Trial Outcomes & Findings for Gynecologic Brachytherapy-Specific Educational Video (NCT NCT04363957)

Last Updated: 2025-10-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

Baseline

Results posted on

2025-10-14

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Consent Patients only receive the standard brachytherapy consent process Standard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.	Standard Consent and Video Intervention Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy Brachytherapy video: Patients will watch a video that contains information about brachytherapy Standard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.
Overall Study STARTED	40	40
Overall Study COMPLETED	29	28
Overall Study NOT COMPLETED	11	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gynecologic Brachytherapy-Specific Educational Video

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Consent n=29 Participants Patients only receive the standard brachytherapy consent process Standard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.	Standard Consent and Video Intervention n=28 Participants Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy Brachytherapy video: Patients will watch a video that contains information about brachytherapy Standard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.	Total n=57 Participants Total of all reporting groups
Age, Continuous	58 Years n=5 Participants	60 Years n=7 Participants	59 Years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Primary Cancer Cervix	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Primary Cancer Uterine	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Primary Cancer Vagina	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Standard Consent n=29 Participants Patients only receive the standard brachytherapy consent process Standard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.	Standard Consent and Video Intervention n=28 Participants Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy Brachytherapy video: Patients will watch a video that contains information about brachytherapy Standard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.
Patient Reported Satisfaction	54 satisfaction score at baseline Interval 45.0 to 54.0	55 satisfaction score at baseline Interval 49.0 to 55.0

SECONDARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Standard Consent n=29 Participants Patients only receive the standard brachytherapy consent process Standard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.	Standard Consent and Video Intervention n=28 Participants Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy Brachytherapy video: Patients will watch a video that contains information about brachytherapy Standard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.
Treatment Related Anxiety	4 anxiety score at baseline Interval 2.0 to 7.0	4 anxiety score at baseline Interval 1.0 to 6.0

Adverse Events

Standard Consent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Consent and Video Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jyoti Mayadev

University of California, San Diego

Phone: (858) 822-5354

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place