Bladder CancerNCT05739968
Impacts and Testing of the "Multi-domains Active-living Program" in Operable Non-Muscle Invasive Bladder Cancer Patients
A study of Bladder Cancer and Quality of Life, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer, Quality of Life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yeur-Hur Lai, Ph.D., +886-2-23123456 ext. 288429, laiyhwk@ntu.edu.tw
About this study
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
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).
Read the 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.
- Conditions
- Bladder Cancer, Quality of Life
- Being tested
- 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
- Keywords
- Bladder Cancer, Personalized Supportive Cancer Care Program, Physical symptom, Fear of cancer recurrence, Physical function, Sexual/intimacy, Physical activity
- Medical subject headings
- Urinary Bladder Neoplasms, Coitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care + oncology case manager (OCM) careOther
Usual care + oncology case manager (OCM) care
Multi-domains Active-living Program (MAP) with e-health enhanced intervention + usual care + oncology case manager (OCM) careOther
Multi-domains Active-living Program (MAP) with e-health enhanced intervention + usual care + oncology case manager (OCM) care
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Control Group: Usual care + oncology case manager (OCM) care, UC group or Control group Receives: Other: Usual care + oncology case manager (OCM) care |
| experimental group | Experimental | 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. Receives: Other: Multi-domains Active-living Program (MAP) with e-health enhanced intervention + usual care + oncology case manager (OCM) care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Quality of Life (consisting of symptoms, function, and health status)
Quality of life will be assessed by the EORTC-QLQ. This Instrument is consists of 30 items to measure three subscales, includes 2 items global health status/quality of life, 15 items functional domains and 13 items cancer common related symptoms or problems. Two items in global health status use a 7-point summated scale (1 = poor; 7 = excellent) and other items are rated on 4-point Likert's Scales (1=not at all; 4=very much). The scores will be transformed to a range from 0 to 100. In global health status and functional domains, the higher scores indicate better function. In the symptoms subscale, lower scores indicate less severe symptoms (Aaronson et al., 1993). The Taiwan Chinese version has been demonstrated to be both reliable and valid (Chie et al., 2004).
Measured: 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
The severity of NMIBC patients' anxiety will be measured by the self-reporting Generalized Anxiety Disorder-7 (GAD-7).
GAD is developed by Spitzer et al. (2006) and was used in a large primary care patient sample (Kroenke et al., 2007; Remes et al., 2016). The GAD-7 is a 7-item anxiety scale and is specifically linked to the DSM-IV (Text Revision) criteria (Spitzer et al., 2006). Response options were "not at all (score=0)," "several days (score=1)," "more than half the days (score=2)," and "nearly every day (score=3)," and the total GAD-7 score range is 0 to 21. The GAD-7 has good internal consistency (Cronbach α = 0.92) and test-retest reliability (intraclass correlation = 0.83) (Spitzer et al., 2006).
Measured: 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
The severity of NMIBC patients' depression will be measured by the self-reporting Patient Health Questionnaire-9 (PHQ-9).
PHQ-9 is form a three page the Patient Health Questionnaire (PHQ) and is the 9-item depression module from the full PHQ (Kroenke et al., 2001). This questionnaire is used to screen for depression in primary care and other medical settings and with good sensitivity and specificity (Levis et al., 2019). In each PHQ-9 component, the lowest score is 0 (not at all), the highest score is 3 (nearly every day) and the total PHQ score range is 0 to 27.
Measured: 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
The 7-item Fear of Cancer Recurrence (FCR7) is a unidimensional instrument to assess cancer patients' concern regarding the coming back or progression of cancer. The FCR7 comprises 4 items measuring the severity of worry about recurrence, 2 items measuring the interference caused by FCR, and 1 item assessing the patient's response to FCR. The first 6 items are scored from 1 (not at all) to 5 (all the time) with higher scores indicating higher levels of FCR. The last item assessing the interference of FCR is scored from 1 (not at all) to 10 (a great deal) with the higher the score, the more the interference. The Chinese version of FCR7 has been validated and proven reliable with overall Cronbach's alpha being 0.90 (Lee et al., 2019).
Measured: 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)
The PSQI, which was developed by Buysee in 1989, is used to assess sleep quality on participants' sleep experiences during the past week (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989). The PSQI is included seven component scores which are sleep duration, sleep disturbances, sleep latency, daytime functioning, habitual sleep efficiency, subjective sleep quality, and sleep medication. In each PSQI component, the lowest score is 0 (better), and the highest score is 3 (worse). The total PSQI score range is from 0 to 21, and the higher the score the worse the sleep. If the total PSQI score is more than 5, the result means the person has sleep problems (Buysse et al.,1989; He et al., 2015;Van Onselen et al., 2010). Both the original as well as the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) have good reliability and validity. In CPSQI, Cronbach's a coefficient for the hospital sample and test-retest reliability were 0.83 and 0.85, respectively (Tsai et al., 2005).
Measured: 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
The Godin Leisure-Time Exercise Questionnaire (GLTEQ) is a simple tool to measure and classify cancer patients' levels of physical activity. The GLTEQ assesses types of leisure-time PA (LTPA) and their frequency and intensity over the previous 7 days. A total GLTEQ score is calculated as: (frequency of mild exercise×3) + (frequency of moderate exercise×5) + (frequency of strenuous exercise×9) (Godin, 2011; Godin \& Shephard, 1985). The GLTEQ score has been proven to have the optimum discriminant functions in classifying percentile of body fat and percentile of maximum oxygen intake (Godin \& Shephard, 1985).
Measured: 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
Mini Nutritional Assessment (MNA) is a comprehensive nutritional assessment scale for the past three months, including anthropometry (body mass index, brachial circumference, calf circumference, skinfold width of the triceps and subscapular muscles), dietary intake, functional geriatric assessment (mini-mental state examination, activities of daily living). The questionnaire includes 18 items with a total score of 0-30 points. The sum of the MNA score distinguishes between elderly patients with: adequate nutritional status, MNA ≥ 24; at risk for malnutrition, MNA between 17 and 23.5. proteincalorie undernutrition, MNA<17. This scale has been widely used, especially established as one of the most valid and most frequently used nutritional screening tools in older persons (Kaiser et al., 2010; Vellas et al., 1999).
Measured: 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
The 14-item Berg Balance Scale (BBS) will be used to measure elderly people's balance (Berg, Wood-Dauphine, Williams, \& Gayton, 1989). It is an easily administrated tool and quick assessment in 10-15 minutes. Each item was scored from 0 (not at all) to 4 (all the time) with the sum score ranged from 0-56. The higher scores indicate better balance function and the score bellowing 45 points indicates the elderly is at fall risk. The BBS has been translated into Chinese and showed satisfying reliability and validity (Lima, Ricci, Nogueira, \& Perracini, 2018).
Measured: 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
We will use Jamar grip strength meter to measure the strength of right and left upper limbs. Grip strength meter provided good reliability and validity for measuring muscle strength in the past studies (Cuesta-Vargas \& Hilgenkamp, 2015; Silva et al., 2019). Patients will be asked to stand up, put arms by sides, and hold the meter to make a fist with maximal force for two times to record upper limbs strength.
Measured: 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
We will use microFET 2 to measure the strength of right and left hip flexor muscle. MicroFET 2 provided good reliability and validity for measuring muscle strength in the past studies (Cuesta-Vargas \& Hilgenkamp, 2015; Silva et al., 2019). Patients will be seated on the chair. The researcher will put the microFET 2 on the upper edge of knee, and then let patient maintain the thigh raise for four seconds to record the strength of right and left hip flexor muscle.
Measured: 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 Functional Mobility
The Timed Up and Go test (TUG) is a frequently used clinical performance-based evaluation of a person's mobility, balance, walking ability, and fall risk (Herman et al., 2011). The patient gets up from an armchair, goes three meters, turns around, walks back, and then sits down again while being watched and timed (Podsiadlo \& Richardson, 1991). A person who needs more than 12 seconds to finish the TUG runs the danger of falling. (Lusardi et al., 2017). The test is a reliable and valid test for quantifying functional mobility and is easily included as part of the medical examination.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Apr 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Responsible party
- Sponsor
- Investigators
- Yeur-Hur Lai, Professor, Study chair, School of Nursing, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739968
- Sponsor's protocol ID
- 201912156RIND
- Status last verified
- Jun 2024
- First submitted
- 26 Jan 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PubMed 8433390Chie WC, Yang CH, Hsu C, Yang PC. Quality of life of lung cancer patients: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and QLQ-LC13. Qual Life Res. 2004 Feb;13(1):257-62. doi: 10.1023/B:QURE.0000015295.74812.06.
PubMed 15058806Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
PubMed 17339617Remes O, Brayne C, van der Linde R, Lafortune L. A systematic review of reviews on the prevalence of anxiety disorders in adult populations. Brain Behav. 2016 Jun 5;6(7):e00497. doi: 10.1002/brb3.497. eCollection 2016 Jul.
PubMed 27458547Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Hinz A, Klein AM, Brahler E, Glaesmer H, Luck T, Riedel-Heller SG, Wirkner K, Hilbert A. Psychometric evaluation of the Generalized Anxiety Disorder Screener GAD-7, based on a large German general population sample. J Affect Disord. 2017 Mar 1;210:338-344. doi: 10.1016/j.jad.2016.12.012. Epub 2016 Dec 18.
PubMed 28088111Lowe 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.
PubMed 18388841Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Accuracy of Patient Health Questionnaire-9 (PHQ-9) for screening to detect major depression: individual participant data meta-analysis. BMJ. 2019 Apr 12;365:l1781. doi: 10.1136/bmj.l1781. No abstract available.
PubMed 30979729Lee YH, Hu CC, Humphris G, Huang IC, You KL, Jhang SY, Chen JS, Lai YH. Screening for fear of cancer recurrence: Instrument validation and current status in early stage lung cancer patients. J Formos Med Assoc. 2020 Jun;119(6):1101-1108. doi: 10.1016/j.jfma.2019.10.007. Epub 2019 Oct 31.
PubMed 31677865Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771He Y, Meng Z, Jia Q, Hu F, He X, Tan J, Zhang G, Li X, Zhang J, Zhang Q, Liu L, Zhao L, Li J, Wang Y, Qian Y, Hou S, Liu H, Wang S, Wang R, Zheng W, Hu T, Liu N, Upadhyaya A, Liu Y. Sleep Quality of Patients with Differentiated Thyroid Cancer. PLoS One. 2015 Jun 17;10(6):e0130634. doi: 10.1371/journal.pone.0130634. eCollection 2015.
PubMed 26083787Van Onselen C, Dunn LB, Lee K, Dodd M, Koetters T, West C, Paul SM, Aouizerat BE, Wara W, Swift P, Miaskowski C. Relationship between mood disturbance and sleep quality in oncology outpatients at the initiation of radiation therapy. Eur J Oncol Nurs. 2010 Dec;14(5):373-9. doi: 10.1016/j.ejon.2009.12.002. Epub 2010 Jan 18.
PubMed 20080444Tsai PS, Wang SY, Wang MY, Su CT, Yang TT, Huang CJ, Fang SC. Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control subjects. Qual Life Res. 2005 Oct;14(8):1943-52. doi: 10.1007/s11136-005-4346-x.
PubMed 16155782Godin, G. The Godin-Shephard Leisure-Time Physical Activity Questionnaire. Health Fit J Can. 2011; 4: 18-22.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05739968
- Acronym / sponsor ID
- 201912156RIND
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Usual care + oncology case manager (OCM) careControl Group: Usual care + oncology case manager (OCM) care, UC group or Control group |
| experimental group | Experimental | Other: Multi-domains Active-living Program (MAP) with e-health enhanced intervention + usual care + oncology case manager (OCM) careThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual care + oncology case manager (OCM) careUsual care + oncology case manager (OCM) care | Other | control group |
| Multi-domains Active-living Program (MAP) with e-health enhanced intervention + usual care + oncology case manager (OCM) careMulti-domains Active-living Program (MAP) with e-health enhanced intervention + usual care + oncology case manager (OCM) care | Other | experimental group |
Primary outcome
Changes in Quality of Life (consisting of symptoms, function, and health status)
Time frame: 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.
Quality of life will be assessed by the EORTC-QLQ. This Instrument is consists of 30 items to measure three subscales, includes 2 items global health status/quality of life, 15 items functional domains and 13 items cancer common related symptoms or problems. Two items in global health status use a 7-point summated scale (1 = poor; 7 = excellent) and other items are rated on 4-point Likert's Scales (1=not at all; 4=very much). The scores will be transformed to a range from 0 to 100. In global health status and functional domains, the higher scores indicate better function. In the symptoms subscale, lower scores indicate less severe symptoms (Aaronson et al., 1993). The Taiwan Chinese version has been demonstrated to be both reliable and valid (Chie et al., 2004).
Changes in Anxiety
Time frame: 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.
The severity of NMIBC patients' anxiety will be measured by the self-reporting Generalized Anxiety Disorder-7 (GAD-7). GAD is developed by Spitzer et al. (2006) and was used in a large primary care patient sample (Kroenke et al., 2007; Remes et al., 2016). The GAD-7 is a 7-item anxiety scale and is specifically linked to the DSM-IV (Text Revision) criteria (Spitzer et al., 2006). Response options were "not at all (score=0)," "several days (score=1)," "more than half the days (score=2)," and "nearly every day (score=3)," and the total GAD-7 score range is 0 to 21. The GAD-7 has good internal consistency (Cronbach α = 0.92) and test-retest reliability (intraclass correlation = 0.83) (Spitzer et al., 2006).
Changes in Depression
Time frame: 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.
The severity of NMIBC patients' depression will be measured by the self-reporting Patient Health Questionnaire-9 (PHQ-9). PHQ-9 is form a three page the Patient Health Questionnaire (PHQ) and is the 9-item depression module from the full PHQ (Kroenke et al., 2001). This questionnaire is used to screen for depression in primary care and other medical settings and with good sensitivity and specificity (Levis et al., 2019). In each PHQ-9 component, the lowest score is 0 (not at all), the highest score is 3 (nearly every day) and the total PHQ score range is 0 to 27.
Changes in Fear of Cancer Recurrence
Time frame: 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.
The 7-item Fear of Cancer Recurrence (FCR7) is a unidimensional instrument to assess cancer patients' concern regarding the coming back or progression of cancer. The FCR7 comprises 4 items measuring the severity of worry about recurrence, 2 items measuring the interference caused by FCR, and 1 item assessing the patient's response to FCR. The first 6 items are scored from 1 (not at all) to 5 (all the time) with higher scores indicating higher levels of FCR. The last item assessing the interference of FCR is scored from 1 (not at all) to 10 (a great deal) with the higher the score, the more the interference. The Chinese version of FCR7 has been validated and proven reliable with overall Cronbach's alpha being 0.90 (Lee et al., 2019).
Changes in Sleep Quality (consisting of sleep duration, sleep disturbances, sleep latency, daytime functioning, habitual sleep efficiency, subjective sleep quality, and sleep medication)
Time frame: 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.
The PSQI, which was developed by Buysee in 1989, is used to assess sleep quality on participants' sleep experiences during the past week (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989). The PSQI is included seven component scores which are sleep duration, sleep disturbances, sleep latency, daytime functioning, habitual sleep efficiency, subjective sleep quality, and sleep medication. In each PSQI component, the lowest score is 0 (better), and the highest score is 3 (worse). The total PSQI score range is from 0 to 21, and the higher the score the worse the sleep. If the total PSQI score is more than 5, the result means the person has sleep problems (Buysse et al.,1989; He et al., 2015;Van Onselen et al., 2010). Both the original as well as the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) have good reliability and validity. In CPSQI, Cronbach's a coefficient for the hospital sample and test-retest reliability were 0.83 and 0.85, respectively (Tsai et al., 2005).
Changes in Physical Activity
Time frame: 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.
The Godin Leisure-Time Exercise Questionnaire (GLTEQ) is a simple tool to measure and classify cancer patients' levels of physical activity. The GLTEQ assesses types of leisure-time PA (LTPA) and their frequency and intensity over the previous 7 days. A total GLTEQ score is calculated as: (frequency of mild exercise×3) + (frequency of moderate exercise×5) + (frequency of strenuous exercise×9) (Godin, 2011; Godin \& Shephard, 1985). The GLTEQ score has been proven to have the optimum discriminant functions in classifying percentile of body fat and percentile of maximum oxygen intake (Godin \& Shephard, 1985).
Changes in Nutrition Status
Time frame: 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.
Mini Nutritional Assessment (MNA) is a comprehensive nutritional assessment scale for the past three months, including anthropometry (body mass index, brachial circumference, calf circumference, skinfold width of the triceps and subscapular muscles), dietary intake, functional geriatric assessment (mini-mental state examination, activities of daily living). The questionnaire includes 18 items with a total score of 0-30 points. The sum of the MNA score distinguishes between elderly patients with: adequate nutritional status, MNA ≥ 24; at risk for malnutrition, MNA between 17 and 23.5. proteincalorie undernutrition, MNA<17. This scale has been widely used, especially established as one of the most valid and most frequently used nutritional screening tools in older persons (Kaiser et al., 2010; Vellas et al., 1999).
Changes in Balance
Time frame: 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.
The 14-item Berg Balance Scale (BBS) will be used to measure elderly people's balance (Berg, Wood-Dauphine, Williams, \& Gayton, 1989). It is an easily administrated tool and quick assessment in 10-15 minutes. Each item was scored from 0 (not at all) to 4 (all the time) with the sum score ranged from 0-56. The higher scores indicate better balance function and the score bellowing 45 points indicates the elderly is at fall risk. The BBS has been translated into Chinese and showed satisfying reliability and validity (Lima, Ricci, Nogueira, \& Perracini, 2018).
Changes in Muscle strength and Endurance in Upper Limbs
Time frame: 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.
We will use Jamar grip strength meter to measure the strength of right and left upper limbs. Grip strength meter provided good reliability and validity for measuring muscle strength in the past studies (Cuesta-Vargas \& Hilgenkamp, 2015; Silva et al., 2019). Patients will be asked to stand up, put arms by sides, and hold the meter to make a fist with maximal force for two times to record upper limbs strength.
Changes in Muscle strength and Endurance in Lower Limbs
Time frame: 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.
We will use microFET 2 to measure the strength of right and left hip flexor muscle. MicroFET 2 provided good reliability and validity for measuring muscle strength in the past studies (Cuesta-Vargas \& Hilgenkamp, 2015; Silva et al., 2019). Patients will be seated on the chair. The researcher will put the microFET 2 on the upper edge of knee, and then let patient maintain the thigh raise for four seconds to record the strength of right and left hip flexor muscle.
Changes in Functional Mobility
Time frame: 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.
The Timed Up and Go test (TUG) is a frequently used clinical performance-based evaluation of a person's mobility, balance, walking ability, and fall risk (Herman et al., 2011). The patient gets up from an armchair, goes three meters, turns around, walks back, and then sits down again while being watched and timed (Podsiadlo \& Richardson, 1991). A person who needs more than 12 seconds to finish the TUG runs the danger of falling. (Lusardi et al., 2017). The test is a reliable and valid test for quantifying functional mobility and is easily included as part of the medical examination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Background: PubMed 8433390Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
- Background: PubMed 15058806Chie WC, Yang CH, Hsu C, Yang PC. Quality of life of lung cancer patients: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and QLQ-LC13. Qual Life Res. 2004 Feb;13(1):257-62. doi: 10.1023/B:QURE.0000015295.74812.06.
- Background: PubMed 17339617Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
- Background: PubMed 27458547Remes O, Brayne C, van der Linde R, Lafortune L. A systematic review of reviews on the prevalence of anxiety disorders in adult populations. Brain Behav. 2016 Jun 5;6(7):e00497. doi: 10.1002/brb3.497. eCollection 2016 Jul.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 28088111Hinz A, Klein AM, Brahler E, Glaesmer H, Luck T, Riedel-Heller SG, Wirkner K, Hilbert A. Psychometric evaluation of the Generalized Anxiety Disorder Screener GAD-7, based on a large German general population sample. J Affect Disord. 2017 Mar 1;210:338-344. doi: 10.1016/j.jad.2016.12.012. Epub 2016 Dec 18.
- Background: PubMed 18388841Lowe 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.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 30979729Accuracy of Patient Health Questionnaire-9 (PHQ-9) for screening to detect major depression: individual participant data meta-analysis. BMJ. 2019 Apr 12;365:l1781. doi: 10.1136/bmj.l1781. No abstract available.
- Background: PubMed 31677865Lee YH, Hu CC, Humphris G, Huang IC, You KL, Jhang SY, Chen JS, Lai YH. Screening for fear of cancer recurrence: Instrument validation and current status in early stage lung cancer patients. J Formos Med Assoc. 2020 Jun;119(6):1101-1108. doi: 10.1016/j.jfma.2019.10.007. Epub 2019 Oct 31.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 26083787He Y, Meng Z, Jia Q, Hu F, He X, Tan J, Zhang G, Li X, Zhang J, Zhang Q, Liu L, Zhao L, Li J, Wang Y, Qian Y, Hou S, Liu H, Wang S, Wang R, Zheng W, Hu T, Liu N, Upadhyaya A, Liu Y. Sleep Quality of Patients with Differentiated Thyroid Cancer. PLoS One. 2015 Jun 17;10(6):e0130634. doi: 10.1371/journal.pone.0130634. eCollection 2015.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yeur-Hur Lai, Professor study chair
School of Nursing, College of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Bladder Cancer and Quality of Life, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeur-Hur Lai, Professor (886-2-23123456 ext. 288429, laiyhwk@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Quality of Life (consisting of symptoms, function, and health status) (time frame: 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.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05739968, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.