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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.
RESUMO
PURPOSE: Pain catastrophizing often has been measured using the Pain Catastrophizing Scale (PCS). Studies of the PCS nearly consistently support its three-factor structure (i.e., helplessness, magnification, and rumination) and satisfactory psychometric properties across different countries and languages. This study aimed to assess the generalizability of the three-factor structure of the PCS to Korean patients with chronic non-cancer pain and to investigate reliability, measurement error, and construct validity of a Korean version of the PCS (K-PCS). METHODS: A total of 182 patients with chronic pain seeking treatment in a tertiary pain center located in Seoul, Korea, participated. RESULTS: Confirmatory factor analysis demonstrated the adequacy of the three-factor structure of the K-PCS; 'helplessness,' 'magnification,' and 'rumination.' The internal consistency for 'helplessness,' 'magnification,' 'rumination,' and total scale of the K-PCS were Cronbach's α = .90, .71, .86, and .93, respectively; test-retest stability, ICC = .77, .73, .65, and .79, respectively; the standard estimation of measurement, 1.93, 1.34, 2.13, and 3.72, respectively; the minimum detectable change, 5.33, 3.70, 5.89, and 10.28, respectively; and the limits of agreement, -7.66 to 9.20, -5.07 to 5.01, -7.30 to 6.86, and -15.26 to 16.46, respectively. At least moderate positive correlations were observed between the K-PCS and pain intensity, depression, and pain-related anxiety, and moderate negative correlations between the K-PCS and physical and psychological functioning. CONCLUSION: The K-PCS has the reliability, measurement error, and construct validity support for assessing pain catastrophizing in a Korean patient sample with chronic non-cancer pain.