Actively Recruiting

Phase Not Applicable
All Genders
NCT05739968

Impacts and Testing of the "Multi-domains Active-living Program" in Operable Non-Muscle Invasive Bladder Cancer Patients

Led by National Taiwan University Hospital · Updated on 2024-06-05

120

Participants Needed

1

Research Sites

300 weeks

Total Duration

On this page

Sponsors

N

National Taiwan University Hospital

Lead Sponsor

N

National Taiwan University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Among bladder cancer, the majority of them (70%) are non-muscle-invasive bladder cancer (NMIBC). The survival time is even longer in NMIBC. Patients with NMIBC receive surgery or transurethral resection of bladder tumor (TURBT). However, patients with NMIBC need to receive a three-month repeatedly intrusive cystoscope from diagnosis for the first year. Furthermore, following each cystoscope, patients will receive 3 to 6 times bladder BCG (Bacille Calmette Guérin) or chemotherapy. These repeatedly intrusive cystoscopes, TURBT, and intensive bladder treatments might cause impacts on patients' life. The investigator aims to (1) construct a Multi-domains Active-living Program (MAP) with e-health enhanced intervention; and (2) compare the effects of the MAP with oncology case manager (OCM) care (experimental group) and OCM care only (control group) on the indicators and quality of life. Intervention study is a 12-month two-group randomized trial, including OCM care only (control), Vs. MAP+OCM program (experimental group). MAP will be constructed based on literature review and preliminary results. Main contents of MAP are to (a) cope multi-domain of distress, and (b) develop an active life style to handle their life after cancer, including effective coping, relaxation, regular physical activities, and balance nutrition. Four face-to face interventions will be delivered, including: day before hospital discharge post-operation, before the last weekly instillations of induction therapy (around 6±2 weeks post operation), 2nd-time cystoscopy and before 1st maintenance therapy (around 3- month post operation) and 3rd-time cystoscopy which before the second cycle of maintenance therapy (around 6- month post operation) \[section 1-4\], respectively. A brief and automatic app reminder (before) and side-effect follow-up (after) from 2nd section of face-to face intervention will be sent. Boosting health education will also be provided by app/ phone calls or in person around 2 to 4 weeks after discharge. Patients in the MAP+OCM group also can raise their questions through APP to receive brief intervention. The outcomes will be assessed at 5 time points: time before first intervention, before 2nd to 4th interventions, and 12 months, T1-T5, respectively. We will use Generalized Estimated Equation (GEE) to analyze the data with total 120 subjects (60 Vs 60 estimated).

CONDITIONS

Official Title

Impacts and Testing of the "Multi-domains Active-living Program" in Operable Non-Muscle Invasive Bladder Cancer Patients

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 years or older
  • Operable newly diagnosed NMIBC patients who know their diagnosis and have not had bladder removal surgery
  • Patients able to verbally communicate with others
  • Patients who can read and speak Mandarin or Chinese
Not Eligible

You will not qualify if you...

  • Patients with inoperable bladder cancer
  • Patients with muscle invasive bladder cancer (MIBC) expected to undergo cystectomy at diagnosis
  • Patients with unknown primary cancer
  • Patients with unclear consciousness

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

Y

Yeur-Hur Lai, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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