Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial
Abstract 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 car...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-12-01
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| Series: | BMC Nursing |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12912-022-01097-5 |
| _version_ | 1811315197029122048 |
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| author | Yun Young Choi Sun Young Rha Sungkun Cho Hye Sun Lee Bomi Hong Jiyeon Lee |
| author_facet | Yun Young Choi Sun Young Rha Sungkun Cho Hye Sun Lee Bomi Hong Jiyeon Lee |
| author_sort | Yun Young Choi |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-04-13T11:25:57Z |
| format | Article |
| id | doaj.art-ec3741a0691643f986874200cc57af97 |
| institution | Directory Open Access Journal |
| issn | 1472-6955 |
| language | English |
| last_indexed | 2024-04-13T11:25:57Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Nursing |
| spelling | doaj.art-ec3741a0691643f986874200cc57af972022-12-22T02:48:42ZengBMCBMC Nursing1472-69552022-12-0121111010.1186/s12912-022-01097-5Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trialYun Young Choi0Sun Young Rha1Sungkun Cho2Hye Sun Lee3Bomi Hong4Jiyeon Lee5College of Nursing and Brain Korea 21 FOUR Project, Yonsei UniversityCollege of Medicine and Yonsei Cancer Center, Yonsei UniversityDepartment of Psychology, Chungnam National UniversityCollege of Medicine, Biostatistics Collaboration Unit, Yonsei UniversityCollege of Nursing and Brain Korea 21 FOUR Project, Yonsei UniversityCollege of Nursing and Mo-Im Kim Research Institute, Yonsei UniversityAbstract 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.https://doi.org/10.1186/s12912-022-01097-5SymptomCopingQuality of lifeSelf-efficacyNursing interventionAdvanced cancer |
| spellingShingle | Yun Young Choi Sun Young Rha Sungkun Cho Hye Sun Lee Bomi Hong Jiyeon Lee Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial BMC Nursing Symptom Coping Quality of life Self-efficacy Nursing intervention Advanced cancer |
| title | Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial |
| title_full | Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial |
| title_fullStr | Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial |
| title_full_unstemmed | Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial |
| title_short | Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial |
| title_sort | enhanced supportive care for advanced cancer patients study protocol for a randomized controlled trial |
| topic | Symptom Coping Quality of life Self-efficacy Nursing intervention Advanced cancer |
| url | https://doi.org/10.1186/s12912-022-01097-5 |
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