Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Other Indications, Women's Studies, Women's Studies, Endometrial Cancer |
| Therapuetic Areas: | Oncology, Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2019 |
| Start Date: | September 2014 |
| End Date: | September 2022 |
Phase I Pilot Study Evaluating Vaginal Dilator Use and Toxicity Following Vaginal Brachytherapy
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.
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.
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.
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)
We found this trial at
1
site
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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