PALLiative care in ONcology (PALLiON): A cluster-randomised trial investigating the effect of palliative care on the use of anticancer treatment at the end of life.

BACKGROUND: Effects on anticancer therapy following the integration of palliative care and oncology are rarely investigated. Thus, its potential effect is unknown. AIM: To investigate the effects of the complex intervention PALLiON versus usual care on end-of-life anticancer therapy. DESIGN: Cluster-randomised controlled trial (RCT), registered at ClinicalTrials.gov (No. NCT01362816). The complex intervention consisted of a physician education program enhancing theoretical, clinical and communication skills, a patient-centred care pathway and patient symptom reporting prior to all consultations. Primary outcome was overall use, start and cessation of anticancer therapy in the last 3 months before death. Secondary outcomes were patient-reported outcomes. Mixed effects logistic regression models and Cox proportional hazard were used. SETTING: A total of 12 Norwegian hospitals (03/2017-02/2021). PARTICIPANTS: Patients ⩾18 years, advanced stage solid tumour, starting last line of anticancer therapy, estimated life expectancy ⩽12 months. RESULTS: A total of 616 (93%) patients were included (intervention: 309/control:307); 63% males, median age 69, 77% had gastrointestinal cancers. Median survival time from inclusion was 8 (IQR 3-14) and 7 months (IQR 3-12), and days between anticancer therapy start and death were 204 (90-378) and 168 (69-351) (intervention/control). Overall, 78 patients (13%) received anticancer therapy in the last month (intervention: 33 [11%]/control: 45 [15%]). No differences were found in patient-reported outcomes. CONCLUSION: We found no significant differences in the probability of receiving end-of-life anticancer therapy. The intervention did not have the desired effect. It was probably too general and too focussed on communication skills to exert a substantial influence on conventional clinical practice.

A complex communication skills training program for physicians providing advanced cancer care - content development and barriers and solutions for implementation.

Background: Early integration of oncology and patient-centered palliative care is the recommended clinical practice model for patients with advanced cancer. General and specific communication skills are necessary to achieve integrated patient-centered care, but require organized training to be adequately mastered. Challenges and barriers on several levels, i.e. organizational, professional and individual may, however, hamper implementation. The development, implementation, and evaluation of such an educational program focusing on communication skills contain many steps, considerations and lessons learned, which are described in this article.Methods: A multi-professional faculty developed, implemented, and evaluated an educational program through a 5-step approach. The program was part of a Norwegian cluster-randomized controlled trial aiming to test the effect of early integration of oncology and palliative care for patients with advanced cancer.Results: The result is the PALLiON educational program; a multi-faceted, evidence-based, and learner-centered program with a specific focus on physicians' communication skills. Four modules were developed: lectures, discussion groups, skills training, and coaching. These were implemented at the six intervention hospitals using different teaching strategies. Evaluation in a subgroup of participants showed a positive appraisal of the group discussions and skills training.Conclusion:We present our experiences and reflections regarding implementation and lessons learned, which should be considered in future developments and implementations; (1) Include experienced faculty with various backgrounds, (2) Be both evidence-based and learner-centered, (3) Choose teaching strategies wisely, (4) Expect resistance and skepticism, (5) Team up with management and gatekeepers, (6) Expect time to fly, and (7) Plan thorough assessment of the evaluation and effect.Trial registration: ClinicalTrials.gov identifier: NCT03088202.

Using Process Indicators to Monitor Documentation of Patient-Centred Variables in an Integrated Oncology and Palliative Care Pathway-Results from a Cluster Randomized Trial.

BACKGROUND: Despite robust evidence from randomized controlled trials (RCTs) demonstrating clinical and patient-reported benefits of integrated oncology and palliative care, the tumour-centred focus is predominant. This single-centre process evaluation monitors documentation of required patient-centred variables during an RCT. METHODS: Performance status, patient self-reported symptoms, weight and summaries to general practitioners were assessed from June 2017 to July 2020 in three consultation types: first oncological after study inclusion and palliative and oncological consultations during chemotherapy. Descriptive statistics were used to monitor if the pre-defined program fulfilment of ≥85% documentation was reached. RESULTS: 435 consultations were monitored in 76 patients; 60.5% males, 86.8% with GI cancers; 76 (17.5%) were from the first oncological consultations, 87 (20.0%) and 272 (62.5%) from palliative or subsequent oncological consultations. Program fulfilment differed across consultation types with 94.8% in the palliative consultations (83.3-100%), relative to 65.8% (62.5-75.0%) and 69.2% (57.0-84.3%) for first and subsequent oncological consultations over time, respectively. Use of self-reported symptoms was consistently lower in the oncological consultations. CONCLUSIONS: The documentation level of required core variables was not satisfactory, notwithstanding their high clinical relevance and continuous reminders during study. Pre-trial optimization strategies are paramount to promote integration and reduce professional and personal barriers towards a more patient-centred focus.

PALLiON - PALLiative care Integrated in ONcology: study protocol for a Norwegian national cluster-randomized control trial with a complex intervention of early integration of palliative care.

BACKGROUND: Several publications have addressed the need for a systematic integration of oncological care focused on the tumor and palliative care (PC) focused on the patient with cancer. The exponential increase in anticancer treatments and the high number of patients living longer with advanced disease have accentuated this. Internationally, there is now a persuasive argument that introducing PC early during anticancer treatment in patients with advanced disease has beneficial effects on symptoms, psychological distress, and survival. METHODS: This is a national cluster-randomized trial (C-RCT) in 12 Norwegian hospitals. The trial investigates effects of early, systematic integration of oncology and specialized PC in patients with advanced cancer in six intervention hospitals compared with conventional care in six. Hospitals are stratified on the size of local catchment areas before randomization. In the intervention hospitals, a three-part complex intervention will be implemented. The backbone of the intervention is the development and implementation of patient-centered care pathways that contain early, compulsory referral to PC and regular and systematic registrations of symptoms. An educational program must be completed before patient inclusion. A total of 680 patients with advanced cancer and one caregiver per patient are included when patients come for start of last line of chemotherapy, defined according to national treatment guidelines. Data registration, clinical variables, and patient- and caregiver-reported outcomes take place every 2 months for 1 year or until death. The primary outcome is use of chemotherapy in the last 3 months of life by comparing the proportion of patients who receive this in the intervention and control groups. Primary outcome is use of chemotherapy in the last 3 months before death, i.e. number of patients. Secondary outcomes are initiation, discontinuation and number of cycles, last 3 months of life, administration of other medical interventions in the last month of life, symptom burden, quality of life (QoL), satisfaction with information and follow-up, and caregiver health, QoL, and satisfaction with care. DISCUSSION: Results from this C-RCT will be used to raise the awareness about the positive outcomes of early provision of specialized palliative care using pathways for patients with advanced cancer receiving medical anticancer treatment. The long-term clinical objective is to integrate these patient-centered pathways in Norwegian cancer care. The specific focus on the patient and family and the organization of a predictable care trajectory is consistent with current Norwegian strategies for cancer care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03088202. Registered on 23 March 2017.

Challenges and Learning Needs for Providers of Advanced Cancer Care: Focus Group Interviews with Physicians and Nurses.

Background: Implementation of integrated oncology and palliative care improves patient outcomes but may represent a demanding task for health care providers (HCPs). Objective: To explore physicians' and nurses' perceived challenges and learning needs in their care for patients with advanced cancer, and to analyze how these perceptions can provide insight on how to improve care for patients with advanced cancer in an integrated care model. Methods: Residents in oncology, oncologists, nurses, and palliative care physicians were recruited to participate in focus group interviews. Six focus group interviews were conducted with 35 informants. Data were analyzed according to principles of thematic analysis. Results: The discussions in the interviews concerned three broad themes: an emphasis on patients' best interest, perceived as hindered by two sets of barriers; unsatisfactory organizational conditions such as time pressure, lack of referral routines, and few arenas for interdisciplinary collaboration, was perceived as one barrier. The other barrier was related to the appraisal of other HCPs' clinical practices. Participating HCPs expressed in general a positive self-view, but were more critical of other HCPs. Conclusion: Currently, implementation of measures to improve care for patients with advanced cancer appears to be challenging due to cultural and organizational factors, and how HCPs perceive themselves and other HCPs. HCPs' perception of challenges in patient care as not related to themselves (externalization) might be an essential obstacle. Interventions targeting both HCP-related and organizational factors are needed. Particularly important are measures aimed at reducing fragmentation and improving collaboration in care.

Symptom profiles and palliative care in advanced pancreatic cancer: a prospective study.

OBJECTIVES: To describe prospectively the prevalence and severity of disease-related symptoms, quality of life (QOL) and need for palliative care in patients with advanced pancreatic cancer. PATIENTS AND METHODS: Fifty-one patients treated for advanced pancreatic cancer filled in the Edmonton Symptom Assessment Scale (ESAS) for symptom registration and the EORTC QLQ-C30 and QLQ-PAN26 quality of life questionnaires at first contact (baseline) and the ESAS in the following consultations. Need for palliative interventions were registered. RESULTS: Of the 22 women and 29 men (mean age, 62 years), 20 had locally unresectable cancer, 19 had metastatic disease, and 12 had recurrent disease after curative resection. Forty-six patients died during follow-up (median survival, 99 days). At baseline, patients reported significantly impaired QOL on nine of 15 scales/items (p<0.01) relative to the general population. Fatigue, loss of appetite, and impaired sense of well-being were the most troublesome symptoms on the ESAS, measured to 4.4(+/-2.8)/5.3(+/-2.3), 4.4(+/-3.2)/5.9(+/-2.7), and 4.0(+/-2.9)/4.6(+/-2.7) (mean+/-SD) at baseline and 8 weeks before death, respectively. Forty-four of the 51 (86%) initial consultations and 107 (58%) of the 185 follow-ups (124 clinical and 61 phone-calls) resulted in palliative care interventions, most frequently changes in opioid or laxative medication and dietary advice. CONCLUSIONS: Patients with advanced pancreatic cancer develop several distressing symptoms. ESAS was useful for assessment of symptom prevalence and intensity and is a clinically adequate method for symptom control. A multidisciplinary approach is necessary for the best palliation of symptoms at the time of diagnosis and during follow-up.