Home-Based Supportive Care Program for NMIBC Patients Receiving Intravesical Perfusion: Construction and Preliminary Application (NMIBC-HSC)
Construction and Preliminary Application of Home-Based Supportive Care Program for Patients With Non-Muscle Invasive Bladder Cancer Undergoing Intravesical Perfusion Therapy
Visão geral do estudo
Status
Descrição detalhada
（1)Identification of Supportive Care Needs for Patients Receiving Postoperative Intravesical Chemotherapy for Non-Muscle-Invasive Bladder Cancer (Qualitative Study): Employing a descriptive qualitative research approach based on the Supportive Care Needs Framework, semi-structured in-depth interviews were conducted with patients undergoing postoperative intravesical chemotherapy for non-muscle-invasive bladder cancer (NMIBC). This systematically explored the authentic care needs of patients across multiple dimensions including physiological, psychological, social, emotional, spiritual, informational, and practical aspects, providing precise evidence for subsequent scheme development.
(2) Summary of Best Evidence for Supportive Care of NMIBC Patients Undergoing Postoperative Intravesical Chemotherapy (Evidence-Based Research): Centered on the core needs identified through qualitative research, an evidence-based nursing research methodology was utilized. Systematic retrieval of domestic and international databases, guideline websites, and evidence-based resource libraries was performed. The retrieved clinical guidelines, expert consensus statements, systematic reviews, randomized controlled trials, and quasi-experimental studies underwent rigorous quality assessment and evidence extraction to formulate a comprehensive summary of best supportive care evidence for this population.
(3) Development of a Supportive Care Scheme for NMIBC Patients Undergoing Postoperative Intravesical Chemotherapy (Delphi Method): Integrating patient needs derived from qualitative research with best evidence from evidence-based research, a draft supportive care scheme was formulated. The Delphi expert consultation method was employed, inviting experts from urology medicine, nursing, and rehabilitation fields to participate in two rounds of consultations. Through calculation of expert positive coefficient, authority coefficient, and Kendall's harmony coefficient, items were screened and revised, ultimately constructing a scientific, systematic, and operable supportive care scheme.
(4) Evaluation of the Feasibility of the Supportive Care Scheme: Following scheme formulation, feasibility evaluation was conducted using NMIBC patients receiving postoperative intravesical chemotherapy attending the outpatient department of a tertiary hospital in Nanjing. Participants were divided into an intervention group (receiving the newly developed supportive care scheme) and a control group (receiving routine outpatient care). During the study, patient recruitment and retention rates, intervention implementation processes, and compliance were observed and recorded. Post-intervention, acceptability of the scheme and perceived implementation burden by both patients and staff were collected to evaluate its feasibility in clinical practice.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Chunhua Zheng, Bachelor
- Número de telefone: +8613584042177
- E-mail: 303618002@qq.com
Locais de estudo
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Jiangsu
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Nanjing, Jiangsu, China, 210001
- Nanjing First Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Patients pathologically diagnosed with NMIBC, who have undergone TURBT and are receiving intravesical perfusion therapy; Aged 18 years old or above; Clear consciousness with basic literacy and communication skills; Expected survival time ≥ 6 months; Voluntary participation with signed informed consent.
Exclusion Criteria:
Patients complicated with severe cardiovascular and cerebrovascular diseases, hepatic or renal dysfunction, or mental disorders; Patients combined with other malignant tumors; Patients with a history of severe allergic reactions or contraindications to intravesical perfusion therapy.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Supportive care program
Establishing a Dedicated Nursing Team: The team consists of one urology specialty nurse (team leader), one attending physician, one rehabilitation therapist, one dietitian, one psychological counselor, and the researchers of this study.
All members received uniform protocol training prior to intervention to ensure homogeneity in intervention delivery.
This comprehensive supportive care program is implemented for patients undergoing post-operative intravesical therapy for non-muscle-invasive bladder cancer, encompassing physiological/practical support, informational support, psychological/emotional support, and social/spiritual support, with the aim of enhancing treatment adherence and quality of life.
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Establishing a Dedicated Nursing Team: The team consists of one urology specialty nurse (team leader), one attending physician, one rehabilitation therapist, one dietitian, one psychological counselor, and the researchers of this study.
All members received uniform protocol training prior to intervention to ensure homogeneity in intervention delivery.
This comprehensive supportive care program is implemented for patients undergoing post-operative intravesical therapy for non-muscle-invasive bladder cancer, encompassing physiological/practical support, informational support, psychological/emotional support, and social/spiritual support, with the aim of enhancing treatment adherence and quality of life.
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Comparador Ativo: Implementing routine urology outpatient infusion nursing
Includes: routine medical history inquiry and verification prior to infusion; monitoring of the patient's vital signs and clinical condition changes during infusion; routine verbal instructions on post-infusion precautions (such as increased water intake and frequent urination) after infusion; distribution of standard outpatient paper educational materials; and simple telephone follow-up in accordance with departmental routine procedures.
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Includes: Routine medical history inquiry and verification before infusion; Monitoring of the patient's vital signs and changes in condition during infusion; Routine verbal instructions on precautions after infusion (such as drinking plenty of water and urinating frequently); Distribution of routine outpatient paper educational leaflets; Conducting simple telephone follow-ups in accordance with the department's routine procedures.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Clinical Treatment Adherence
Prazo: 6 months after intervention
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Treatment adherence will be evaluated by infusion completion rate,calculated as (actual number of infusions received / total planned infusions prescribed) × 100%.
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6 months after intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Bladder-cancer-specific quality of life
Prazo: Baseline、3 months、6 months after intervention
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This outcome will evaluate bladder-cancer-specific quality of life using the validated Chinese version of the EORTC-QLQ-NMIBC24 scale.
Higher scores correspond to greater symptom burden and worse quality-of-life status.
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Baseline、3 months、6 months after intervention
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Recruitment rate and infoermed consent rate
Prazo: Baseline
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Calculate the proportion of eligible patients who sign informed consent and formally enroll into the study among all screened eligible subjects.
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Baseline
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Patient Satisfaction and Acceptance
Prazo: 3months after intervention
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A self-designed questionnaire with 5 items using 5-point Likert scale is adopted to score patients'satisfaction and acceptance of the supportive care program
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3months after intervention
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Satisfaction of supportive care needs
Prazo: Baseline, 3 months after intervention, 6 months after intervention
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The Short-Form Supportive Care Needs Survey (SCNS-SF34) is administered at three time points to evaluate changes in patients' supportive care needs between two groups.
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Baseline, 3 months after intervention, 6 months after intervention
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Urogenitais Masculinas
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Neoplasias por Tipo Histológico
- Neoplasias Glandulares e Epiteliais
- Neoplasias Urológicas
- Carcinoma
- Doenças da Bexiga Urinária
- Neoplasias da Bexiga Urinária
- Neoplasias Não Musculares Invasivas da Bexiga
Outros números de identificação do estudo
- KY20260723-09
Plano para dados de participantes individuais (IPD)
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