Background
Lung cancer remains the leading cause of cancer-related death worldwide, accounting for approximately 18% of all cancer deaths [1]. Based on the latest statistics released by the National Cancer Centre of China in 2022, lung cancer is common in China, and it is the leading cause of death [2]. Lung cancer has emerged as a significant public health concern in China due to its increasing incidence and mortality rates, imposing substantial economic and social burdens on affected families and the healthcare system.
Surgical resection remains the optimal therapeutic treatment for patients with early-stage non-small cell lung cancer [3]. Lung cancer resection is complex and invasive, and it can negatively affect the quality of life of patients. In addition, patients experience pain, fatigue, loss of respiratory capacity and impaired physical function after lung cancer surgery [4]. Patients with lung cancer have also reported higher levels of distress, anxiety, fatigue and breathlessness than other cancer patients [5].
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Lung cancer surgery is also an intense experience for family caregivers. They need to take on the responsibilities and tasks of caring for cancer patients physically, emotionally and financially [6]. However, family caregivers are unprepared for their roles, and they do not have sufficient resources, such as knowledge and skills of caring for patients. Consequently, family caregivers may undergo severe psychological distress, increased caregiver burden and decreased quality of life related to their caregiving role [7‐10]. Apart from the demanding care responsibilities, family caregivers deal with the uncertainty of the future and grief associated with their loved ones’ impending departure [11]. All of these factors could put caregivers in a high level of distress [12], which may deteriorate their own physical and psychological health as well as that of patients [13‐18].
Some studies have shown that caregivers’ distress was often more severe than patients’ distress [14, 19‐24]. Previous studies have indicated that 30–60% of family caregivers of patients with lung cancer experience anxiety or depressive symptoms [25‐27]. In studies involving family caregivers of patients with lung cancer, including those who underwent surgery, the physical and mental health of family caregivers were worse than those of the normal population [28, 29]. Although family caregivers of patients with lung cancer experience deteriorated well-being regarding caregiving, they receive minimal attention and support from healthcare providers who are generally focused on cancer patients. The absence of support is related to caregiver adverse health consequences, whilst assistance through education, encouragement and resources improves quality of life. Being equipped with adequate resources, materials and strategies enhances knowledge and comfort whilst reducing anxiety, fear and stress throughout the cancer trajectory of care delivery [30]. Thus, interventions targeting distressed caregivers are urgently needed to reduce their psychological distress and improve their ability to care for patients with lung cancer.
Previous studies have shown that psychosocial interventions for caregivers of patients with lung cancer can reduce caregiver anxiety and depression, alleviate caregiver burden and improve quality of life, self-efficacy and coping abilities. However, these studies targeted caregivers of patients with advanced lung cancer [29, 31] and those with nonsurgical lung cancer [32], and the results could not be generalised to caregivers of patients with early-stage lung cancer. Early-stage lung cancer patients have unique care requirements that differ from advanced cases, including intensive post-surgical monitoring and rehabilitation needs. Understanding how to effectively support caregivers during this specific phase can lead to better patient outcomes and reduced healthcare system burden. There is a paucity of research on the psychological distress of family caregivers of patients who underwent lung surgery. Porter et al. [33] compared the effectiveness of caregiver-assisted coping skill training and education/support for patients with early-stage lung cancer (80.5% of patients underwent surgery). They found that in both cases, caregiver anxiety improved from baseline to 4-month follow-up. Sun et al. [34] developed a multimedia self-management intervention based on the Chronic Care Self-Management Model to prepare patients and family caregivers for lung surgery. They found that the intervention was feasible and acceptable in supporting the physical and psychosocial readiness and preparedness for lung surgery and postoperative recovery. However, the study paid minimal attention to the caregivers’ psychological distress and stress coping. Furthermore, these two studies were based on participants with an American cultural background, which may not be applicable to Chinese population. In Chinese culture, caregiving is deeply rooted in the concept of “filial piety” and family obligations. Chinese family caregivers often feel intense pressure to provide direct care themselves rather than seeking external help, as delegating care responsibilities may be seen as failing their familial duties. Additionally, Chinese families typically prefer to handle psychological distress within the family unit rather than seeking professional psychological support, which differs from Western approaches to caregiver support.
Unmet needs related to perioperative support can affect the quality of life of a patient and increase the psychological distress of family caregivers [35]. Therefore, developing interventions targeting distressed caregivers is necessary to support and help them play their role in patient assistance and ongoing care throughout the entire perioperative care trajectory. Multi-faceted interventions embracing typical caregiver needs produced better outcomes than singular focused interventions [6, 30, 36‐40]. In general, multicomponent interventions, including education, support and communication functioning as a whole for caregivers, are important and successful. Therefore, we previously developed a perioperative support program integrating coping and communication skill training with psychoeducational strategies based on the Stress-Coping Model to reduce the psychological distress of family caregivers of patients with early-stage lung cancer [41]. In this study, a pilot randomised controlled trial was conducted to assess the feasibility, acceptability and preliminary efficacy of the intervention that we developed among family caregivers of patients with early-stage lung cancer. This study addresses a practical clinical need identified through direct observation of caregiver struggles during the perioperative period, rather than merely filling a research gap.
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Methods
Study design
This study adopted a randomised controlled trial with two measurement points in two wards of the thoracic surgery department of a university-affiliated hospital in Changsha, China, between March and May 2022. The intervention group received usual care and the perioperative support program, whereas the control group received usual care only. This study was conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) checklist for randomised controlled trials [42].
Participants
Family caregivers of patients with stage I or II lung cancer who were scheduled to undergo lung resection surgery were recruited if they met the following criteria: (1) identified by the patients as primary caregivers who would provide daily assistance and emotional support during perioperative period, (2) aged 18 years or older, (3) able to read and speak Chinese and (4) able to provide a written informed consent. The exclusion criteria for family caregivers were as follows: (1) multiple caregivers from the same household, (2) caregivers with cognitive diseases or other conditions that may impact their caregiver burden, (3) caregivers who had benefited from the same type of support intervention, and (4) caregivers who were paid.
Sample size
The target sample size was 70 participants, 35 participants per group as recommended for pilot study sample size [43]. A total of 98 patients with early-stage lung cancer received surgical resection in thoracic surgery department of the study hospital per month. Therefore, a conservative estimate of recruitment allowed us to recruit our pilot sample size in two wards of the thoracic surgery department within 3 months.
Recruitment
Research staff worked closely with the thoracic surgeons on a daily basis to identify eligible patients upon admission. Eligible patients were identified from the electronic patient data management system by the principal investigator. When eligibility was established, the principal investigator would contact the eligible family caregivers of patients and explain the purpose of the study, answer questions and ascertain interest in enrolment. If the caregivers agreed to enrol, then informed consent would be obtained. Family caregivers were subjected to a complete baseline assessment after providing informed consent. The reasons for not taking part in the study and for exclusion were documented.
Randomisation and blinding
All eligible participants were randomly allocated to the intervention or control group (allocation ratio = 1:1) by a research assistant who was not involved in other processes of the study. Randomisation was conducted by using computer-generated numbers. The research assistant used a web-based randomisation tool (www.randomization.com) to prepare the numbered sealed opaque envelopes used to preform block randomisation with a block size of four or six. After written informed consent forms had been signed and obtained, the research assistant drew up and opened the envelope for each participant to ensure that they were equally assigned to the intervention or control group based on group numbers. Given the nature of the intervention, the participants and intervener were not blinded. However, outcome assessors were blinded to group allocation.
Intervention group
The Stress-Coping Model was used as the theoretical framework that guided the development of the perioperative support program. Based on the Stress-Coping Model, psychological stress occurs when individuals feel overwhelmed by situations beyond their coping abilities. For lung cancer caregivers, this manifests through multiple challenges including disease uncertainty, treatment management, and addressing both physical and emotional needs. Caregivers often face intense stress while dealing with unpredictable diagnoses and supporting patients through treatment complications. While they typically use coping strategies and seek support, psychological distress develops when they feel their resources are insufficient for caregiving demands. This study’s perioperative support program addresses these issues by strengthening caregivers’ coping abilities through targeted education, skill development, and support systems, aiming to improve their caregiving capacity while reducing psychological burden. The intervention was developed by a multidisciplinary team that included two thoracic surgeons, three clinical nurses, two psychologists and five family caregivers of patients with early-stage lung cancer. The perioperative support program integrated coping and communication skill training with psychoeducational strategies, which aims to improve not only caregivers’ perioperative care knowledge and coping skills to reduce psychological distress and caregiver burden, but also their quality of life. The program was composed of four 1-h face-to-face intervention sessions during the patient’s hospital stay, followed by two weekly 15-minute telephone follow-up sessions after discharge. The face-to-face sessions covered: (1) knowledge foundation: building trust with caregivers while assessing their needs and enhancing their understanding of early-stage lung cancer, (2) skills development: equipping caregivers with essential coping mechanisms, communication skills, and self-care strategies, (3) clinical management: training caregivers in practical symptom management and developing their problem-solving abilities, and (4) treatment navigation: addressing treatment-related concerns while helping caregivers set achievable goals and strengthen their resilience. The telephone follow-ups were conducted to reinforce previously acquired skills in managing rehabilitation challenges and psychological stresses within the home environment, while addressed any emerging concerns or questions. While more detailed information about the program can be found in the study protocol [41]. The intervention aims to improve caregivers’ perioperative care knowledge and coping skills to reduce psychological distress and caregiver burden as well as their quality of life. The intervention was delivered by the principal investigator, who is an oncology nurse with 4 years of experience.
The principal investigator documented any tailoring of the intervention to meet caregiver needs, caregiver’s engagement in the session and caregiver’s verbalisation of understanding of the session content. The dose of the intervention was tracked by recording the duration of each session, any additional contacts with the caregiver and any missed visits by the caregiver.
Control group
Participants assigned to the control group received standard care, which consisted of routine nursing care provided by ward nurses. This included standard perioperative care instructions and basic rehabilitation guidance typically offered to family caregivers. The standard care protocol encompassed essential information about post-operative recovery and basic caregiving instructions. To maintain ethical standards, family caregivers in the control group were offered the opportunity to participate in the perioperative support program after finishing the study at 1 month.
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Data collection and outcome measures
Family caregivers were invited by a trained research assistant to complete a set of outcome measures at baseline (T0) in person and 4 weeks after the intervention (T1) by telephone calls. The 4 weeks after the intervention was chosen as the follow-up time point, as it was deemed optimal for family caregivers to accumulate sufficient practical experience and develop a comprehensive understanding of their caregiving role, thereby enabling a more accurate and meaningful assessment of the intervention’s effectiveness. The participants in the intervention group were invited to assess the feasibility and acceptability of the program after the intervention.
Feasibility
Feasibility was evaluated on the basis of the recruitment rate, attrition rate, time spent on completing the questionnaire and duration of each session.
Acceptability
Acceptability was assessed after the last intervention session using the Client Satisfaction Questionnaire (CSQ-8) [44] and open-ended questions. The CSQ-8 is an 8-item questionnaire that assesses participant’s perceptions of the value of and overall satisfaction with the services received. The CSQ-8 is evaluated on a four-point Likert scale. Scores range from 8 to 32 with higher scores showing more satisfaction with the intervention. A series of studies of this measure has shown high internal consistency (Cronbach’s alpha 0.92 to 0.93) along with criterion and construct validity. Furthermore, open-ended questions on the most important and useful parts of the program, perceived help, program limits and recommendations on improving the program were used to gather more detailed feedback on participants’ views and comments about the program.
Preliminary efficacy
The preliminary efficacy of the program was assessed at baseline (T0) and 4 weeks after the intervention (T1) using the Hospital Anxiety and Depression Scale, Zarit Caregiver Burden Interview, the Quality of Life Family Version, Simplified Coping Style Questionnaire and Social Support Rate Scale. Details of the questionnaire used can be found in the published study protocol [41].
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Data analysis
This pilot study was not designed for adequate statistical power, but rather to test the feasibility, acceptability and preliminary efficacy of the intervention. All analyses were performed using IBM SPSS Statistics for Windows, version 26.0 (IBM Corp., Armonk, N.Y., USA). An intention-to-treat analysis was used for data analysis. Descriptive statistics were produced to summarise sociodemographic variables. Frequencies, percentages, means and standard deviations were calculated to describe the feasibility and acceptability of the program. Cohen’s d effect sizes and confidence intervals were calculated to examine the effect size of any changes in psychological distress, caregiver burden, active coping, negative coping, social support and quality of life. A generalised estimating equation (GEE) model was also used to evaluate differential changes in outcomes between the intervention and control groups at two endpoints (T0 and T1). Models included not only the main effects of the study group and time, but also all interaction effects (group × time). Intervention effects were determined as significant group × interaction time. Statistical significance was set as two-tailed P < 0.05 in all analyses. For the outcome variables such as psychological distress, caregiver burden and negative coping, the negative sign of the estimated coefficient (β) indicates an improvement, whereas for active coping, social support and quality of life, the positive sign does so.
Cohen’s d was used to evaluate the intervention’s effect size on the outcome variables. Mean differences between the two groups from T0 to T1 were used to assess the effect size because the intervention had been completed at T1, which was the study’s endpoint.
Results
Participant characteristics
From March to May 2022, 89 family caregivers were screened for eligibility, of which 78 met the sample selection criteria and 70 (89.7%) agreed to participate (Fig. 1). We randomly assigned 35 participants to the intervention group and 35 to the control group. The demographic characteristics of the participants are summarised in Table 1. The patients were generally middle-aged (mean age 55.9 [SD = 10.8] years) female (60.0%) with a mean length of hospital stay of 7.3 (SD = 2.2) days. Most of the family caregivers were spouses (58.6%), and their mean age was 45.4 (SD = 10.8) years. As for clinical characteristics, 13 patients in the intervention and control groups had comorbid chronic diseases in addition to lung cancer. The majority (95.7%) was adenocarcinoma. Lymph node metastases were identified in two patients of the intervention group. Postoperative complications occurred in five of all patients, including prolonged persistent air leak (one patient), subcutaneous emphysema (three patients) and postoperative pulmonary infection (one patient). There were no significant differences in the baseline characteristics between groups, except for patients’ and caregivers’ sex and caregivers’ perceived financial hardship.
Fig. 1
CONSORT flow chart
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Table 1
Demographic and characteristics of patients and caregivers
Characteristics | Total (n = 70) n (%) | IG (n = 35) n (%) | CG (n = 35) n (%) | t | χ2 | P |
|---|---|---|---|---|---|---|
Patients | ||||||
Age (years) | 0.11 | 0.912a | ||||
Mean (SD) | 55.9 (10.8) | 56.1 (11.0) | 55.8 (10.7) | |||
Sex | 5.95 | 0.015b | ||||
Female | 42 (60.0) | 16 (45.7) | 26 (74.3) | |||
Male | 28 (40.0) | 19 (54.3) | 9 (25.7) | |||
Family history of lung cancer | 0.00 | 1.000b | ||||
Yes | 18 (25.7) | 9 (25.7) | 9 (25.7) | |||
No | 52 (74.3) | 26 (74.3) | 26 (74.3) | |||
Smoking status | 2.55 | 0.307c | ||||
Nonsmoker | 46 (65.7) | 20 (57.1) | 26 (74.3) | |||
Current or former smoker | 24 (34.3) | 15 (42.9) | 9 (25.7) | |||
Health insurance | 1.67 | 0.432b | ||||
Basic medical insurance for urban employees | 35 (50.0) | 19 (54.3) | 16 (45.7) | |||
Basic medical insurance for urban residents | 12 (17.1) | 7 (20.0) | 5 (14.3) | |||
New rural cooperative medical insurance | 23 (32.9) | 9 (25.7) | 14 (40.0) | |||
Chronic disease | 0.00 | 1.000b | ||||
Yes | 26 (37.1) | 13 (37.1) | 13 (37.1) | |||
No | 44 (62.9) | 22 (62.9) | 22 (62.9) | |||
Histology | 2.70 | 0.239c | ||||
Adenocarcinoma | 67 (95.7) | 32 (91.4) | 35 (100.0) | |||
Squamous cell carcinoma | 2 (2.9) | 2 (5.7) | 0 (0.0) | |||
Others | 1 (1.4) | 1 (2.9) | 0 (0.0) | |||
Tumour stage | 6.70 | 0.116c | ||||
I A1 | 31 (44.3) | 13 (37.1) | 18 (51.4) | |||
I A2 | 25 (35.7) | 13 (37.1) | 12 (34.3) | |||
I A3 | 8 (11.4) | 3 (8.6) | 5 (14.3) | |||
I B | 4 (5.7) | 4 (11.5) | 0 (0.0) | |||
II B | 2 (2.9) | 2 (5.7) | 0 (0.0) | |||
Lymph node metastasis | 0.493c | |||||
Yes | 2 (2.9) | 2 (5.7) | 0 (0.0) | |||
No | 68 (97.1) | 33 (94.3) | 35 (100.0) | |||
Surgery type | 1.57 | 0.456b | ||||
Wedge resection | 16 (22.9) | 6 (17.1) | 10 (28.6) | |||
Segmentectomy | 28 (40.0) | 16 (45.7) | 12 (34.3) | |||
Lobectomy | 26 (37.1) | 13 (37.2) | 13 (37.1) | |||
Postoperative complications | 2.29 | 0.282c | ||||
No | 65 (92.9) | 33 (94.3) | 32 (91.4) | |||
Yes | 5 (7.1) | 2 (5.7) | 3 (8.6) | |||
Length of stay (days) | 0.97 | 0.337a | ||||
Mean (SD) | 7.3 (2.2) | 7.6 (2.3) | 7.1 (2.1) | |||
Caregivers | ||||||
Age (years) | -0.18 | 0.861a | ||||
Mean (SD) | 45.5 (10.8) | 45.3 (11.7) | 45.7 (10.0) | |||
Sex | 4.63 | 0.031b | ||||
Female | 35 (50.0) | 22 (62.9) | 13 (37.1) | |||
Male | 35 (50.0) | 13 (37.1) | 22 (62.9) | |||
Education level | 5.09 | 0.386c | ||||
Elementary school or below | 1 (1.4) | 0 (0.0) | 1 (2.9) | |||
Junior high school | 9 (12.9) | 6 (17.1) | 3 (8.6) | |||
Senior high school | 24 (34.3) | 10 (28.6) | 14 (40.0) | |||
Junior college | 14 (20.0) | 10 (28.6) | 4 (11.4) | |||
University or above | 22 (31.4) | 9 (25.7) | 13 (37.1) | |||
Relationship of caregiver to patient | 1.31 | 0.628c | ||||
Spouse | 41 (58.6) | 22 (62.9) | 19 (54.2) | |||
Son/daughter | 28 (40.0) | 13 (37.1) | 15 (42.9) | |||
Other family members/friends | 1 (1.4) | 0 (0.0) | 1 (2.9) | |||
Perceived financial hardship | 10.73 | 0.010 c | ||||
None | 21 (30.0) | 13 (37.2) | 8 (22.8) | |||
Mild | 30 (42.9) | 9 (25.7) | 21 (60.0) | |||
Moderate | 14 (20.0) | 11 (31.4) | 3 (8.6) | |||
Severe | 5 (7.1) | 2 (5.7) | 3 (8.6) | |||
Feasibility results
As shown in Fig. 1, among 78 participants who were eligible for recruitment, 70 participants agreed to participant (recruitment rate = 89.7%). All these 70 participants completed the baseline measures and the intervention (completion rate of the intervention = 100%). The attrition rate was relatively low at 10%, with seven participants withdrawing from the study during the follow-up period (three from the intervention group and four from the control group) due to loss of contact or refusal to continue participation. The time spent on completing the questionnaire by all participants was 18–39 minutes with a mean of 24.52 (SD = 4.85) minutes. All participants were generally satisfied with the questionnaires and length of time needed to complete them. The duration of each intervention session was 53 to 69 minutes, and the mean duration of sessions was 59.43 (SD = 6.24) minutes, which could be perceived as a feasible time by the participants. The intervention showed no harmful or adverse effects.
Acceptability results
The mean program satisfaction rating was 30.60 (SD = 1.38), indicating that the participants were satisfied with the program. A summary of the CSQ-8 scores is displayed in Table 2. With regard to the response of participants to the open-ended questions, about 90.9% of the participants indicated that the program was informative and helpful. Moreover, 63.6% of the caregivers said that participating in the program gave them more confidence when caring for perioperative patients. Participants also provided some recommendations for improving the program. Four participants said they would like to know more about subsequent therapies such as chemotherapy, targeted therapy or immunotherapy. Two participants expressed a desire to see more videos or live demonstrations related to patient rehabilitation.
Table 2
Post-intervention scores on client satisfaction Questionnaire-8 (n = 35)
Item | Responses | |||
|---|---|---|---|---|
1 | 2 | 3 | 4 | |
1. How would you rate the quality of service you received | 0% | 0% | 11.4% | 88.6% |
2. Did you get the kind of service you wanted | 0% | 2.9% | 5.7% | 91.4% |
3. To what extend has our program met your needs | 0% | 0% | 14.3% | 85.7% |
4. If a friend were in need of similar help, would you recommend our program to him or her? | 0% | 0% | 17.1% | 82.9% |
5. How satisfied are you with the amount of help you received | 0% | 0% | 11.4% | 88.6% |
6. Have the services you received helped you to deal more effectively with your problems? | 0% | 2.9% | 31.4% | 68.6% |
7. In an overall, general sense, how satisfied are you with the service you have received? | 0% | 0% | 25.7% | 74.3% |
8. If you were to seek help again, would you come back to our program? | 0% | 0% | 14.3% | 85.7% |
Preliminary effects
Changes of outcome measures over time between the study groups are shown in Table 3. The results of GEE analysis indicated that the intervention tended to reduce psychological distress, although the reduction was not statistically significant (β = −2.44, P = 0.106, Cohen’s d = − 0.28). In addition, there were no significant between-group differences in caregiver burden, active coping, negative coping, social support, and quality of life (P > 0.05 for all; effect sizes range = -0.26–0.24).
Table 3
Generalized estimating equation (GEE) model for the comparison of outcome variables between the intervention and control groups
Outcome variables | Group | Time 1 | Group × Time 1 | |||
|---|---|---|---|---|---|---|
β (95%CI) | P | β (95%CI) | P | β (95%CI) | P | |
Psychological distress | 0.88 (-1.96, 3.73) | 0.544 | 1.71 (-0.40, 3.82) | 0.112 | -2.44 (-5.39, 0.52) | 0.106 |
Caregiver burden | -3.89 (-9.98, 2.21) | 0.211 | 3.95 (-2.49, 10.39) | 0.229 | 1.43 (-7.55, 10.41) | 0.755 |
Active coping | 0.08 (-0.17, 0.33) | 0.523 | 0.15 (-0.09, -0.39) | 0.233 | -0.21 (-0.52, 0.10) | 0.184 |
Negative coping | 0.14 (-0.12, 0.39) | 0.306 | 0.39 (0.15, 0.63) | 0.002* | -0.19 (0.51, 0.13) | 0.241 |
Social support | -1.14 (-5.36, 3.09) | 0.306 | -2.71 (-6.82, 1.40) | 0.196 | 2.04 (-2.95, 7.03) | 0.423 |
Quality of life | 0.13 (-0.56, 0.82) | 0.703 | -2.52 (-0.69, 0.18) | 0.263 | 0.12 (-0.53, 0.77) | 0.708 |
Table 4
Changes of outcome measures over time between the study groups
Variables | IG | CG | Pa | Cohen’s d |
|---|---|---|---|---|
Psychological distress | ||||
Baseline (T0) | 14.63 (5.04) | 13.74 (5.18) | 0.471 | |
Post-intervention (T1) | 13.69 (6.51) | 15.58 (6.78) | 0.262 | -0.28 |
Caregiver burden | ||||
Baseline (T0) | 40.54 (12.93) | 42.31 (12.64) | 0.564 | |
Post-intervention (T1) | 45.97 (12.35) | 46.23 (11.91) | 0.933 | -0.02 |
Active coping | ||||
Baseline (T0) | 1.81 (0.57) | 1.73 (0.55) | 0.543 | |
Post-intervention (T1) | 1.74 (0.48) | 1.86 (0.45) | 0.326 | -0.26 |
Negative coping | ||||
Baseline (T0) | 1.07 (0.53) | 0.96 (0.41) | 0.303 | |
Post-intervention (T1) | 1.27 (0.52) | 1.35 (0.62) | 0.581 | -0.14 |
Social support | ||||
Baseline (T0) | 40.97 (7.77) | 43.09 (9.23) | 0.303 | |
Post-intervention (T1) | 40.59 (8.91) | 40.35 (8.72) | 0.915 | 0.03 |
Quality of life | ||||
Baseline (T0) | 202.20 (44.11) | 198.54 (34.76) | 0.701 | |
Post-intervention (T1) | 198.63 (35.52) | 191.26 (25.89) | 0.352 | 0.24 |
Discussion
To our knowledge, it is the first study to explore a comprehensive perioperative support program specifically designed for family caregivers of patients with early-stage lung cancer. This addresses a crucial gap in the literature and clinical practice. In addition, the high feasibility and acceptability of the program demonstrate that the intervention can be successfully implemented in clinical settings, providing a foundation for the large-scale study. Although the family caregivers had taken on various caregiving roles and had cared for perioperative patients with early-stage lung cancer, the attrition rate was low (only 10%). While a numerical trend suggested less deterioration in the intervention group compared to the control group, the differences did not reach statistical significance (P > 0.05). The effects of the intervention on negative coping and quality of life had similar non-significant but beneficial results for family caregivers receiving the intervention compared with the control group. While the intervention showed promise in terms of feasibility and acceptability, its effectiveness requires further investigation through large-scale study.
The recruitment rate for the study was satisfactory (89.7%), and the attrition rate was relatively low (10%), indicating that the participants were willing to participant and remain in the study. Participants considered the content of the program and the duration of each session to be feasible. During intervention delivery, the caregivers were highly attentive. They also showed a keen interest in the content that was being provided and demonstrated a desire to learn more.
After the intervention, the participants showed satisfaction with the intervention by giving a high sore on the satisfaction form and by thanking the researcher in person. Although the evaluation findings were satisfactory, there was still room for improvement. In particular, caregivers expect that future interventions will add content related to subsequent treatment of lung cancer and live demonstrations related to rehabilitation, and that paper-based educational materials will be provided to them.
This intervention was designed to decrease caregivers’ psychological distress. However, a non-significant effect was found in the psychological distress of caregivers between the two groups. In addition, the effect of time on psychological distress was not significant probably because we collected the data at 4 weeks after the intervention, whilst caregivers still felt enormous psychological distress. Patients with early-stage lung cancer have more evident symptoms such as cough, dyspnoea and pain within 1 month after lung resection surgery [45]. Caregivers worried about the patients’ possible symptoms after discharge. The caregiver’s concern for patient might contribute to the increased psychological distress, which was not due to the intervention. Secondly, the intervention duration might have been insufficient to produce significant changes in caregivers’ psychological outcomes. Future study could consider extending the intervention period and incorporating booster sessions to reinforce the learned skills. Thirdly, this study was conducted during the COVID-19 pandemic, during which time family caregivers experienced added substantial stress, anxiety and uncertainty when they take care of their loved ones. To improve the effectiveness of the intervention, we have made the following modifications in the large-scale trial: (1) implementing a more intensive intervention schedule with increased frequency of sessions, (2) incorporating more practical hands-on training components, particularly for rehabilitation care, and (3) adding a peer support component to facilitate experience sharing among caregivers. Additionally, the large-scale trial included multiple assessment time points to better capture the intervention’s long-term effects.
Although this study did not demonstrate statistically significant results, it has highlighted several important implications for clinical practice and the large-scale study. Family caregivers play an increasingly vital role in the cancer care continuum, particularly during the perioperative period. The findings suggest that healthcare professionals, especially nurses, need to recognize and address the complex needs of family caregivers. While statistical significance was not achieved, the observed trends in caregiver outcomes align with previous research [46‐48] indicating the potential benefits of structured support interventions. The implementation of perioperative support programs, even if not showing immediate statistical significance, represents an important step toward developing comprehensive care models that include family caregivers as integral members of the healthcare team. The challenges identified in this study provide valuable insights for refining future intervention and highlight the need for continued research with larger sample sizes and longer follow-up periods to better understand the impact of caregiver support program. Moreover, this study contributes to the growing body of evidence emphasizing the importance of family-centered care approaches in oncology. The findings suggest that while immediate measurable effects may be subtle, supporting caregivers during the perioperative period remains a crucial aspect of comprehensive cancer care that warrants further investigation and development.
Limitations
This study has also some limitations. Firstly, participants from a tertiary hospital were included, and the findings may not be generalisable to other areas or populations. In addition, only a single time assessment was performed after the intervention. Therefore, the results of the outcome evaluation are inconclusive and only exploratory, which need further research, including more hospital sites and longer duration to examine the effects of the perioperative support program on psychological distress amongst family caregivers of patients with early-stage lung cancer.
Conclusion
The findings of this pilot study indicate that the perioperative support program is feasible and acceptable for family caregivers of patients with early-stage lung cancer. The program provides caregivers coping and communication skill training and psychoeducational strategies, which can help them face the perioperative challenges of caring for patients with early-stage lung cancer. Although the sample size may be small to detect a significant difference, it does not mean that the perioperative support program is ineffective in helping family caregivers of patients with early-stage lung cancer reduce psychological distress. Based on the promising results of this pilot study, we have conducted a large-scale randomised controlled trial to rigorously evaluate the intervention’s effectiveness, and data analysis is currently underway. This expanded study will address the limitations identified in the pilot phase while maintaining the core elements that demonstrated feasibility and acceptability.
Acknowledgements
The authors thank all the patients and their caregivers for their time and participation in the study and thank all our colleagues who helped us with clinical data collection.
Declarations
Ethics approval and consent to participate
This study was conducted in accordance with relevant guidelines and regulations, and received approval from the Ethics Committee of the Second Xiangya Hospital of Central South University (LYG2022003). The participants were informed that they could decide to withdraw from the study at any point during the study. Informed consent was obtained from all participants. In addition, to protect the anonymity and privacy of participants, data were processed anonymously by numbered codes and were kept confidential.
Consent for publication
Not applicable.
Completing interests
No conflict of interest has been declared by the authors.
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