A complex family adaptation intervention for Chinese families of hospitalised children with newly diagnosed cancer: study protocol for a cluster randomized controlled trial design

Abstract

Background

Paediatric cancer diagnoses significantly affect the psychosocial well-being of children and their families. Existing evidence shows that a multicomponent family intervention model is beneficial for improving the mental health and quality of life of families of children with cancer; however, these models have faced criticisms related to their cultural sensitivity and clinical applicability. To date, there is insufficient evidence on complex interventions and their application for families of hospitalised children with cancer in China. aiming to evaluate the effectiveness of a complex family adaptation intervention specifically designed for Chinese families of hospitalised children with newly diagnosed cancer.

Methods

This study will develop a family adaptation complex intervention covered nine thematic contents and a three-day stress management program primarily consists of disease information support and common stress management techniques. Standardized scales will be used to collect self-reported data from parents and children, while generalised estimating equations, repeated measures analysis of variance, and regression models will be used for data analysis. A cluster randomised controlled trial design will be employed involving four hospitals across Changsha, Hunan Province, China. Hospitals will be randomly assigned to either the intervention group, which will receive the complex family adaptation intervention, or the control group, which will undergo a stress management course. The participants will include families of children aged 5–12 years newly diagnosed with cancer. The primary outcomes to be measured include post-traumatic stress, family adaptation, emotional reactivity, quality of life, and additional health outcomes. Assessments will be performed at baseline, post-intervention, and follow-ups at 2 and 6 months.

Discussion

This project follows the MRC framework for developing and evaluating complex interventions and will use a cluster randomized controlled design to ensure methodological rigor. The multi-component, culturally tailored, family-centered intervention addresses the psychosocial needs of hospitalized pediatric cancer patients and their families in China, a population that has been under-represented in psychosocial oncology research. Targeting family adaptation, stress reduction, and quality of life, the intervention demonstrates strong feasibility and potential for integration into routine pediatric oncology care if proven effective.

Trial registration

The study was registered on the Chinese Clinical Trial Registry (ChiCTR) platform, http://www.chictr.org.cn (Record ID: ChiCTR2300076764, October 18, 2023), the protocol version number: V1.0.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12887-025-06427-5.

Background

According to the World Health Organization (WHO), approximately 200,000 children are diagnosed with cancer globally each year, with China ranking second in the number of new cases [1]. The annual growth rate in China is increasing at an alarming rate of 2.8%, which is significantly higher than that in the United States (0.6%) and Europe (1.1%) [2]. This rapid increase presents a substantial challenge for the Chinese healthcare system. Providing comprehensive care and support to a large population of paediatric cancer patients has become an urgent challenge that must be addressed.

Due to the sudden onset, prolonged treatment cycle, and irregular complications of childhood cancer, newly diagnosed children often require hospitalisation [3]. The inpatient experience with cancer is considered one of the most traumatic events for children and their families. Hospitalisation not only reduces children’s quality of life but may also induce a series of emotional and behavioural problems, such as anxiety, depressive symptoms, and social withdrawal [4, 5]. Family members also face personal and social disruptions, including changes in social roles, increased psychological stress, negative emotions, and family imbalance, potentially leading to severe post-traumatic stress symptoms (PTSS) [6, 7]. PTSS refer to psychological symptoms occurring after major traumatic events, specifically intrusive re-experience, avoidance and numbness, hyperarousal, negative cognitive and emotional changes [8], and treatment and rehabilitation [9].

The comprehensive Paediatric Medical Traumatic Stress Model (PMTS) [10] describes the linear response process of families to traumatic medical events, indicating that families enter an acute response period following a childhood cancer diagnosis, with the risk of PTSS in children and caregivers peaking at this time. The incidence of PTSS in families of children with cancer during hospitalisation is high, with up to 99% of families having at least one member with PTSS. The incidence rates for PTSS in children and their parents during hospitalization are 22–42% and 40–83%, respectively [11, 12]. Psychosocial stress in children and their parents can lead to further symptom burden, reduced treatment adherence, and serious impacts on disease outcomes and long-term quality of life [13].

The family is considered a crucial environment for the growth and development of children and plays a critical role during a cancer diagnosis. Family adaptation refers to a balanced and stable state achieved through the collective efforts of the entire family in response to stress or crisis events, involving adjustments made by all family members [14]. Positive family dynamics significantly influence psychosocial stress (e.g., PTSS) and the quality of life of children and caregivers [15]. The Family Adjustment and Adaptation Response (FAAR) Model [16] provides a comprehensive explanation of the adjustment and adaptation processes of families of children with cancer, emphasising that the family reacts to traumatic events as a system. The reaction process involves responding to the disease and treatment demands (family demands), utilising family resources and coping styles (family capabilities), and forming a cognitive assessment of the traumatic situation (family meanings). Positive family interactions and communication can foster positive perceptions of trauma, thereby positively impacting family adaptation outcomes. Cognitive assessment of the traumatic situation by cancer patients and their caregivers can influence each other, and there is a significant correlation between psychosocial stress symptoms (PTSS, anxiety, and depression) among children with cancer and their parents [17].

Current interventions aimed at addressing psychosocial stress faced by children with cancer and their families focus on individual-level psychosocial targets, such as cognitive behavioural therapy (CBT) or behavioural therapy (BT) based intervention measures [18], therapeutic video games [19], sports and entertainment activities [20]and art therapy [21]. All have shown positive effects in alleviating psychological stress and improving the quality of life of children with cancer. However, these interventions have encountered significant implementation challenges including high attrition rates, low adherence, limited applicability to preschool-aged children, impracticality within hospital settings, and insufficient consideration of family attachment and function in paediatric oncology treatment. In developed countries, multi-component interventions integrating family therapy and cognitive behavioural therapy have been developed to address the psychosocial stress needs of families of paediatric cancer patients. These interventions include the Surviving Cancer Capacity Intervention Program (SCCIP) [22], Family-oriented Cognitive Behavioural Therapy interventions (FAMOS) [23], and the SCCIP for families of children with newly diagnosed cancer (SCCIP-ND) [24]. These interventions have been effective in reducing PTSS, anxiety, and depression among families of paediatric cancer patients. However, interventions for families of children with cancer in China are limited. Furthermore, existing studies have primarily focused on interventions such as the family centred Community Care Intervention (FCCNI) [25] and the Family Positive Behavior Support Program (FPBSP) [26]. However, these studies predominantly addressed the children themselves and have overlooked the broader psychosocial stress needs of both children and their families. Consequently, the impact of these interventions on other family members and overall family adaptation remains unclear.

The adaptation process of families of hospitalised children with cancer in China is shaped by the country’s unique social and cultural context and medical service system. In traditional Chinese culture, children are the focal points of families and have significant family expectations. Children’s health status affects not only family happiness but also the family’s future [27]. Despite continuous improvements in childhood cancer medical assistance policies in China, the country’s large population has resulted in a relatively high number of childhood cancer cases, leading to strained hospital resources and increased pressure on families during treatment [28]. Therefore, implementing appropriate psychosocial interventions for families of newly diagnosed children with cancer, tailored to the local Chinese cultural context, is particularly important for helping these families cope more effectively with the challenges they face. There is a pressing need for more complex interventions and robust evidence regarding the application of psychosocial intervention among Chinese families to cope with paediatric cancer.

Therefore, we integrated the PMTS and FAAR models to form the theoretical framework of this study, the Trauma-Focused Family Adjustment and Adaptation Model (TF-FAAM) (Fig. 1). This integrated model provides insights and guidance for the positive transition process towards “normalization” in families with paediatric cancer and identifies potential targets for developing intervention programs. Guided by the conceptual framework for complex interventions issued by the British Medical Research Council (MRC) [29], a complex intervention for family adaptation in hospitalised children with newly diagnosed cancer in China was developed based on a comprehensive review and assessment of previous evidence on relevant interventions. Additionally, individual-and family level factors of newly diagnosed hospitalised children with cancer were considered based on the TF-FAAM.

Fig. 1.

The trauma focused-family adjustment and adaptation model (TF-FAAM)

Aims

This project aims to evaluate the effectiveness of a complex family adaptation intervention for Chinese families of hospitalised children with newly diagnosed cancer.

The main objectives of this study are as follows:

1. To examine the effect of a complex family adaptation intervention on alleviating PTSS and improving the emotional reactivity and quality of life of children with cancer and their caregivers.

2. To evaluate the complex family adaptation intervention in improving the family adaptation of caregivers of children with cancer.

3. To evaluate the complex family adaptation intervention for improving childhood cancer caregivers’ coping styles, social support, posttraumatic cognitive assessment, disease and treatment stress, sleep quality, and salivary cortisol levels..

4. To analyze the effects of the complex family adaptation intervention on post-traumatic cognitive assessment, disease progress and outcome, sleep quality, and salivary cortisol levels in children with cancer..

5. Based on the TF-FAAM model, we will evaluate the variables involved in the family adaptation process (such as cognitive assessment, coping styles, and social support), the main adjustment variables (such as family social demographic characteristics and disease characteristics), and their contribution to and influence on the primary and secondary indicators of children with cancer and their caregivers..

Methods

The protocol was written in accordance with the SPIRIT 2013: Standard Protocol Items for Interventional Trials.

Study settings

We will use random sampling to select four hospitals in Hunan Province, China, as study sites. All tertiary grade A hospitals with pediatric oncology wards will be numbered and randomly selected using a random number generator. The four hospitals include three general hospitals and one specialist pediatric hospital, these four medical institutions are the primary facilities for pediatric oncology patients in Hunan, admitting over 650 children with cancer annually, ensuring sufficient sample size and representativeness for this study.

Study design

This study will be designed as a parallel, cluster-randomised controlled trial with repeated-measures analysis. Randomisation will be performed on a cluster (hospital) basis, and data collection will be performed at both the cluster (hospital) and within-cluster (household) levels. To test the effect of the intervention, measurements will be taken at baseline (T0), post-intervention (T1), two months follow-up (T2), and six months follow-up (T3). Families in the intervention group will participate in a complex family adaptation intervention, including three consecutive days of sessions (1.5 h daily), followed by two months of intensive intervention, with follow-up reinforcement. Families in the control group will receive three days of routine stress management sessions (1.5-hour daily) and telephone follow-up. A flowchart of the study design is shown in Fig. 2.

Fig. 2.

Flow diagram of study design

Eligibility criteria

This study will recruit families as a unit, with a family of children with cancer defined as a family consisting of one newly diagnosed hospitalised child with cancer and one or more primary caregivers.

Cancer patient

The inclusion criteria were as follows: (1) first diagnosed with leukaemia or cerebral cancer confirmed by pathological examination (leukaemia and cerebral cancer are the two most serious malignancies in children in China [30]); (2) age 5–12 years (persistent post-diagnosis PTSS has been reported more often in 5-year-old or older than in younger children [31]); (3) no history of mental illness; and (4) children provided oral consent to participate, and their parents provided written consent.

Exclusion criteria were: (1) current or previous participation in psychosocial intervention trials; (2) severe physical illness or having experienced major life events (e.g., parents’ divorce, one parent died, etc.) in the past six months, in addition to the cancer diagnosis; and (3) the disease was in the terminal stage.

Caregivers of patients with cancer

The inclusion criteria were as follows: (1) inclusion criteria for the cancer patient has been met; (2) parent or other primary caregivers of the child; (3) no serious audio-visual impairments, cognitive impairment, or history of organic mental illness; and (4) voluntary participation in the survey.

Exclusion criteria were as follows: (1) do not live with children and (2) have experienced major life events (e.g., divorce or death) other than the child’s cancer diagnosis.

Participant recruitment

Data collection will begin in January 2025. Based on a precalculated sample size, 220 families will be recruited. Trained and registered nurses will refer to the medical records of the relevant departments and conduct a brief communication with the parents to identify children and families who meet the discharge criteria. Once identified, the research assistant will conduct a 15–30 min face-to-face conversation with the children’s family to explain the purpose, content, research methodology, risks, and benefits of the intervention, they will also clarify that participation is voluntary, with the right to withdraw at any time, and allow the family ample time to consider and ask questions freely, and ultimately obtain their voluntary participation.

Simple size

The sample size was calculated using PASS software developed by the Number Cruncher Statistical System (NCSS) in the United States. As PTSS has increasingly been adopted as the primary outcome measure in comparable research, the present study calculated its sample size based on a core hypothesis: that the intervention will alleviate PTSS among caregivers of children newly diagnosed with cancer. Considering that previous studies to reduce PTSS of childhood cancer families had an effect size of 0.48 [22], our estimations – using 80% power and a significance level of 0.05, for a two-tailed test - yielded a sample size of 90 families in each group. The study involves four medical institutions as research sites, and with a predetermined number of clusters k = 44, the required sample size N considers both individual randomised conditions and the intracluster correlation coefficient (ICC). Using Hemming et al.‘s sample size estimation formula for cluster-controlled trials with a fixed number of clusters to calculate the sample size [32] [N= (nk1-ρ)/k-nρ], and setting the ICC at 0.03 (medium correlation), the cluster number k is 44, and each cluster requires at least 94 families. To account for potential dropouts, the sample size was increased by 15%, resulting in a requirement of 110 families per group, totalling 220 families. Based on previous studies of similar types [33], we estimated the consent rate for this study to be 95%.

Randomization and blinding

In the forthcoming study, to mitigate the risk of communication (contamination) between families in the intervention and control groups, a cluster-randomised controlled clinical trial will be conducted with randomisation and interventions conducted at the cluster (hospital) level. Before the intervention begins, the four hospitals will be randomly divided into an intervention group and a control group in a l: l ratio using the random number table method. Families will be recruited as the units for this study. Given the appropriateness of the complex intervention for implementation within small groups of families (4–5 families), each cluster will comprise five families. Assuming a target sample size of 220 families, 11 distinct study periods will be established across four hospitals (based on a proposed intervention protocol involving three days of intensive intervention followed by two months of enhanced follow-up, with each month constituting a study period). This will yield 44 clusters (4 × 11). The 44 clusters will then be divided into a control group or an intervention group based on their prior hospital grouping, resulting in 22 clusters per group. Due to ethical considerations, blinding of participants will not be feasible because they will be informed of the study’s objectives and group allocation through a written informed consent process. Therefore, assessor blinding will be adopted, wherein postgraduate students trained in the use of measurement tools will collect questionnaires and remain unaware of their group assignments and intervention statuses. Randomization process flow diagram is shown in Fig. 3.

Fig. 3.

Randomization process flow diagram

Intervention

Intervention group

Families in the intervention group will participate in a family adaptation complex intervention consisting of a three-day intensive intervention (with five families forming a group for approximately 1.5 h per session) and four enhancement follow-up sessions. The intensive intervention will occur in a quiet, secluded room and will cover nine thematic contents: Introduction, Family Interview on the Impact of Traumatic Stress, “House-Tree-Person” Thematic Drawing, Multi-family Video Discussion Group, Adversity-Belief-Outcome Model, Thematic Drawing “Safe Haven”, Family Survival Roadmap, Placing Cancer in its Rightful Context, and Thematic Drawing “Collaborative Family Landscape” (Table S1 in the Supplementary file.). The enhancement follow-up intervention will be delivered via video-based art psychotherapy on the WeChat platform, occurring every two weeks for 30 min per session, over two months. During these sessions, patients will engage in free-theme drawing with the assistance of caregivers and have the opportunity to ask questions and discuss their drawings with an interventionist.

Control group

Families in the control group will receive a three-day stress management course (once daily, 1.5 h per session) and routine telephone follow-up. The stress management program primarily consists of disease information support and common stress management techniques, excluding the core elements of family adaptation complex interventions (Table 1). Utilising a stress management program as a control intervention provides a comparable intervention dosage for the intervention group, reduces dropout rates among control participants, and allows for a more robust examination of the effects of the complex family adaptation intervention. Following the three intensive stress management sessions, families in the control group will continue with their normal activities and receive routine medical care during the intervention phase, with telephone follow-ups every two weeks for two months. To prevent contamination, the staff members assigned to the control and intervention groups will not overlap. After data collection, families in the control group will be invited to participate in the family adaptation complex intervention.

Table 1.

Stress management course

Time and course	Intervention technology
Day 1:(90 min) Understand stress and stress management	The psychological and physical manifestations of stress will be explored, along with the potential negative impacts of prolonged stress. Counselors will tailor appropriate stress reduction techniques, such as breathing exercises or progressive muscle relaxation, to the preferences and specific needs of the participants. These techniques aim to help children and their families alleviate psychological distress through effective stress management strategies.
Day 2:(90 min) Recognize and cope with the side effects of treatment	Educate children with cancer and their families about the common side effects of cancer treatment, addressing both physical (e.g., fatigue, nausea, pain) and psychological (e.g., anxiety, mood swings) impacts. Additionally, provide coping strategies to help manage these challenges effectively.
Day 3:(90 min) Diet and exercise guidance	Introduce children with cancer and their families to ways of boosting the immune system and supporting recovery through a balanced diet and moderate exercise during treatment. Emphasize the role of nutrient-rich foods in aiding physical recovery, and present simple, adaptive exercise programs to help children stay active and promote overall healing.

Data collection

Eligible participants will first complete a brief survey to collect demographic information and details related to their disease treatment. This survey will collect basic information such as age, sex, family structure, economic status, education level, and specific information on disease diagnosis, treatment methods, and disease duration. Its purpose is to establish a comprehensive understanding of each family’s background and provide essential baseline data for subsequent analyses. Data will be collected at four time points for both the intervention and control groups: baseline (T0), post-intensive intervention (T1), two months follow-up (T2), and six months follow-up (T3). Initially, face-to-face questionnaire surveys will be administered by trained research assistants or nurses at baseline and immediately after the intensive intervention. The researchers will assist children and parents in completing the scales, providing professional explanations if participants have difficulty understanding any items. After completion, the questionnaires will be collected immediately and checked for completeness and accuracy. For the two month follow-up and six-month post-intervention assessments, survey links will be distributed via the WeChat platform to improve convenience and response rates among participants. To maintain data integrity and accuracy, multiple reminder strategies will be employed and technical support and remote guidance will be available to assist participants in successfully completing the questionnaires.

Outcomes

Primary outcomes

Family adaptation: The family adaptation of caregivers will use the Chinese version of the Family Adaptability Cohesion Environment Scale (FACES II-CV), which contains 30 items with a 5-point scale and was revised in 1991 by Lipeng et al. [34]. This scale evaluates two aspects-closeness and adaptability. The difference between the “actual” and “ideal” status of closeness and adaptability indicates the degree of dissatisfaction with family closeness and adaptability, and the larger the absolute value, the greater the degree of dissatisfaction.

Posttraumatic Stress: The PTSS of children with cancer will be evaluated using the Chinese version of the Post-traumatic Stress Disorder Reaction Index (PTSD-RI). The scale includes 20 items across three dimensions of re-experiencing, avoidance, and hypervigilance on a 5-point Likert scale range from 0 (never) to 4 (most of the time) with a total score of 0 to 80 [35]. A child with a total score of 36 or higher will be considered to have PTSS. Caregivers’ PTSS will be assessed using the Impact of Event Scale-6 (IES-6). It contains a simplified version of the Event Scale-Revised (IES-R) to measure posttraumatic stress reactions. The IES-6 has good validity for measuring post-traumatic stress, with a Cronbach’s Alpha of 0.80 [36].

Emotional reactivity: Children’s emotional reactivity will be measured using the Chinese version of the Positive and Negative Affect Scale (PANAS), which consists of 20 adjectives and includes both positive and negative emotional dimension [37]. A high score on the positive mood scale indicates an energetic, focused, and happy emotional state, whereas a low score indicates apathy. A high score for negative emotions indicates that the person is subjectively confused and worried, whereas a low score indicates calmness. Caregivers’ emotional reactivity will be assessed using the Chinese version of the Depression Anxiety Stress Scale (DASS) which contains 21 items. The scale consists of three subscales - depression, anxiety, and stress - rated on a 4-point Likert scale ranging from 0 (strongly disagree) to 3 (strongly agree) [38].

Quality of Life: The Euro-Qol 5-dimension Youth version Scale (EQ-5D-Y) will be used for children. The questionnaire was developed by the European Quality of Life Organization to be understood by children and young people by modifying the content and wording of the EQ-5D questionnaire, and children are asked to rate their health on that day [39]. Caregivers will use the Chinese version of the Euro-Qol 5-dimension questionnaire (EQ-5D). The questionnaire consists of five dimensions of health (mobility, self-care, daily activities, pain or discomfort, anxiety or unhappiness) and a visual analogue scale [40], and a score of 100 means “best health” and a score of 0 means “worst health”.

Secondary outcome

Coping style: Caregivers’ coping style will be measured using the Simplified Coping Style Questionnaire (SCSQ) [41].

Social support: Caregivers’ social support will be measured using the Social Support Rating Scale (SSRS) [42].

Disease and treatment stress: Caregivers’ disease and treatment stress will be measured using the Family Inventory of Life Events and Changes (FILE) [43].

Post-traumatic cognitive assessment: Caregivers’ post-traumatic cognitive assessment will be measured using the Stress Appraisal Measure (SAM) [44]. Children’s post-traumatic cognitive assessment will be assessed using the Child Post-Traumatic Cognition Inventory (CPTCI) [45].

Clinical outcomes: Health-related clinical outcomes included the progression and prognosis of paediatric patients’ conditions, sleep quality, and salivary cortisol concentrations in both patients and caregivers. Paediatric patients’ conditions will be assessed through a thorough review of medical records and consultation with attending physicians. For paediatric leukaemia patients, the primary focus is on bone marrow pathology results, whereas for patients with brain tumours, cranial imaging outcomes will serve as the primary basis for evaluation. The sleep quality of both patients and caregivers will be continuously monitored using the Xiaomi Mi Band [46], which measures total sleep time, deep sleep, and light sleep durations. Salivary cortisol concentrations will be collected from both patients and caregivers in the morning by professional nursing staff, adhering strictly to the established collection protocol, which requires obtaining 1.5 to 2.5 milliliters of saliva. Covariates such as sociodemographic factors, disease diagnosis, and treatment variables will also be collected.

Process outcomes

Following each intervention session, the research team will perform fidelity checks using a checklist and administer immediate evaluations to assess the acceptability and satisfaction with the intervention for both patients and caregivers.

A fidelity checklist will be developed based on the intervention manual to ensure consistency and accuracy of intervention delivery. The checklist will include key components of the intervention, such as session structure, content coverage, facilitator-participant interaction, and adherence to timing. Independent raters will use direct observation to assess intervention fidelity at each session. All intervention providers will receive standardized training guided by a detailed manual, followed by a competency assessment to ensure uniform understanding and delivery of intervention procedures. To further maintain quality, periodic supervision meetings will be held to review implementation issues. After each intervention cycle, feedback will be collected from intervention providers to identify potential barriers and facilitators to the delivery of the intervention as planned, which will inform subsequent refinement.

The acceptability of the intervention will be evaluated using both quantitative and qualitative approaches. Post-intervention surveys will be conducted separately to children and parents to assess satisfaction, perceived usefulness, clarity of materials and relevance to family needs. Separate questionnaires will be designed for children and parents to ensure age appropriate and role relevant assessment. Each questionnaire will include both open-ended items, allowing participants to express suggestions for improvement. In addition, semi-structured interviews will be conducted with some parents and children to gain deeper insights into their perceptions of the intervention’ s relevance and practicality in daily family life. Engagement indicators, such as attendance rates, session completion, and participation in follow-up activities, will also be recorded to complement the subjective measures of acceptability Table 2.

Table 2.

SPIRIT flow diagram for the schedule of enrolment, intervention, and assessment

		Study period
Participants				Children					Caregivers
Timepoint		Enrollment	Randomization	T0a	Intervention	T1a	T2a	T3a	T0a	Intervention	T1a	T2a	T3a
Enrolment:
Eligibility screen		X
Informed consent		X
Randomization			X
Interventions					X					X
Complex family adaptation intervention					X					X
Stress management course
Assessment
Primary outcomes	Questionnaire
Family adaptation	FACES II - CV								X		X	X	X
Post-traumatic stress symptoms	PTSD - RI			X		X	X	X
	IES-6								X		X	X	X
Emotional reactivity	PANAS			X		X	X	X
	DASS-21								X		X	X	X
Quality of life	EQ-5D								X		X	X	X
	EQ-5D-Y			X		X	X	X
Secondary outcomes	Questionnaire
Disease and treatment stress	FILE								X		X	X	X
Social support	SSRS								X		X	X	X
Coping styles	SCSQ								X		X	X	X
Cognitive assessment	CPTCI			X		X	X	X
	SAM								X		X	X	X
Physical examination
Disease progress and outcome				X		X	X	X
Sleep quality				X		X	X	X	X		X	X	X
Salivary cortisol concentration				X		X	X	X	X		X	X	X

Abbreviations: FACES II - CV Family Adaptability Cohesion Environment Scale, PTSD - RI Post-traumatic Stress Disorder Reaction Index, IES-6 Impact of Event Scale-6 Questionnaire, PANAS Positive and Negative Affect Scale, DASS-21, Depression Anxiety Stress Scale-21, EQ-5D-Y Euro - Qol five-dimension Youth version scale, FILE Family Inventory of Life Events and Changes, SSRS Social Support Rating Scale, SCSQ Simplified Coping Style Questionnaire, CPTCI Child Post-traumatic Cognition Inventory, SAM Stress Appraisal Measure

^aT0=Baseline survey, T1 = post-intervention survey, T2 = 2-month follow up; T3 = 6-month follow up

Data analysis

All statistical analyses will be conducted using SPSS version 25.0. Baseline data will be evaluated using independent sample t-tests and chi-square tests (χ²tests) to compare disease and treatment factors, socio-demographic characteristics of families, and outcome variables, ensuring statistical comparability between groups without significant differences. If the baseline data between the two groups did not perfectly match, generalised estimating equations (GEE) will be employed to adjust for the effects of confounding factors on the outcome variables. Descriptive statistics, including mean values, standard deviations, and percentage frequencies, will be provided for all variables. Repeated measures analysis of variance (ANOVA) will be used to explore changes in family adaptation, PTSS, emotional reactivity, quality of life, and other secondary outcomes over time and between groups. A repeated-measures model incorporating two treatment levels (intervention and control) and four time points (T0, T1, T2, and T3) will be used to test the effectiveness of the intervention. Linear regression will be applied to explore the direct effects of the intervention on the mediating variables, while logistic regression will be employed to analyse the combined effects of the intervention and mediating variables on the outcomes. Indirect effects will be quantified by calculating the product of the two path coefficients, and a 95% confidence interval will be constructed using the bootstrap method to assess significance. The significance level for the statistical tests will be set at 0.05, and an intention-to-treat (ITT) analysis approach will be adopted for data handling.

To better assess whether the changes induced by complex intervention strategies are clinically meaningful, this study introduces the concept of the Minimal Clinically Important Difference (MCID) to evaluate changes in primary outcomes (family adaptation, PTSS in children and caregivers, emotional responses, and quality of life). The MCID represents the smallest change in a patient-reported outcome that patients perceive as beneficial, regardless of side effects or costs. The literature review revealed a lack of established MCID thresholds for the measurement tools of these primary outcomes. Therefore, this study adopts MCID = 0.5 × SD to determine the MCID for these measures in the Chinese families of children with cancer. The study will assess whether the changes in primary outcomes for children and caregivers exceed the MCID after the complex intervention.

We will establish a Data and Safety Monitoring Board consisting of 5–6 members, including oncologists, pediatricians, pediatric nurses, psychologists, and statisticians, to monitor the clinical trial, ensuring participant safety and the reliability of the data.

Quality control

Key personnel involved in this project will receive systematic and specialised training on the procedures of complex intervention strategies, content and use of research tools, and the operational plan for interventions. Immediately after data collection, the survey information will be entered into the RedCap system for dual checking by an independent research assistant. This project will adhere to the Consolidated Standards of Reporting Trials (CONSORT) guidelines for the design and reporting of cluster randomized controlled trials to ensure scientific rigor and reliability. To address the potential loss to follow-up, which may lead to incomplete data, we will apply the intention-to-treat (ITT) principle to determine the participants’ group assignments based on their initial random allocation. For missing data due to loss to follow-up, we will employ multiple imputation techniques, assuming that the data are missing at random [47]. Primary analysis is based on observed data, and if missing data are only related to observed variables, an asymptotically unbiased estimate of the relevant effects can be obtained. Recognising that missing data may not be completely random, we will conduct sensitivity analyses, particularly when missing rates exceed 20% and the intervention conditions are imbalanced. These analyses will explore different missing data mechanisms, including mixture or selection patterns, to enhance the robustness of our conclusions.

Ethical principles

This study was approved by the Ethics Committee of Xiangya School of Nursing, Central South University (Approval Number: E2024134). The ethics committee will meet at least once a month at random to assess investigator compliance with the implementation protocol. Professionally trained research assistants will distribute informed consent forms to eligible children and their caregivers. After a thorough explanation of the project content, research design, potential risks and benefits, and compensation measures, participants will have the right to voluntarily decide whether to join the study. They will also have the right to terminate participation or withdraw from the study at any time. The informed consent process will include verbal consent from the child and written consent from the guardians. Throughout the intervention phase, psychologists will monitor the psychological states of both children and caregivers and conduct regular assessments. If any psychological discomfort is observed, the study will be immediately halted and free psychological counselling will be provided. For children or caregivers who exhibit severe negative psychological symptoms during the baseline survey, the research team will activate the study’s free referral mechanism, offer timely psychological support, and guide them towards medical attention. Stringent confidentiality measures will be implemented to ensure the security of the participants’ family information. All collected information will be de-identified and stored in password-protected computer folders accessible only to authorised research team members. The results of this project will be disseminated in peer-reviewed journals and conferences. Publications or other work based on this project’s data will adhere to confidentiality agreements prohibiting the disclosure of any personal or family information by the study participants.

Discussion

This study aims to address the clinical issue of poor psychosocial adaptation among families with paediatric cancer from a family system perspective. Utilising the Paediatric Medical Trauma Stress (PMTS) and Family Adjustment and Adaptation Response (FAAR) models, this study will comprehensively examine the holistic adaptation processes of these families. This is the first cluster randomised controlled trial in China to evaluate the effectiveness of a complex family adaptation intervention specifically targeting newly diagnosed hospitalised children with cancer and their families. Baseline assessments will be established, followed by evaluations immediately after the concentrated intervention, upon completion of enhanced follow-ups, and six months post-intervention. These assessments will systematically measure the short- and long-term effectiveness of the intervention in enhancing the psychosocial health of children with cancer and their families.

This study has several notable strengths. As a complex intervention, this study will comprehensively address the psychosocial health challenges faced by newly diagnosed hospitalised children with cancer and their families in China. Following the guidance framework for complex interventions proposed by the Medical Research Council (MRC) [29], this study examines not only the direct effects of the intervention, but also its potential multidimensional impacts, and how recent research findings could inform clinical practice and policy development. Additionally, it addresses the limitations of previous studies, such as small sample sizes (< 50) and high attrition rates due to prolonged intervention periods (2–6 months) [48–50]. By employing a short-cycle, large-sample, cluster RCT, this study may minimise contamination between samples, reduce attrition rates, and enhance the credibility of the conclusions. Furthermore, the research design considers cultural and societal context specificity, which is crucial for exploring the effectiveness of interventions in China.

However, this study has several limitations. First, the trial focuses exclusively on newly diagnosed paediatric cancer inpatients aged 5–12 years in Changsha, Hunan Province, China. Consequently, the results may not be generalisable to other age groups or regions, necessitating further research to validate their universality. Second, the primary and secondary outcome measures rely mostly on questionnaire surveys, which may be influenced by the subjective perceptions of the study participants.

Despite these limitations, this complex family adaptation intervention strategy represents an initial systematic attempt to promote the psychosocial health of newly diagnosed hospitalised children with cancer and their families in China. This study not only offers a novel perspective for public health research on paediatric cancer in China, but also provides robust support for practice and policy improvements. Future research should expand the sample scope and geographical distribution and employ multiple assessment methods to further validate and optimise this intervention.

Authors’ contributions

GC, ZS, XJ, LL and CQ were responsible for the study conception and design. GC and ZY drafted the proposal. ZZ, PY, XY and MG gave advice on drafting the manuscript, GC, LL, WC, and CC revised the manuscript. GC obtained funding and supervised the study. All authors have read and approved the final manuscript.

Funding

This study was supported by the National Natural Science Foundation of China (Grant No.82272924), the China Medical Board (Grant No. #20–369) and the Social Science Foundation of Hunan Province (Grant No.19YBA348).

Data availability

No datasets were generated or analysed during the current study.

Declarations

Ethics approval and consent to participate

This study was approved by the Ethics Committee of Xiangya School of Nursing, Central South University (Approval Number: E2024134). All individuals will voluntarily participate in this study and obtain informed consent prior enrollment in the study. Participants will also be made aware that they are free to exit the study or choose to withdraw consent at any time during the participation process without any repercussion.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.