consisted of medical oncologists, palliative care nurses, dietitians and psychologists. The quality of life [functional assessment of cancer therapy-lung (FACT-L) scale], psychological state [hospital anxiety and depression scale (HADS) and patient health questionnaire-9 (PHQ-9)], nutritional status [patient-generated subjective global assessment (PG-SGA)], and cancer pain status [numerical rating scale (NRS)] were observed and compared between the two groups before and after the 6 months treatment, respectively. Results: A total of 45 patients completed 6 months treatment, including 24 males and 21 females, aged 38-82 (60.5±1.7), with 23 patients in the EPC group and 22 patients in the SC group. Patients assigned to EPC group had a better quality of life than those assigned to SC group [FACT-L scale: (122.3±1.6) vs (111.8±2.1), P<0.001]. Fewer patients had anxiety and depressive symptoms in the EPC group than those in the SC group [HADS anxiety subscale: (1.1±0.3) vs (2.9±0.4), P<0.001; HADS depression subscale: (0.7±0.3) vs (3.6±0.4), P<0.001]. The PHQ-9 results showed that 100.0% (23/23) patients were free of depression in the EPC group, while 45.5% (10/22) patients were free of depression in SC group (P<0.001). Furthermore, patients in the EPC group had a better nutritional status [moderate malnutrition: 60.9% (14/23); no malnutrition: 39.1% (9/23)] than those in the SC group [severe malnutrition: 40.9% (9/22); moderate malnutrition: 50.0% (11/22); no malnutrition: 9.1% (2/22)] (P<0.001). There was no significant difference in NRS score between EPC group and SC group (P=0.140). Conclusion: Early interdisciplinary palliative care based on WARM model can improve the quality of life, psychological state and nutritional status in NSCLC patients.

Randomized controlled trial of geriatric consultation versus standard care in older adults with hematologic malignancies.

We conducted a randomized controlled trial in older adults with hematologic malignancies to determine the impact of geriatrician consultation embedded in our oncology clinic alongside standard care. From February 2015 to May 2018, transplant-ineligible patients aged ≥75 years who presented for initial consultation for lymphoma, leukemia, or multiple myeloma at Dana-Farber Cancer Institute (Boston, MA, USA) were eligible. Pre-frail and frail patients, classified based on phenotypic and deficit-accumulation approaches, were randomized to receive either standard oncologic care with or without consultation with a geriatrician. The primary outcome was 1-year overall survival. Secondary outcomes included unplanned care utilization within 6 months of follow-up and documented end-of-life (EOL) goals-of-care discussions. Clinicians were surveyed as to their impressions of geriatric consultation. One hundred sixty patients were randomized to either geriatric consultation plus standard care (n=60) or standard care alone (n=100). The median age of the patients was 80.4 years (standard deviation = 4.2). Of those randomized to geriatric consultation, 48 (80%) completed at least one visit with a geriatrician. Consultation did not improve survival at 1 year compared to standard care (difference: 2.9%, 95% confidence interval: -9.5% to 15.2%, P=0.65), and did not significantly reduce the incidence of emergency department visits, hospital admissions, or days in hospital. Consultation did improve the odds of having EOL goals-of-care discussions (odds ratio = 3.12, 95% confidence interval: 1.03 to 9.41) and was valued by surveyed hematologic-oncology clinicians, with 62.9%-88.2% of them rating consultation as useful in the management of several geriatric domains.

Incorporating palliative care principles to improve patient care and quality of life in urologic oncology.

Palliative care — specialized healthcare focused on improving quality of life for patients with serious illnesses — can help urologists to care for patients with unmet symptom, coping and communication needs. Society guidelines from the American Society of Clinical Oncology and the National Comprehensive Cancer Network recommend incorporating palliative care into standard oncological care, based on multiple randomized trials demonstrating that it significantly improves physical well-being, patient satisfaction and goal concordant care. Misconceptions regarding the objective and ideal timing of palliative care are common; a key concept is that palliative care and treatments seeking to cure or prolong life are not mutually exclusive. Urologists are well positioned to champion the integration of palliative care into surgical urologic oncology and should be aware of palliative care guidelines, indications for palliative care use and how the field of urologic oncology can adopt best practices.

ACCEPT®: A Complementary Anthroposophical Program for the Palliative Treatment of Lung Cancer – Rationale and a Randomized Feasibility Study

Background: Lung cancer is the oncological disease with the highest mortality worldwide. Health-related quality of life is severely compromised in the majority of patients. While the efficacy of early palliative psychosocial therapy has been demonstrated in several recent studies, appropriate therapy modules could so far not be integrated into daily practice of care. Therefore, an additive multimodal treatment concept for oncological centers was drafted: the Additive anthroposophic integrative medicine Cancer Concept of Early supportive or Palliative lung cancer Treatment (ACCEPT®). Patients and Methods: The first module consisted of a 3-month health education program, the second module was a concept of psychosocial interventions, and the third module was a supervised home training program. Between 2017 and 2018, 20 lung cancer patients (UICC IIIB/IV) were included and randomly assigned to treatment (n = 10) or a waiting control group (n = 10). The treatment group started ACCEPT® for 3 months immediately after diagnosis and received also standard oncological care (SOC) while the waiting control group received SOC only for 3 months, followed by ACCEPT® after this period. Health-related quality of life, disease management, disease-specific symptoms, and feasibility of the ACCEPT® were monitored at 4 time points. Results: 7 out of 10 patients in the treatment group (3 dropped out) and 6 out of 10 in the waiting control group (4 died during the intervention) completed treatment. Discussion/Conclusion: Lung cancer patients with high symptom load may benefit from ACCEPT®. The feasibility of this adjunctive therapy was demonstrated. The combination of SOC and ACCEPT® is feasible and applicable to a heterogeneous patient group and should be further evaluated with respect to efficacy and dosing.

Abstract 576: A single institution experience with Guardant360 liquid biopsy for therapeutic decision in advanced solid tumors

Abstract Background: Analysis of genomic alterations in advanced malignant disease is quickly becoming the standard of care in oncology. Biopsies are risky, often costly and may not capture genetic changes that can emerge over time or in response to therapy. In contrast, GUARDANT360, a blood-based liquid biopsy (LB) approach that analyzes circulating tumor DNA (ctDNA), offers a simple and comprehensive tool for real-time tumor NGS (next generation sequencing) genetic profiling in advanced refractory cancer patients. Methods: We studied the performance of GUARDANT360 in several advanced solid cancers already refractory to conventional therapy. GUARDANT360 is a single-molecule next-generation digital sequencing assay with ability to detect somatic mutations, gene fusions and copy number variations with exquisite sensitivity. The assay covers sequences across a total of 74 actionable genes covering approximately 80 kbps and it also detects MSI (microsatellite instability). Thus, therapeutic decisions were made on the basis of ctDNA actionable alterations detected. A total of 90 plasma samples (2 for each patient) of 45 patients with advanced solid tumors and refractory to convencional therapy were studied. Results: The overall detection rate of somatic pathogenic variants potentially actionable (PVPA) in ctDNA approached 64% (29 patients) for all indications (the range of detectable ctDNA mutations was 0.03%-57%). The total number of PVPA in all 29 patients was 50 as follows. CRC( Colorectal Cancer): 12 (27%) tested, in 10 we found 23 PVPA: KRAS - 4, MSI-H -1, ATM - 2, FGFR1(amp)- 1, PIK3CA - 3, BRCA1 - 1, BRCA2 - 2, APC - 4, PTEN - 1, MTOR - 1, NF1 - 1, BRAF - 1, MAP2K1 - 1. Pancreatic cancer: 7 (16%) tested, in 3 we found 4 PVPA: STK11 - 1, AKT1 - 1, APC - 1, FGFR1 amp- 1. NSCLC(Non-Small Cell Lung Adenocarcinoma): 6(14%) tested, in 4 we found 4 PVPA: ALK-EML4 fusion - 1, ERBB2 (G776 Delins VC) - 1, ATM -2. Ovarian cancer: 3(7%) tested, in 3 we found 3 PVPA: BRCA1 - 1, PIK3CA - 2. Breast cancer: 4(9%) tested, in 3 we found 7 PVPA: ESR1 - 2, PIK3CA -1, FGFR1 amp -2, ERBB2 amp -1, CCND1 - 1. Head and Neck cancers: 2(4.5%) tested, in 1 we found 3 PVPA: PTEN - 1, PIK3CA - 1, FGFR1 amp - 1. CUP (carcinoma of unknown primary): 2 (4.5%) tested, in 2 we found 2 PVPA: CDK6 - 1, FGFR1 amp - 1. Renal cancer: 1 tested, in 1 we found 2 PVPA: NF1 - 1, JAK2 -1. Prostate cancer: 1 (2%) tested, in 1 we found 1 PVPA: AR. NET (neuroendocrine tumor): 1 (2%) tested, in 1 we found 1 PVPA: ATM. We also tested 1(1%) gallbladder, 1(1%) GIST, 1(1%) endometrial 1(1%) duodenal, 1(1%) SCLC (Small Cell Lung Cancer) and 1(1%) sarcoma and no PVPA were found. Conclusion: Our results suggest that GUARDANT360 LB is a highly feasible, comprehensive and sensitive LB technology and should be used for a routine laboratory detection of the important genomic variations to determine the targeted therapy in patients with varied advanced solid tumors with with clear benefits compared to tissue diagnosis. Citation Format: Andre Marcio Murad, José Claudio Casali da Rocha. A single institution experience with Guardant360 liquid biopsy for therapeutic decision in advanced solid tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 576.

Implementation of a Palliative Oncology Tumor Board

ContextThe integration of palliative care into standard oncologic care has been shown to improve multiple outcomes in patients with advanced cancer. Ideal methods for integrating these disciplines is an ongoing area of discussion. One method of integration is a palliative oncology tumor board (POTB). ObjectivesTo describe the implementation of a POTB in a community cancer center as a method of integrating oncology and palliative care by providing a forum for multidisciplinary discussion of complex cases. MethodsDuring development of the POTB, multiple influencing factors and barriers were considered including the setting of implementation, culture prior to implementation, design elements, engagement of stakeholders, and evaluation of implementation. The focus of this POTB was to address the identified communication gap between inpatient and outpatient care teams. Two complex hospitalized oncology patients were selected to be discussed weekly. ResultsConferences were attended by an average of 23 individuals. The highest proportion of attendees were members of oncology support services (including nurse navigators, social workers, chaplains, dietitians, financial counselors; OSS; 31%), followed by medical oncology (25%). The most common theme of discussion was methods of communication with patient and/or family (68% of cases). Thirty days after presentation, a total of 50 new referrals were placed to inpatient palliative care, OSS, and outpatient palliative care and 11 new advance care plans were documented in the electronic medical record. ConclusionThis paper describes a sustainable method to implement a POTB in a community cancer center setting, which is one method of integrating palliative care into standard oncologic care.

The efficacy of group cognitive behavioural therapy in improving adaptive cognitive emotion regulation in Nigerian breast cancer patients

AbstractThe burden of cancer and psychological distress resulting from cancer‐related experiences may have an impact on women's cognitive emotion regulation. The study investigated the efficacy of a 12‐week group cognitive behavioural therapy (GCBT) programme in enhancing adaptive cognitive emotion regulation (CER) in women with breast cancer at a tertiary healthcare institution in Nigeria. Thirty‐one (31) women with breast cancer were randomly allocated to the treatment group (TG, N = 16) and a control group (CG, N = 15). The TG received a 12‐week course of 90‐min GCBT sessions, while the CG received a booklet containing information on cancer and how to deal with cancer. Assessments were carried out for both groups at the baseline (pretest), post‐test and 2‐month follow‐up with the Cognitive Emotion Regulation Questionnaire. Data were analysed with the independent‐samples t test and the chi‐square test for continuous and categorical variables, respectively. The results showed that participants in the TG had a significant increase in adaptive CER and decrease in maladaptive CER compared with the CG both at post‐treatment and at 2‐month follow‐up. Cognitive behavioural therapy is effective in the improvement of adaptive CER in women with breast cancer. The use of psychotherapy (such as CBT) as complementary treatment to standard oncology care in the management of breast cancer patients in Nigeria is therefore emphasised.

A randomized trial of medical cannabis in patients with stage IV cancers to assess feasibility, dose requirements, impact on pain and opioid use, safety, and overall patient satisfaction.

The prevalence of medical cannabis (MC) use in patients with cancer is growing, but questions about safety, efficacy, and dosing remain. Conducting randomized, controlled trials (RCTs) using state-sponsored MC programs is novel and could provide data needed to guide patients and providers. A pilot RCT of patients with stage IV cancer requiring opioids was conducted. Thirty patients were randomized 1:1 to early cannabis (EC, n = 15) versus delayed start cannabis (DC, n = 15). The EC group obtained 3months (3M) of MC through a state program at no charge, while the DC group received standard oncology care without MC for the first 3M. Patients met with licensed pharmacists at one of two MC dispensaries to determine a suggested MC dosing, formulation, and route. Patients completed surveys on pain levels, opioid/MC use, side effects, and overall satisfaction with the study. Interest in the study was high as 36% of patients who met eligibility criteria ultimately enrolled. The estimated mean daily THC and CBD allotments at 3M were 34mg and 17mg, respectively. A higher proportion of EC patients achieved a reduction in opioid use and improved pain control. No serious safety issues were reported, and patients reported high satisfaction. Conducting RCTs using a state cannabis program is feasible. The addition of MC to standard oncology care was well-tolerated and may lead to improved pain control and lower opioid requirements. Conducting larger RCTs with MC in state-sponsored programs may guide oncology providers on how to safely and effectively incorporate MC for interested patients.

Acceptability and Feasibility of Early Palliative Care Among Women with Advanced Epithelial Ovarian Cancer: A Randomized Controlled Pilot Study.

To evaluate the acceptability of early palliative care (EPC) among patients with advanced ovarian cancer and to determine the feasibility of larger-scale phase III trials. We performed a randomized controlled pilot study of adult women (>18 years) with pathologically confirmed epithelial ovarian cancer that had recurred or progressed on first-line therapy and had no immediate need for palliative care. We randomly assigned patients to either EPC or standard oncologic care (SOC), and collected patient-reported outcomes (PRO) at baseline, 3 months, and 6 months; end-of-life care quality indicators were collected at study completion. Study endpoints were rates of enrollment, EPC adherence, and PRO completion. Of 32 eligible patients approached, 23 enrolled (72%; 95% CI 53-86) and were randomly assigned to either EPC (n = 12) or SOC (n = 11). At baseline, participants had poor physical and emotional wellbeing, high rates of depression (65%), and understood that their disease was not curable (87%). Eleven patients (92%; 95% CI 62-100) attended their EPC consultation, and all visits took place within 4 weeks of enrollment. However, PRO completion was low due to deaths by 3 (5/23) and 6 months (9/23). Patients had accurate perceptions of their disease status, were willing to be randomly assigned to EPC, and attended scheduled appointments. However, a definitive trial in this group is not feasible without major adjustments to eligibility criteria and a multicentre, international effort. We propose that EPC be considered routinely at progression or recurrence given patients' symptom burden and clear acceptance of the intervention, as well as evidence of benefit from adequately powered trials in other malignancies.

The impact of early palliative care on the quality of life of patients with advanced pancreatic cancer: The IMPERATIVE study.

12116 Background: Pancreatic cancer (PDAC) is an aggressive, deadly disease. Chemotherapy (CT) can improve survival by months, but symptom burden is heavy and quality of life (QOL) is poor. Early palliative care (EPC) alongside standard oncologic care improves QOL and survival in other types of cancer; however, the impact on QOL and symptom burden in advanced PDAC is not known. The primary objective of this study was to test for improvement in QOL between baseline (BL) and 16 weeks (wks) among patients receiving EPC. A secondary objective was to test for decreased symptom burden between BL and 16 wk. Methods: In this prospective case-crossover study, patients &gt;18 years with advanced PDAC received EPC provided by a subspecialist palliative care physician and advanced practice nurse plus standard oncologic care. Ambulatory EPC visits occurred every 2 wks for the first month, then every 4 wks until wk 16, and then as needed. The Functional Assessment of Cancer Therapy – hepatobiliary (FACT-hep) and Edmonton Symptom Assessment System (ESAS) questionnaires were completed at enrollment and every 4 wks until wk 16. Least square means and 95% confidence intervals were computed. A generalized linear mixed model was used to test for statistically significant change in scores between BL and wk 16. A sample size of 20 patients provides 80% power after controlling for covariates; 40 patients were enrolled to account for anticipated attrition and missing data. Results: Of 40 patients, 25 (62.5%) were male, 28 (70%) had metastatic disease, 31 (77.5%) had an ECOG performance status of 0-1, 17 (42.5%) had a body mass index (BMI) &gt;25, 35 (89.7%) had an elevated CA19-9 and 31 (77.5%) received CT. Median age was 70.2 (range 63.0-77.5). BL and wk 16 questionnaires were completed by 100% and 70% of patients, respectively. The mean FACT-hep score at BL was 118.8, compared to 125.7 at wk 16, for a mean change of 6.89, [95%CI (-1.69-15.6); p = 0.11]. The mean change from BL to wk 16 for FACT-hep was statistically significant in patients receiving CT, 10.1 [95%CI (0.32-19.8); p = 0.04], patients with metastatic disease, 14.7 [95%CI (5.30-24.1); p = 0.0030] and patients with a BMI &gt;25, 12.5 [95%CI (1.29-23.7); p = 0.03]. The mean ESAS total symptom score at BL was 25.3, compared to 22.7 at wk 16 (p = 0.28). In those with metastatic disease the mean change was statistically significant, -5.73 [95%CI (-11.21 to -0.24); p = 0.04]. Conclusions: EPC resulted in improved QOL in pts with PDAC receiving CT and those with a BMI &gt;25, and improved QOL and symptom burden in patients with metastatic disease. Given minimal attrition and high rates of questionnaire completion, our sample size was robust, resulting in strong power. Providing palliative care alongside standard oncologic care results in clinically meaningful improvements. Access to palliative care, shortly after diagnosis, should be available for patients with advanced PDAC. Clinical trial information: NCT03837132.

Early, integrated palliative rehabilitation improves quality of life of patients with newly diagnosed advanced cancer: The Pal-Rehab randomized controlled trial

Background: Early integration of palliative care into oncology treatment is widely recommended. Palliative rehabilitation has been suggested as a paradigm which integrates enablement, self-management, and self-care into the holistic model of palliative care. Aim: We hypothesized that early integration of palliative rehabilitation could improve quality of life. Design: The Pal-Rehab study (ClinicalTrials.gov NCT02332317) was a randomized controlled trial. The 12-week intervention offered by a specialized palliative care team was two mandatory consultations and the opportunity of participating in an interdisciplinary group program. Supplementary individual consultations were offered, if needed. Setting/participants: At Vejle University Hospital, Denmark, adults diagnosed with advanced cancer within the last 8 weeks were randomized 1:1 to standard oncology care or standard care plus intervention. Assessments at baseline and after six and 12 weeks were based on the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). At baseline participants were asked to choose a “primary problem” from a list of QLQ-C30 domains. The primary endpoint was the change in that “primary problem” measured as area under the curve across 12 weeks (T-scores, European mean value = 50, SD = 10). Results: In all, 288 were randomized of whom 279 were included in the modified intention-to-treat analysis (146 in the standard care group and 133 in the intervention group). The between-group difference for the primary outcome was 3.0 (95% CI [0.0–6.0]; p = 0.047) favoring the intervention. Conclusion: Early integration of palliative rehabilitation into standard oncology treatment improved quality of life for newly diagnosed advanced cancer patients. Trial registration: Clinicaltrials.gov Identifier: NCT02332317, registered on December 30, 2014.

Patterns of integrating palliative care into standard oncology in an early ESMO designated center: a 10-year experience

BackgroundIntegration of specialist palliative care (PC) into standard oncology care is recommended. This study investigated how integration at the Cantonal Hospital St. Gallen (KSSG) was manifested 10 years after initial accreditation as a European Society for Medical Oncology (ESMO) Designated Center (ESMO-DC) of Integrated Oncology and Palliative Care.MethodsA chart review covering the years 2006-2009 and 2016 was carried out in patients with an incurable malignancy receiving PC. Visual graphic analysis was utilized to identify patterns of integration of PC into oncology based on the number and nature of medical consultations recorded for both specialties. A follow-up cohort collected 10 years later was analyzed and changes in patterns of integrating specialist PC into oncology were compared.ResultsThree hundred and forty-five patients from 2006 to 2009 and 64 patients from 2016 were included into analyses. Four distinct patterns were identified using visual graphic analysis. The ‘specialist PC-led pattern’ (44.9%) and the ‘oncology-led pattern’ (20.3%) represent disciplines that took primary responsibility for managing patients, with occasional and limited involvement from other disciplines. Patients in the ‘concurrent integrated care pattern’ (18.3%) had medical consultations that frequently bounced between specialist PC and oncology. In the ‘segmented integrated care pattern’ (16.5%), patients had sequences of continuous consultations provided by one discipline before alternating to a stretch of consultations provided by the other specialty. In the 2016 follow-up, while the ‘oncology-led pattern’ occurred significantly less frequently relative to the ‘specialist PC-led pattern’ and the ‘segmented integrated care pattern’, the ‘concurrent integrated care pattern’ emerged more frequently when compared with the 2006-2009 follow-up.ConclusionThe ‘specialist PC-led pattern’ was the most prominent pattern in this data. The 2016 follow-up showed that a growing number of patients received a collaborative pattern of care, indicating that integration of specialist PC into standard oncology can manifest as either segmented or concurrent care pathways. Our data suggest a closer, more dynamic and flexible collaboration between oncology and specialist PC early in the disease course of patients with advanced cancer and concurrent with active treatment.

Palliative care in day-hospital for advanced cancer patients: a study protocol for a multicentre randomized controlled trial

BackgroundTeam-based and timely integrated palliative care is a gold standard of care in oncology, but issues concerning its optimal organization remain. Palliative Care in Day-Hospital (PCDH) could be one of the most efficient service model of palliative care to deliver interdisciplinary and multidimensional care addressing the complex supportive care needs of patients with advanced cancer. We hypothesize that, compared to conventional outpatient palliative care, PCDH allows the clinical benefits of palliative care to be enhanced.Methods/designThis study is a multicentre parallel group trial with stratified randomization. Patient management in PCDH will be compared to conventional outpatient palliative care. The inclusion criteria are advanced cancer patients referred to a palliative care team with an estimated life expectancy of more than 2 months and less than 1 year. The primary endpoint is health-related quality of life with deterioration-free survival based on the EORTC QLQ-C30 questionnaire. The secondary objectives are the following: increase in patient satisfaction with care using the EORTC PATSAT-C33 and OUT-PATSAT7 questionnaires, better understanding of the prognosis using the PTPQ questionnaire and advance care planning; decrease in the need for supportive care among relatives using the SCNS-P&C-F questionnaire, and reduction in end-of-life care aggressiveness. Patients will complete one to five questionnaires on a tablet before each monthly visit over 6 months and will be followed for 1 year. A qualitative study will take place, aiming to understand the specificity of palliative care management in PCDH. Cost-effectiveness, cost-utility and, an additional economic evaluation based on capability approach will be conducted from a societal point of view.DiscussionThe first strength of this study is that it combines the main relevant outcomes assessing integrated palliative care; patient quality of life and satisfaction; discussion of the prognosis and advance care planning, family well-being and end-of-life care aggressiveness. The second strength of the study is that it is a mixed-method study associating a qualitative analysis of the specificity of PCDH organization, with a medical-economic study to analyse the cost of care.Trial registrationName of the registry: IDRCB 2019-A03116–51Trial registration number:NCT04604873Date of registration: October 27, 2020URL of trial registry record