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- Title
Early Integrated Palliative Care in Patients With Advanced Cancer: A Randomized Clinical Trial.
- Authors
Kang, EunKyo; Kang, Jung Hun; Koh, Su-Jin; Kim, Yu Jung; Seo, Seyoung; Kim, Jung Hoon; Cheon, Jaekyung; Kang, Eun Joo; Song, Eun-Kee; Nam, Eun Mi; Oh, Ho-Suk; Choi, Hye Jin; Kwon, Jung Hye; Bae, Woo Kyun; Lee, Jeong Eun; Jung, Kyung Hae; Yun, Young Ho
- Abstract
This randomized clinical trial investigates the change in quality of life, survival rates, and self-management skills associated with an early palliative care program for patients with advanced cancer. Key Points: Question: Does systematic, integrated, early palliative care (EPC) improve quality of life, enhance self-management competency or coping skill, and increase survival rates in patients with advanced cancer but who are not terminally ill for whom standard chemotherapy has not been effective? Findings: In this randomized clinical trial of 144 patients with advanced cancer, those randomized to the EPC intervention group experienced better quality of life at 18 months, but not at 12 or 24 months, compared with the control group. Patients in the intervention group reported lower existential burden and enhanced coping skills compared with the control group. Meaning: Findings from this study suggest the need to develop guidelines for systematic EPC to improve its quality and to develop various methods of providing EPC to increase patients' adherence with interventions. Importance: Limited data suggest that early palliative care (EPC) improves quality of life (QOL) and survival in patients with advanced cancer. Objective: To evaluate whether comprehensive EPC improves QOL; relieves mental, social, and existential burdens; increases survival rates; and helps patients develop coping skills. Design, Setting, and Participants: This nonblinded randomized clinical trial (RCT) recruited patients from 12 hospitals in South Korea from September 2017 to October 2018. Patients aged 20 years or older with advanced cancer who were not terminally ill but for whom standard chemotherapy has not been effective were eligible. Participants were randomized 1:1 to the control (receiving usual supportive oncological care) or intervention (receiving EPC with usual oncological care) group. Intention-to-treat data analysis was conducted between September and December 2022. Interventions: The intervention group received EPC through a structured program of self-study education materials, telephone coaching, and regular assessments by an integrated palliative care team. Main Outcomes and Measures: The primary outcome was the change in overall QOL score (assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care) from baseline to 24 weeks after enrollment, with evaluations also conducted at 12 and 18 weeks. Secondary outcomes were social and existential burdens (assessed with the McGill Quality of Life Questionnaire) as well as crisis-overcoming capacity and 2-year survival. Results: A total of 144 patients (83 males [57.6%]; mean [SD] age, 60.7 (7.2) years) were enrolled, of whom 73 were randomized to the intervention group and 71 to the control group. The intervention group demonstrated significantly greater changes in scores in overall health status or QOL from baseline, especially at 18 weeks (11.00 [95% CI, 0.78-21.22] points; P =.04; effect size = 0.42). However, at 12 and 24 weeks, there were no significant differences observed. Compared with the control group, the intervention group also showed significant improvement in self-management or coping skills over 24 weeks (20.51 [95% CI, 12.41-28.61] points; P <.001; effect size = 0.93). While the overall survival rate was higher in the intervention vs control group, the difference was not significant. In the intervention group, however, those who received 10 or more EPC interventions (eg, telephone coaching sessions and care team meetings) showed a significantly increased probability of 2-year survival (53.6%; P <.001). Conclusions and Relevance: This RCT demonstrated that EPC enhanced QOL at 18 weeks; however, no significant improvements were observed at 12 and 24 weeks. An increased number of interventions sessions was associated with increased 2-year survival rates in the intervention group. Trial Registration: ClinicalTrials.gov Identifier: NCT03181854
- Subjects
SOUTH Korea; GASTROINTESTINAL tumors; PALLIATIVE treatment; SURVIVAL rate; HEALTH status indicators; SELF-management (Psychology); MEETINGS; RESEARCH funding; STATISTICAL sampling; QUESTIONNAIRES; BREAST tumors; PSYCHOLOGICAL adaptation; RANDOMIZED controlled trials; MENTORING; DESCRIPTIVE statistics; KAPLAN-Meier estimator; QUALITY of life; LUNG tumors; QUALITY assurance; TUMORS; CONFIDENCE intervals; DATA analysis software; SOCIAL support; WELL-being; OVERALL survival
- Publication
JAMA Network Open, 2024, Vol 7, Issue 8, pe2426304
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.26304