The ENABLE III randomized controlled trial of concurrent palliative oncology care.
Abstract
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. Methods: We conducted a ‘fast track’ RCT of patients with advanced cancer in a rural, NCI-designated cancer center, VAMC, and community clinics in NH and VT to determine the effect of immediate vs. delayed (3 months after diagnosis) entry patients into the ENABLE concurrent oncology palliative care intervention on primary outcome measures: QOL (FACIT-pal), symptom impact (Symptom impact subscale of the QUAL-E, mood (CES-D), at 3 and 6 months and survival at 1 year (from enrollment to death or study completion). Other outcomes included: resource use (hospital and ICU days and ER visits-measured by chart review), and quality of EOL care. Results: Participants (immediate n=104; delayed=103) were mean age 65; 52% male; 65% married; 96% white; 42% lung; 46% newly diagnosed with advanced disease; 17% with brain metastases. The estimated treatment effects (TE) using a terminal decline model (Cohen’s d; immediate minus delayed) for patients from randomization to 3 months were: (mean [SE]: .13 (21.39) for QOL (P=.34), -.21 (3.63) for symptom impact (P=.09), and .04 (3.91) for depressed mood (P=.33). 104 participants died (immediate n=49; delayed n=55) during the study. Compared to delayed entry patients, the risk of death (hazard ratio [HR] (95% CI)) was lower for immediate participants at 1 year 0.72 (95% CI, 0.57-0.89) (P=0.003). Median survival for immediate entry patients was 18.3 months (95% CI, 13.2, 28.0) and 11.8 months (95% CI, 9.0, 24.1) for delayed entry patients (P=0.17). Overall median hospital days (3), ICU days (0), and ER visits (1) were identical. 55% (27) of 49 deaths in immediate and 49% (27) of delayed deaths occurred at home. Conclusions: Immediate vs delayed entry patients experienced a significant survival advantage at 1 year; however longitudinal TE were not statistically different. Future research is needed to define mechanisms of survival advantage in palliative care trials. Clinical trial information: NCT01245621.
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Palliative care has been associated with equal or longer survival in randomized and nonrandomized trials of patients with advanced cancer.
“In distinction from chemotherapy after the second-line setting, palliative care has been associated with equal103–106 or longer107–109 survival in randomized and nonrandomized110 trials of patients with advanced cancer.”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [107]
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Masters, G. A., Temin, S., Azzoli, C. G., Giaccone, G., Baker, S., Brahmer, J. R., Ellis, P. M., Gajra, A., Rackear, N., Schiller, J. H., et al. (2015) · Journal of Clinical Oncology · doi:10.1200/jco.2015.62.1342 · Cited by 850 · see citing works
Dionne-Odom, J. N., Azuero, A., Lyons, K. D., Hull, J. G., Tosteson, T. D., Li, Z., Li, Z., Frost, J., Dragnev, K. H., Akyar, İ., et al. (2015) · Journal of Clinical Oncology · doi:10.1200/jco.2014.58.7824 · Cited by 500 · see citing works
“Patient outcomes are reported separately.(26)”
Self-citationMay, P., Garrido, M. M., Cassel, J. B., Kelley, A. S., Meier, D. E., Normand, C. E. M., Smith, T. J., Stefanis, L., & Morrison, R. S. (2015) · Journal of Clinical Oncology · doi:10.1200/jco.2014.60.2334 · Cited by 279 · see citing works
Hanna, N. H., Johnson, D. H., Temin, S., & Masters, G. A. (2017) · Journal of Oncology Practice · doi:10.1200/jop.2017.026716 · Cited by 100 · see citing works
Tatum, P., & Mills, S. (2020) · Medical Clinics of North America · doi:10.1016/j.mcna.2020.01.001 · Cited by 88 · see citing works
Hahne, J., Wang, X., Liu, R., et al. (2022) · BMC Medical Ethics · doi:10.1186/s12910-022-00750-7 · Cited by 21 · see citing works
“advanced cancer patients showed the median survival of patients receiving palliative care immediately after diagnosis was more than six months longer than patients who began palliative care three months after diagnosis [33].”
BackgroundMay, P., Garrido, M. M., Fabbro, E. D., Noreika, D. M., Normand, C. E. M., Skoro, N., & Cassel, J. B. (2019) · Medical Care Research and Review · doi:10.1177/1077558718823919 · Cited by 20 · see citing works
“This approach is suboptimal since mortality is in principle an outcome that the intervention can affect, and as such all analyses are conducted in the context of multiple prior studies demonstrating that palliative care does not reduce survival but may in some cases extend it (Bakitas et al., 2014; Temel et al., 2010;…”
ResultTelehealth in Palliative Care: Communication Strategies From the COVID-19 Pandemic
Stockdill, M., Barnett, M. D., Taylor, R. A., Dionne-Odom, J. N., & Bakitas, M. A. (2021) · Clinical journal of oncology nursing · doi:10.1188/21.cjon.17-22 · Cited by 13 · see citing works
Self-citationStockdill, M. L., Dionne-Odom, J. N., Wells, R., Ejem, D., Azuero, A., Keebler, K., Sockwell, E., Tims, S., Burgio, K. L., Engler, S., et al. (2023) · Journal of Palliative Care · doi:10.1177/0825859720975978 · Cited by 11 · see citing works
Self-citationEarly palliative care in cancer patients
Kwon, J. H. (2014) · Korean Journal of Clinical Oncology · doi:10.14216/kjco.14030 · Cited by 2 · see citing works
“올해 American Society of Clinical Oncology에서 Bakitas 등[22]은 진단 초기부터의 완화의료의 개입과 3개월 이후 시점 완화의료의 개입을 비교하는 전향적 3상 연구를 통하여 조기 완화의료의 개입 이 1년 시점의 생존율을 향상 시킨다는 보고를 하였다( ≤ 1 year hazard ratio [HR] = 0.”
Kim, J. Y., Park, I. J., Yu, C. S., Lim, S., Lee, J. L., Yoon, Y. S., Kim, C. W., & Kim, J. C. (2014) · Korean Journal of Clinical Oncology · doi:10.14216/kjco.14011
The Role of Palliative Care in Cirrhosis
Fine, R. L. (2019) · Springer eBooks · doi:10.1007/978-3-030-24490-3_16
- Authors
- Bakitas, M., Tosteson, T., Li, Z., Lyons, K., Hull, J., Li, Z., Dionne-Odom, J. N., Frost, J., Hegel, M., Azuero, A., Ahles, T., Rigas, J. R., Pipas, J. M., & Dragnev, K. H.
- Affiliations
- University of Alabama at Birmingham (US)
- Dartmouth Cancer Center (US)
- Dartmouth College (US)
- The University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL
- Memorial Sloan Kettering Cancer Center (US)
- Dartmouth–Hitchcock Medical Center (US)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2014-05-20
- Volume
- 32
- Issue
- 15_suppl
- Pages
- 9512-9512
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2595207967
- Cited by
- 12
- References
- 0
- Citations by year
- 2022: 1 · 2021: 1 · 2020: 2 · 2019: 2 · 2017: 1 · 2015: 3 · 2014: 2
- Type
- conference abstract
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative Care and End-of-Life Issues
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative and Oncologic Care
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Keywords
- advanced cancer, early palliative care, timing of palliative care initiation, quality of end-of-life care, quality of life, symptom impact, depression, survival, hospital resource utilization, rural cancer care, lung cancer, brain metastases, community clinics, Veterans Affairs health care, treatment effect estimation
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