Clinical trial NCT04363957: Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video
Official title: Prospective, Randomized Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Uterine Cancer
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

1. Patient has the ability to understand and the willingness to sign a written informed consent.
2. Patient must be female, all races and ethnic groups are eligible.
3. Must be \> 18 years of age, or have parental approval for inclusion.
4. Must carry a diagnosis of gynecologic malignancy.
5. Is deemed to require high-dose rate gynecologic brachytherapy procedure (intracavitary, hybrid intracavitary/interstitial, or interstitial).
6. Any prior external beam radiation therapy is allowed.
7. Any performance status is allowed.
8. 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)

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Patient Reported Satisfaction
timeFrame: from study enrollment to the final dose of brachytherapy, up to 6 weeks
Secondary outcomes:
measure: Treatment Related Anxiety
timeFrame: from study enrollment to the final dose of brachytherapy, up to 6 weeks
Other outcomes:
measure: Height (meters)
timeFrame: from study enrollment to the final dose of brachytherapy, up to 6 weeks
measure: Weight (kilograms)
timeFrame: from study enrollment to the final dose of brachytherapy, up to 6 weeks
measure: Radiation Dose Administered (Gy)
timeFrame: At each dose from study enrollment to the final dose of brachytherapy, up to 6 weeks
Locations:
city: La Jolla
country: United States
facility: Moores UC San Diego Cancer Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Jyoti Mayadev, MD
role: PRINCIPAL_INVESTIGATOR
References: