Home-Based Supportive Care Program for NMIBC Patients Receiving Intravesical Perfusion: Construction and Preliminary Application (NMIBC-HSC)

August 20, 2026 updated by: Nanjing First Hospital, Nanjing Medical University

Construction and Preliminary Application of Home-Based Supportive Care Program for Patients With Non-Muscle Invasive Bladder Cancer Undergoing Intravesical Perfusion Therapy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

（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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chunhua Zheng, Bachelor
  • Phone Number: +8613584042177
  • Email: 303618002@qq.com

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210001
        • Nanjing First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
Active Comparator: 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.
Behavioral: Implementing routine urology outpatient infusion nursing
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Treatment Adherence
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%.
6 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bladder-cancer-specific quality of life
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.
Baseline、3 months、6 months after intervention
Recruitment rate and infoermed consent rate
Time Frame: Baseline
Calculate the proportion of eligible patients who sign informed consent and formally enroll into the study among all screened eligible subjects.
Baseline
Patient Satisfaction and Acceptance
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
3months after intervention
Satisfaction of supportive care needs
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.
Baseline, 3 months after intervention, 6 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 20, 2026

First Submitted That Met QC Criteria

August 20, 2026

First Posted (Actual)

August 24, 2026

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20260723-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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