Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
Conditions
Brief summary
This phase I trial investigates how well a healthy eating program works in improving outcomes in patients with bladder cancer. The behavioral dietary program consists of educational materials, live phone calls, and interactive voice response phone messages. Participating in the healthy eating program may improve eating habits and/or reduce the risk of bladder cancer from coming back.
Detailed description
PRIMARY OBJECTIVES: I. Develop an evidence-based behavioral intervention to increase cruciferous vegetable intake, with the goal of attaining desirable urinary isothiocyanates (ITC) levels effective for anti-cancer activities. II. Conduct a feasibility pilot of our dietary behavioral intervention through a hybrid I implementation randomized controlled design in 80 non-muscle invasive bladder cancer (NMIBC) survivors, where the treatment group (n=40) will receive an evidence-based telephone intervention to increase cruciferous vegetable intake and the control group (n=40) will receive a general fruit and vegetable intake intervention based on National Cancer Institute (NCI) guidelines. SECONDARY OBJECTIVE: I. To ascertain the level of gene expression changes in urinary exfoliated epithelial cells (due to the intervention) as a surrogate for intermediate efficacy. EXPLORATORY OBJECTIVE: I. Engage the clinical care providers of patients enrolled in our intervention to ascertain the barriers and facilitators of intervention implementation within clinical practice through conducting 20 semi-structured interviews. OUTLINE: AIM I: Develop an evidence-based behavioral intervention using a systematic process consisting of information gathering, discussion groups, and mock intervention delivery. AIM II: Patients are randomized to 1 of 2 arms. ARM A (HEALTHY EATING PROGRAM A): Patients receive mailed educational materials about the importance of consuming cruciferae, setting healthier eating goals, and the importance of keeping track of what they eat. Patients also receive one phone call from study staff to make sure they understood the educational materials received and 11 interactive voice response (IVR) phone messages over 6 months. ARM B (HEALTHY EATING PROGRAM B): Patients receive mailed educational materials about general fruit and vegetable intake, setting healthier eating goals, and the importance of keeping track of what they eat. Patients also receive one phone call from study staff to make sure they understood the educational materials received and 11 IVR phone messages over 6 months.
Interventions
BEHAVIORALBehavioral Dietary Intervention
Receive live phone call
OTHEREducational Intervention
Receive educational materials
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Roswell Park Cancer Institute
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
Yes
Inclusion criteria
* CANCER PATIENT: Age 18 years old or older (no upper limit) * CANCER PATIENT: English speaking * CANCER PATIENT: Diagnosed with stage Tis, Ta, or T1 bladder cancer * CANCER PATIENT: Resides in the Western New York catchment area * CANCER PATIENT: Did not receive a partial or radical cystectomy * CANCER PATIENT: Does not have a prior cancer diagnosis within 12 months of their bladder cancer diagnosis * CANCER PATIENT: Does not have a subsequent more advanced bladder cancer diagnosis * CANCER PATIENT: For Roswell Park Cancer Registry only: Bladder cancer diagnosed 2016-2018, 2019-current * CANCER PATIENT: Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. * PHYSICIAN: English speaking * PHYSICIAN: Physician in a clinic located in the catchment area * PHYSICIAN: Currently treats bladder cancer patients
Exclusion criteria
* CANCER PATIENT: Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * CANCER PATIENT: Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * CANCER PATIENT: Adults unable to consent * CANCER PATIENT: Adults unable to complete study measures in English * CANCER PATIENT: Individuals who are not yet adults (infants, children, teenagers) * CANCER PATIENT: Uncontrolled intercurrent 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. * CANCER PATIENT: Unwilling or unable to follow protocol requirements * PHYSICIAN: Unable to complete the study measures in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Isothiocyanates Levels | 6 months | Will be measured using high performance liquid chromatography (HPLC)-based cyclocondensation assay. The outcome is defined as change from baseline in measured levels. Between-group difference of change from baseline was analyzed using Wilcoxon rank-sum tests. |
| Cruciferae Intake Change | 6 months | Will be assessed using a questionnaire adapted from Thomson et al. to capture both intake and cooking styles. The outcome is defined as change from baseline in measured levels. Between-group difference of change from baseline was analyzed using Wilcoxon rank-sum tests. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gene Expression | 6 months | Will be evaluated via ribonucleic acid-sequencing (RNA-seq) as a surrogate for intermediate efficacy, conducted at Roswell Park's Genomics Shared Resource using NextSeq500 platform (Illumina Inc.). Will summarize changes between pre- and post-intervention for both arms and calculate point estimates and their corresponding 95% confidence intervals. Will analyze between-group differences in the change of outcome variables between baseline and post-intervention using ANCOVA. |
| Change in Cruciferous Vegetable Intake, Cups/Day | 6 months | Will be evaluated by three non-consecutive 24-hour dietary recalls (two weekdays, one weekday) conducted by trained staff using the interview-administered Nutrition Data System for Research (NDSR). The outcome is defined as change from baseline in measured levels. Between-group difference of change from baseline was analyzed using Wilcoxon rank-sum tests. |
Countries
United States
Participant flow
Recruitment details
Forty nine patients were randomized; 7 participants were subsequently excluded due to death, loss of interest, other medical problems, they underwent a cystectomy, or loss to follow-up. Thus, a total of 42 participants completed both baseline and 6-month follow-up assessments, yielding a retention rate of 86%.
Participants by arm
| Arm | Count |
|---|---|
| Arm A (Experimental Arm) 6-month Cruciferae intervention | 22 |
| Arm B (Control Arm) 6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors | 20 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Not eligible. Participant underwent cystectomy in August | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Arm B (Control Arm) | Total | Arm A (Experimental Arm) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 28 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 14 Participants | 8 Participants |
| Age, Continuous | 68.1 years STANDARD_DEVIATION 9.1 | 67.4 years STANDARD_DEVIATION 9.3 | 66.8 years STANDARD_DEVIATION 9.6 |
| 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 42 Participants | 22 Participants |
| Region of Enrollment United States | 20 participants | 42 participants | 22 participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 14 Participants | 30 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 1 / 24 |
| other Total, other adverse events | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
Primary
Cruciferae Intake Change
Will be assessed using a questionnaire adapted from Thomson et al. to capture both intake and cooking styles. The outcome is defined as change from baseline in measured levels. Between-group difference of change from baseline was analyzed using Wilcoxon rank-sum tests.
Time frame: 6 months
Population: One patient missed follow up date and was not included in the final analysis. Hence only 19 patients are included in the arm B(Control arm) for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Experimental Arm) | Cruciferae Intake Change | 0.78 cups/day | Standard Deviation 0.87 |
| Arm B (Control Arm) | Cruciferae Intake Change | 0.058 cups/day | Standard Deviation 1.17 |
p-value: 0.005495% CI: [0.06, 1.38]Wilcoxon (Mann-Whitney)
Primary
Urinary Isothiocyanates Levels
Will be measured using high performance liquid chromatography (HPLC)-based cyclocondensation assay. The outcome is defined as change from baseline in measured levels. Between-group difference of change from baseline was analyzed using Wilcoxon rank-sum tests.
Time frame: 6 months
Population: One patient from Arm B (Control arm) missed baseline and another patient from Arm B (Control arm) missed follow up data. Hence, only 18 patients are included in the final analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Experimental Arm) | Urinary Isothiocyanates Levels | 10.4 mM | Standard Deviation 22.5 |
| Arm B (Control Arm) | Urinary Isothiocyanates Levels | 4.3 mM | Standard Deviation 14.1 |
p-value: 0.2895% CI: [-5.72, 17.99]Wilcoxon (Mann-Whitney)
Secondary
Change in Cruciferous Vegetable Intake, Cups/Day
Will be evaluated by three non-consecutive 24-hour dietary recalls (two weekdays, one weekday) conducted by trained staff using the interview-administered Nutrition Data System for Research (NDSR). The outcome is defined as change from baseline in measured levels. Between-group difference of change from baseline was analyzed using Wilcoxon rank-sum tests.
Time frame: 6 months
Population: Cruciferous vegetable intake, cups/day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Experimental Arm) | Change in Cruciferous Vegetable Intake, Cups/Day | 1.01 cups/day | Standard Deviation 1.31 |
| Arm B (Control Arm) | Change in Cruciferous Vegetable Intake, Cups/Day | 0.07 cups/day | Standard Deviation 0.92 |
p-value: 0.009895% CI: [0.24, 1.65]Wilcoxon (Mann-Whitney)
Secondary
Gene Expression
Will be evaluated via ribonucleic acid-sequencing (RNA-seq) as a surrogate for intermediate efficacy, conducted at Roswell Park's Genomics Shared Resource using NextSeq500 platform (Illumina Inc.). Will summarize changes between pre- and post-intervention for both arms and calculate point estimates and their corresponding 95% confidence intervals. Will analyze between-group differences in the change of outcome variables between baseline and post-intervention using ANCOVA.
Time frame: 6 months
Population: No data was collected for this outcome.