Effects of ‘timing It Right’ on Comprehensive Unmet Needs and Psychological Pain in Radiotherapy Patients: A Randomized Controlled Trial

doi:10.21203/rs.3.rs-861232/v1

Purpose To explore the effects of ‘Timing It Right’ on the comprehensive unmet needs and psychological pain of patients receiving radiotherapy.

Design A prospective randomized controlled trial.

Methods A randomized controlled trial was conducted, and 140 patients receiving radiotherapy were randomly divided into two groups, with 70 cases in the intervention group and 70 cases in the control group. The intervention group received routine care follow-up and a comprehensive nursing mode intervention based on ‘Timing It Right’, while the control group received routine care and follow-up. The comprehensive needs and psychological pain of radiotherapy patients before intervention, at discharge, 3 months after discharge, and 6 months after discharge were compared.

Results A total of 137 patients completed the study. At discharge, 3 months after discharge, and 6 months after discharge, information needs (z=3.369,6.240,6.440, p＜0.01), health and psychological problems (z=2.185, 3.200, 3.380, p＜0.05), health care staff (z=2.829, 4.518, 4.708, p＜0.01), physical symptoms (z=4.167, 5.742, 5.742, p＜0.01), health facilities and services (z=2.829, 4.304, 4.630, p＜0.01), religious/spiritual support (z=2.296, 3.470, 3.470, p＜0.05) of the TIR group were improved compared with the control group. Psychological pain (z=2.115, 2.329, 2.411, p＜0.05) of the TIR group was significantly less than that of the control group. Information needs, health care staff, physical symptoms, health facilities and services differed significantly at points in time, groups, and interactions. In addition to practical support, the remaining indicators of both groups differed significantly at different observation points.

Conclusions TIR had positive effects on meeting the needs of radiotherapy patients and improving their psychological pain, therefore supporting TIR’s use as an effective psychological management and intervention strategy in the early stages of long-term rehabilitation of radiotherapy patients.

Cancer Biology

radiotherapy

care

cancer patients

needs

timing it right

Cancer is the world's second leading cause of death, and the number of deaths and morbidity have increased annually. The World Health Organization estimates that the number of cancer cases in the world could increase by 60 percent over the next 20 years and that prevention and control needs will be unrelenting¹. With the development of cancer diagnosis and treatment measures, the role and status of radiotherapy in cancer treatment have become increasingly prominent. At present, there are approximately 1.7 million new cancer patients each year in China. Approximately 70 % of cancers need radiotherapy or chemotherapy in the treatment process, and 40 % of cancers can be cured by radiotherapy². However, while the radiotherapy process effectively kills cancer cells, it also damages normal tissues³. In addition, daily hospitalization and radiotherapy take a toll on patients’ psychological well-being; this added mental pressure is not helpful to their treatment and rehabilitation⁴. This makes radiotherapy a major problem in continuous nursing.

Patient-centered care is the gold standard for medical care⁵. The International Psycho-Oncology Society (IPOS) published the quality standard for cancer care, which is designed to integrate psychosocial support into routine cancer care to support the development and implementation of new clinical practice guidelines⁶. Therefore, cancer care should not only focus on providing medical services but also pay attention to the psychological status of patients, as well as their comprehensive needs for information and social support. If the needs of patients are not met, it will affect their physical and mental health and even recovery from the disease. Thus, we should provide comprehensive nursing based on the demands of cancer patients.

Although many studies have involved nursing interventions for various types of cancer patients in Asian countries during radiotherapy, they only discussed a specific type of cancer, lacking comprehensiveness, or only discussed unilateral intervention programmes such as some complications, psychological problems, or social needs during radiotherapy⁷^,⁸^,⁹. Early detection of the combined needs of cancer patients during radiotherapy can not only reduce the suffering of patients but also improve the quality of cancer care. Understanding the needs of cancer patients during radiotherapy and improving care interventions are therefore crucial.

Cameron et al. proposed ‘Timing It Right (TIR)’ , which is a programme that divides the disease process into five stages¹⁰. The researchers suggested that patients' needs for information, emotional support, etc., be evaluated for possible interventions at each stage of the disease. TIR also emphasizes the timing of dynamic nursing services for patients¹¹. TIR has been used in patients with acute respiratory distress syndrome, stroke and other chronic diseases¹²^,¹³^,¹⁴, and it has demonstrated a beneficial effect on nursing and the prognoses of patients. However, according to our literature review, the use of TIR in patients undergoing radiotherapy has not been reported. It is necessary to study whether this theory can help support the physical and mental health of these patients so that they can successfully return to family and society.

Therefore, in this study, we used TIR as a theoretical framework and focused on the nursing needs of patients at different stages of radiotherapy to understand how the hospital-family holistic nursing model based on TIR effectively promotes the physical and mental health of these patients. With this study, we aim to meet the needs of patients, reduce psychological distress and provide a theoretical and practical basis for hospital-family care of radiotherapy patients.

2.1 Theoretical framework

The conceptual framework of this study was based on the TIR theory, which emphasizes the special needs of patients at five different stages of the disease process10, as shown in Table 1. The first is the disease event/diagnosis stage, and the patient’s information needs about the diagnosis, treatment and prognosis of the disease. Nurses should pay attention to the patient’s emotional response to illness and strange environments. The second stage is the stable stage, and the patient’s information needs are about the cause of the disease and the need for disease care and rehabilitation exercise. A lack of nursing support and information at this stage will increase anxiety, stress and depression in patients, so nurses should provide correct guidance and emotional support. The third stage of discharge preparation addresses the needs of patients in obtaining continuous nursing assistance. Patients are concerned about the prognosis of the disease, so nurses should provide continuous nursing guidance and emotional support. The last two stages are the implementation stage and the adaptation stage. In these two stages, patients need to obtain information support to improve their daily living abilities, participate in social activities and restore life and work assistance. In terms of emotional support, patients need to hear from other patients who had similar experiences, and they need to continuously evaluate the effectiveness of patient health management.

2.2 Design

A clinical randomized controlled trial was conducted in a general hospital in Xi’an. The subjects were hospitalized patients undergoing radiotherapy, aged 18 years and above. The exclusion criteria were as follows: (a) illiterate; (b) direct transfer to the ICU or discharge after surgery; and (c) history of brain diseases and mental illnesses. In addition, persons who were physically ill or who used psychotropic substances during the intervention and who were unable to continue to participate in other psychosocial support treatments were excluded.

The sample size was estimated with the Comprehensive Needs Assessment Tool in Cancer for Patients (CNAT) total score. One hundred and twelve patients were required, with a statistically significant success rate of 80%. The sample size was increased to 140 patients to compensate for a loss rate of 20%. These 140 patients were randomly allocated to the intervention and control groups (70 per group) via a computer-generated random numbers table.

2.3 Establish TIR care intervention group

The investigation team was made up of eleven medical staff (five competent physicians, five responsible nurses, and one scientific researcher). Among them, the competent physician had more than 5 years of radiotherapy treatment experience, with an education level of college or above and research experience; the nurses had more than 5 years of radiotherapy nursing experience, with an education level of college or above and research experience; the scientific researcher’s field was tumour radiotherapy, with a master's degree or above and clinical and research experience. All team members learned the theory of TIR and hospital-home holistic care skills.

2.4 TIR care intervention plan

The TIR nursing intervention programme was based on the theoretical framework of TIR theory, literature review and treatment characteristics of radiotherapy. Interventions at each stage include radiotherapy-related knowledge introduction, drug guidance, rehabilitation guidance, psychological guidance and dietary guidance. A preliminary draft of the TIR theoretical nursing intervention programme was developed by the research group and then reviewed by senior experts and nurses. At the same time, 10 radiotherapy patients were invited to review the programme. They were strong communicators with varying degrees of education. They read the procedure carefully and proposed revisions. The final revision was the hospital-family holistic nursing intervention programme composed of the following intervention stages: pre-radiotherapy, perioperative radiotherapy, discharge preparation, adjustment and adaptation period. The specific interventions are shown in Table 2 below.

2.5 TIR care intervention group

The intervention group carried out intervention measures according to the hospital-family holistic nursing model on the basis of routine nursing. The first three stages of intervention in the hospital were face-to-face teaching, bedside guidance and demonstration, lectures or videos and other forms of intervention. After two stages of intervention outside the hospital, internet tools, such as We Chat/QQ/telephone follow-up, were used. The five nurses in the study group were the intervention implementers who completed the intervention measures at different stages of the patient's disease. They explained the relevant contents of radiotherapy nursing to the patients, provided psychological support, and responded to patient confusion. According to the characteristics of the Ebbinghaus forgetting curve¹⁵, the frequency of intervention was set as 2 times per week telephone follow-up and 2 weeks outpatient service in the first month of each stage, 1 telephone follow-up every 2 weeks in the second month and 1 outpatient service in the third month and after. In the process of intervention according to the actual situation, timely adjustments were made.

2.6 Control group

Patients in the control group were given basic routine nursing and follow-up. After admission, nurses distributed traditional health education manuals to patients, and patients received routine nursing care, including attention to environment, diet, rest, activity, examination, medication, radiotherapy, adverse reactions of radiotherapy and treatment measures. Health education was carried out according to hospital nursing procedures. Before discharge, the nurse provided diet, medicine, rest and other care instructions. After discharge, routine telephone follow-up and outpatient visits were conducted by the same nurse.

Collect demographic and disease data on admission. Before intervention and 6 months after discharge, the nursing needs and psychological pain of patients with radiotherapy at different stages were investigated. For discharged patients, follow-up data were collected through one-on-one communication and We Chat.

The Comprehensive Needs Assessment Tool in Cancer for Patients (CNAT) developed by Shim et al.¹⁶ in 2011 is the latest and most systematic scale used to assess the needs of cancer patients. In 2017, Zhao Xin Shuang¹⁷, a Chinese scholar, was authorized to translate the tool into Chinese. The scale contains 59 items, which involve seven aspects: information, health and psychological problems, health care staff, physical symptoms, health facilities and services, religious/spiritual support and practical support. The total score of the scale is 0–100. The Cronbach's α and test-retest reliability coefficients of the Chinese version of the CNAT were 0.95 and 0.80, respectively. The results showed that the Chinese version of the CNAT had good cross-time stability.

In 2003, the National Comprehensive Cancer Network (NCCN) launched the Distress Thermometer (DT) ¹⁸. The DT is composed of a single-item thermometer (0~10 scale) and a list of 38 questions (Problem List, PL). DT can evaluate the degree of psychological distress of patients. Chinese scholar Tang Li li et al.¹⁹ adapted the DT for Chinese patients, creating a list of 40 questions, which are widely used to screen patients for further evaluation and treatment.

Study quality control included the following aspects: (a) the nurses who measured the subjective and objective indicators of both groups were blind to the study aims and interventions; (b) research subjects were chosen strictly according to inclusion and exclusion criteria, thereby reducing selection bias and ensuring comparability of data; (c) all the investigators and intervention implementers were trained professionally by uniform standards; (d) the intervention and investigation were conducted in a quiet environment and using plain language; (e) the database was established (double entry) through Epidata 3.1, and all data were entered in pairs and checked for consistency; and (f) the inconsistent data were verified until the consistency reached 100%.

The general data of the two groups were described according to the number and percentage of cases, and the differences in CNAT and psychological pain scores between the two groups at different intervention time points were analysed using the generalized linear hybrid model and Mann-Whitney U test. Group, time, and group × time interaction were considered fixed effects, while the patient was considered a random effect. Lost data due to follow-up loss were considered to be randomly missing. All P values were two-sided, and <.05 was considered statistically significant. All statistical analyses were performed using the software package SPSS version 22 (IBM, Armonk, New York).

In this study, there were 70 cases in the intervention group, from which 1 case was lost, and there were 70 cases in the control group, from which 2 cases were lost; thus, there was a total of 137 cases and a completion rate of 97.86%. Figure 1 shows the flowchart of the participants, including the remaining number of patients in the intervention group and the control group and the number of follow-up visits lost in the study. There was no significant difference between baseline socioeconomic and clinical characteristics (P>0.05; Table 3).

Mixed linear models indicate that at discharge, 3 months after discharge, and 6 months after discharge, information needs (z=3.369,6.240,6.440, p＜0.01), health and psychological problems (z=2.185, 3.200, 3.380, p＜0.05), health care staff (z=2.829, 4.518, 4.708, p＜0.01), physical symptoms (z=4.167, 5.742, 5.742, p＜0.01), health facilities and services (z=2.829, 4.304, 4.630, p＜0.01), religious/spiritual support (z=2.296, 3.470, 3.470, p＜0.05) of the TIR group were significantly improved compared with the control group; psychological pain (z=2.115, 2.329, 2.411, p＜0.05 of the TIR group was also significantly less than that of the control group.

The interaction between time points and groups indicates that the influence of time factors varies between groups. Information needs, health care staff, physical symptoms, health facilities and services differed significantly at points in time, groups, and interactions. In addition to practical support, the remaining indicators of both groups differed significantly at different observation points. Full details and statistical outcomes are presented in Table 4.

During radiotherapy, patients often show different types of needs. Most patients are prone to anxiety and depression during radiotherapy due to their lack of understanding of the disease and concern about the prognosis. Investigations and psychological support interventions for patients during radiotherapy have always been the focus of research²⁰. In this study, we adopted the theoretical framework of the TIR theory to study the needs of patients in different stages of radiotherapy and provided multifaceted, holistic, systematic and dynamic health education.

Clinical randomized controlled trials have examined the impact of TIR on the needs of patients receiving radiotherapy. In this study, to improve the pertinence and effectiveness of interventions, the needs of radiotherapy patients were assessed before interventions were implemented, and nurses provided individualized measures according to the needs of patients in different environments and at different stages of disease. We provided patients with disease treatment information to compensate for patients' lack of knowledge about treatment, drugs, disease progression, etc., and alleviated their unmet needs for information.

Due to the direct or indirect complications of cancer and the toxicity of radiotherapy, patients often have nausea and vomiting, pain, hair loss, insomnia, and fatigue after receiving large doses of irradiation, and acute oedema or erythema caused by radiation-induced acute inflammation and related vascular leakage can occur²¹. These side effects significantly reduce the quality of life of patients²². Therefore, face-to-face intervention during hospitalization and internet follow-up intervention after discharge closely monitored the health status of patients and provided professional support and continuous care measures for patients. At the same time, we worked with other medical staff to effectively control the side effects of radiotherapy and drugs and to meet patient needs for health care services.

TIR was found to significantly improve meeting the needs of patients who underwent radiotherapy; at discharge, 3 months after discharge, and 6 months after discharge, the information needs, health and psychological problems, health care staff, physical symptoms, health facilities and services, and religious/spiritual support of the TIR group were improved compared with the control group, consistent with other related reports²³^,²⁴^,²⁵. Meanwhile, these improved conditions were accompanied by a decrease in psychological distress score. The findings indicate that the TIR is a promising intervention for the physical and mental rehabilitation of radiotherapy patients.

Due to the cost of treatments, such as radiotherapy and surgery, cancer patients may bear a huge financial burden, which may lead to the unemployment of patients and caregivers and the reduction of family income²⁶^,²⁷. We provided patients with information about health insurance policies and ways to obtain social support during the intervention to alleviate their worries and need to rejoin the workforce. The results showed that practical support improved after the intervention, but there was no significant difference between the control group and the TIR group, which may be related to the local health care system and social security system. We should strengthen close contact and cooperation with social security organizations to ensure that the practical support needs of patients are improved.

As an auxiliary means of surgical treatment, radiotherapy is often long and challenging, but some patients are afraid of radiotherapy or its side effects and experience psychological problems, such as depression, fear, anxiety or social isolation²⁸^,²⁹. In addition, patients will be reminded of the diagnosis of cancer during each treatment, which may increase their psychological stress³⁰. In response, we conducted a psychological evaluation of patients and provided personalized psychological support, which aimed to prevent and/or reduce the emotional impact of radiotherapy on patients, to improve their level of hope and to help alleviate their emotional needs. The results showed that the psychological pain scores of patients in the TIR group decreased significantly at discharge, 3 months after discharge and 6 months after discharge. This finding is consistent with the results of other related reports. These studies³¹^,³²^,³³^,³⁴ applied structural group psychotherapy, peer support and mindfulness-based stress reduction therapy as intervention strategies and supported the further use of TIR as an alternative psychological intervention for patients who underwent radiotherapy.

7.1 Limitations

There are some potential limitations in this study. Considering factors such as manpower, material resources and time, we only included 140 cases in this study with 6 months of intervention and within the same geographical area. In addition, we did not collect data on economic indicators, such as readmission rate and medical costs, to comprehensively evaluate the impact of intervention programmes on the health outcomes of radiotherapy patients. However, our study has several strengths, as well. To the best of our knowledge, this is the first time that TIR theory has been applied to radiotherapy patients, which represents achievements in this regard; our findings provide a theoretical basis for the implementation of continuous care. Based on the nursing needs of patients at different stages in radiotherapy treatment and rehabilitation, overall, dynamic and personalized evaluations and interventions were realized by using the TIR theoretical framework. Instant messaging tools such as We Chat and QQ were used to facilitate follow-up, facilitate nurse-patient and patient-peer communication, and strengthen the continuity and integrity of interventions and follow-up. However, the TIR theory is still in the exploratory stage. Therefore, in future studies, it is necessary to expand the sample size, extend the research time and further verify the effectiveness of the intervention programme.

7.2 Clinical Implications

Our findings indicate that the TIR theory-based hospital-home holistic nursing intervention effectively improves the needs of patients with radiotherapy and reduces the psychological pain of patients.

It is important to understand the unmet needs and psychological pain of radiotherapy patients in rehabilitation. Timely intervention through TIR theory can ensure that radiotherapy patients remain in contact with others during this treatment stage, that their needs are met and they are supported while renegotiating their life purpose. Given the different demographic characteristics, such as age, gender, and race, appropriate adjustments should be made to accommodate patient-specific circumstances when implementing an intervention strategies.

The findings of this study support the positive impact of TIR theory-based hospital holistic care intervention as an effective psychological management and intervention strategy for radiotherapy patients in the early stages of long-term rehabilitation. This kind of psychological intervention approach will enable medical staff to have confidence in improving the unmet needs and psychological distress of radiotherapy patients, thus providing better support and guidance for psychological intervention during radiotherapy.

Funding: No funding was received for the completion of this study.

Conflicts of interest/Competing interests: The authors declare no confict of interest.

Availability of data and material: Data supporting the findings of this study will be made available from the corresponding author upon reasonable request.

Code availability: Not applicable.

Authors' contributions: Teng Li, Yin-Ping Zhang conceived and designed the analysis, contributed data or analysis tools, and contributed to manuscript writing. Jun-Juan Kong conceived and designed the analysis and collected data. Min Kong, Yi-Tong Jia, Wen-Xin Shi conceived, designed, and performed the analysis and contributed to manuscript writing.

Ethics approval: The trial protocol received ethical approval from the Biomedical Ethics Committee of Xi’an Medical University. Ethics Approval Reference No：XYLS2020147. Written informed consent was obtained from each recruited patient before the intervention and questionnaire survey.

Consent to participate: Informed consent was obtained from all individual participants included in the study

Consent for publication: Not applicable.

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Table 1 ‘‘Timing It Right’’ model for patients with radiotherapy

Phase	Setting	Care focus
Ⅰ phase: Event/diagnosis --- Pre-radiotherapy	Acute care hospital	Radiotherapy nursing Family care Concerned about the effect and prognosis of radiotherapy Not aware of what the radiotherapy may entail as a result of this illness event
Ⅱ phase: Stablization --- Peri-radiotherapy	Acute care hospital	Radiotherapy nursing Patient has stabilized Family care A lot of uncertainty about radiation
Ⅲ phase: Preparation --- Discharge preparation	Acute/Rehab	Radiotherapy nursing Nursing focus on discharge or hospital rehabilitation family care Return to home or community with greater focus on care needs Concerns about ability to meet care recipients needs in community
Ⅳ phase: Implementation --- Adjustment	Home	Radiotherapy nursing Adapting to family or community life Community Services and care Drug use after radiotherapy Family care Family doctor
Ⅴ phase: Adaptation --- Adaptation	Home	Radiotherapy nursing Family care Adapted to living in the home Reintegration of communities Increased confidence in care or rehabilitation activities

Table 2 Intervention measures of Timing it right (TIR) for radiotherapy patients

Steps	Content	Implementation
Ⅰ.pre-radiotherapy	Hospitalization to the beginning of radiotherapy period.	(a) Emotional support, such as comforting and caring for patients, providing life assistance, establishing friendly nurse-patient relationship, reducing anxiety and fear of patients, guiding patients to vent negative emotions and reducing negative events ; (b) Disease knowledge, presentation of the condition and treatment options, and leading the patient to film and locate the radiation area, and providing the patient with radiotherapy-related knowledge manuals and videos ; (C) Ward environment information, introduces the medical team and ward environment to patients, so that patients experience less strangeness and more sense of belonging.
Ⅱ.peri-radiotherapy	A period from the beginning of radiotherapy to one week after the end of radiotherapy	(a) Information needs create an information exchange card and researchers issue information kits for newly admitted patients, including one pen and one notebook. Guide patients to write troubled problems or suggestions to notebooks, encourage patients to express their discomfort, reduce mental pain. Collect regularly every day, after each collection of information is completed, individual-centered, one by one answer and guidance. (b) Video-assisted instruction, group-based broadcast, 3-5 in each group, in patient wards. Play time was before radiotherapy, 1 week, 2 weeks, 3 weeks, 4 weeks after radiotherapy, once a week, each time about 40 minutes. Video includes : rehabilitation exercise, disease prevention and control, radiotherapy education. (c) Researchers visited patients once a day to understand the patient ' s knowledge of radiotherapy, observe the patient ' s radiation dermatitis classification, rehabilitation exercise and compliance. 24 hours dynamic assessment of patient needs, supervision of patients with good cooperation. (d) Emotional support includes encouragement, comfort and psychological counseling.
Ⅲ.discharge preparation	Period before discharge	(a) Follow-up information, such as review and follow-up timetable ; (b) Out-of-hospital rehabilitation programme information, such as diet, medication, rest and exercise guidance and preventive measures ; (c) Emotional support, such as self-affirmation, rehabilitation confidence enhancement and role conversion.
Ⅳ.adjustment	From discharge to return to society for 3 months	(a) Patients’ follow-up care was tracked by telephone follow-up / QQ / WeChat, and their disease recovery, home health behavior and adaptation to family environment were evaluated; (b) Encouraging patients to express their needs, identify their bad emotions in time and resolve them ; Evaluate the social support of patients and encourage them to seek peer support; (c) Evaluate the compliance and confidence of patients with self-management, and answer and guide the problems encountered in the actual rehabilitation process. Correct wrong living habits in time and enhance their confidence in disease response
Ⅴ.adaptation	During 3-6 months of discharge	(a) Providing accessible community health resources and encouraging patients to use community health resources for self-management. (b) Continue to assess and meet their rehabilitation needs, and help them improve their self-efficacy. (c) Individual guidance was given to the adjustment of social activities and living habits according to the patient ’ s situation, including energy-saving skills in life in life and methods to maintain a comfortable mood, so as to enable them to master effective self-management methods. The above measures are implemented through WeChat videos, online classrooms and health education manuals.

Table 3 Socio-demographic and clinical characteristics of the patients in the intervention group and control group (n, %)

Characteristics		Total（n=140）	Intervention group （n=70）	Control group （n=70）	t/F	P value
Age（years）(Mean ± SD)	(range 21-88)	58.66±12.13	59.41 ±13.05	59.91 ±11.96	0.24	0.80
Gender	Man	74（52.8）	38（54.3）	36（51.4）	1.47	0.22
	Woman	66（47.2）	32（45.7）	34（48.6）
Employment status	Unemployed/Retired/widowed	41（29.3）	17（24.3）	24（34.2）	0.89	0.48
	Employed	99（70.7）	53（75.7）	46（65.7）
Marital status	Married	122（87.1）	63（90.0）	59（84.3）	0.29	0.82
	Other marital status	18（12.9）	7（10.0）	11（15.7）
Education level	Primary and below	33（23.6）	16（22.9）	17（24.3）	0.54	0.65
	Junior high school	48（34.3）	26（37.1）	22（31.4）
	Senior high school	37（26.4）	17（24.3）	20（28.6）
	College	22（15.7）	11（15.7）	11（15.7）
Family monthly income per capita (RMB)	Less than500	37（26.4）	20（28.6）	17（24.3）	0.36	0.78
	500-1000	32（22.9）	21（30.0）	11（15.7）
	1000-2000	30（21.4）	12（17.1）	18（25.7）
	More than 2000	41（29.3）	17（24.3）	24（34.3）
Medical expense	Public expense	2（1.4）	1（1.4）	1（1.4）	1.11	0.33
	Own expense	44（31.4）	36（51.4）	8（11.4）
	Medical insurance	94（67.2）	33（47.1）	61（87.1）
Metastasis	Yes	58（41.4）	28（40.0）	30（42.9）	2.90	0.34
	No	82（58.6）	42（60.0）	40（57.1）
Cancer type	Digestive system	31（22.1）	17（24.3）	14 （20.0）	1.94	0.58
	head and neck cancer	39（27.8）	12（17.1）	27（38.6）
	Respiratory system	23（16.4）	11（15.7）	12（17.2）
	Breast cancer	13（9.3）	9（12.9）	4（5.7）
	Reproductive system	12（8.6）	5（7.1）	7（10.0）
	Osteosarcoma	3（2.2）	2（2.9）	1（1.4）
	Other	19（13.6）	14（20.0）	5（7.1）
Treatment measures	postoperation radiotherapy	61（42.6）	31（44.3）	30（42.9）	0.15	0.69
	radiotherapy	78（55.7）	38（54.3）	40（57.1）
	Radiotherapy + chemotherapy	1（0.7）	1（1.4）	0（0）
Together with caregiver	Yes	122（87.1）	62（88.6）	60（85.7）	0.23	0.88
	No	18（12.9）	8（11.4）	10（14.3）
Religious affiliation	Yes	10（7.1）	7（10.0）	3（4.3）	0.34	0.56
	No	130（92.9）	63（90.0）	67（95.7）

Table 4 Comparison of outcome between the two groups before and after intervention

Measures(M ± SD)	Before the intervention		Discharge		3 months after discharge		6 months after discharge		F_groups	F_times	F_groupstimes*
	Control group	TIR nursing group	Control group	TIR nursing group	Control group	TIR nursing group	Control group	TIR nursing group
CNAT Information	19.10±7.53	18.67±9.04	18.62±8.78	13.51±6.02	17.93±5.92	11.25±5.03	16.74±5.75	9.78±6.16	6.548	32.372	8.445
Z	-0.006		-3.369		-6.240		-6.440		—	—	—
P	0.995		0.001		＜0.001		＜0.001		0.011	＜0.001	0.004
CNAT Health and psychological problems	13.11±9.16	12.88±10.25	12.85±9.91	9.41±8.89	11.76±6.86	8.13±6.39	10.78±6.74	7.06±4.70	1.864	15.334	1.973
Z	-0.409		-2.185		-3.200		-3.380		—	—	—
P	0.683		0.029		0.001		0.001		0.173	＜0.001	0.161
CNAT Health care staff	17.31±6.23	17.48±7.43	17.08±7.37	13.62±7.27	16.17±5.65	11.42±6.12	15.59±6.28	9.59±5.74	1.807	33.837	12.422
Z	-1.079		-2.829		-4.518		-4.708		—	—	—
P	0.281		0.005		＜0.001		＜0.001		0.047	＜0.001	＜0.001
CNAT Physical symptoms	15.11±11.25	16.18±11.73	16.74±11.65	8.67±8.64	15.37±8.73	7.09±5.29	14.26±8.11	6.16±5.19	5.691	20.267	9.555
Z	-0.446		-4.167		-5.742		-5.742		—	—	—
P	0.655		＜0.001		＜0.001		＜0.001		0.017	＜0.001	0.002
CNAT Health facilities and services	12.74±6.26	11.95±7.34	12.00±7.34	8.50±6.37	11.87±5.79	7.55±4.63	11.24±7.10	5.96±4.34	4.989	20.637	7.299
Z	-0.906		-2.829		-4.304		-4.630		—	—	—
P	0.365		0.005		＜0.001		＜0.001		0.026	＜0.001	0.007
CNAT Religious/spiritual support	4.77±3.84	4.35±4.91	4.41±4.68	2.84±3.83	4.09±3.09	2.38±2.21	3.99±3.43	2.16±2.19	3.376	9.215	1.704
Z	-1.397		-2.296		-3.470		-3.470		—	—	—
P	0.162		0.022		0.001		0.001		0.067	0.003	0.192
CNAT Practical support	7.10±4.42	6.34±5.58	6.24±5.42	5.28±4.75	6.16±4.15	4.94±3.36	5.99±4.28	4.13±3.47	1.452	7.558	1.144
Z	-1.369		-0.867		-1.638		-1.640		—	—	—
P	0.171		0.386		0.101		0.101		0.229	0.006	0.285
Psychological pain	4.20±1.88	4.04±2.73	4.31±2.65	3.37±2.57	3.89±2.68	2.91±2.61	3.25±2.22	2.13±2.08	2.121	25.905	1.795
Z	-0.331		-2.115		-2.329		-2.411		—	—	—
P	0.741		0.034		0.02		0.02		0.146	＜0.001	0.181

Note:* Sample size of the TIR nursing group: n=70( before the intervention), n=70( discharge),n=70(3 months after discharge), n=69(6 months after discharge)

Sample size of the control group: n=70( before the intervention), n=70( discharge), n=70(3 months after discharge), n=68(6 months after discharge)

CNAT: Comprehensive Needs Assessment Tool in Cancer for Patients

Psychological pain: the Distress Thermometer.

Effects of ‘timing It Right’ on Comprehensive Unmet Needs and Psychological Pain in Radiotherapy Patients: A Randomized Controlled Trial

Status:

Version 1

Abstract

Figures

1. Introduction

2. Methods

3. Data Collection

4. Quality Control

5. Statistical Analysis

6. Results

7. Discussion

8. Conclusions

Declarations

References

Tables

Status:

Version 1