Stesura Seveso Archivio Italiano di Urologia e Andrologia 2023; 95, 1 ORIGINAL PAPER men, bladder cancer accounts for 70.7 cases per 100,000, while women account for 16.3 cases per 100,000 and it accounts for 3.6 per cent of all cancer mortalities (4.9 per cent men and 1.8 per cent women). The main risk factors include age, gender (men are considered to be at higher risk), smoking, exposure to chemicals; certain drugs used in cancer treatment, such as cyclophosphamide; chronic bladder inflammation such as urinary infections or cysti- tis; family history (4). There are various types of treatment including open, laparoscopic, and robotic surgery, immunotherapy, chemotherapy, and radiotherapy (5). Surgery is the primary treatment for bladder cancer. Depending on the patient's clinical need, bladder cancer surgery may include removal of the tumour from the bladder wall by cystoscopy (TUR-V) or removal of the entire bladder (radical cystectomy). Patients undergoing radical cystectomy may be candidates for bladder and urinary tract reconstruction or urinary diversion surgery. Patients undergoing radical cystectomy (RC) and ileal conduit must learn to manage an ostomy that requires daily care, manual skills and must cope with the psychosocial impacts that accompany urostomy place- ment. Maintaining patients' good quality of life (QoL) depends largely on the caregiver's preparation and man- agement skills (6). In this regard, before and after surgery, nursing and medical staff teach the patient and caregivers how to manage the new physical condition (4). The caregiver's role is of crucial importance; they will be entrusted to follow their relative's assistance at home, throughout the complete clinical and rehabilitation process (7). Unfortunately, many caregivers are not ade- quately prepared to cope with the physical and psycho- logical changes of post-cystectomy life and this leads to worsen the patients' quality of life (8). The aim of this study is to examine caregivers' experiences and training needs after radical cystectomy with urinary diversion for the first three months following the patient's discharge. Our study is the first of its kind in Italy, and it focuses exclusively on the three-month period at home, fol- lowing discharge. Objective: To examine caregivers' experiences and training needs after radical cystectomy with urinary diversion for the first three months following the patient's discharge. Methods: This study applied a phenomenological design approach through open-ended interviews and descriptive analysis. Phenomenology applied to empirical research requires researchers to explore the empirical facts narrated by partici- pants. This study followed the Consolidated Criteria for Reporting Qualitative Research guidelines, a 32 – item checklist for inter- views and focus groups. The study population included caregivers of bladder cancer patients, admitted to three Italian hospitals. Data were collected between March 2020 and March 2022. Results: Fifty-two caregivers of patients who underwent cystecto- my with urinary diversion from three Italian hospitals (41 males and 11 females) participated to the study. The data analysis con- verged in the identification of three themes – with sub-themes – that included various aspects of the caregiver’s lived experiences: 1) living with the burden of being indispensable, for the family member, 2) feeling abandoned by institutions, 3) tiredness and less willingness to look after the relative due to work burden. Conclusions: Our study demonstrates that the caregiver of a patient with bladder cancer and urostomy in the first three months of hospital discharge is very worried and stressed. Despite the training program received in hospital, the caregiver does not recognize the newly acquired skills and has difficulty applying them. Further study would be required. KEY WORDS: Bladder cancer; Caregiver burden; Quality of life; Urostomy. Submitted 20 November 2022; Accepted 22 November 2022 INTRODUCTION A bladder neoplasia is a malignant tumour that forms in the bladder wall (1). Worldwide, it is the ninth most common tumour and the most frequent of the genitouri- nary tract (2), while it accounts for (3, 4) per cent of all malignancies (America Cancer Society). It also ranks fourth among all malignant tumours affecting men and eighth among those affecting women (3). According to the Italian Society Cancer Registry (AIRT) every year among Management of the patient with urostomy: Caregiver needs during the three months after discharge. A qualitative study Tatiana Bolgeo 1, Federico Ruta 2, Denise Gatti 1, Francesca Gambalunga 3, Laura Iacorossi 4, Roberta Di Matteo 1, Salvatore Cotroneo 5, Carmelo Boccafoschi 6, Antonio Maconi 1 1 Department of Research and Innovation - Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy; 2 General Direction, ASL BAT (Health Agency), Andria, Italy; 3 Department of Biomedicine and Prevention, University of Rome “Tor Vergata”, Rome, Italy; 4 National Cancer Institute “Regina Elena”, Rome, Italy; 5 SC Urology, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy; 6 City of Alessandria Clinic Monza Polyclinic, Alessandria, Italy. DOI: 10.4081/aiua.2023.11024 Summary Archivio Italiano di Urologia e Andrologia 2023; 95, 1 T. Bolgeo, F. Ruta, D. Gatti, F. Gambalunga, L. Iacorossi, R. Di Matteo, S. Cotroneo, C. Boccafoschi, A. Maconi MATERIAL AND METHODS Design This study applied a phenomenological design approach through open-ended interviews and descriptive analysis (9, 10). According to Mortari (10), phenomenology applied to empirical research requires researchers to explore the empirical facts narrated by participants. The research questions focused on caregivers' experiences while caring for a family member with bladder cancer, who underwent radical cystectomy surgery with urosto- my, during the 3 months following discharge. The study followed the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines, a 32 – item checklist for interviews and focus group (11). This research was approved by the Ethical Committee of SS Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy and data collec- tion took place between March 2020 and March 2022. Participants This study employed targeted sampling. The study popu- lation included caregivers of bladder cancer patients, who underwent radical cystectomy surgery with the creation of an urostomy in three Italian hospitals, willing to share their experiences after their family member's hospital discharge. A minimum of 10 caregivers from each hospital were invit- ed to participate, and recruitment continued until data sat- uration. Caregiver recruitment took place at the hospital during patient discharge to facilitate collection of the care- givers’ experience in the daily management of the disease during the three months following discharge. The inclu- sion criteria were knowledge of the Italian and English lan- guage, as well as experience in home care giving. The physicians and nurses in charge and working in the hospi- tal unit made the initial contact with caregivers at least 48 hrs. before researchers, to ensure that the potential partici- pants had enough time to consider their involvement (12). Caregivers also received a leaflet, outlining the study's prin- ciples and inviting their participation. We agreed on this approach, as it was felt that presence of the patient could jeopardise the participant’s willingness to be open about some of the more negative aspects of caregiving and thus impact on our aim of obtaining in-depth and richly diverse experiences from the caregivers. Participants provided written informed consent prior to enrolment, and they pro- vided written informed consent to have their anonymized data presented or published. Data collection The study setting was represented by the following hos- pitals: AOU Policlinico Bari, Puglia; Azienda Ospedaliera Alessandria, Piedemont; Clinica Città di Alessandria, Piedmont. The data was collected through a semi-struc- tured open-ended interview; according to this type of interview the caregivers were able to describe their expe- riences according to how and what they thought essential to share. The interviews were conducted by RF (male, Phd MSN, RN), TB (female, PHD, MSN, RN) and (CB male RN, MSN). The interviews were in part face-to-face within the hospital and in part by telephone. Each partic- ipant chose between the two methods according to their personal needs. For the caregivers who choose face-to- face interviews, a room within the hospital facility was available to maintain the confidentiality and the serenity necessary to share their story. The interviews were audio- recorded and verbatim transcribed by the interviewer. A total of 52 interviews were conducted (the time ranged from 30 to 60 minutes) (Table 1). Data analysis All Interviews were transcribed verbatim by NVivo 12 and subsequently reviewed by nurse research scientists TB (RN PhD) and FR (RN, PhD). Interviews were analysed using Colaizzi’s (1978) descriptive analysis framework revisited by Mortari (2019), which included the following steps: (1) in-depth reading of the transcripts to gain a deeper understanding and meaning of what was being said, by three researchers (TB, FR, CB); (2) extrac- tion of meaningful descriptions provided by participants (TB, FR); (3) re-formulation of meanings into sub-themes and themes (TB, FR); (4) construction of themes’ descrip- tions of empirical-phenomenological qualities (TB, FR); (5) sharing results with participants for verification (TB, FR); (6) integration of the results into a complete descrip- tion, i.e. the definition of general statements to sum- marise the participants' lived experience. The Qualitative Research Data Analysis Software NVivo (12) was used for data management. Table 1. Caregiver semi-structured interviews. Did the healthcare staff regarding the postoperative management of your family member, provide useful explanations and advice? At discharge, did you have any doubts about the management of the necessary guardianship for your family member? Has your life changed from before surgery? Could you describe what your typical day is like now? Have you ever thought about going to the accident and emergency unit (A&E) in case of difficulty? What are the major difficulties encountered in the three months following discharge? Table 2. Caregiver socio-demographic characteristics. Characteristics Caregivers n = 52 Age Range 27-73 Gender Male 41 Female 11 Educational level Elementary 28 Lower intermediate 15 Upper intermediate 7 Bachelor’s degree 2 Occupation Employed full time 26 Employed part time 7 Unemployed 3 Retired 16 Relationship with patient Spouse 34 Daughter 6 Son 12 Home Same 42 Different 10 Archivio Italiano di Urologia e Andrologia 2023; 95, 1 MAP-URO RESULTS Fifty-two caregivers of patients who underwent cystecto- my with urinary diversion in three Italian hospitals (41 males and 11 females) participated in the study. Their socio-demographic characteristics is shown in Table 2. The data analysis converged in the identification of three themes – with sub-themes – that include various aspects of the caregiver’s experiences: 1) living with the burden of being indispensable, for the family member, 2) feeling abandoned by institutions, 3) tiredness and less willing- ness to look after the relative due to work. Theme 1: Living with the burden of being indispensable to the family member This theme describes the burden the caregiver experiences after discharge. Returning home and managing the family member alone, causes insecurity and increases the burden of the caregivers and awareness of their own abilities and limits. Disease management involves the development of skills that the caregiver did not previously possess. Returning home after discharge involves taking full per- sonal custody of the family member, increasing the burden of responsibility. Replacing professional healthcare staff involves the fear of making mistakes and causing harm. Two subthemes have been identified, a) "I am not a health- care professional" and b) "I am afraid of making mistakes." Sub-Theme 1a: "I am not a healthcare professional" During hospitalization, the patient identified and named his caregiver, who participated in an educational training program that included several meetings with doctors and nurses to plan for possible difficulties to be faced while managing the stoma at home. The caregivers in hospital feel secure and are confident that they are capable of cop- ing with the post-discharge process. At home, however, the situation does not reflect the same feelings: “The prob- lem is that at home I don't have the opportunity to compare myself with someone who understands .... I'm alone” (C6CF), “I am not a nurse and I do not know what to do sometimes ..... I get anxious ... I am afraid of making mistakes” (C2RS) Sub-Theme 1b: "I am afraid of making mistakes" “In the hospital I felt protected and when I looked after my family member, I had no hesitation. I knew there was some- one always ready in case of difficulty” (C9RE); “Even though I understand what I have to do, the emotional side stops me” (C4AS); “It would be enough for me to look at the doctor's eyes and I would have the strength to go on” (C11ET); “My family members look at me and monitor me; they think I can make mistakes at any moment” (C8AP). Theme 2: Feeling abandoned by institutions The second theme describes the condition of feeling abandoned and the stress that the carer feels after hospi- tal discharge. The distancing from healthcare staff causes not only fear but also a sense of strong insecurity. Loneliness decreases the awareness of one's own abilities and increases the possibility of making mistakes A sub- theme was identified: "the network does not exist". Sub-Theme: “The network does not exist” At home, the caregiver starts an adaptive phase and tries to implement all the operational instructions they have learnt from the healthcare professionals. In most cases the caregiver changes their habits and moves into the home of the family member they are caring for to avoid leaving them alone. From the interviews it emerged that after a week or so the caregiver tries to contact the family doctor to discuss the hospital discharge letter and new treat- ments to be administered. "One must remember that the doctor .... if he answers..... does so at set times and first one has to talk to the secretary...... I hope I never get sick after 7 p.m. otherwise I will have to go to the Accident and Emergency Unit" (C21NM); "You must go to the District....there, they will order you the supplies......but I need them now, so how will I manage? (C24OP); "The gen- eral practitioner told me to be patient......it takes a few days ......then I try phoning the hospital but even there it' s like win- ning the lottery. The phone rings but nobody answers.... I try again until the switchboard tells me to hold...... again!!!!.......if I can't speak to anyone by tomorrow, I'll go to the hospital." (C26UN); "My brother told me don't worry, I'll try to call or go in person and ask what we should do......" (C14LP), Theme 3: Tiredness and less willingness to look after the relative due to work This theme describes the caregiver's mood and work dif- ficulties during the three months after discharge. They must cope with a new organisation, which in most cases means a lack of free time as they must take care of a fam- ily member, in need of assistance. Such a situation can be a source of enormous stress for the caregivers, who, in addition to their work, must worry about an equally tir- ing and demanding subsidiary activity. Two sub-themes are identified: a) tiredness and b) sense of responsibility. Sub-Theme 3a: Tiredness The thought of being the only family member caring for the patient causes a sense of fatigue that in the long term impairs daily life. Symptoms such as insomnia and asthe- nia arise, leading to irritability "I hardly sleep at night and I'm nervous during the day... I didn't think taking care of my mum was so demanding... I don't know if I can do it much longer!" (C31TM); "I no longer have time to do anything......my life is centred on my mother's needs and she calls me all the time.....I am tired!" (C36VL) Sub-Theme 3b: Sense of responsibility "Every morning I get up with the thought that I have to go to work... I pray that nothing happens at home otherwise how can I manage? I can't leave work and I don't know who to call...." (C2NM); "The problem is that M. doesn't need continuous care but if a tube comes out and I'm not there he gets scared and who knows what happens... it happened once, a few hours passed... and then we had to go to hospital" (C14UN). DISCUSSION Caregivers caring for family members with bladder cancer who have undergone cystectomy and urinary diversion carry a burden.1 Many of them are not adequately pre- pared to cope with post-ostomy life, and they reported that these difficulties often led to a reduced quality of life for the family member as well (8, 13). Our study con- Archivio Italiano di Urologia e Andrologia 2023; 95, 1 T. Bolgeo, F. Ruta, D. Gatti, F. Gambalunga, L. Iacorossi, R. Di Matteo, S. Cotroneo, C. Boccafoschi, A. Maconi ducted in Italian hospitals on caregiver experiences, notes some similarities with other studies conducted in other countries. Similar difficulties and problems are men- tioned such as the need for communication, an increased network, burden and caregiver stress (1, 7). Our study reinforces themes highlighted in other studies that cite the importance of good caregiver health education during the family member's hospitalization and identifies a weaker development of community-based services com- pared to the rest of Europe (12). It also reinforces the con- cept about the sense of duty felt by caregivers and empha- sizes the need to obtain some free time for relaxation and leisure to continue caregiving subsequently (8, 14). The originality and strength of this study is to investigate care- givers' difficulties in the first three months after discharge. There are no studies in literature investigating this context. The first months reveal all the doubts and critical issues of caregivers and are the ones most at risk of improper hospital admissions. It emerged from the study themes, that in addition to the training program, an active net- work and more effective communication with healthcare staff, even after discharge, are crucial. CONCLUSIONS Our study demonstrates that the caregiver of a patient with bladder cancer and urostomy in the first three months after hospital discharge is very worried and stressed. Despite the training program received in hospital, the caregiver does not recognize the newly acquired skills and has difficulty applying them. The lack of an active network and effective communication causes insecurity and subsequent hospital re-admissions. There were no substantial differences with- in the three hospitals for study performance. However, this study has not analysed the different approaches among dif- ferent informal caregivers and financial status. Therefore, further study would be required. REFERENCES 1. Fitch MI, Miller D, Sharir S, McAndrew A. Radical cystectomy for bladder cancer: a qualitative study of patient experiences and impli- cations for practice. Can Oncol Nurs J Rev Can Nurs Oncol. 2010; 20:177-187. 2. Linee guida carcinoma della vescica. Published online 2015. 3. 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Correspondence Tatiana Bolgeo, RN PhD tbolgeo@ospedale.al.it Denise Gatti, RN dgatti@ospedale.al.it Roberta Di Matteo RN MSN1, (Corrsponding Author) rdimatteo@ospedale.al.it Antonio Maconi, MD amaconi@ospedale.al.it Department of Research and Innovation - Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo Via Venezia 16, 15100 Alessandria (Italy) Federico Ruta, RN PhD Federico.Ruta@aslbat.it General Direction, ASL BAT (Health Agency), Andria (Italy) Francesca Gambalunga, RN PhD francescagambalunga86@gmail.com Department of Biomedicine and Prevention, University of Rome “Tor Vergata”, Rome (Italy) Laura Iacorossi, RN PhD laura.iacorossi@gmail.com National Cancer Institute “Regina Elena”, Rome (Italy) Salvatore Cotroneo, RN scotroneo@ospedale.al.it SC Urology, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria (Italy) Carmelo Boccafoschi, MD cboccafoshi@libero.al.it City of Alessandria Clinic Monza Polyclinic, Alessandria (Italy) Conflict of interest: The authors declare no potential conflict of interest.