Trial Title:
Impacts and Testing of the "Multi-domains Active-living Program" in Operable Non-Muscle Invasive Bladder Cancer Patients
NCT ID:
NCT05739968
Condition:
Bladder Cancer
Quality of Life
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Conditions: Keywords:
Bladder Cancer
Personalized Supportive Cancer Care Program
Physical symptom
Fear of cancer recurrence
Physical function
Sexual/intimacy
Physical activity
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Triple (Participant, Care Provider, Investigator)
Masking description:
This study was not fully blinded; however, the group allocation was concealed from the
patient and primary researcher until after baseline assessments were completed. A primary
researcher obtained patient consent, collected self-reported assessments, and if the
patients were randomized to intervention group, the intervention trainer explained the
MAP program to participants. The study statistician and data managers remained blinded at
all times.
Intervention:
Intervention type:
Other
Intervention name:
Usual care + oncology case manager (OCM) care
Description:
Usual care + oncology case manager (OCM) care
Arm group label:
control group
Intervention type:
Other
Intervention name:
Multi-domains Active-living Program (MAP) with e-health enhanced intervention + usual care + oncology case manager (OCM) care
Description:
Multi-domains Active-living Program (MAP) with e-health enhanced intervention + usual
care + oncology case manager (OCM) care
Arm group label:
experimental group
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.
Criteria for 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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yeur-Hur Lai, Ph.D.
Phone:
+886-2-23123456
Phone ext:
288429
Email:
laiyhwk@ntu.edu.tw
Start date:
April 1, 2021
Completion date:
December 31, 2026
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Collaborator:
Agency:
National Taiwan University
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05739968
