Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial

BMC Nursing

Study Protocol

Sun Young Rha¹  Hye Sun Lee²  Yun Young Choi³  Bomi Hong³  Jiyeon Lee⁴  Sungkun Cho⁵ 

[1] College of Medicine and Yonsei Cancer Center, Yonsei University, Seoul, Korea;College of Medicine, Biostatistics Collaboration Unit, Yonsei University, Seoul, Korea;College of Nursing and Brain Korea 21 FOUR Project, Yonsei University, Seoul, Korea;College of Nursing and Mo-Im Kim Research Institute, Yonsei University, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Korea;Department of Psychology, Chungnam National University, Daejeon, Korea;

关键词: Symptom;    Coping;    Quality of life;    Self-efficacy;    Nursing intervention;    Advanced cancer;   

DOI  :  10.1186/s12912-022-01097-5

 received in 2022-09-20, accepted in 2022-11-04,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundEarly 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.MethodsA 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT04407013. Registered on May 29, 2020, https://www.clinicaltrials.gov/ct2/show/study/NCT04407013. The protocol version is ESC 1.0.

【 授权许可】

CC BY   
© The Author(s) 2022

【 图 表 】

Fig. 1

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