Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-06639 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 661820 | Other Identifier | Roswell Park Cancer Institute | |
| R21CA253910 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Experimental arm) | Experimental | 6-month Cruciferae intervention |
|
| Arm B (Control arm) | Active Comparator | 6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Dietary Intervention | Behavioral | Receive live phone call |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karen Yeary | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
Not provided
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%.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A ( Experimental Arm) | 6-month Cruciferae intervention |
| FG001 | Arm B (Control Arm) | 6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral Dietary Intervention | Behavioral | Receive IVR phone messages |
|
| Educational Intervention | Other | Receive educational materials |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| 6 months |
| 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. | 6 months |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline analysis was performed on participants who completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Experimental Arm) | 6-month Cruciferae intervention |
| BG001 | Arm B (Control Arm) | 6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Mean | Standard Deviation | mM | 6 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | cups/day | 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | No data was collected for this outcome. | Posted | 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Cruciferous vegetable intake, cups/day | Posted | Mean | Standard Deviation | cups/day | 6 months |
|
|
6 months
Adverse events will be labeled as to whether attributed to behavior intervention or not, classified as mild, moderate, severe, life threatening, or causing death, and reported to Roswell Park IRB and NIH under Institute guidelines.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A ( Experimental Arm) | 6-month Cruciferae intervention | 0 | 25 | 0 | 25 | 0 | 25 |
| EG001 | Arm B (Control Arm) | 6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors | 1 | 24 | 0 | 24 | 0 | 24 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katy Wang | Roswell Park Comprehensive Cancer Center | 716-845-2300 | Chong.Wang@roswellpark.org |
| Jun 3, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 20, 2023 | May 8, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Participants |
|
|
|