RecruitingNot ApplicableNCT05739968

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

Impacts and Testing of the "Multi-domains Active-living Program (MAP)" in Newly Diagnosed Operable Non-Muscle Invasive Bladder Cancer Patients - Current Status and the Effects of Combining With eHealth-Enhanced Randomized Controlled Trial


Sponsor

National Taiwan University Hospital

Enrollment

120 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing a program called the "Multi-domains Active-living Program" (MAP) for people with non-muscle invasive bladder cancer (a type of bladder cancer that hasn't grown deep into the bladder wall). The program aims to increase physical activity and improve health outcomes. **You may be eligible if...** - You are 20 years old or older - You have been newly diagnosed with non-muscle invasive bladder cancer (your bladder has not been removed) - You are able to communicate verbally - You speak and read Mandarin or Chinese **You may NOT be eligible if...** - Your bladder cancer is the more advanced muscle-invasive type requiring bladder removal - The primary source of your cancer is unknown - You have unclear consciousness or cognitive impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERUsual care + oncology case manager (OCM) care

Usual care + oncology case manager (OCM) care

OTHERMulti-domains Active-living Program (MAP) with e-health enhanced intervention + usual care + oncology case manager (OCM) care

Multi-domains Active-living Program (MAP) with e-health enhanced intervention + usual care + oncology case manager (OCM) care


Locations(1)

National Taiwan University Hospital

Taipei, Taiwan

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NCT05739968


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