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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-02400 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| GYN0005 | Other Identifier | OnCore |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized, pilot phase I trial studies whether phone or email reminders increases vaginal dilator use in patients with endometrial, cervical, or vaginal cancers after they undergo brachytherapy. Brachytherapy is a type of internal radiation which uses radioactive material placed directly into or near a tumor to kill tumor cells. A reminder program may help increase use of vaginal dilators and decrease long-term side effects following brachytherapy.
PRIMARY OBJECTIVES:
I. Evaluate whether vaginal dilator adherence is improved with additional reminder phone calls and/or email reminder survey.
SECONDARY OBJECTIVES:
I. Evaluate whether there are differences in the length of vaginal canal between the non-intervention and intervention groups. Evaluate rates of gynecologic, urinary, and gastrointestinal toxicity.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive no additional reminders.
ARM II: Patients receive a reminder email survey every 2 weeks for 1 year after completing radiation.
ARM III: Patients receive a reminder email survey as in Arm I and 4 additional phone calls at 4-8 weeks, 3-5 months, 7-8 months, and 10-11 months during their first year of follow-up.
After completion of study, patients are followed up at 10-14 weeks, 5-7 months, 8-10 months, 11-13 months, 15-17 months, 19-21 months, and 23-25 months post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (no intervention) | No Intervention | Patients receive no additional reminders. | |
| Arm II (email survey) | Experimental | Patients receive a reminder email survey every 2 weeks for 1 year after completing radiation. |
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| Arm III (email surveys and phone calls) | Experimental | Patients receive a reminder email survey as in Arm I and 4 additional phone calls at 4-8 weeks, 3-5 months, 7-8 months, and 10-11 months during their first year of follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| survey administration | Other | Receive reminder email survey |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal dilator adherence, measured by the average number of times per week patient uses a form of vaginal dilation | The vaginal dilator adherence measurements will analyzed in repeated measures model with treatment as a fixed effect and time as a within subject effect. The overall mean of vaginal dilator adherence among the 3 groups will also be measured and compared. The interaction between treatment and time will also be tested to see if the behavior over time is different depending on which treatment arm the patient is in. | Up to 25 months after completing radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal canal length | The vaginal canal length will be measured using an extra small dilator and it will be calculated in centimeters. The vaginal canal length measurements will be analyzed in a repeated measures model with treatment as a fixed effect and time as a within subject effect. The interaction between treatment and time will also be tested to see if the behavior over time is different depending on which treatment arm the patient is in. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Kidd | Stanford University Hospitals and Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Stanford | California | 94305 | United States |
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| computer-assisted intervention | Other | Receive reminder email survey |
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| telephone-based intervention | Behavioral | Receive reminder phone call |
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| Up to 25 months after completing radiation |
| Incidence of adverse events (AE), reported by type and grade using the Common Terminology Criteria for Adverse Events version 4.03 | The adverse events will be tabulated by type and grade at each follow up. The total number of AE's as well as the number of AE's in each category: gynecologic, urinary and gastrointestinal will tabulated. The test of proportion will be done per category of AE. Since it is possible that the rates will be low, an exact test will be used to compare the rates. | Up to 30 days after the last dose of study treatment |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D011832 | Radiation Injuries |
| D014625 | Vaginal Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014947 | Wounds and Injuries |
| D014623 | Vaginal Diseases |
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