Clinical trial NCT05739968: Impacts and Testing of the "Multi-domains Active-living Program" in Operable Non-Muscle Invasive Bladder Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Quality of Life
Keywords: Bladder Cancer
Personalized Supportive Cancer Care Program
Physical symptom
Fear of cancer recurrence
Physical function
Sexual/intimacy
Physical activity
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University
First posted: 2023-02-22
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled clinical trial which to compare the effects of the OCM care only (control) vs. MAP+OCM program (experimental group) on non-muscle invasive bladder cancer (NMIBC) patients.

For both groups, we assessed patients' outcomes (including baseline data) for 5 times (T1=baseline/during hospitalization of receiving surgery \& before their hospital; T2 to T5 = 6±2 weeks, 3, 6, 12 months after operation).
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Detailed description: Background: Non-muscle invasive bladder cancer (NMIBC) covers the majority of bladder cancer incidence. Operable NMIBC patients have to receive Transurethral Resection of Bladder Tumor (TURBT), every-three-month repeated cystoscopes and bladder-irrigated chemotherapy in the first year. The intrusion, repeated cystoscope/treatments and recurrence concern may influence NMIBC patients' quality of life.

Purposes: This is a 2-phase study. The aim of Phase I (first year) is to (1) test the psychometrics of NMIBC-specific Quality of Life (QOL) questionnaire "EORTC QLQ NMIBC 24-Chinese"; (2) examine patients' distress across multi-domains, including impacts on QOL, symptoms, physical function (upper/lower leg muscle power, balance), sexual/intimacy, fear of recurrence, and physical activity. Phase II (2nd\&3rd year) is a two-group randomized trial for newly diagnosed NMIBC patients. It 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) of the effects on the above indicators (phase I) and the number of unexpected hospital visits.

Methods: Phase I is an instrument validation study. The "EORTC QLQ-NMIBC24-Chinese" will be to develop and examine of its psychometrics. We will also explore the above mentioned domains of QOL, distress, care needs, frequency of taking physical activities, etc. by questionnaire interview/assessment; and objective physical function measures (low leg muscle strengths and balance ability). An estimated sample size is 240 subjects. Phase II 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).

Expected Outcome: This is the first study to test EORTC QLQ-NMIBC24 Chinese version, patients' distress and physical function as well as construct and test of a multi-domain MAP program. It would help us further build up evidence-based care and generalize to bladder cancer patients.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Quality of Life (consisting of symptoms, function, and health status)
timeFrame: The outcomes will be assessed at 5 time points: day before hospital discharge post-operation(Day 0), around 6±2 weeks post operation, around 3-month, 6-month and 12-month post operation.
measure: Changes in Anxiety
timeFrame: The outcomes will be assessed at 5 time points: day before hospital discharge post-operation(Day 0), around 6±2 weeks post operation, around 3-month, 6-month and 12-month post operation.
measure: Changes in Depression
timeFrame: The outcomes will be assessed at 5 time points: day before hospital discharge post-operation(Day 0), around 6±2 weeks post operation, around 3-month, 6-month and 12-month post operation.
measure: Changes in Fear of Cancer Recurrence
timeFrame: The outcomes will be assessed at 5 time points: day before hospital discharge post-operation(Day 0), around 6±2 weeks post operation, around 3-month, 6-month and 12-month post operation.
measure: Changes in Sleep Quality (consisting of sleep duration, sleep disturbances, sleep latency, daytime functioning, habitual sleep efficiency, subjective sleep quality, and sleep medication)
timeFrame: The outcomes will be assessed at 5 time points: day before hospital discharge post-operation(Day 0), around 6±2 weeks post operation, around 3-month, 6-month and 12-month post operation.
measure: Changes in Physical Activity
timeFrame: The outcomes will be assessed at 5 time points: day before hospital discharge post-operation(Day 0), around 6±2 weeks post operation, around 3-month, 6-month and 12-month post operation.
measure: Changes in Nutrition Status
timeFrame: The outcomes will be assessed at 5 time points: day before hospital discharge post-operation(Day 0), around 6±2 weeks post operation, around 3-month, 6-month and 12-month post operation.
measure: Changes in Balance
timeFrame: The outcomes will be assessed at 5 time points: day before hospital discharge post-operation(Day 0), around 6±2 weeks post operation, around 3-month, 6-month and 12-month post operation.
measure: Changes in Muscle strength and Endurance in Upper Limbs
timeFrame: The outcomes will be assessed at 5 time points: day before hospital discharge post-operation(Day 0), around 6±2 weeks post operation, around 3-month, 6-month and 12-month post operation.
measure: Changes in Muscle strength and Endurance in Lower Limbs
timeFrame: The outcomes will be assessed at 5 time points: day before hospital discharge post-operation(Day 0), around 6±2 weeks post operation, around 3-month, 6-month and 12-month post operation.
measure: Changes in Functional Mobility
timeFrame: The outcomes will be assessed at 5 time points: day before hospital discharge post-operation(Day 0), around 6±2 weeks post operation, around 3-month, 6-month and 12-month post operation.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: School of Nursing, College of Medicine, National Taiwan University
name: Yeur-Hur Lai, Professor
role: STUDY_CHAIR
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