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

NCT07781956 | Not Yet Recruiting

• 1 other identifier: KY20260723-09
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Muscle-Invasive Bladder Cancer (NMIBC)

Keywords

Non-muscle invasive bladder cancer (NMIBC); intravesical perfusion therapy; supportive care; program construction

Outcome Measures

Primary Outcomes (1)

• Clinical Treatment Adherence

  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 Outcomes (4)

• Bladder-cancer-specific quality of life

  Baseline、3 months、6 months after intervention

• Recruitment rate and infoermed consent rate

  Baseline

• Patient Satisfaction and Acceptance

  3months after intervention

• Satisfaction of supportive care needs

  Baseline, 3 months after intervention, 6 months after intervention

Study Arms (2)

Supportive care program

EXPERIMENTAL

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

Implementing routine urology outpatient infusion nursing

ACTIVE COMPARATOR

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

Interventions

Supportive care program BEHAVIORAL

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.

Supportive care program

Implementing routine urology outpatient infusion nursing BEHAVIORAL

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.

Implementing routine urology outpatient infusion nursing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210001, China

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Chunhua Zheng, Bachelor

CONTACT

+8613584042177; 303618002@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)