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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое Usual care + oncology case manager (OCM) care
  Usual care + oncology case manager (OCM) care
• Другое Multi-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

Первичные конечные точки

• Changes in Quality of Life (consisting of symptoms, function, and health status) [Срок оценки: 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.]
• Changes in Anxiety [Срок оценки: 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.]
• Changes in Depression [Срок оценки: 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.]
• Changes in Fear of Cancer Recurrence [Срок оценки: 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.]
• Changes in Sleep Quality (consisting of sleep duration, sleep disturbances, sleep latency, daytime functioning, habitual sleep efficiency, subjective sleep quality, and sleep medication) [Срок оценки: 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.]
• Changes in Physical Activity [Срок оценки: 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.]
• Changes in Nutrition Status [Срок оценки: 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.]
• Changes in Balance [Срок оценки: 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.]
• Changes in Muscle strength and Endurance in Upper Limbs [Срок оценки: 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.]
• Changes in Muscle strength and Endurance in Lower Limbs [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Публикации

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Идентификаторы

NCT: NCT05739968 · 201912156RIND

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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