Clinical trial · Interventional
Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy
Phase I Pilot Study Evaluating Vaginal Dilator Use and Toxicity Following Vaginal Brachytherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Radiation Toxicity | — | UNRESOLVED | — |
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| computer-assisted intervention | Other | — | UNRESOLVED |
| survey administration | Other | — | UNRESOLVED |
| telephone-based intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Arm I (no intervention)
- description
- Patients receive no additional reminders.
- type
- EXPERIMENTAL
- label
- Arm II (email survey)
- description
- Patients receive a reminder email survey every 2 weeks for 1 year after completing radiation.
- interventionNames
- Other: survey administration
- Other: computer-assisted intervention
- type
- EXPERIMENTAL
- label
- Arm III (email surveys and phone calls)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available