Marie Bakitas

Effects of a Palliative Care Intervention on Clinical Outcomes in Patients With Advanced Cancer: The Project ENABLE II Randomized Controlled Trial

CONTEXT There are few randomized controlled trials on the effectiveness of palliative care interventions to improve the care of patients with advanced cancer. OBJECTIVE To determine the effect of a nursing-led intervention on quality of life, symptom intensity, mood, and resource use in patients with advanced cancer. DESIGN, SETTING, AND PARTICIPANTS Randomized controlled trial conducted from November 2003 through May 2008 of 322 patients with advanced cancer in a rural, National Cancer Institute-designated comprehensive cancer center in New Hampshire and affiliated outreach clinics and a VA medical center in Vermont. INTERVENTIONS A multicomponent, psychoeducational intervention (Project ENABLE [Educate, Nurture, Advise, Before Life Ends]) conducted by advanced practice nurses consisting of 4 weekly educational sessions and monthly follow-up sessions until death or study completion (n = 161) vs usual care (n = 161). MAIN OUTCOME MEASURES Quality of life was measured by the Functional Assessment of Chronic Illness Therapy for Palliative Care (score range, 0-184). Symptom intensity was measured by the Edmonton Symptom Assessment Scale (score range, 0-900). Mood was measured by the Center for Epidemiological Studies Depression Scale (range, 0-60). These measures were assessed at baseline, 1 month, and every 3 months until death or study completion. Intensity of service was measured as the number of days in the hospital and in the intensive care unit (ICU) and the number of emergency department visits recorded in the electronic medical record. RESULTS A total of 322 participants with cancer of the gastrointestinal tract (41%; 67 in the usual care group vs 66 in the intervention group), lung (36%; 58 vs 59), genitourinary tract (12%; 20 vs 19), and breast (10%; 16 vs 17) were randomized. The estimated treatment effects (intervention minus usual care) for all participants were a mean (SE) of 4.6 (2) for quality of life (P = .02), -27.8 (15) for symptom intensity (P = .06), and -1.8 (0.81) for depressed mood (P = .02). The estimated treatment effects in participants who died during the study were a mean (SE) of 8.6 (3.6) for quality of life (P = .02), -24.2 (20.5) for symptom intensity (P = .24), and -2.7 (1.2) for depressed mood (P = .03). Intensity of service did not differ between the 2 groups. CONCLUSION Compared with participants receiving usual oncology care, those receiving a nurse-led, palliative care-focused intervention addressing physical, psychosocial, and care coordination provided concurrently with oncology care had higher scores for quality of life and mood, but did not have improvements in symptom intensity scores or reduced days in the hospital or ICU or emergency department visits. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00253383.

Patients' Need for Information About Cancer Therapy

PURPOSE/OBJECTIVES To obtain detailed information about the preferences of patients with cancer and their need for information about side effects of cancer treatment to design an interactive multimedia educational program. DESIGN Qualitative. SETTING Regional rural academic medical center. SAMPLE 51 patients and 14 spouses of patients who either currently were undergoing or recently had completed chemotherapy or radiation therapy for cancer. METHODS Focus groups. MAIN RESEARCH VARIABLES Information needs and common and distressing symptoms. FINDINGS Patients wanted information about the process of getting treatment, specific side effects that might occur, and the impact of treatment on their lives. Patients sought information from a variety of sources, but many found that other patients were the most helpful source. Although most patients wanted as much information as possible so they would be prepared for whatever happened, some patients preferred to avoid information about possible side effects. Several obstacles related to information were reported, including access to providers, communication difficulties with providers, informational overload, and problems with retention. CONCLUSIONS Several aspects regarding information needs confirmed previous findings, and new aspects were illuminated. This led to a conclusion that multimedia technology offered many advantages to meet these informational needs. IMPLICATIONS FOR NURSING New approaches to patient education that will meet the needs of patients as well as clinicians and educators need to be developed.

Reliability and Validity of the Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) Scale

The Functional Assessment of Chronic Illness Therapy (FACIT) system provides a general, multidimensional measure of health-related quality of life (FACT-G) that can be augmented with disease or symptom-specific subscales. The 19-item palliative care subscale of the FACIT system has undergone little psychometric evaluation to date. The aim of this paper is to report the internal consistency, factor structure, and construct validity of the instrument using the palliative care subscale (FACIT-Pal). Two hundred fifty-six persons with advanced cancer in a randomized trial testing a palliative care psychoeducational intervention completed the 46-item FACIT-Pal at baseline. Internal consistency was greater than 0.74 for all subscales and the total score. Seventeen of the 19 palliative care subscale items loaded onto the four-factor solution of the established core measure (FACT-G). As hypothesized, total scores were correlated with measures of symptom intensity (r=-0.73, P<0.001) and depression (r=-0.75, P<0.001). The FACIT-Pal was able to discriminate between participants who died within three months of completing the baseline and participants who lived for at least one year after completing the baseline assessment (t=-4.05, P<0.001). The functional well-being subscale discriminated between participants who had a Karnofsky performance score of 70 and below and participants with a Karnofsky performance score of 80 and above (t=3.40, P<0.001). The findings support the internal consistency reliability and validity of the FACIT-Pal as a measure of health-related quality of life for persons with advanced cancer.

Proxy perspectives regarding end-of-life care for persons with cancer.

Each year, greater than a half million people die of cancer in the U.S. Despite progress in increasing access to palliative oncology services, end‐of‐life care still needs improvement. Measuring the quality of the end‐of‐life experience is difficult because of patient debility and reduced consciousness as death approaches. Family proxies have been proposed as valuable informants regarding the quality of end‐of‐life care. This article describes family proxy perspectives concerning care at the end of life in patients who died of advanced cancer.

Palliative Care Consultations for Heart Failure Patients: How Many, When, and Why?

OBJECTIVE In preparation for development of a palliative care intervention for patients with heart failure (HF) and their caregivers, we aimed to characterize the HF population receiving palliative care consultations (PCCs). METHODS AND RESULTS Reviewing charts from January 2006 to April 2011, we analyzed HF patient data including demographic and clinical characteristics, Seattle Heart Failure scores, and PCCs. Using Atlas qualitative software, we conducted a content analysis of PCC notes to characterize palliative care assessment and treatment recommendations. There were 132 HF patients with PCCs, of which 37% were New York Heart Association functional class III and 50% functional class IV. Retrospectively computed Seattle Heart Failure scores predicted 1-year mortality of 29% [interquartile range (IQR) 19-45] and median life expectancy of 2.8 years [IQR 1.6-4.2] years. Of the 132 HF patients, 115 (87%) had died by the time of the audit. In that cohort the actual median time from PCC to death was 21 [IQR 3-125] days. Reasons documented for PCCs included goals of care (80%), decision making (24%), hospice referral/discussion (24%), and symptom management (8%). CONCLUSIONS Despite recommendations, PCCs are not being initiated until the last month of life. Earlier referral for PCC may allow for integration of a broader array of palliative care services.

Patient perspectives on participation in the ENABLE II randomized controlled trial of a concurrent oncology palliative care intervention: Benefits and burdens:

Background: ENABLE (Educate, Nurture, Advise Before Life Ends) II was one of the first randomized controlled trials (RCTs) examining the effects of a concurrent oncology palliative care intervention on quality of life, mood, and symptom control for advanced cancer patients and their caregivers. However, little is known about how participants experience early palliative care and the benefits and burdens of participating in a palliative care clinical trial. Aim: To gain a deeper understanding of participants’ perspectives of the intervention and palliative care trial participation. Design: A qualitative descriptive study using thematic analysis to determine benefits and burdens of a new palliative care intervention and trial participation. Setting/participants: Of the 72 participants who were alive when the study commenced, 53 agreed to complete an in-depth, semi-structured interview regarding the ENABLE II intervention and clinical trial participation. Results: Participants’ perceptions of intervention benefits were represented by four themes: enhanced problem-solving skills, better coping, feeling empowered, and feeling supported or reassured. Three themes related to trial participation: helping future patients and contributing to science, gaining insight through completion of questionnaires, and trial/intervention aspects to improve. Conclusions: The benefits of the intervention and the positive aspects of trial participation outweighed trial “burdens”. This study raises additional important questions relevant to future trial design and intervention development: when should a palliative care intervention be initiated and what aspects of self-care and healthy living should be offered in addition to palliative content for advanced cancer patients when they are feeling well?

Palliative medicine and decision science: the critical need for a shared agenda to foster informed patient choice in serious illness.

Assisting patients and their families in complex decision making is a foundational skill in palliative care; however, palliative care clinicians and scientists have just begun to establish an evidence base for best practice in assisting patients and families in complex decision making. Decision scientists aim to understand and clarify the concepts and techniques of shared decision making (SDM), decision support, and informed patient choice in order to ensure that patient and family perspectives shape their health care experience. Patients with serious illness and their families are faced with myriad complex decisions over the course of illness and as death approaches. If patients lose capacity, then surrogate decision makers are cast into the decision-making role. The fields of palliative care and decision science have grown in parallel. There is much to be gained in advancing the practices of complex decision making in serious illness through increased collaboration. The purpose of this article is to use a case study to highlight the broad range of difficult decisions, issues, and opportunities imposed by a life-limiting illness in order to illustrate how collaboration and a joint research agenda between palliative care and decision science researchers, theorists, and clinicians might guide best practices for patients and their families.

DEVELOPING SUCCESSFUL MODELS OF CANCER PALLIATIVE CARE SERVICES

OBJECTIVES This article describes successful institutionally based programs for providing high-quality palliative care to persons with cancer and their family members. Challenges and opportunities for program development are also described. DATA SOURCES Published literature from 2000 to present describing concurrent oncology palliative care clinical trials, standards, and guidelines were reviewed. CONCLUSION Clinical trials have shown feasibility and positive outcomes and formed the basis for consensus guidelines that support concurrent oncology palliative care models. IMPLICATIONS FOR NURSING PRACTICE Oncology nurses should advocate for all patients with advanced cancer and their families to have access to concurrent oncology palliative care from the time of diagnosis with a life-limiting cancer.

Effect of early palliative care on depression and survival in patients with advanced cancer.

5 Background: We previously demonstrated improved depression and survival in advanced cancer patients participating in two palliative care (PC) RCTs: ENABLE II (EII; N=322) compared intervention vs. usual care, and ENABLE III (EIII; N=207) compared immediate vs. delayed intervention. The interventions were identical, except in EIII, the intervention included support for family caregivers and the delayed group began the intervention 12 weeks after enrollment. Both EII and EIII included an in-person PC consultation, weekly phone sessions facilitated by a nurse coach, and monthly follow-up calls. The Center for Epidemiologic Studies-Depression (CES-D) scale was collected at baseline and every 6 weeks until death or study completion. Our aim was to examine the moderating effects of baseline depression on the intervention effect and on survival outcomes in both RCTs. METHODS After combining data from the two RCTs the sample consisted of 529 patients. We conducted Cox proportional hazard analyses to examine the effect of the intervention (as a time-varying covariate) and baseline depression scores on subsequent survival. RESULTS The intervention significantly reduced mortality risk in this sample (Hazard Ratio [HR]= 0.78, CI: 0.63-0.98, p=.029). Adding baseline CES-D scores and the interaction of the intervention and CES-D scores as predictor variables yielded a significant interaction (HR= 0.97, p =.035) that remained after controlling for cancer type. Following this analysis, patients were classified as clinically depressed (baseline CES-D 16) or not, and Cox analyses were conducted using the intervention as the sole predictor within each depression group. Receiving the intervention significantly reduced mortality risk among clinically depressed patients (HR = 0.65, CI: 0.44-0.95, p =.029), but not among non-depressed patients (HR = 0.89, CI: 0.65-1.21, p >.45). CONCLUSIONS The ENABLE intervention improved survival in this combined sample of advanced cancer patients. The intervention effect on survival was moderated by baseline depression levels, such that patients who were depressed at baseline and received the intervention had a longer survival compared with non-depressed intervention patients.

Preliminary assessment of a neuropathic pain treatment and referral algorithm for patients with cancer.

CONTEXT The purpose of this case series study was to pilot test an evidence-based neuropathic pain (NP) treatment and referral algorithm for use by oncology nurses when managing cancer-related NP. OBJECTIVES The primary study objective was to assess patient-reported outcomes (pain severity, changes in activities of daily living, and satisfaction) resulting from algorithm use. METHODS Outpatients (n=20) with cancer-related NP scores ≥4 on a 0-10 numeric rating scale participated in the study. NP assessment, treatment, and referral to ancillary providers were guided by an evidence-based NP algorithm that was implemented by oncology nurse practitioners. Based on efficacy evidenced through randomized clinical trials published at the time of study implementation, the following drugs were included in the algorithm: lidocaine patch, gabapentin, oxycodone, tramadol, morphine, methadone, duloxetine, pregabalin, and nortriptyline. Recommendations for starting dose, dose escalation, drug combinations, treatment duration, and contraindications were included for first-tier drugs. Patient-reported outcomes (pain severity, functional capacity, and satisfaction) were assessed monthly over 12 weeks. RESULTS Average NP severity (P=0.001), general activity (P<0.001), mood (P=0.002), walking ability (P=0.01), ability to perform normal work (P=0.002), relationships (P=0.002), sleep (P=0.01), life enjoyment (P<0.001), and patient satisfaction (P=0.003) all improved by 12 weeks. CONCLUSION Evidence from this pilot study suggests that NP evidence-based treatment may result in improved symptoms, function, and patient satisfaction. A randomized controlled trial is needed to further assess algorithm efficacy.