Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-domains Active-living Program (MAP) with e-health enhanced intervention + usual care + oncology case manager (OCM) care | Other | — | UNRESOLVED |
| Usual care + oncology case manager (OCM) care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- control group
- description
- Control Group: Usual care + oncology case manager (OCM) care, UC group or Control group
- interventionNames
- Other: Usual care + oncology case manager (OCM) care
- type
- EXPERIMENTAL
- label
- experimental group
- description
- The experimental group is Multi-domains Active-living Program (MAP) with e-health enhanced intervention + usual care + oncology case manager (OCM) care. 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * age ≥20 years * operable newly diagnosed NMIBC patients who know their diagnosis and do not receive cystectomy (still keep their own bladder) * patients can verbally communicate with others * Mandarin / Chinese-reading and speaking Exclusion Criteria: * patients who has inoperable bladder cancer * patient who has muscle invasive bladder cancer (MIBC) with expected cystectomy surgery in the time of diagnosed * primary cancer unknown * conscious unclear
References
Publications (24)
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- BACKGROUNDLowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.