Cervical CancerNCT04363957
Gynecologic Brachytherapy-Specific Educational Video
A study testing Brachytherapy video and Standard Brachytherapy Consent Process in people with Cervical Cancer and Uterine Cancer, run by University of California, San Diego at 1 site in United States.
Trial summary
Brachytherapy is a highly technical and integral component of the definitive treatment of gynecologic cancers [1]. To enhance provider communication and patient engagement, our study investigates a video consent on impact of patient treatment-related outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Uterine Cancer
- What is being tested?
- Brachytherapy video and Standard Brachytherapy Consent Process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2020to 22 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient has the ability to understand and the willingness to sign a written informed consent.
- Patient must be female, all races and ethnic groups are eligible.
- Must be > 18 years of age, or have parental approval for inclusion.
- Must carry a diagnosis of gynecologic malignancy.
- Is deemed to require high-dose rate gynecologic brachytherapy procedure (intracavitary, hybrid intracavitary/interstitial, or interstitial).
- Any prior external beam radiation therapy is allowed.
Show all 11Show fewer
- Any performance status is allowed.
- Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for # days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
Who cannot join
- 1. Patient has had prior high-dose rate gynecologic brachytherapy at any point in the past.
- 2. . Patient is a non English speaker
- 3. Patient is unable to watch the video
- 4. Patient declines consent to the study
- 5. Study-specific exclusion criteria.
- 6. Patient has a severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).
Trial locations and contacts
1 site in 1 country.
United States1 site
Moores UC San Diego Cancer Center
La Jolla, California, 92093
About this study
Official title: Prospective, Randomized Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video
Brachytherapy is a highly technical and integral component of the definitive treatment of gynecologic cancers [1]. To enhance provider communication and patient engagement, our study investigates a video consent on impact of patient treatment-related outcomes.
The study team will use a detailed brachytherapy video in addition to the standard brachytherapy verbal consent to evaluate patient-reported satisfaction and patient anxiety for gynecologic high-dose rate brachytherapy (a radiation procedure).
Read the detailed description
1:1 randomized trial using blocked randomization based on chronologic arrival in clinic, a group of patients will be randomized to the standard of care verbal consent (Arm A), or the standard of care consent plus the online brachytherapy informed video consent (Arm B). There will be three time points for the collection: After the standard consent process as the baseline, following the standard only vs standard and educational video consent process prior to the first brachytherapy procedure, and prior to the last brachytherapy procedure. The patients in the brachytherapy video consent process will be watching this online. The patient will be given a specific log in to use, and study researchers will be able to track the number of times the patient watches the video and the completion of the video view. The patient is allowed to watch the video as many times as desired
- Conditions
- Cervical Cancer, Uterine Cancer
- Being tested
- Brachytherapy video, Standard Brachytherapy Consent Process
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachytherapy videoOther
Patients will watch a video that contains information about brachytherapy
Standard Brachytherapy Consent ProcessOther
Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.
| Study group | Role | What they receive |
|---|---|---|
| Standard Consent | Other | Patients only receive the standard brachytherapy consent process Receives: Other: Standard Brachytherapy Consent Process |
| Standard Consent and Video Intervention | Experimental | Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy Receives: Other: Brachytherapy video; Other: Standard Brachytherapy Consent Process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Satisfaction
Primary Analysis based on Intention-to-Treat population, defined as all individuals who were randomized to arm A or arm B. A Likert-scale study specific questionnaire (no unabbreviated scale title, Likert-scale is a general untitled tool) is used to calculate satisfaction score.
Using the brachytherapy specific questionnaire, the study team will examine three patient reported time points for impact: baseline, after the consent process, and prior to the last brachytherapy procedure. For primary endpoint, a two-sample t-test will be used to compare differences of satisfaction scores at two time points (baseline and following consent process) between groups. The reporting scale is the following:
Strongly disagree (1); Disagree (2); Uncertain (3); Agree (4); Strongly agree (5)
Minimum: 1; Maximum: 5.
Questionnaire had 12 questions. Minimum possible score is 12; Maximum possible score is 60. Higher score means higher satisfaction.
Measured: Baseline
Secondary outcomes (1)
Treatment Related Anxiety
Satisfactory scores at three time points will be analyzed using a mixed effect model for repeated measures (MMRM) to assess satisfactory scores trajectories between two arms. The MMRM model will include terms for time, consent arm, baseline score, arm-by-time interaction, baseline score by time interaction, plus covariates that include age, stage. Time will be treated as categorical. If values of last two time points are similar, analysis of covariance model (ANCOVA) will be used to model the change in satisfactory scores. The mean of the last two time points will be calculated. That is, the after consent score (mean values) will be regressed upon baseline score and consent arms. Patient treatment-related anxiety between groups, defined as National Comprehensive Cancer Network (NCCN) distress score, are also collected at three time points and will be analyzed using the same strategy. The NCCN distress scale is from 0 (min) -10 (max) with 10 being a value that is more distress- worse.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 Apr 2020
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this open-label study design, eligible participants will be randomized using a simple 1:1 schedule to either brachytherapy verbal standard consent (Arm A), or the brachytherapy specific video (Arm B), based on chronological arrival in clinic
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jyoti Mayadev, MD, University of California, San Diego
- Investigators
- Jyoti Mayadev, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363957
- Sponsor's protocol ID
- 181519
- Status last verified
- Sep 2025
- First submitted
- 3 Apr 2020
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kotha NV, Guram K, Morgan K, Deshler L, Brown D, Rash D, Dyer B, McHale M, Yashar C, Scanderbeg D, Einck J, Mayadev J. A randomized patient education trial investigating treatment-related distress and satisfaction with the use of an at-home gynecologic brachytherapy educational video. Int J Gynecol Cancer. 2023 Jul 3;33(7):1125-1131. doi: 10.1136/ijgc-2023-004331.
PubMed 37247940
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video
- ClinicalTrials.gov ID
- NCT04363957
- Acronym / sponsor ID
- 181519
- Conditions
- Cervical Cancer, Uterine Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brachytherapy is a highly technical and integral component of the definitive treatment of gynecologic cancers [1]. To enhance provider communication and patient engagement, our study investigates a video consent on impact of patient treatment-related outcomes.
The study team will use a detailed brachytherapy video in addition to the standard brachytherapy verbal consent to evaluate patient-reported satisfaction and patient anxiety for gynecologic high-dose rate brachytherapy (a radiation procedure).
Detailed description
1:1 randomized trial using blocked randomization based on chronologic arrival in clinic, a group of patients will be randomized to the standard of care verbal consent (Arm A), or the standard of care consent plus the online brachytherapy informed video consent (Arm B). There will be three time points for the collection: After the standard consent process as the baseline, following the standard only vs standard and educational video consent process prior to the first brachytherapy procedure, and prior to the last brachytherapy procedure. The patients in the brachytherapy video consent process will be watching this online. The patient will be given a specific log in to use, and study researchers will be able to track the number of times the patient watches the video and the completion of the video view. The patient is allowed to watch the video as many times as desired
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this open-label study design, eligible participants will be randomized using a simple 1:1 schedule to either brachytherapy verbal standard consent (Arm A), or the brachytherapy specific video (Arm B), based on chronological arrival in clinic
| Arm | Type | Receives |
|---|---|---|
| Standard Consent | Other | Other: Standard Brachytherapy Consent ProcessPatients only receive the standard brachytherapy consent process |
| Standard Consent and Video Intervention | Experimental | Other: Brachytherapy video, Other: Standard Brachytherapy Consent ProcessPatients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient has the ability to understand and the willingness to sign a written informed consent.
- Patient must be female, all races and ethnic groups are eligible.
- Must be > 18 years of age, or have parental approval for inclusion.
- Must carry a diagnosis of gynecologic malignancy.
- Is deemed to require high-dose rate gynecologic brachytherapy procedure (intracavitary, hybrid intracavitary/interstitial, or interstitial).
Key exclusion criteria (6 listed)
- 1. Patient has had prior high-dose rate gynecologic brachytherapy at any point in the past.
- 2. . Patient is a non English speaker
- 3. Patient is unable to watch the video
- 4. Patient declines consent to the study
- 5. Study-specific exclusion criteria.
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 |
|---|---|---|
| Brachytherapy videoPatients will watch a video that contains information about brachytherapy | Other | Standard Consent and Video Intervention |
| Standard Brachytherapy Consent ProcessPatients will have the standard clinical brachytherapy consent and education including discussion with their physician. | Other | Standard Consent, Standard Consent and Video Intervention |
Primary outcome
Patient Reported Satisfaction
Time frame: Baseline
Primary Analysis based on Intention-to-Treat population, defined as all individuals who were randomized to arm A or arm B. A Likert-scale study specific questionnaire (no unabbreviated scale title, Likert-scale is a general untitled tool) is used to calculate satisfaction score. Using the brachytherapy specific questionnaire, the study team will examine three patient reported time points for impact: baseline, after the consent process, and prior to the last brachytherapy procedure. For primary endpoint, a two-sample t-test will be used to compare differences of satisfaction scores at two time points (baseline and following consent process) between groups. The reporting scale is the following: Strongly disagree (1); Disagree (2); Uncertain (3); Agree (4); Strongly agree (5) Minimum: 1; Maximum: 5. Questionnaire had 12 questions. Minimum possible score is 12; Maximum possible score is 60. Higher score means higher satisfaction.
1 secondary outcome
Treatment Related Anxiety
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37247940Kotha NV, Guram K, Morgan K, Deshler L, Brown D, Rash D, Dyer B, McHale M, Yashar C, Scanderbeg D, Einck J, Mayadev J. A randomized patient education trial investigating treatment-related distress and satisfaction with the use of an at-home gynecologic brachytherapy educational video. Int J Gynecol Cancer. 2023 Jul 3;33(7):1125-1131. doi: 10.1136/ijgc-2023-004331.
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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.
Jyoti Mayadev, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachytherapy video and Standard Brachytherapy Consent Process in people with Cervical Cancer and Uterine Cancer, run by University of California, San Diego 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 11 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 14 Oct 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Reported Satisfaction (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04363957, which also lists 1 linked publication.
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 14 Oct 2025.