{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T06:12:58Z","timestamp":1788502378899,"version":"build-2803163510"},"reference-count":63,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T00:00:00Z","timestamp":1787097600000},"content-version":"unspecified","delay-in-days":18,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82272924"],"award-info":[{"award-number":["82272924"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,7,29]]},"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Post-traumatic stress symptoms (PTSS) are prevalent among children with cancer and their families. Although family-based interventions such as the Surviving Cancer Competently Intervention Programme (SCCIP) are effective, their reliance on mental health specialists limits scalability, highlighting the need for nurse-led approaches. This trial aims to evaluate the efficacy of SCCIP-N, a nurse-led family-based psychosocial intervention, in reducing PTSS among families of paediatric cancer patients in China.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      This multicentre randomised controlled trial will enrol 110 families across Hunan and Xinjiang. Participants will be randomly assigned (1:1) to the intervention group or an active control group, stratifying randomisation by study site. The study employs a hybrid outcome assessment strategy that integrates validated psychosocial measures with objective physiological monitoring. Assessments occur at baseline (T\n                      <jats:sub>0<\/jats:sub>\n                      ), 1\u2009week (T\n                      <jats:sub>1<\/jats:sub>\n                      ), 4 weeks (T\n                      <jats:sub>2<\/jats:sub>\n                      ) and 8 weeks (T\n                      <jats:sub>3<\/jats:sub>\n                      ) postintervention. The primary outcome is PTSS in children and caregivers. Secondary outcomes include post-traumatic growth, post-traumatic cognitions, anxiety, depression, family management, family hardiness, quality of life, sleep quality and objective physiological measures collected from primary caregivers. Wearable devices will continuously record these physiological measures, including total sleep time, sleep score, heart rate and resting heart rate. A process evaluation will apply the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Data will be analysed according to intention-to-treat principles using linear mixed-effects models. Recruitment of participants began on 20 December 2025, and the study is expected to be completed by 20 December 2026.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study was approved by the Ethics Review Committee of Xiangya School of Nursing, Central South University (approval number: E2025172) and the Medical Ethics Committee of Central South University (approval number: CSUMEC-E2025011). Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed publications and conference presentations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ChiCTR2500114338.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-119064","type":"journal-article","created":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T12:00:50Z","timestamp":1787227250000},"page":"e119064","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Multicentre randomised controlled trial of a nurse-led family intervention on post-traumatic stress symptoms in families of children with cancer in China: protocol for the SCCIP-N trial"],"prefix":"10.1136","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-9401-7611","authenticated-orcid":false,"given":"Xiaorou","family":"Zeng","sequence":"first","affiliation":[{"name":"Central South University Xiangya School of Nursing, Changsha, Hunan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Kong","sequence":"additional","affiliation":[{"name":"School of Nursing, Xin Jiang Medical University, Urumqi, Xinjiang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ya","family":"Shi","sequence":"additional","affiliation":[{"name":"School of Nursing, Shandong Xiehe University, Jinan, Shandong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-4930-4333","authenticated-orcid":false,"given":"Ying","family":"Ye","sequence":"additional","affiliation":[{"name":"Central South University Xiangya School of Nursing, Changsha, Hunan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5135-822X","authenticated-orcid":false,"given":"Can","family":"Gu","sequence":"additional","affiliation":[{"name":"Central South University Xiangya School of Nursing, Changsha, Hunan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,8,19]]},"reference":[{"key":"2026090322303560000_16.8.e119064.1","doi-asserted-by":"crossref","DOI":"10.26633\/RPSP.2023.164","article-title":"Developing and sustaining high-quality care for children with cancer: the WHO Global Initiative for Childhood Cancer","volume":"47","author":"Ortiz","year":"2023","journal-title":"Rev Panam Salud Publica"},{"key":"2026090322303560000_16.8.e119064.2","doi-asserted-by":"crossref","DOI":"10.1016\/j.apjon.2024.100568","article-title":"Prevalence and associated factors of post-traumatic stress symptoms in hospitalised children with cancer and their parents in South China: A multicentred cross-sectional study","volume":"11","author":"Peng","year":"2024","journal-title":"Asia Pac J Oncol Nurs"},{"key":"2026090322303560000_16.8.e119064.3","doi-asserted-by":"publisher","DOI":"10.1016\/s0140-6736(22)01541-0"},{"key":"2026090322303560000_16.8.e119064.4","doi-asserted-by":"publisher","DOI":"10.1016\/s1470-2045(20)30425-3"},{"key":"2026090322303560000_16.8.e119064.5","doi-asserted-by":"crossref","first-page":"256","DOI":"10.1037\/hea0001132","article-title":"Trajectories of resilience and posttraumatic stress in childhood cancer: Consistency of child and parent outcomes","volume":"41","author":"Sharp","year":"2022","journal-title":"Health Psychol"},{"key":"2026090322303560000_16.8.e119064.6","doi-asserted-by":"crossref","DOI":"10.3390\/jcm12051784","article-title":"Severity and Longitudinal Course of Depression, Anxiety and Post-Traumatic Stress in Paediatric and Young Adult Cancer Patients: A Systematic Review and Meta-Analysis","volume":"12","author":"Lee","year":"2023","journal-title":"J Clin Med"},{"key":"2026090322303560000_16.8.e119064.7","article-title":"Prevalence of Anxiety and Depression among Parents of Children with Cancer-A Preliminary Study","volume":"11","author":"Lewandowska","year":"2024","journal-title":"Children (Basel)"},{"key":"2026090322303560000_16.8.e119064.8","doi-asserted-by":"crossref","unstructured":"Association AP . Diagnostic and statistical manual of mental disorders: american psychiatric association. 2013.","DOI":"10.1176\/appi.books.9780890425596"},{"key":"2026090322303560000_16.8.e119064.9","doi-asserted-by":"crossref","DOI":"10.1080\/20008066.2022.2156053","article-title":"A systematic literature review of the relationship between parenting responses and child post-traumatic stress symptoms","volume":"14","author":"Afzal","year":"2023","journal-title":"Eur J Psychotraumatol"},{"key":"2026090322303560000_16.8.e119064.10","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2024.03.067"},{"key":"2026090322303560000_16.8.e119064.11","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2021-060629","article-title":"Efficacy of a smartphone-based care support programme in improving post-traumatic stress in families with childhood cancer: protocol of a randomised controlled trial","volume":"12","author":"Ma","year":"2022","journal-title":"BMJ Open"},{"key":"2026090322303560000_16.8.e119064.12","article-title":"Posttraumatic stress symptoms in Chinese children with ongoing cancer treatment and their parents: Are they elevated relative to healthy comparisons?","volume":"31","author":"Yang","year":"2022","journal-title":"European J Cancer Care"},{"key":"2026090322303560000_16.8.e119064.13","doi-asserted-by":"crossref","unstructured":"Xiang LA , Wan HW , Zhu Y . Effects of cognitive behavioral therapy on resilience among adult cancer patients: a systematic review and meta-analysis. BMC Psychiatry 2025;25. doi:10.1186\/s12888-025-06628-3","DOI":"10.1186\/s12888-025-06628-3"},{"key":"2026090322303560000_16.8.e119064.14","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-014-2193-4"},{"key":"2026090322303560000_16.8.e119064.15","doi-asserted-by":"crossref","unstructured":"Pelcastre-Neri A , Garc\u00eda-Solano B , Herrera-Paredes JM , et al . Interventions for psychological problems in caregivers of children with cancer: a systematic review. Acta Paul Enferm 2025;38. doi:10.37689\/acta-ape\/2025ar001835i","DOI":"10.37689\/acta-ape\/2025ar001835e"},{"key":"2026090322303560000_16.8.e119064.16","doi-asserted-by":"crossref","first-page":"2293498","DOI":"10.1080\/16078454.2023.2293498","article-title":"Cognitive-behavioral stress management relieves anxiety, depression, and post-traumatic stress disorder in parents of pediatric acute myeloid leukemia patients: a randomized, controlled study","volume":"29","author":"Wang","year":"2024","journal-title":"Hematology"},{"key":"2026090322303560000_16.8.e119064.17","doi-asserted-by":"crossref","DOI":"10.1002\/pon.70086","article-title":"Cognitive-Behavioral Intervention for Children With Hematological Cancer Receiving Chemotherapy: A Randomized Controlled Trial","volume":"34","author":"Melesse","year":"2025","journal-title":"Psychooncology"},{"key":"2026090322303560000_16.8.e119064.18","doi-asserted-by":"publisher","DOI":"10.1016\/j.cbpra.2024.01.004"},{"key":"2026090322303560000_16.8.e119064.19","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1111\/j.1545-5300.1999.00176.x","article-title":"Surviving cancer competently intervention program (SCCIP): a cognitive-behavioral and family therapy intervention for adolescent survivors of childhood cancer and their families","volume":"38","author":"Kazak","year":"1999","journal-title":"Fam Process"},{"key":"2026090322303560000_16.8.e119064.20","doi-asserted-by":"publisher","DOI":"10.1037\/0893-3200.18.3.493"},{"key":"2026090322303560000_16.8.e119064.21","doi-asserted-by":"crossref","unstructured":"Ma G , Peng Y , Liu L , et al . Bridging the gap: a systematic cultural adaptation of the Surviving Cancer Competently Intervention Program (SCCIP) for Chinese families using the ADAPT-ITT framework. Transl Behav Med 2026;16. doi:10.1093\/tbm\/ibag016","DOI":"10.1093\/tbm\/ibag016"},{"key":"2026090322303560000_16.8.e119064.22","doi-asserted-by":"crossref","first-page":"104916","DOI":"10.1016\/j.ijnurstu.2024.104916","article-title":"Effectiveness of nurse-led self-care interventions on quality of life, social support, depression and anxiety among people living with HIV: A systematic review and meta-analysis of randomized controlled trials","volume":"161","author":"Huang","year":"2025","journal-title":"Int J Nurs Stud"},{"key":"2026090322303560000_16.8.e119064.23","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2024.03.028"},{"key":"2026090322303560000_16.8.e119064.24","doi-asserted-by":"crossref","first-page":"3570","DOI":"10.1200\/JCO.24.00048","article-title":"Randomized Controlled Trial of a Nurse-Led Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer","volume":"42","author":"Greer","year":"2024","journal-title":"JCO"},{"key":"2026090322303560000_16.8.e119064.25","doi-asserted-by":"crossref","unstructured":"Mohammadi F , Hosseiny SMM , Khazaei S , et al . Effect of nurse-led intervention programs based on spiritual care on the resilience and death anxiety in parents of children and adolescents with cancer, a randomized clinical trial. BMC Psychol 2025;13. doi:10.1186\/s40359-025-03179-w","DOI":"10.1186\/s40359-025-03179-w"},{"key":"2026090322303560000_16.8.e119064.26","doi-asserted-by":"publisher","DOI":"10.1016\/j.pediatrneurol.2024.03.003"},{"key":"2026090322303560000_16.8.e119064.27","doi-asserted-by":"crossref","first-page":"102934","DOI":"10.1016\/j.ejon.2025.102934","article-title":"The impact of dignity therapy on demoralization syndrome in patients undergoing chemotherapy: A randomized controlled trial exploring a nurse-led psychotherapeutic approach in oncology care","volume":"77","author":"Soleimani","year":"2025","journal-title":"Eur J Oncol Nurs"},{"key":"2026090322303560000_16.8.e119064.28","doi-asserted-by":"crossref","DOI":"10.1136\/bmj-2024-081660","article-title":"SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials","volume":"389","author":"Hr\u00f3bjartsson","year":"2025","journal-title":"BMJ"},{"key":"2026090322303560000_16.8.e119064.29","unstructured":"Peng Y . The cultural adaptation and initial application ofsurvivorship cancer competently intervention programfor families of children with [master\u2019s thesis] . Central south university, 2024"},{"key":"2026090322303560000_16.8.e119064.30","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.20910"},{"key":"2026090322303560000_16.8.e119064.31","doi-asserted-by":"publisher","DOI":"10.1007\/s11920-004-0048-2"},{"key":"2026090322303560000_16.8.e119064.32","doi-asserted-by":"crossref","DOI":"10.3389\/fpsyt.2020.00724","article-title":"Use of Prazosin for Pediatric Post-Traumatic Stress Disorder With Nightmares and\/or Sleep Disorder: Case Series of 18 Patients Prospectively Assessed","volume":"11","author":"Ferrafiat","year":"2020","journal-title":"Front Psychiatry"},{"key":"2026090322303560000_16.8.e119064.33","unstructured":"Lin F , Jin C , Suman W , et al . Validity and reliability of the Chinese Version of the University of California at Los Angeles Posttraumatic Stress Disorder Reaction Index for DSM-IV (Revision 1, Children version). Chinese Mental Health Journal\/Zhongguo Xinli Weisheng Zazhi 2018;32."},{"key":"2026090322303560000_16.8.e119064.34","doi-asserted-by":"crossref","unstructured":"Weiss DS . The impact of event scale: revised. In: Cross-Cultural Assessment of Psychological Trauma and PTSD. Springer, 2007: 219\u201338.","DOI":"10.1007\/978-0-387-70990-1_10"},{"key":"2026090322303560000_16.8.e119064.35","doi-asserted-by":"publisher","DOI":"10.1016\/j.brat.2003.07.010"},{"key":"2026090322303560000_16.8.e119064.36","doi-asserted-by":"publisher","DOI":"10.1007\/s00127-003-0611-x"},{"key":"2026090322303560000_16.8.e119064.37","doi-asserted-by":"publisher","DOI":"10.1007\/BF02103658"},{"key":"2026090322303560000_16.8.e119064.38","doi-asserted-by":"publisher","DOI":"10.1016\/j.cpr.2011.06.003"},{"key":"2026090322303560000_16.8.e119064.39","doi-asserted-by":"crossref","first-page":"186","DOI":"10.1093\/jpepsy\/jsy069","article-title":"Adjustment in Childhood Cancer Survivors, Healthy Peers, and Their Parents: The Mediating Role of the Parent-Child Relationship","volume":"44","author":"Schepers","year":"2019","journal-title":"J Pediatr Psychol"},{"key":"2026090322303560000_16.8.e119064.40","first-page":"26","article-title":"Revision of the posttraumatic growth inventory and testing its reliability and validity","volume":"26","author":"Wang","year":"2011","journal-title":"J Nurs Sci"},{"key":"2026090322303560000_16.8.e119064.41","doi-asserted-by":"crossref","first-page":"193","DOI":"10.1177\/1073191116685401","article-title":"The Development of a Brief Version of the Posttraumatic Cognitions Inventory (PTCI-9)","volume":"26","author":"Wells","year":"2019","journal-title":"Assessment"},{"key":"2026090322303560000_16.8.e119064.42","doi-asserted-by":"publisher","DOI":"10.1037\/\/1040-3590.11.3.303"},{"key":"2026090322303560000_16.8.e119064.43","doi-asserted-by":"crossref","first-page":"291","DOI":"10.1037\/pas0001309","article-title":"Factor structure, measurement invariance, and psychometric properties of the Posttraumatic Cognitions Inventory (PTCI) and its brief version (PTCI-9) in Chinese adolescents and adults","volume":"36","author":"Zhan","year":"2024","journal-title":"Psychol Assess"},{"key":"2026090322303560000_16.8.e119064.44","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.166.10.1092"},{"key":"2026090322303560000_16.8.e119064.45","doi-asserted-by":"publisher","DOI":"10.1046\/j.1525-1497.2001.016009606.x"},{"key":"2026090322303560000_16.8.e119064.46","doi-asserted-by":"publisher","DOI":"10.1093\/jpepsy\/jsp034"},{"key":"2026090322303560000_16.8.e119064.47","first-page":"19","article-title":"Validity and reliability of the Chinese version of Family Management Measure","volume":"25","author":"Zhang","year":"2009","journal-title":"Chinese Journal of Practical Nursing"},{"key":"2026090322303560000_16.8.e119064.48","unstructured":"McCubbin HI , Thompson AI , McCubbin MA . Family assessment: resiliency, coping and adaptation: inventories for research and practice. 1996."},{"key":"2026090322303560000_16.8.e119064.49","first-page":"770","article-title":"Reliability and validity of the Chinese version of family hardiness index","volume":"11","author":"Liu","year":"2014","journal-title":"J Nurs Adm"},{"key":"2026090322303560000_16.8.e119064.50","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.10428"},{"key":"2026090322303560000_16.8.e119064.51","doi-asserted-by":"crossref","DOI":"10.1186\/1477-7525-9-103","article-title":"Measuring health-related quality of life in children with cancer living in mainland China: feasibility, reliability and validity of the Chinese mandarin version of PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module","volume":"9","author":"Ji","year":"2011","journal-title":"Health Qual Life Outcomes"},{"key":"2026090322303560000_16.8.e119064.52","doi-asserted-by":"publisher","DOI":"10.1097\/00005650-199603000-00003"},{"key":"2026090322303560000_16.8.e119064.53","doi-asserted-by":"publisher","DOI":"10.1016\/0165-1781(89)90047-4"},{"key":"2026090322303560000_16.8.e119064.54","doi-asserted-by":"crossref","DOI":"10.1186\/s12955-021-01803-y","article-title":"Psychometric properties of the Chinese version of the Pittsburgh Sleep Quality Index (PSQI) among Hong Kong Chinese childhood cancer survivors","volume":"19","author":"Ho","year":"2021","journal-title":"Health Qual Life Outcomes"},{"key":"2026090322303560000_16.8.e119064.55","doi-asserted-by":"crossref","DOI":"10.2196\/64955","article-title":"Inter- and Intrapersonal Associations Between Physiology and Mental Health: A Longitudinal Study Using Wearables and Mental Health Surveys","volume":"27","author":"Presby","year":"2025","journal-title":"J Med Internet Res"},{"key":"2026090322303560000_16.8.e119064.56","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pdig.0000473","article-title":"Predicting stress in first-year college students using sleep data from wearable devices","volume":"3","author":"Bloomfield","year":"2024","journal-title":"PLOS Digit Health"},{"key":"2026090322303560000_16.8.e119064.57","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2022.12.004"},{"key":"2026090322303560000_16.8.e119064.58","doi-asserted-by":"publisher","DOI":"10.2105\/ajph.89.9.1322"},{"key":"2026090322303560000_16.8.e119064.59","doi-asserted-by":"crossref","DOI":"10.1186\/s13063-024-08249-9","article-title":"A deprescribing programme aimed to optimise blood glucose-lowering medication in older people with type 2 diabetes mellitus, the OMED2-study: the study protocol for a randomised controlled trial","volume":"25","author":"Andriessen","year":"2024","journal-title":"Trials"},{"key":"2026090322303560000_16.8.e119064.60","doi-asserted-by":"crossref","first-page":"104891","DOI":"10.1016\/j.ijnurstu.2024.104891","article-title":"Nursing interventions for pediatric patients with cancer and their families: A scoping review","volume":"160","author":"R\u00f8rbech","year":"2024","journal-title":"Int J Nurs Stud"},{"key":"2026090322303560000_16.8.e119064.61","doi-asserted-by":"publisher","DOI":"10.1002\/pon.1113"},{"key":"2026090322303560000_16.8.e119064.62","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1093\/jpepsy\/jsac062","article-title":"Effects on Pediatric Cancer Survivors: The FAMily-Oriented Support (FAMOS) Randomized Controlled Trial","volume":"48","author":"Bidstrup","year":"2023","journal-title":"J Pediatr Psychol"},{"key":"2026090322303560000_16.8.e119064.63","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0323483","article-title":"Impact of technology- and parent-based psychosocial interventions on family dynamics factors in children with cancer: A systematic review","volume":"20","author":"Zhang","year":"2025","journal-title":"PLoS ONE"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2026-119064","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T05:30:58Z","timestamp":1788499858000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2026-119064"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8]]},"references-count":63,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2026,8,19]]},"published-print":{"date-parts":[[2026,8]]}},"alternative-id":["10.1136\/bmjopen-2026-119064"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2026-119064","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8]]}}}