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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05739968
• Other study ID #: 201912156RIND
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: National Taiwan University Hospital
• Contact: Yeur-Hur Lai, Professor
• Phone: 886-2-23123456
• Email: laiyhwk[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Quality of Life
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Taiwan University

Country where clinical trial is conducted

Taiwan, 

References & Publications (24)

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. — View Citation

Accuracy 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. — View Citation

Berg KO, Wood-Dauphinee SL, Williams JI, Gayton D. Measuring balance in the elderly: preliminary development of an instrument. Physiother Can. 1989; 41(6):304-11.

Buysse 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. — View Citation

Chie 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. — View Citation

Cuesta-Vargas A, Hilgenkamp T. Reference Values of Grip Strength Measured with a Jamar Dynamometer in 1526 Adults with Intellectual Disabilities and Compared to Adults without Intellectual Disability. PLoS One. 2015 Jun 8;10(6):e0129585. doi: 10.1371/journal.pone.0129585. eCollection 2015. — View Citation

Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6. — View Citation

Godin, G. The Godin-Shephard Leisure-Time Physical Activity Questionnaire. Health Fit J Can. 2011; 4: 18-22.

He 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. — View Citation

Herman T, Giladi N, Hausdorff JM. Properties of the 'timed up and go' test: more than meets the eye. Gerontology. 2011;57(3):203-10. doi: 10.1159/000314963. Epub 2010 May 20. — View Citation

Hinz 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. — View Citation

Kaiser MJ, Bauer JM, Ramsch C, Uter W, Guigoz Y, Cederholm T, Thomas DR, Anthony PS, Charlton KE, Maggio M, Tsai AC, Vellas B, Sieber CC; Mini Nutritional Assessment International Group. Frequency of malnutrition in older adults: a multinational perspective using the mini nutritional assessment. J Am Geriatr Soc. 2010 Sep;58(9):1734-8. doi: 10.1111/j.1532-5415.2010.03016.x. — View Citation

Kroenke 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. — View Citation

Kroenke 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. — View Citation

Lee 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. — View Citation

Lima CA, Ricci NA, Nogueira EC, Perracini MR. The Berg Balance Scale as a clinical screening tool to predict fall risk in older adults: a systematic review. Physiotherapy. 2018 Dec;104(4):383-394. doi: 10.1016/j.physio.2018.02.002. Epub 2018 Feb 15. — View Citation

Lowe 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. — View Citation

Lusardi MM, Fritz S, Middleton A, Allison L, Wingood M, Phillips E, Criss M, Verma S, Osborne J, Chui KK. Determining Risk of Falls in Community Dwelling Older Adults: A Systematic Review and Meta-analysis Using Posttest Probability. J Geriatr Phys Ther. 2017 Jan/Mar;40(1):1-36. doi: 10.1519/JPT.0000000000000099. — View Citation

Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x. — View Citation

Remes 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. — View Citation

Spitzer 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. — View Citation

Tsai 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. — View Citation

Van 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. — View Citation

Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.
Primary	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 a = 0.92) and test-retest reliability (intraclass correlation = 0.83) (Spitzer et al., 2006).	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.
Primary	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.	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.
Primary	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).	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.
Primary	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).	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.
Primary	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).	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.
Primary	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).	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.
Primary	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).	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.
Primary	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.	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.
Primary	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.	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.
Primary	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.	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.