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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNanjing First Hospital, Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Supportive care programExperimental treatment 1 intervention
Group B: Implementing routine urology outpatient infusion nursingActive comparator 1 intervention

Trial outcomes

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%.

Time frame
6 months after intervention

Secondary outcomes

1

Bladder-cancer-specific quality of life

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、3 months、6 months after intervention
2

Recruitment rate and infoermed consent rate

Calculate the proportion of eligible patients who sign informed consent and formally enroll into the study among all screened eligible subjects.

Time frame
Baseline
3

Patient Satisfaction and Acceptance

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
3months after intervention
4

Satisfaction of supportive care needs

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.

Time frame
Baseline, 3 months after intervention, 6 months after intervention

Other outcomes

Sponsors and contacts

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