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Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy

Primary Purpose

Cervical Cancer, Endometrial Cancer, Radiation Toxicity

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

survey administration

computer-assisted intervention

telephone-based intervention

About this trial

This is an interventional supportive care trial for Cervical Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients with gynecologic cancer who are undergoing vaginal brachytherapy as part of their treatment
Patients cannot have previously received pelvic external beam radiation or brachytherapy. Patients may be enrolled while undergoing vaginal brachytherapy radiation treatment.
Patients should have a life expectancy of at least 1 year
No Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status requirements
No organ and marrow function requirements
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Patients who have received prior pelvic external beam radiation or brachytherapy will be excluded
No restrictions regarding use of other investigational agents
No exclusion requirements due to co-morbid disease or intercurrent illness
No investigational agent, so no exclusion requirements regarding history of allergic reactions attributed to compounds of similar chemical or biologic composition to investigational agent or device
No exclusion criteria relating to concomitant medications
No exclusion criteria for pregnant or nursing patients from participating in this study (Of note, pregnant patients will not be treated with vaginal brachytherapy, a requirement for enrolling on this study)

Sites / Locations

Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Arm I (no intervention)

Arm II (email survey)

Arm III (email surveys and phone calls)

Arm Description

Patients receive no additional reminders.

Patients receive a reminder email survey every 2 weeks for 1 year after completing radiation.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02058550

First Posted

February 6, 2014

Last Updated

August 16, 2021

Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02058550

Brief Title

Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy

Official Title

Phase I Pilot Study Evaluating Vaginal Dilator Use and Toxicity Following Vaginal Brachytherapy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

January 2019 (Actual)

Study Completion Date

October 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer, Endometrial Cancer, Radiation Toxicity, Vaginal Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (no intervention)

Arm Type

No Intervention

Arm Description

Patients receive no additional reminders.

Arm Title

Arm II (email survey)

Arm Type

Experimental

Arm Description

Patients receive a reminder email survey every 2 weeks for 1 year after completing radiation.

Arm Title

Arm III (email surveys and phone calls)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

survey administration

Intervention Description

Receive reminder email survey

Intervention Type

Other

Intervention Name(s)

computer-assisted intervention

Intervention Description

Receive reminder email survey

Intervention Type

Behavioral

Intervention Name(s)

telephone-based intervention

Intervention Description

Receive reminder phone call

Primary Outcome Measure Information:

Title

Vaginal dilator adherence, measured by the average number of times per week patient uses a form of vaginal dilation

Description

Time Frame

Up to 25 months after completing radiation

Secondary Outcome Measure Information:

Title

Vaginal canal length

Description

Time Frame

Up to 25 months after completing radiation

Title

Incidence of adverse events (AE), reported by type and grade using the Common Terminology Criteria for Adverse Events version 4.03

Description

Time Frame

Up to 30 days after the last dose of study treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with gynecologic cancer who are undergoing vaginal brachytherapy as part of their treatment Patients cannot have previously received pelvic external beam radiation or brachytherapy. Patients may be enrolled while undergoing vaginal brachytherapy radiation treatment. Patients should have a life expectancy of at least 1 year No Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status requirements No organ and marrow function requirements Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Patients who have received prior pelvic external beam radiation or brachytherapy will be excluded No restrictions regarding use of other investigational agents No exclusion requirements due to co-morbid disease or intercurrent illness No investigational agent, so no exclusion requirements regarding history of allergic reactions attributed to compounds of similar chemical or biologic composition to investigational agent or device No exclusion criteria relating to concomitant medications No exclusion criteria for pregnant or nursing patients from participating in this study (Of note, pregnant patients will not be treated with vaginal brachytherapy, a requirement for enrolling on this study)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Kidd

Organizational Affiliation

Stanford University Hospitals and Clinics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University, School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy

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