Bladder Urothelial Carcinoma In Situ, Recurrent Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8, Superficial Bladder Urothelial Carcinoma
Conditions
Keywords
Urinary Bladder
Brief summary
This phase II trial studies the safety and feasibility of utilizing acupuncture in patients with high-risk bladder cancer that has not spread to the surrounding muscle (non-muscle invasive) undergoing treatment with Intravesical BCG. BCG is a weakened form of the bacterium Mycobacterium bovis that does not cause disease. It is used in a solution to stimulate the immune system in the treatment of bladder cancer. Unfortunately, many patients experience side effects such as pelvic pain, painful urination, severe urgency, frequency, urge incontinence, need to urinate at night, and/or infectious complications. These side effects may cause patients to delay or stop BCG treatment. Acupuncture is a medical intervention in which fine metallic needles are inserted into anatomical locations of the body to stimulate the peripheral and the central nervous system. Giving acupuncture before each intravesical BCG treatment may help to reduce the side effects of intravesical BCG, and help patients complete treatment. Specific outcomes of interest include acceptability to patients, effect of acupuncture on intravesical BCG-related side effects, and adverse events associated with acupuncture.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. ARM II: Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy. After completion of study, patients are followed up at 1 week.
Interventions
OTHERQuestionnaire Administration
Ancillary studies
DEVICEAcupuncture Therapy
Undergo acupuncture therapy
BIOLOGICALBCG Solution
Given by intravesical injection
OTHERBest Practice
Receive standard of care symptom management
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English-speaking * Diagnosis of American Urological Association (AUA) high-risk non-muscle invasive bladder cancer (NMIBC), including high grade (HG) pT1 (invading only the lamina propria of the bladder), recurrent HG pTa (superficial tumors), HG pTa \> 3 cm in size or multifocal, any carcinoma in situ, any variant histology, any lymphovascular invasion, and HG prostatic urethral involvement * Diagnosis with urothelial carcinoma (primary histologic subtype), localized to the bladder, in the absence of nodal or other visceral metastases * Patients who have been indicated for induction intravesical BCG in shared-decision-making with their primary urologist * Have not received acupuncture in the previous 3 months * Access to phone for study contacts * Willing and able to participate in trial activities * Platelets: 20,000/ uL or greater * Absolute neutrophil count (ANC): 500 cells/uL or greater * Able to understand and willing to sign written informed consent in English
Exclusion criteria
* Subjects who have had intravesical or systemic chemotherapy or radiation therapy for bladder cancer or for other malignancies prior to entering the study * Subjects who are indicated to receive other intravesical agents or therapies concurrently with BCG will be excluded * Subjects who have muscle-invasive bladder cancer, radiographic evidence of lymph node metastases or metastatic disease involving other organs including brain metastases * Patients with predominant histology other than urothelial carcinoma of the bladder who would not otherwise be considered candidates for BCG * BCG is contraindicated in: * Patients who are pregnant or lactating * Patients with active tuberculosis * Immunosuppressed patients with congenital or acquired immune deficiency, whether due to concurrent disease (e.g. acquired immunodeficiency syndrome \[AIDS\], lymphoma, leukemia), concomitant cancer therapy (cytotoxic drugs, radiation), or immunosuppressive therapy (e.g. corticosteroids, disease-modifying anti-rheumatic drugs \[DMARDs\]) * Symptomatic urinary tract infection * Febrile illness * Patients requiring chronic treatment with certain antibiotics that may interfere with the effectiveness of BCG * Any previous allergies or severe reactions to BCG * Not pregnant or trying to become pregnant. Acupuncture points included in the protocol are contraindicated with pregnancy * Does not have a pacemaker. There is potential of electrostimulation interfering with the operation and function of pacemakers * Patients requiring chronic treatment with certain antibiotics that may interfere with the effectiveness of BCG. Fluoroquinolone therapy may decrease the efficacy of intravesical BCG. Antibiotic therapy for ongoing treatment of active tuberculosis will decrease the efficacy of intravesical BCG * Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded. Acupuncture points included in the protocol are contraindicated with pregnancy and BCG is contraindicated in pregnancy * Pacemaker. Patients with pacemakers are restricted due to the potential of electrostimulation interfering with a pacemakers operation * Platelets: \< 20,000/ uL. Risk of bleeding with acupuncture * ANC: \< 500 cells/uL. Risk of infection with acupuncture * Received acupuncture in the previous 3 months. Acupuncture treatment effects persist after a course of treatment, previous exposure to the intervention has the potential to affect the baseline data for treatment and control arms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | Up to 1 week after completion of treatment, an average of 7 weeks | BCG related adverse events compared between patients receiving acupuncture and patients receiving standard of care. |
| Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing) | Baseline, up to 1 week after completion of treatment, an average of 7 weeks | Will be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction. |
| Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Up to 1 week after completion of treatment, an average of 7 weeks | Will be described via qualitative report. Protocol adherence is defined as completion of the acupuncture interventions and follow-up surveys if randomized to the acupuncture arm or completion of the follow-up surveys if randomized to the control arm. |
| Patient Satisfaction | At 3 weeks and after completion of treatment, an average of 7 weeks | Patients' responses to the Cancer Care Satisfaction survey at 3 weeks and at the conclusion of induction Bacillus Calmette-Guerin (BCG) between two arms will be compared using t-test. |
| Clinic Staff's Responses to Surveys | Up to 1 week after completion of treatment, an average of 7 weeks | Clinic staff's responses to surveys assessing the healthcare burden of this protocol and time spent undergoing the acupuncture therapy for the experimental arm will be described via qualitative report |
| Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled | Up to 1 week after completion of treatment, an average of 7 weeks | Will be described via qualitative report. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bladder and Bowel Symptoms as Self Reported by Patients | From week 1 to week 6 of treatment | Assessed using the EORTC - Non-Muscle Invasive Bladder Cancer 24 (EORTC-NMIBC24) symptom index, which was specifically designed to assess bladder and bowel symptoms for patients with NMIBC including assessments of impact of intravesical therapy. All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. |
| Quality of Life: EORTC-QLQ-C30 | From week 1 to week 6 of treatment | Assessed using the EORTC Health and Quality of Life Rating Scale (EORTC-QLQ-C30). All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. |
| Median Weekly Pill Counts of Medications Prescribed for the Management of BCG-related Side Effects, Standardized by Dosage Across Medication Types | Up to 1 week after completion of treatment, an average of 7 weeks | Will be compared via Wilcoxon rank sum test. |
| BCG Instillation Adherence (Out of a Possible Planned Six Treatments) | Up to 1 week after completion of treatment, an average of 7 weeks | BCG instillation adherence (successful adherence defined as the number of successfully administered BCG instillations of a possible 6 total) and weeks missed (measured as total weeks that BCG was not administered of the planned 6 weekly induction doses of intravesical BCG). Results between the acupuncture and control arms will be compared via t-test. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Acupuncture, BCG) Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management.
Acupuncture Therapy: Undergo acupuncture therapy
BCG Solution: Given by intravesical injection
Best Practice: Receive standard of care symptom management
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies | 28 |
| Arm II (BCG, Standard of Care) Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy.
Acupuncture Therapy: Undergo acupuncture therapy
BCG Solution: Given by intravesical injection
Best Practice: Receive standard of care symptom management
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies | 15 |
| Total | 43 |
Baseline characteristics
| Characteristic | Total | Arm I (Acupuncture, BCG) | Arm II (BCG, Standard of Care) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 27 Participants | 21 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 7 Participants | 9 Participants |
| Age, Continuous | 70.27 years | 72.6 years | 64.7 years |
| Charlson Comorbidity Index 0 | 13 Participants | 7 Participants | 6 Participants |
| Charlson Comorbidity Index 1 | 8 Participants | 5 Participants | 3 Participants |
| Charlson Comorbidity Index 2 or greater | 22 Participants | 16 Participants | 6 Participants |
| Eastern Cooperative Oncology Group (ECOG) performance status 0 | 16 Participants | 7 Participants | 9 Participants |
| Eastern Cooperative Oncology Group (ECOG) performance status 1 | 9 Participants | 5 Participants | 4 Participants |
| Eastern Cooperative Oncology Group (ECOG) performance status 2 | 18 Participants | 16 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 28 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 39 Participants | 27 Participants | 12 Participants |
| Region of Enrollment United States | 43 Participants | 28 Participants | 15 Participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Male | 34 Participants | 23 Participants | 11 Participants |
| Smoking Status Current | 7 Participants | 1 Participants | 6 Participants |
| Smoking Status Former | 19 Participants | 13 Participants | 6 Participants |
| Smoking Status Never | 9 Participants | 8 Participants | 1 Participants |
| Smoking Status Unknown | 8 Participants | 6 Participants | 2 Participants |
| Tumor stage pT1 | 21 Participants | 15 Participants | 6 Participants |
| Tumor stage pTa | 13 Participants | 10 Participants | 3 Participants |
| Tumor stage pTis | 4 Participants | 2 Participants | 2 Participants |
| Tumor stage Unknown | 5 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 14 |
| other Total, other adverse events | 24 / 26 | 14 / 14 |
| serious Total, serious adverse events | 0 / 26 | 0 / 14 |
Outcome results
Primary
Clinic Staff's Responses to Surveys
Clinic staff's responses to surveys assessing the healthcare burden of this protocol and time spent undergoing the acupuncture therapy for the experimental arm will be described via qualitative report
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
Population: Data were not collected
Primary
Number of Adverse Events
BCG related adverse events compared between patients receiving acupuncture and patients receiving standard of care.
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
Population: The number of AEs are not mutually exclusive and participants may have reported more than one AE
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Screened for Trial Eligibility | Number of Adverse Events | Hematuria | 13 Adverse Events |
| Screened for Trial Eligibility | Number of Adverse Events | Urinary Symptoms | 37 Adverse Events |
| Screened for Trial Eligibility | Number of Adverse Events | Pain | 9 Adverse Events |
| Screened for Trial Eligibility | Number of Adverse Events | Bowel Symptoms | 14 Adverse Events |
| Screened for Trial Eligibility | Number of Adverse Events | Fatigue | 36 Adverse Events |
| Screened for Trial Eligibility | Number of Adverse Events | Flu-like Symptoms | 16 Adverse Events |
| Screened for Trial Eligibility | Number of Adverse Events | Other | 8 Adverse Events |
| Screened for Trial Eligibility | Number of Adverse Events | Headache | 13 Adverse Events |
| Arm II (BCG, Standard of Care) | Number of Adverse Events | Pain | 11 Adverse Events |
| Arm II (BCG, Standard of Care) | Number of Adverse Events | Flu-like Symptoms | 3 Adverse Events |
| Arm II (BCG, Standard of Care) | Number of Adverse Events | Other | 4 Adverse Events |
| Arm II (BCG, Standard of Care) | Number of Adverse Events | Hematuria | 11 Adverse Events |
| Arm II (BCG, Standard of Care) | Number of Adverse Events | Headache | 0 Adverse Events |
| Arm II (BCG, Standard of Care) | Number of Adverse Events | Bowel Symptoms | 5 Adverse Events |
| Arm II (BCG, Standard of Care) | Number of Adverse Events | Urinary Symptoms | 24 Adverse Events |
| Arm II (BCG, Standard of Care) | Number of Adverse Events | Fatigue | 15 Adverse Events |
Primary
Patient Satisfaction
Patients' responses to the Cancer Care Satisfaction survey at 3 weeks and at the conclusion of induction Bacillus Calmette-Guerin (BCG) between two arms will be compared using t-test.
Time frame: At 3 weeks and after completion of treatment, an average of 7 weeks
Population: Data were not collected
Primary
Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)
Will be described via qualitative report. Protocol adherence is defined as completion of the acupuncture interventions and follow-up surveys if randomized to the acupuncture arm or completion of the follow-up surveys if randomized to the control arm.
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screened for Trial Eligibility | Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Protocol adherence | 17 Participants |
| Screened for Trial Eligibility | Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Withdrew due to patient preference | 0 Participants |
| Screened for Trial Eligibility | Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Delay due to treatment of other comorbid condition | 0 Participants |
| Screened for Trial Eligibility | Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Missed visits due to UTI | 4 Participants |
| Screened for Trial Eligibility | Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Logistics/Scheduling Issues | 4 Participants |
| Screened for Trial Eligibility | Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Withdrew due to disease progression | 3 Participants |
| Arm II (BCG, Standard of Care) | Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Logistics/Scheduling Issues | 5 Participants |
| Arm II (BCG, Standard of Care) | Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Protocol adherence | 8 Participants |
| Arm II (BCG, Standard of Care) | Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Missed visits due to UTI | 0 Participants |
| Arm II (BCG, Standard of Care) | Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Withdrew due to patient preference | 1 Participants |
| Arm II (BCG, Standard of Care) | Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Withdrew due to disease progression | 2 Participants |
| Arm II (BCG, Standard of Care) | Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Delay due to treatment of other comorbid condition | 1 Participants |
Primary
Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled
Will be described via qualitative report.
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screened for Trial Eligibility | Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled | Eligible and agreed to participate | 45 Participants |
| Screened for Trial Eligibility | Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled | Did not meet inclusion criteria | 0 Participants |
| Screened for Trial Eligibility | Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled | Declined to participate | 3 Participants |
| Screened for Trial Eligibility | Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled | Regulatory hold 12/17/21-1/13/22 | 2 Participants |
Primary
Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing)
Will be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction.
Time frame: Baseline, up to 1 week after completion of treatment, an average of 7 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screened for Trial Eligibility | Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing) | Number of enrolled and retained participants | 25 Participants |
| Screened for Trial Eligibility | Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing) | Lost to follow-up: refractory hematuria | 1 Participants |
| Screened for Trial Eligibility | Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing) | Lost to follow-up: disease progression | 2 Participants |
| Screened for Trial Eligibility | Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing) | Lost to follow-up: patient decision | 0 Participants |
| Arm II (BCG, Standard of Care) | Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing) | Lost to follow-up: patient decision | 1 Participants |
| Arm II (BCG, Standard of Care) | Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing) | Number of enrolled and retained participants | 14 Participants |
| Arm II (BCG, Standard of Care) | Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing) | Lost to follow-up: disease progression | 2 Participants |
| Arm II (BCG, Standard of Care) | Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing) | Lost to follow-up: refractory hematuria | 0 Participants |
Secondary
BCG Instillation Adherence (Out of a Possible Planned Six Treatments)
BCG instillation adherence (successful adherence defined as the number of successfully administered BCG instillations of a possible 6 total) and weeks missed (measured as total weeks that BCG was not administered of the planned 6 weekly induction doses of intravesical BCG). Results between the acupuncture and control arms will be compared via t-test.
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Screened for Trial Eligibility | BCG Instillation Adherence (Out of a Possible Planned Six Treatments) | Instillation adherence | 6 Visits |
| Screened for Trial Eligibility | BCG Instillation Adherence (Out of a Possible Planned Six Treatments) | Missed visits | 0 Visits |
| Arm II (BCG, Standard of Care) | BCG Instillation Adherence (Out of a Possible Planned Six Treatments) | Instillation adherence | 6 Visits |
| Arm II (BCG, Standard of Care) | BCG Instillation Adherence (Out of a Possible Planned Six Treatments) | Missed visits | 0 Visits |
Comparison: This p value relates to instillation adherencep-value: 0.97t-test, 2 sided
Comparison: This p value relates to missed visits.p-value: 0.17t-test, 2 sided
Secondary
Bladder and Bowel Symptoms as Self Reported by Patients
Assessed using the EORTC - Non-Muscle Invasive Bladder Cancer 24 (EORTC-NMIBC24) symptom index, which was specifically designed to assess bladder and bowel symptoms for patients with NMIBC including assessments of impact of intravesical therapy. All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.
Time frame: From week 1 to week 6 of treatment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Screened for Trial Eligibility | Bladder and Bowel Symptoms as Self Reported by Patients | Diarrhea Symptoms | 0 score on a scale |
| Screened for Trial Eligibility | Bladder and Bowel Symptoms as Self Reported by Patients | Constipation Symptoms | 0 score on a scale |
| Screened for Trial Eligibility | Bladder and Bowel Symptoms as Self Reported by Patients | Urinary Symptoms | -9.52 score on a scale |
| Arm II (BCG, Standard of Care) | Bladder and Bowel Symptoms as Self Reported by Patients | Diarrhea Symptoms | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Bladder and Bowel Symptoms as Self Reported by Patients | Constipation Symptoms | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Bladder and Bowel Symptoms as Self Reported by Patients | Urinary Symptoms | 0 score on a scale |
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Constipation Symptoms.p-value: 0.5638Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Diarrhea Symptoms.p-value: 0.1753Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Urinary Symptoms.p-value: 0.2062Chi-squared
Secondary
Median Weekly Pill Counts of Medications Prescribed for the Management of BCG-related Side Effects, Standardized by Dosage Across Medication Types
Will be compared via Wilcoxon rank sum test.
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
Population: Data were not collected
Secondary
Quality of Life: EORTC-QLQ-C30
Assessed using the EORTC Health and Quality of Life Rating Scale (EORTC-QLQ-C30). All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.
Time frame: From week 1 to week 6 of treatment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Global Health Organization | -8.33 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Physical Function | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Emotional Function | 2.78 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Social Function | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Fatigue Symptoms | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Pain Symptoms | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Malaise Symptoms | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Role Function | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Cognitive Function | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Nausea Symptoms | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Dyspnoea Symptoms | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Insomnia Symptoms | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Appetite Loss Symptoms | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Finances | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Intravesical Symptoms | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Worries | -11.11 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Bloating Symptoms | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Sexual Function | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Male Sex Problems | 0 score on a scale |
| Screened for Trial Eligibility | Quality of Life: EORTC-QLQ-C30 | Intimacy | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Sexual Function | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Global Health Organization | -4.17 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Dyspnoea Symptoms | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Physical Function | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Worries | -8.33 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Emotional Function | -4.17 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Insomnia Symptoms | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Social Function | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Intimacy | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Fatigue Symptoms | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Appetite Loss Symptoms | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Pain Symptoms | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Bloating Symptoms | -8.33 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Malaise Symptoms | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Finances | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Role Function | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Male Sex Problems | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Cognitive Function | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Intravesical Symptoms | 0 score on a scale |
| Arm II (BCG, Standard of Care) | Quality of Life: EORTC-QLQ-C30 | Nausea Symptoms | 0 score on a scale |
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Global Health.p-value: 0.8092Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Physical Function.p-value: 0.5492Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Emotional Function.p-value: 0.6464Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Social Function.p-value: 0.586Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Fatigue Symptoms.p-value: 0.8999Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Pain Symptoms.p-value: 0.2007Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Malaise Symptoms.p-value: 0.9921Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Role Function.p-value: 0.5723Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Cognitive Function.p-value: 0.812Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Nausea Symptoms.p-value: 0.96Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Dyspnoea Symptoms.p-value: 0.1062Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Insomnia Symptoms.p-value: 0.3259Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Appetite Loss Symptoms.p-value: 0.9664Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Finances.p-value: 0.4564Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intravesical Symptoms.p-value: 0.1036Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Worries.p-value: 0.1789Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Bloating Symptoms.p-value: 0.5186Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Sexual Function.p-value: 0.0757Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Male Sex Problems.p-value: 0.1174Chi-squared
Comparison: For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intimacy.p-value: 0.3129Chi-squared