Abstract
Purpose
Although early palliative care is recommended, resource limitations prevent its routine implementation. We report on the preliminary findings of a mixed methods study involving a randomized controlled trial (RCT) of Symptom screening with Targeted Early Palliative care (STEP) and qualitative interviews.
Methods
Adults with advanced solid tumors and an oncologist-estimated prognosis of 6–36 months were randomized to STEP or symptom screening alone. STEP involved symptom screening at each outpatient oncology visit; moderate to severe scores triggered an email to a palliative care nurse, who offered referral to in-person outpatient palliative care. Patient-reported outcomes of quality of life (FACT-G7; primary outcome), depression (PHQ-9), symptom control (ESAS-r-CS), and satisfaction with care (FAMCARE P-16) were measured at baseline and 2, 4, and 6 months. Semi-structured interviews were conducted with a subset of participants.
Results
From Aug/2019 to Mar/2020 (trial halted due to COVID-19 pandemic), 69 participants were randomized to STEP (n = 33) or usual care (n = 36). At 6 months, 45% of STEP arm patients and 17% of screening alone participants had received palliative care (p = 0.009). Nonsignificant differences for all outcomes favored STEP: difference in change scores for FACT-G7 = 1.67 (95% CI: −1.43, 4.77); ESAS-r-CS = −5.51 (−14.29, 3.27); FAMCARE P-16 = 4.10 (−0.31, 8.51); PHQ-9 = −2.41 (−5.02, 0.20). Sixteen patients completed qualitative interviews, describing symptom screening as helpful to initiate communication; triggered referral as initially jarring but ultimately beneficial; and referral to palliative care as timely.
Conclusion
Despite lack of power for this halted trial, preliminary results favored STEP and qualitative results demonstrated acceptability. Findings will inform an RCT of combined in-person and virtual STEP.
![](http://media.springernature.com/m312/springer-static/image/art%3A10.1007%2Fs00520-023-07870-9/MediaObjects/520_2023_7870_Fig1_HTML.png)
![](http://media.springernature.com/m312/springer-static/image/art%3A10.1007%2Fs00520-023-07870-9/MediaObjects/520_2023_7870_Fig2_HTML.png)
![](http://media.springernature.com/m312/springer-static/image/art%3A10.1007%2Fs00520-023-07870-9/MediaObjects/520_2023_7870_Fig3_HTML.png)
Similar content being viewed by others
Data availability
The data of this study are available from the corresponding author upon reasonable request.
References
Ferrell BR, Temel JS, Temin S, Alesi ER, Balboni TA, Basch EM et al (2017) Integration of palliative care into standard oncology care: American society of clinical oncology clinical practice guideline update. J Clin Oncol 35(1):96–112. https://doi.org/10.1200/JCO.2016.70.1474
Jordan K, Aapro M, Kaasa S, Ripamonti CI, Scotte F, Strasser F et al (2018) European Society for Medical Oncology (ESMO) position paper on supportive and palliative care. Ann Oncol 29(1):36–43. https://doi.org/10.1093/annonc/mdx757
Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A et al (2014) Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. The Lancet 383(9930):1721–1730. https://doi.org/10.1016/s0140-6736(13)62416-2
Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA et al (2010) Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med 363(8):733–742. https://doi.org/10.1056/NEJMoa1000678
Temel JS, Greer JA, El-Jawahri A, Pirl WF, Park ER, Jackson VA et al (2017) Effects of early integrated palliative care in patients with lung and GI cancer: a randomized clinical trial. J Clin Oncol 35(8):834–841. https://doi.org/10.1200/JCO.2016.70.5046
Vanbutsele G, Pardon K, Van Belle S, Surmont V, De Laat M, Colman R et al (2018) Effect of early and systematic integration of palliative care in patients with advanced cancer: a randomised controlled trial. Lancet Oncol 19(3):394–404. https://doi.org/10.1016/S1470-2045(18)30060-3
Maltoni M, Scarpi E, Dall'Agata M, Zagonel V, Berte R, Ferrari D et al (2016) Systematic versus on-demand early palliative care: results from a multicentre, randomised clinical trial. Eur J Cancer 65:61–68. https://doi.org/10.1016/j.ejca.2016.06.007
Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J et al (2009) Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the project ENABLE II randomized controlled trial. JAMA 302(7):741–749. https://doi.org/10.1001/jama.2009.1198
Lupu D (2010) American Academy of H, Palliative Medicine Workforce Task F. Estimate of current hospice and palliative medicine physician workforce shortage. J Pain Symptom Manage 40(6):899–911. https://doi.org/10.1016/j.jpainsymman.2010.07.004
Sleeman KE, de Brito M, Etkind S, Nkhoma K, Guo P, Higginson IJ et al (2019) The escalating global burden of serious health-related suffering: projections to 2060 by world regions, age groups, and health conditions. Lancet Glob Health 7(7):e883–ee92. https://doi.org/10.1016/S2214-109X(19)30172-X
Hui D, Hannon BL, Zimmermann C, Bruera E (2018) Improving patient and caregiver outcomes in oncology: team-based, timely, and targeted palliative care. CA Cancer J Clin 68(5):356–376. https://doi.org/10.3322/caac.21490
Vogt J, Beyer F, Sistermanns J, Kuon J, Kahl C, Alt-Ep** B et al (2021) Symptom burden and palliative care needs of patients with incurable cancer at diagnosis and during the disease course. Oncologist 26(6):e1058–e1e65. https://doi.org/10.1002/onco.13751
Rodin R, Swami N, Pope A, Hui D, Hannon B, Le LW et al (2022) Impact of early palliative care according to baseline symptom severity: secondary analysis of a cluster-randomized controlled trial in patients with advanced cancer. Cancer Med 11(8):1869–1878. https://doi.org/10.1002/cam4.4565
Zimmermann C, Pope A, Hannon B, Krzyzanowska MK, Rodin G, Li M et al (2021) Phase II Trial of Symptom screening with Targeted Early Palliative care for patients with advanced cancer. J Natl Compr Canc Netw 20(4):361–70.e3. https://doi.org/10.6004/jnccn.2020.7803
Creswell JW, Plano Clark VL (2018) Designing and conducting mixed methods research, 3rd edn. Sage Publications, Thousand Oaks, CA
Alcalde J, Hannon B, Zimmermann C (2023) Mixed Methods research. In: Higginson IJ, Costantini M, Preston NJ, Currow DC, Bruera E, Larkin PJ (eds) Research methods in palliative care, 2nd edn. Oxford University Press. In press
Farquhar MC, Ewing G, Booth S (2011) Using mixed methods to develop and evaluate complex interventions in palliative care research. Palliat Med 25(8):748–757. https://doi.org/10.1177/0269216311417919
Curry L, Nunez-Smith M (2015) Mixed methods in health sciences research: a practical primer. In:Thousand Oaks. SAGE Publications, Inc., California. https://doi.org/10.4135/9781483390659https://methods.sagepub.com/book/mixed-methods-in-health-sciences-research-a-practical-primer
Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET et al (1982) Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 5(6):649–655
Katzman R, Brown T, Fuld P, Peck A, Schechter R, Schimmel H (1983) Validation of a short orientation-memory-concentration test of cognitive impairment. Am J Psychiatry 140(6):734–739. https://doi.org/10.1176/ajp.140.6.734
Watanabe SM, Nekolaichuk C, Beaumont C, Johnson L, Myers J, Strasser F (2011) A multicenter study comparing two numerical versions of the Edmonton Symptom Assessment System in palliative care patients. J Pain Symptom Manage 41(2):456–468. https://doi.org/10.1016/j.jpainsymman.2010.04.020
Dudgeon D, King S, Howell D, Green E, Gilbert J, Hughes E et al (2012) Cancer Care Ontario's experience with implementation of routine physical and psychological symptom distress screening. Psychooncology 21(4):357–364. https://doi.org/10.1002/pon.1918
Pereira J, Green E, Molloy S, Dudgeon D, Howell D, Krzyzanowska MK et al (2014) Population-based standardized symptom screening: Cancer Care Ontario's Edmonton Symptom Assessment System and performance status initiatives. J Oncol Pract 10(3):212–214. https://doi.org/10.1200/JOP.2014.001390
Follwell M, Burman D, Le LW, Wakimoto K, Seccareccia D, Bryson J et al (2009) Phase II study of an outpatient palliative care intervention in patients with metastatic cancer. J Clin Oncol 27(2):206–213. https://doi.org/10.1200/JCO.2008.17.7568
Ontario CC: managing symptoms, Side Effects & Well-Being. https://www.cancercareontario.ca/en/symptom-management. Accessed December 18 2022.
Mah K, Swami N, Le LW, Chow R, Hannon BL, Rodin G et al (2020) Validation of the 7-item Functional Assessment of Cancer Therapy-General (FACT-G7) as a short measure of quality of life in patients with advanced cancer. Cancer 126(16):3750–3757. https://doi.org/10.1002/cncr.32981
Hannon B, Dyck M, Pope A, Swami N, Banerjee S, Mak E et al (2015) Modified Edmonton Symptom Assessment System including constipation and sleep: validation in outpatients with cancer. J Pain Symptom Manage 49(5):945–952. https://doi.org/10.1016/j.jpainsymman.2014.10.013
Kroenke K, Spitzer RL, Williams JB (2001) The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 16(9):606–613. https://doi.org/10.1046/j.1525-1497.2001.016009606.x
Zimmerman M (2012) Symptom severity and guideline-based treatment recommendations for depressed patients: implications of DSM-5's potential recommendation of the PHQ-9 as the measure of choice for depression severity. Psychother Psychosom 81(6):329–332. https://doi.org/10.1159/000342262
Yanez B, Pearman T, Lis CG, Beaumont JL, Cella D (2013) The FACT-G7: a rapid version of the functional assessment of cancer therapy-general (FACT-G) for monitoring symptoms and concerns in oncology practice and research. Ann Oncol 24(4):1073–1078. https://doi.org/10.1093/annonc/mds539
Lo C, Burman D, Rodin G, Zimmermann C (2009) Measuring patient satisfaction in oncology palliative care: psychometric properties of the FAMCARE-patient scale. Qual Life Res 18(6):747–752. https://doi.org/10.1007/s11136-009-9494-y
Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR (2002) Clinical significance consensus meeting G. Methods to explain the clinical significance of health status measures. Mayo Clin Proc 77(4):371–383. https://doi.org/10.4065/77.4.371
Ringash J, O'Sullivan B, Bezjak A, Redelmeier DA (2007) Interpreting clinically significant changes in patient-reported outcomes. Cancer 110(1):196–202. https://doi.org/10.1002/cncr.22799
Sandelowski M (2000) Whatever happened to qualitative description? Res Nurs Health 23(4):334–340. https://doi.org/10.1002/1098-240x(200008)23:4<334::aid-nur9>3.0.co;2-g
Braun V, Clarke V (2006) Using thematic analysis in psychology. Qual Res Psychol 3(2):77–101. https://doi.org/10.1191/1478088706qp063oa
Charlson ME, Pompei P, Ales KL, MacKenzie CR (1987) A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 40(5):373–383. https://doi.org/10.1016/0021-9681(87)90171-8
Hannon B, Swami N, Pope A, Leighl N, Rodin G, Krzyzanowska M et al (2016) Early Palliative care and its role in oncology: a qualitative study. Oncologist 21(11):1387–1395. https://doi.org/10.1634/theoncologist.2016-0176
Hannon B, Swami N, Rodin G, Pope A, Zimmermann C. Experiences of patients and caregivers with early palliative care: a qualitative study. Palliat Med 2016;31(1):72-81. https://doi.org/10.1177/0269216316649126.
Zimmermann C, Swami N, Krzyzanowska M, Leighl N, Rydall A, Rodin G et al (2016) Perceptions of palliative care among patients with advanced cancer and their caregivers. CMAJ 188(10):E217–Ee27. https://doi.org/10.1503/cmaj.151171
Hannon B, Mak E, Al Awamer A, Banerjee S, Blake C, Kaya E et al (2021) Palliative care provision at a tertiary cancer center during a global pandemic. Support Care Cancer 29(5):2501–2507. https://doi.org/10.1007/s00520-020-05767-5
Tasneem S, Kim A, Bagheri A, Lebret J (2019) Telemedicine video visits for patients receiving palliative care: a qualitative study. Am J Hosp Palliat Care 36(9):789–794. https://doi.org/10.1177/1049909119846843
Eastman P, Dowd A, White J, Carter J, Ely M (2021) Telehealth: rapid adoption in community palliative care due to COVID-19: patient and professional evaluation. BMJ Support Palliat Care. https://doi.org/10.1136/bmjspcare-2021-002987
Acknowledgements
Camilla Zimmermann is supported by the Harold and Shirley Lederman Chair in Psychosocial Oncology and Palliative Care, a joint Chair among the University of Toronto, Princess Margaret Cancer Centre/University Health Network and the Princess Margaret Cancer Foundation. The authors thank the patients who participated in this study, the medical oncologists who referred patients to this study, and the clinical and administrative staff of the palliative care team at the Princess Margaret Cancer Centre for their facilitation of this research.
Funding
This study was funded by the Canadian Institutes of Health Research (Grant No. 152996 to Dr. Zimmermann).
Author information
Authors and Affiliations
Contributions
CZ: conceptualization and design, obtaining funding, interpretation of data, writing and critical revision of the report
AP: acquisition and interpretation of data, critical revision of the report, administrative support
BH: conceptualization and design, interpretation of data and critical revision of the report
PLB, GR, ND, ML, LH, MKK, DH, JJK, NBL, SS, AMO, SL, CMB, GL: interpretation of data and critical revision of the report
JAC: interpretation of data, writing and critical revision of the report
NS: acquisition and interpretation of data, critical revision of the report, administrative support
RSAQ: acquisition and interpretation of data, writing and critical revision of the report
AR: interpretation of data and critical revision of the report
LWL: conceptualization and design, analysis and interpretation of data, critical revision of the report
All authors have provided final approval of the version to be published.
Corresponding author
Ethics declarations
Ethics approval
The study was approved by the University Health Network Research Ethics Board (REB# 19-5007). We certify that the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
Consent to participate
Informed consent was obtained from all individual participants included in the study.
Competing interests
The authors have no competing interests to declare that are relevant to the content of this article.
Additional information
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
ClinicalTrials.gov Identifier: NCT03987906
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Zimmermann, C., Pope, A., Hannon, B. et al. Symptom screening with Targeted Early Palliative care (STEP) versus usual care for patients with advanced cancer: a mixed methods study. Support Care Cancer 31, 404 (2023). https://doi.org/10.1007/s00520-023-07870-9
Received:
Accepted:
Published:
DOI: https://doi.org/10.1007/s00520-023-07870-9