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Purpose Randomized controlled trials have supported integrated oncology and palliative care (PC); however, optimal timing has not been evaluated. We investigated the effect of early versus delayed PC on quality of life (QOL), symptom impact, mood, 1-year survival, and resource use. Patients and Methods Between October 2010 and March 2013, 207 patients with advanced cancer at a National Cancer Institute cancer center, a Veterans Affairs Medical Center, and community outreach clinics were randomly assigned to receive an in-person PC consultation, structured PC telehealth nurse coaching sessions (once per week for six sessions), and monthly follow-up either early after enrollment or 3 months later. Outcomes were QOL, symptom impact, mood, 1-year survival, and resource use (hospital/intensive care unit days, emergency room visits, chemotherapy in last 14 days, and death location). Results Overall patient-reported outcomes were not statistically significant after enrollment (QOL, P = .34; symptom impact, P = .09; mood, P = .33) or before death (QOL, P = .73; symptom impact, P = .30; mood, P = .82). Kaplan-Meier 1-year survival rates were 63% in the early group and 48% in the delayed group (difference, 15%; P = .038). Relative rates of early to delayed decedents' resource use were similar for hospital days (0.73; 95% CI, 0.41 to 1.27; P = .26), intensive care unit days (0.68; 95% CI, 0.23 to 2.02; P = .49), emergency room visits (0.73; 95% CI, 0.45 to 1.19; P = .21), chemotherapy in last 14 days (1.57; 95% CI, 0.37 to 6.7; P = .27), and home death (27 [54%] v 28 [47%]; P = .60). Conclusion Early-entry participants' patient-reported outcomes and resource use were not statistically different; however, their survival 1-year after enrollment was improved compared with those who began 3 months later. Understanding the complex mechanisms whereby PC may improve survival remains an important research priority.

48 Background: Little is known whether early palliative care (PC) support for family caregivers (FCGs) impacts grief and depression after care recipients die. We conducted a randomized controlled trial (RCT) of a nurse-led, phone-based concurrent PC intervention for FCGs delivered at the time of care recipients’ advanced cancer diagnosis (early group) or 12 weeks later (delayed group). We hypothesized that grief and depression scores would be lower for early compared to delayed group FCGs. Methods: Early vs. delayed RCT (10/2010-9/2013) of 123 FCGs of community dwelling persons with advanced cancer in a rural, New Hampshire NCI-designated comprehensive cancer center and affiliated outreach clinics and a Vermont VA medical center receiving a multicomponent intervention (ENABLE [Educate, Nurture, Advise, Before Life Ends]) consisting of 3 weekly sessions, monthly follow-up, and a bereavement call. FCGs of persons dying during the study period completed the Center for Epidemiological Study-Depression scale (CESD) and the Prigerson Inventory of Complicated Grief-Short Form (PG13) 8-12 weeks after care recipients’ deaths. Generalized estimating equations were used to compute group means, standard deviations, and between-group effect size differences. Results: For care recipients who died (n = 70), 44 FCGs (early: n = 19; delayed: n = 25) completed after-death questionnaires. Mean depression scores (CESD) for the early group was 14.6 (SD = 10.7) and for the delayed group was 17.6 (SD = 11.8). Mean grief scores (PG13) for the early group was 22.7 (SD = 4.9) and for the delayed group was 24.9 (SD = 6.9). Between-group effect size differences were not statistically significant (CESD: d = -.27, p = .38; PG13: d = -.36, p = .24). Conclusions: Though statistically insignificant, the magnitude of the observed between-group differences for depression was small and for grief was medium. Considering the small sample size and the delayed group’s mean depression score surpassing the clinical cutoff (CESD score > 16), the clinical relevance of these findings cannot be ruled out. Future upstream FCG PC interventions initiated long before end of life should continue to examine intervention effects on FCG after-death outcomes. Clinical trial information: NCT01245621.

29 Background: Little is known about the impact that having a family caregiver (FCG) has on individuals with advanced cancer. We examined patient characteristics and outcomes most associated with having versus not having a primary FCG. Methods: Secondary data analysis of a randomized controlled trial of an early palliative care intervention (Project ENABLE [Educate, Nuture, Advise, Before Life Ends]) for patients with advanced cancer and their primary FCGs (10/2010-9/2013). Sociodemographic and patient reported outcomes data were abstracted from the baseline questionnaires of 122 patients who enrolled with FCG and 85 patients who enrolled without a FCG. Sociodemographic variables included age, gender, education, race, social support (MSPSS: Multidimensional Scale of Perceived Social Support, score range: 12-84), and Karnofsky Functional status. Patient reported outcomes included symptom impact (QUAL-E Symptom Impact, score range: 4-20), quality of life (QOL) (Functional Assessment of Chronic Illness Therapy-Palliative Care, score range: 0-184), depression (Center for Epidemiological Studies-Depression Scale, score range: 0-60), perceived quality of care (Patient Assessment of Chronic Illness Care, score range: 20-100), and hospital days and emergency department visits in the past 3 months. Structured tree analysis was used to identify a set of variables strongly associated with the presence or lack of a FCG. Results: In the final model, for patients with MSPSS scores 52.5 (N=105), 73% (N=77) had a FCG. For female patients with MSPSS scores >77.5 (N=29), 69% (N=20) had a FCG. For female patients with MSPSS scores 126.1 (N=25), 20% (N=5) had a FCG. For female patients with MSPSS scores 26 (N=10), 20% (N=2) had a FCG. For female patients with MSPSS scores

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.

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

9512 Background: Evidence from randomized controlled trials (RCTs) supports integration of oncology and palliative care; how soon after diagnosis to initiate palliative care has not been defined. M...