Educate, Nurture, Advise, Before Life Ends Research Articles

Project EPIC (Empowering People to Independence in COPD): Study protocol for a hybrid effectiveness-implementation pilot randomized controlled trial of telephonic, geriatrics-palliative care nurse-coaching in older adults with COPD and their family caregivers

BackgroundEPIC (Empowering People to Independence in COPD) is a geriatric-palliative care telephonic, nurse coach intervention informed by Baltes' Theory of Successful Aging and adapted from the ENABLE (Educate, Nurture, Advise, Before Life Ends) intervention. EPIC, focused on improving independence, mobility, well-being, and COPD symptoms, has undergone formative and summative evaluation for adults with COPD. MethodsThe primary study aim is to assess the refined EPIC intervention's feasibility and acceptability via a pilot hybrid effectiveness-implementation randomized control trial in community-dwelling older adults with moderate to severe COPD and their family caregivers. The secondary aim is to explore the impact of EPIC on patient and caregiver outcomes. Older adults with COPD and their family caregivers (target N = 60 dyads) will be randomized to EPIC (intervention) or usual COPD care (control). EPIC includes six patient and four family caregiver weekly, telephone-based nurse coach sessions using a manualized curriculum (Charting Your Course), plus three monthly follow-up calls. Feasibility will be measured as completion of EPIC intervention and trial components (e.g., recruitment, retention, data collection). Acceptability will be evaluated using satisfaction surveys and post-study feedback interviews. A blinded data collector will assess exploratory outcomes (e.g., Life-Space mobility, quality of life, caregiver burden, emotional symptoms, loneliness, cognitive impairment, functional status, healthcare utilization) at baseline, 12, and 24 weeks. DiscussionThis intervention fills a gap in addressing the geriatrics and palliative care needs and equity for adults with COPD and their family caregivers.Trial registration:ClinicalTrials.gov Identifier: NCT05040386

ENABLE-SG (Educate, Nurture, Advise, Before Life Ends for Singapore) as a proactive palliative care model: protocol for a hybrid type 1 effectiveness-implementation randomized wait-list controlled trial

BackgroundSpecialist palliative care is often provided late in the patient’s disease trajectory in response to uncontrolled symptoms. Shifting from this reactionary illness-stress paradigm to a proactive health-wellness approach, the ENABLE (Educate, Nurture, Advise, Before Life Ends) telehealth model aims to enhance the coping, stress and symptom management, self-care, and advance care planning skills of patients with advanced cancers and their caregivers. The ENABLE model has been culturally adapted to Singapore (ENABLE-SG) and pilot-tested. A hybrid type 1 effectiveness-implementation design will be used to evaluate the effectiveness of ENABLE-SG while collecting real-world implementation data.MethodsThis single-centre, assessor-blind, wait-list (immediately vs. 6 months) randomized controlled trial will recruit 300 adult patients within 60 days of an advanced cancer diagnosis and their family caregivers from the National Cancer Centre of Singapore. ENABLE-SG comprises structured psychoeducational sessions with a telehealth coach, covering essential topics of early palliative care. Participants will be assessed at baseline and every 3 months until patient’s death, 12 months (caregivers), or end of study (patients). The primary outcome is patient quality of life 6 months after baseline. Secondary patient-reported outcomes include mood, coping, palliative care concerns, and health status. Secondary caregiver-reported outcomes include caregiver quality of life, mood, coping, and care satisfaction. Mixed-effects regression modelling for repeated measurements will be used. To assess the effectiveness of ENABLE-SG versus usual care, patient and caregiver outcomes at 6 months will be compared. To compare earlier versus delayed ENABLE-SG, patient and caregiver outcomes at 12 months will be compared. Within the hybrid type 1 effectiveness-implementation design, implementation outcomes will be evaluated in both the early and delayed groups. Acceptability, adoption, appropriateness, and feasibility will be assessed using a feedback survey and semi-structured interviews with a purposive sample of patients, caregivers, and healthcare providers. Transcribed interviews will be analysed thematically. Other implementation outcomes of penetration, fidelity, and cost will be assessed using records of study-related processes and summarized using descriptive statistics. A cost-effectiveness analysis will also be conducted.DiscussionThis study will assess both effectiveness and implementation of ENABLE-SG. Insights into implementation processes can facilitate model expansion and upscaling.Trial registrationRegistered prospectively on ClinicalTrials.gov, NCT06044441. Registered on 21/09/2023.

ENABLE-LVAD: Development and Implementation of a Novel Training Program for Clinicians Supporting Family Caregivers of Patients With a Left Ventricular Assist Device.

Despite significant family caregiver (FCG) burnout, there are currently no tested interventions to support the FCG role after left ventricular assist device (LVAD) implantation or formalized training for clinicians to support FCGs. We adapted the existing ENABLE (Educate, Nurture, Advise Before Life Ends) intervention to LVAD clinicians and FCGs and assessed clinical implementation and dissemination. ENABLE-LVAD is an interactive, self-paced clinician training coupled with FCG-facing guidebooks and resources. Implementation and dissemination were evaluated by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. As of May 2023, 187 clinicians registered for the training, and 41 completed all modules (22.0% completion rate). Of those who completed the training and responded to a 6-month survey, one-third (n = 10, 33.3%) used ENABLE-LVAD with FCGs, and 100% of those planned to continue using it. The primary barrier to completing the training was time. The ENABLE-LVAD clinician training was successfully disseminated and implemented as a useful resource to support LVAD FCGs.

The Project ENABLE Cornerstone randomized controlled trial: study protocol for a lay navigator-led, early palliative care coaching intervention for African American and rural-dwelling advanced cancer family caregivers

BackgroundFamily caregivers play a vital, yet stressful role in managing the healthcare needs and optimizing the quality of life of patients with advanced cancer, from the time they are newly diagnosed until end of life. While early telehealth palliative care has been found to effectively support family caregivers, little work has focused on historically under-resourced populations, particularly African American and rural-dwelling individuals. To address this need, we developed and are currently testing Project ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone, a lay navigator-led, early palliative care coaching intervention for family caregivers of African American and rural-dwelling patients with newly diagnosed advanced cancer.MethodsThis is a 2-site, single-blind, hybrid type I implementation-effectiveness trial of the Cornerstone intervention versus usual care. Cornerstone is a multicomponent intervention based on Pearlin’s Stress-Health Process Model where African American and/or rural-dwelling family caregivers of patients with newly diagnosed advanced cancer (target sample size = 294 dyads) are paired with a lay navigator coach and receive a series of six, brief 20–60-min telehealth sessions focused on stress management and coping, caregiving skills, getting help, self-care, and preparing for the future/advance care planning. Subsequent to core sessions, caregivers receive monthly follow-up indefinitely until the patient’s death. Caregiver and patient outcomes are collected at baseline and every 12 weeks until the patient’s death (primary outcome: caregiver distress at 24 weeks; secondary outcomes: caregiver: quality of life and burden; patient: distress, quality of life, and healthcare utilization). Implementation costs and the intervention cost effectiveness are also being evaluated.DiscussionShould this intervention demonstrate efficacy, it would yield an implementation-ready model of early palliative care support for under-resourced family caregivers. A key design principle that has centrally informed the Cornerstone intervention is that every caregiving situation is unique and each caregiver faces distinct challenges that cannot be addressed using a one-size-fits all approach. Hence, Cornerstone employs culturally savvy lay navigator coaches who are trained to establish a strong, therapeutic alliance with participants and tailor their coaching to a diverse range of individual circumstances.Trial registrationClinicalTrials.gov NCT04318886. Registered on 20 March, 2020.

A lay navigator-led, early palliative care intervention for African American and rural family caregivers of individuals with advanced cancer (Project Cornerstone): Results of a pilot randomized trial.

The objective of this study was to assess the feasibility, acceptability, and potential efficacy of ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone-a lay navigator-led, early palliative care telehealth intervention for African American/Black and/or rural-dwelling family caregivers of individuals with advanced cancer (ClinicalTrials.gov identifier NCT03464188). This was a pilot randomized trial (November 2019 to March 2021). Family caregivers of patients with newly diagnosed, stage III/IV, solid-tumor cancers were randomized to receive either an intervention or usual care. Intervention caregivers were paired with a specially trained lay navigator who delivered 6 weekly, 20-minute to 60-minute telehealth coaching sessions plus monthly follow-up for 24 weeks, reviewing skills in stress management, self-care, getting help, staying organized, and future planning. Feasibility was assessed according to the completion of sessions and questionnaires (predefined as a completion rate ≥80%). Acceptability was determined through intervention participants' ratings of their likelihood of recommending the intervention. Measures of caregiver distress and quality of life were collected at 8 and 24 weeks. Sixty-three family caregivers were randomized (usual care, n = 32; intervention, n = 31). Caregivers completed 65% of intervention sessions and 87% of questionnaires. Average ratings for recommending the program were 9.4, from 1 (not at all likely) to 10 (extremely likely). Over 24 weeks, the mean ± SE Hospital Anxiety and Depression Scale score improved by 0.30 ± 1.44 points in the intervention group and worsened by 1.99 ± 1.39 points in the usual care group (difference, -2.29; Cohen d, -0.32). The mean between-group difference scores in caregiver quality of life was -1.56 (usual care - intervention; d, -0.07). Similar outcome results were observed for patient participants. The authors piloted ENABLE Cornerstone, an intervention for African American and rural-dwelling advanced cancer family caregivers. The acceptability of the intervention and data collection rates were high, and the preliminary efficacy for caregiver distress was promising. To date, very few programs have been developed to support under-resourced cancer family caregivers. To address this need, the authors successfully pilot tested an early palliative care program, called Educate, Nurture, Advise, Before Life Ends (ENABLE) Cornerstone, for African American and rural family caregivers of individuals with advanced cancer. Cornerstone is led by specially trained lay people and involves a series of weekly phone sessions focused on coaching caregivers to manage stress and provide effective support to patients with cancer. The authors are now testing Cornerstone in a larger trial. If the program demonstrates benefit, it may yield a model of caregiver support that could be widely implemented.

Dispositional hope as a potential outcome parameter among patients with advanced malignancy: An analysis of the ENABLE database.

Hopefulness, whether inherently present (dispositional hope) or augmented (by enhancement techniques), may affect outcomes. This study was performed to determine the association of dispositional hope with survival among patients diagnosed with advanced cancer. Data from ENABLE (Educate, Nurture, Advise, Before Life Ends), a palliative care intervention, were reanalyzed to determine the association of higher dispositional hope and patient survival. This was a secondary analysis of data combined from the ENABLE II and ENABLE III randomized controlled trials (RCTs) with respect to dispositional hope and survival. A dispositional hope index was created from 3 hope items from 2 validated baseline questionnaires. Dispositional hope and survival data were collected during the 2 RCTs. In ENABLE II, participants were randomly assigned to the ENABLE intervention or to usual care. In ENABLE III, participants were randomly assigned to receive the intervention immediately or 12 weeks after enrollment. In all, 529 persons were included in Cox proportional hazards regression analyses to model the effects of dispositional hope on survival. An initial analysis without covariates yielded a significant effect of hope (Wald statistic, 8.649; hazard ratio, 0.941; confidence interval, 0.904-0.980; P = .003), such that higher dispositional hope was associated with longer survival. In a subsequent analysis that included all covariates, the effect of dispositional hope approached statistical significance (Wald statistic, 2.96; hazard ratio, 0.933; confidence interval, 0.863-1.010; P = .085). Higher levels of dispositional hope were associated with longer survival in patients with advanced cancer. Prospective trials are needed to determine the effects of dispositional and augmented hope on the outcomes of patients with advanced cancer.

A cluster randomized controlled trial comparing Virtual Learning Collaborative and Technical Assistance strategies to implement an early palliative care program for patients with advanced cancer and their caregivers: a study protocol

BackgroundVirtual Learning Collaboratives (VLC), learning communities focused on a common purpose, are used frequently in healthcare settings to implement best practices. Yet, there is limited research testing the effectiveness of this approach compared to other implementation strategies. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers.MethodsUsing Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Proctor’s Implementation Outcomes Frameworks, this two-arm hybrid type-III cluster-randomized controlled trial (RCT) will compare two implementation strategies, VLC versus TA, among the 48 National Cancer Institute Community Oncology Research Program (NCORP) practice clusters that have not historically provided palliative care to all patients with advanced cancer. Three cohorts of practice clusters will be randomized to the study arms. Each practice cluster will recruit 15–27 patients and a family caregiver to participate in ENABLE. The primary study outcome is ENABLE uptake (patient level), i.e., the proportion of eligible patients who complete the ENABLE program (receive a palliative care assessment and complete the six ENABLE sessions over 12 weeks). The secondary outcome is overall program implementation (practice cluster level), as measured by the General Organizational Index at baseline, 6, and 12 months. Exploratory aims assess patient and caregiver mood and quality of life outcomes at baseline, 12, and 24 weeks. Practice cluster randomization will seek to keep the proportion of rural practices, practice sizes, and minority patients seen within each practice balanced across the two study arms.DiscussionThis study will advance the field of implementation science by evaluating VLC effectiveness, a commonly used but understudied, implementation strategy. The study will advance the field of palliative care by building the capacity and infrastructure to implement an early palliative care program in community oncology practices.Trial registrationClinicaltrials.gov. NCT04062552; Pre-results. Registered: August 20, 2019. https://clinicaltrials.gov/ct2/show/NCT04062552?term=NCT04062552&draw=2&rank=1

The Project ENABLE Cornerstone Randomized Pilot Trial: Protocol for Lay Navigator-Led Early Palliative Care for African-American and Rural Advanced Cancer Family Caregivers

BackgroundPatients newly-diagnosed with advanced cancer often rely on family caregivers to provide daily support to manage healthcare needs and maintain quality of life. Early telehealth palliative care has been shown to effectively provide an extra layer of support to family caregivers, however there has been little work with underserved populations, especially African-Americans and rural-dwellers. This is concerning given the lack of palliative care access for these underserved groups. Study DesignSingle-site, small-scale pilot randomized controlled trial (RCT) of Project ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone, a lay navigator-led, early palliative care coaching intervention for family caregivers of African-American and rural-dwelling patients with newly-diagnosed advanced cancer. Family caregivers are paired with a trained lay navigator overseen by specialist palliative care clinicians and receive a series of brief in-person and telehealth sessions focusing on stress management and coping, caregiving skills and organization, getting help, self-care, and preparing for the future/advance care planning. This pilot trial is assessing acceptability of the intervention, feasibility of recruitment and data collection procedures, and preliminary efficacy compared to usual care on caregiver and patient quality of life and mood over 24 weeks. ConclusionOnce acceptability and feasibility are determined and issues addressed, the ENABLE Cornerstone intervention for underserved family caregivers of persons with advanced cancer will be primed for a fully powered efficacy RCT. Given its use of lay navigators and telehealth delivery, the intervention is potentially highly scalable and capable of overcoming many of the geographic, human resource, and cultural obstacles to accessing early palliative care support.

Needs Assessment for Turkish Family Caregivers of Older Persons with Cancer: First-Phase Results of Adapting an Early Palliative Care Model.

Background: Although palliative care is expanding globally for patients with serious illness, Turkey has not had widespread integration of early concurrent oncology palliative care. Hence, adapting and testing models of concurrent oncology palliative care for Turkish patients is imperative. Furthermore, it is critical that these care models also address the needs of family caregivers. Objective: To assess needs and elicit suggestions that would inform the adaptation of the ENABLE (Educate, Nurture, Advise, Before Life Ends) evidence-based early palliative care model for Turkish family caregivers of older persons with cancer. Methods: Formative evaluation study. Semi-structured interviews were conducted with 25 primary family caregivers of older individuals with cancer. Thematic analyses yielded themes in four domains: meaning of caregiving, effect of caregiving, education and consulting needs, and preferences about the delivery of the ENABLE model of palliative care support. Results: Caregivers described the impact of the cancer on their daily lives and responsibilities in the areas of physical, psychological, work, social, and family life. Caregivers emphasized their needs for information about symptoms, physical care, cancer pathology, and prognosis. Regarding the ENABLE model of early concurrent palliative care, participants wanted encounters to be in-person with educational material support that was simple and focused on disease information (prognosis, medication, handling emergency situations), psychological support, caring, nutrition, and acquiring community services. Conclusion: Themes from this study will be used to modify the ENABLE intervention protocol for future pilot and efficacy testing in Turkish caregivers.

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.

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.

Developing a "toolkit" to measure implementation of concurrent palliative care in rural community cancer centers.

Despite national guidelines recommending early concurrent palliative care for individuals newly diagnosed with metastatic cancer, few community cancer centers, especially those in underserved rural areas do so. We are implementing an early concurrent palliative care model, ENABLE (Educate, Nurture, Advise, Before Life Ends) in four, rural-serving community cancer centers. Our objective was to develop a "toolkit" to assist community cancer centers that wish to integrate early palliative care for patients with newly diagnosed advanced cancer and their family caregivers. Guided by the RE-AIM (Reach, Effectiveness-Adoption, Implementation, Maintenance) framework, we undertook an instrument-development process based on the literature, expert and site stakeholder review and feedback, and pilot testing during site visits. We developed four instruments to measure ENABLE implementation: (1) the ENABLE RE-AIM Self-Assessment Tool to assess reach, adoption, implementation, and maintenance; (2) the ENABLE General Organizational Index to assess institutional implementation; (3) an Implementation Costs Tool; and (4) an Oncology Clinicians' Perceptions of Early Concurrent Oncology Palliative Care survey. We developed four measures to determine early palliative care implementation. These measures have been pilot-tested, and will be integrated into a comprehensive "toolkit" to assist community cancer centers to measure implementation outcomes. We describe the lessons learned and recommend strategies for promoting long-term program sustainability.

"There were more decisions and more options than just yes or no": Evaluating a decision aid for advanced cancer patients and their family caregivers.

Few decision aids are available for patients with a serious illness who face many treatment and end-of-life decisions. We evaluated the Looking Ahead: Choices for Medical Care When You're Seriously Ill® patient decision aid (PtDA), one component of an early palliative care clinical trial. Our participants included individuals with advanced cancer and their caregivers who had participated in the ENABLE (Educate, Nurture, Advise, Before Life Ends) early palliative care telehealth randomized controlled trial (RCT) conducted in a National Cancer Institute-designated cancer center, a U.S. Department of Veterans Affairs medical center, and affiliated outreach clinics in rural New England. ENABLE included six weekly patient and three weekly family caregiver structured sessions. Participants watched the Looking Ahead PtDA prior to session 3, which covered content on decision making and advance care planning. Nurse coaches employed semistructured interviews to obtain feedback from consecutive patient and caregiver participants approximately one week after viewing the Looking Ahead PtDA program (booklet and DVD). Between April 1, 2011, and October 31, 2012, 57 patients (mean age = 64), 42% of whom had lung and 23% gastrointestinal cancer, and 20 caregivers (mean age = 59), 80% of whom were spouses, completed the PtDA evaluation. Participants reported a high degree of satisfaction with the PtDA format, as well as with its length and clarity. They found the format of using patient interviews "validating." The key themes were: (1) "the earlier the better" to view the PtDA; (2) feeling empowered, aware of different options, and an urgency to participate in advance care planning. The Looking Ahead PtDA was well received and helped patients with a serious illness realize the importance of prospective decision making in guiding their treatment pathways. We found that this PtDA can help seriously ill patients prior to the end of life to understand and discuss future healthcare decision making. However, systems to routinely provide PtDAs to seriously ill patients are yet not well developed.

Measuring implementation of early, concurrent palliative care in community settings.

145 Background: ASCO recommends “…combined standard oncology and palliative care…early in the course of illness for any patient with metastatic cancer and/or high symptom burden”. Few settings have implemented this recommendation and rural community cancer centers (CCC) are particularly disadvantaged due to scarce palliative care (PC) resources. The evidenced-based ENABLE (Educate, Nurture, Advise, Before Life Ends) early concurrent PC intervention has demonstrated efficacy and benefit for rural patients and caregivers and we are implementing ENABLE using a virtual learning collaborative funded by the American Cancer Society. Since no PC-specific implementation measures exist, one of our primary efforts has been instrument development. Methods: This Implementation Study includes 4 racially-diverse CCCs: Gibbs Cancer Center, Spartanburg, SC; Mitchell Cancer Institute, Mobile, AL; Birmingham VAMC; and Gyn Oncology/University of Alabama at Birmingham. The project aims are to: 1. Build an interactive research community to assess sites’ institutional structure and PC resources; and 2. Evaluate pre- and post-ENABLE implementation using RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. An expert panel assisted with implementation measure development specific to ENABLE’s essential elements. Instruments include: the General Organizational Index, the RE-AIM Assessment Tool, Oncology Providers Perceptions of Early Concurrent PC, and Implementation Costs. Results: All measures were found to have face and content validity. Feasibility and inter-rater reliability were determined during pilot-testing. Data, (housed in a REDCap database), have been collected using face-to-face interviews and web-based platforms over 2 cycles of pre- and post-implementation site visits. Measurement challenges include: 1. Inconsistent IRB interpretation of implementation science practices; 2. Limited implementation resources (space, staff, and time); and 3. Difficulties with centralized data collection. Conclusions: Valid measures are critical to determine implementation success. We will present implementation measures (Toolkit) and examples of outcome data.

Benefits of immediate versus delayed palliative care to informal family caregivers of persons with advanced cancer: Outcomes from the ENABLE III randomized clinical trial.

LBA9513 Background: Family caregivers of individuals with advanced cancer experience significant burden and diminished QOL; few interventions have been found to reduce these outcomes. Methods: Randomized clinical trial conducted from 10/11/2010 to 9/5/2013 of immediate versus delayed (initiated 12 weeks after randomization) entry patients (n=207) and caregivers (n=122) into ENABLE (Educate, Nurture, Advise, Before Life Ends), a phone-based concurrent oncology palliative care intervention. QOL (Caregiver Quality of Life-Cancer, lower scores=better QOL), depression (Center for Epidemiological Study-Depression) and burden (Montgomery Borgatta Caregiver Burden Scale; subjective burden [SB], objective burden [OB]; demand burden [DB]) measures were collected at baseline, 6, 12, 18, and 24 weeks, and every 12 weeks until patient death or study completion. Results: Estimated treatment effects (immediate minus delayed) for caregivers from randomization to 12 weeks were (mean [SE]): -3.1 [2.3] for QOL (P=.17), -4.1 [1.3] for depression (P=.003), -1.0 [0.4] for SB (P=.02), 0.3 [0.6] for OB (P=.60), and -0.5 [0.6] for DB (P=.39). Estimated treatment effects (immediate minus delayed) from intervention initiation to 12 weeks were (mean [SE]): -6.4 [3.4] for QOL (P=.06), -7.4 [2] for depression (P<.001), -1.0 [0.6] for SB (P=.08), -0.6 [0.7] for OB (P=.44), and -0.5 [0.8] for DB (P=.50). Estimated treatment effects (immediate minus delayed) measured backwards from the time of patient’s death were (mean [SE]): of -4.9 [2.6] for QOL (P=.07), -3.8 [1.5] for depression (P=.02), -1.1 [0.4] for SB (P=.01), -0.6 [0.6] for OB (P=.26), and -0.7 [0.6] for DB (P=.22). Conclusions: Caregivers in the immediate group had lower depression, SB, and trends towards better QOL in comparisons up to 12 weeks, following initiation of the intervention in both groups, and in the terminal decline analysis. These results suggest that concurrent oncology palliative care should be initiated as early as possible to maximize benefit to caregivers. Clinical trial information: NCT01245621.

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?

Nursing Roles in Health Care Decision Making

Patients newly-diagnosed with advanced cancer often rely on family caregivers to provide daily support to manage healthcare needs and maintain quality of life. Early telehealth palliative care has been shown to effectively provide an extra layer of support to family caregivers, however there has been little work with underserved populations, especially African-Americans and rural-dwellers. This is concerning given the lack of palliative care access for these underserved groups.Single-site, small-scale pilot randomized controlled trial (RCT) of Project ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone, a lay navigator-led, early palliative care coaching intervention for family caregivers of African-American and rural-dwelling patients with newly-diagnosed advanced cancer. Family caregivers are paired with a trained lay navigator overseen by specialist palliative care clinicians and receive a series of brief in-person and telehealth sessions focusing on stress management and coping, caregiving skills and organization, getting help, self-care, and preparing for the future/advance care planning. This pilot trial is assessing acceptability of the intervention, feasibility of recruitment and data collection procedures, and preliminary efficacy compared to usual care on caregiver and patient quality of life and mood over 24 weeks.Once acceptability and feasibility are determined and issues addressed, the ENABLE Cornerstone intervention for underserved family caregivers of persons with advanced cancer will be primed for a fully powered efficacy RCT. Given its use of lay navigators and telehealth delivery, the intervention is potentially highly scalable and capable of overcoming many of the geographic, human resource, and cultural obstacles to accessing early palliative care support.

Project ENABLE: a palliative care demonstration project for advanced cancer patients in three settings.

At the end of the 1990s, based on data from two major studies of end-of-life (EOL) care, the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment (SUPPORT), and the Hospitalized Elderly Longitudinal Project (HELP), a consensus panel report documented the problems and needs of patients with cancer and other life-limiting diagnoses at end-of-life. A national program of The Robert Wood Johnson Foundation (RWJF), Promoting Excellence in End-of-Life Care, attempted to address these needs by funding demonstration projects to test various approaches to improve identified deficits. In 1998, Project ENABLE (Educate, Nurture, Advise Before Life Ends), one of four RWJF-funded cancer center/hospice collaborations of the Promoting Excellence program, began to address these issues. The jointly sponsored Norris Cotton Cancer Center (NCCC)/Hospice of Vermont and New Hampshire (Hospice VNH) program provided an integrated approach to the management of life-limiting cancer. Project ENABLE was aimed at alleviating the symptoms of disease and treatment, enhancing clinician and patient/family communication, offering support for families, friends and other caregivers, addressing emotional and spiritual needs of dying people and providing conceptual and administrative structure to provide EOL care consistent with patients' values and preferences. Although patient symptom data is not yet available, other measures of success included improved access to hospice and palliative care services from the time of diagnosis and a sustained palliative care program at two of the three sites in which the program was implemented.