Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video

Cervical Cancer Clinical Trial

Official title:

Prospective, Randomized Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363957
• Other study ID #: 181519
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: April 22, 2022

Study information

• Verified date: July 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 22, 2022
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cancer
• Uterine Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Moores UC San Diego Cancer Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Height (meters)	Participants height will be measured	from study enrollment to the final dose of brachytherapy, up to 6 weeks
Other	Weight (kilograms)	Participants weight will be measured	from study enrollment to the final dose of brachytherapy, up to 6 weeks
Other	Radiation Dose Administered (Gy)	Amount of radiation administered to the patient will be measured.	At each dose from study enrollment to the final dose of brachytherapy, up to 6 weeks
Primary	Patient Reported Satisfaction	The primary analysis will be based on the Intention-to-Treat population, defined as all individuals who were randomized to arm A or arm B. A Likert-scale questionnaire 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. It is not anticipated that there are any possible confounders, if any study team will include it in the secondary analysis.The reporting scale is the following: Strongly disagree (1) Disagree (2) Uncertain (3) Agree (4) Strongly agree (5) A higher score means a better outcome	from study enrollment to the final dose of brachytherapy, up to 6 weeks
Secondary	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 NCCN distress score, are also collected at three time points and will be analyzed using the same strategy. The NCCN distress scale is from 0-10 with 10 being a value that is more distress- worse.	from study enrollment to the final dose of brachytherapy, up to 6 weeks