Background: Early palliative care along with standard cancer treatments is recommended in current clinical guidelines to improve the quality of life and survival of cancer patients. This study protocol aims to evaluate the effect of “Enhanced Supportive Care”, an early primary palliative care provided by nurses. Methods: A randomized controlled trial (RCT) will be conducted including advanced cancer patients scheduled for first-line palliative chemotherapy (N=360) and their caregivers in South Korea. Participants will be randomly assigned to the intervention or control group in a 1:1 ratio. Participants in the intervention group will receive the “Enhanced Supportive Care”, which provides five sessions of symptom management and coping enhancement counseling by nurses. The control group will receive symptom monitoring five times. The primary endpoints are symptoms, coping, and quality of life (QoL) at 3 months. Secondary endpoints are symptoms, coping, and QoL at 6 months, depression and self-efficacy for coping with cancer at 3 and 6 months, symptom and depression change from baseline to 3 months, survival at 6 and 12 months among patients, and depression among caregivers at 3 and 6 months. Discussion: This RCT will evaluate the effects of “Enhanced Supportive Care” on symptoms, depression, coping, self-efficacy for coping with cancer, QoL and survival of patients, as well as depression of caregivers. It will provide evidence of a strategy to implement early primary palliative care provided by nurses, which may consequently improve cancer care for newly diagnosed patients with advanced stage cancer. Trial registration: ClinicalTrials.gov, NCT04407013. Registered on May 29, 2020, https://www.clinicaltrials.gov/ct2/show/study/NCT04407013. The protocol version is ESC 1.0.
|Publication status||Published - 2022 Dec|
Bibliographical noteFunding Information:
The present study was supported by the Basic Science Research Program through the National Research Foundation of Korea, funded by the Ministry of Education, Science, and Technology (2019R1A2C1087026) and has undergone peer-review by the funding body. Yun Young Choi and Bomi Hong received a scholarship from the Brain Korea 21 FOUR Project funded by the National Research Foundation (NRF) of Korea, Yonsei University College of Nursing. The funding body has no role in research design, or collection, analysis and interpretation of data. All evaluation will be independent from the funding body.
© 2022, The Author(s).
All Science Journal Classification (ASJC) codes