Cervical CancerPhase 1NCT02058550
Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy
A Phase 1 study testing survey administration, computer-assisted intervention and telephone-based intervention in people with Cervical Cancer and Endometrial Cancer, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Radiation Toxicity
- What is being tested?
- survey administration, computer-assisted intervention and telephone-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 23 Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Stanford, California, 94305
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate whether vaginal dilator adherence is improved with additional reminder phone calls and/or email reminder survey.
SECONDARY OBJECTIVES:
- 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.
- Being tested
- survey administration, computer-assisted intervention, telephone-based intervention
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Radiation Injuries, Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey administrationOther
Receive reminder email survey
computer-assisted interventionOther
Receive reminder email survey
telephone-based interventionBehavioural
Receive reminder phone call
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: survey administration; Other: computer-assisted intervention |
| 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. Receives: Other: survey administration; Other: computer-assisted intervention; Behavioral: telephone-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 25 months after completing radiation
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2019
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Kidd, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058550
- Sponsor's protocol ID
- IRB-29074
- Other IDs
- NCI-2013-02400, GYN0005
- Status last verified
- Aug 2021
- First submitted
- 6 Feb 2014
- Last updated
- 17 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Pilot Study Evaluating Vaginal Dilator Use and Toxicity Following Vaginal Brachytherapy
- ClinicalTrials.gov ID
- NCT02058550
- Acronym / sponsor ID
- IRB-29074
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2014
- Primary completion
- Jan 2019 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 10 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate whether vaginal dilator adherence is improved with additional reminder phone calls and/or email reminder survey.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (no intervention) | No intervention | –Patients receive no additional reminders. |
| Arm II (email survey) | Experimental | Other: survey administration, Other: computer-assisted interventionPatients receive a reminder email survey every 2 weeks for 1 year after completing radiation. |
| Arm III (email surveys and phone calls) | Experimental | Other: survey administration, Other: computer-assisted intervention, Behavioral: telephone-based interventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| survey administrationReceive reminder email survey | Other | Arm II (email survey), Arm III (email surveys and phone calls) |
| computer-assisted interventionReceive reminder email survey | Other | Arm II (email survey), Arm III (email surveys and phone calls) |
| telephone-based interventionReceive reminder phone call | Behavioural | Arm III (email surveys and phone calls) |
Primary outcome
Vaginal dilator adherence, measured by the average number of times per week patient uses a form of vaginal dilation
Time frame: Up to 25 months after completing radiation
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.
2 secondary outcomes
Vaginal canal length
Time frame: 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
Time frame: Up to 30 days after the last dose of study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Kidd principal investigator
Stanford University Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing survey administration, computer-assisted intervention and telephone-based intervention in people with Cervical Cancer and Endometrial Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal dilator adherence, measured by the average number of times per week patient uses a form of vaginal dilation (time frame: Up to 25 months after completing radiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.