Prospective, Randomized Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Cancer
- Sponsor
- University of California, San Diego
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Patient Reported Satisfaction
- Status
- Completed
- Last Updated
- 6 months ago
Overview
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
Investigators
Jyoti Mayadev, MD
Associate Clinical Professor
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- •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.
- •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
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).
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Treatment Related Anxiety(Baseline)