Nanjing First Hospital
Nanjing, Jiangsu, 210001, China
NCT Number: NCT07781956
This study focuses on patients with non-muscle-invasive bladder cancer who receive intravesical perfusion therapy. Outpatient perfusion treatment is usually short-term and procedure-oriented, so patients often lack continuous, comprehensive support after returning home, and may face physical discomfort, psychological stress and unmet self-management needs during home recovery. This study aims to identify real-world difficulties and needs of patients in home-based recovery, construct a personalized home supportive care program covering physical symptom relief, psychological support and disease management education, and test its preliminary application effect. It is expected to reduce patients' treatment-related discomfort, improve treatment adherence, and enhance their quality of life.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, 210001, China
(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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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.
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.
Time frame: 6 months after intervention
Treatment adherence will be evaluated by infusion completion rate,calculated as (actual number of infusions received / total planned infusions prescribed) × 100%.
Time frame: Baseline、3 months、6 months after intervention
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.
Time frame: Baseline
Calculate the proportion of eligible patients who sign informed consent and formally enroll into the study among all screened eligible subjects.
Time frame: 3months after intervention
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
Time frame: Baseline, 3 months after intervention, 6 months after intervention
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.
Contact information is provided by the study sponsor or research team.
Nanjing First Hospital, Nanjing Medical University
Other
Construction and Preliminary Application of Home-Based Supportive Care Program for Patients With Non-Muscle Invasive Bladder Cancer Undergoing Intravesical Perfusion Therapy
Acronym: NMIBC-HSC
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