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
Aperçu de l'étude
Statut
Description détaillée
（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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Chunhua Zheng, Bachelor
- Numéro de téléphone: +8613584042177
- E-mail: 303618002@qq.com
Lieux d'étude
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Jiangsu
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Nanjing, Jiangsu, Chine, 210001
- Nanjing First Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Clinical Treatment Adherence
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Bladder-cancer-specific quality of life
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies urogénitales masculines
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Tumeurs par type histologique
- Tumeurs, glandulaires et épithéliales
- Tumeurs urologiques
- Carcinome
- Maladies de la vessie urinaire
- Tumeurs de la vessie urinaire
- Tumeurs de la vessie non envahissantes sur le plan musculaire
Autres numéros d'identification d'étude
- KY20260723-09
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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