Back to resultsEvaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video
Primary Purpose
Cervical Cancer, Uterine Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brachytherapy video
Standard Brachytherapy Consent Process
Sponsored by
About this trial
This is an interventional health services research trial for Cervical Cancer
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
- 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).
Sites / Locations
- Moores UC San Diego Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Standard Consent
Standard Consent and Video Intervention
Arm Description
Patients only receive the standard brachytherapy consent process
Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04363957
First Posted
April 3, 2020
Last Updated
July 12, 2022
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT04363957
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
April 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Uterine Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Consent
Arm Type
Other
Arm Description
Patients only receive the standard brachytherapy consent process
Arm Title
Standard Consent and Video Intervention
Arm Type
Experimental
Arm Description
Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy
Intervention Type
Other
Intervention Name(s)
Brachytherapy video
Intervention Description
Patients will watch a video that contains information about brachytherapy
Intervention Type
Other
Intervention Name(s)
Standard Brachytherapy Consent Process
Intervention Description
Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.
Primary Outcome Measure Information:
Title
Patient Reported Satisfaction
Description
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
Time Frame
from study enrollment to the final dose of brachytherapy, up to 6 weeks
Secondary Outcome Measure Information:
Title
Treatment Related Anxiety
Description
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.
Time Frame
from study enrollment to the final dose of brachytherapy, up to 6 weeks
Other Pre-specified Outcome Measures:
Title
Height (meters)
Description
Participants height will be measured
Time Frame
from study enrollment to the final dose of brachytherapy, up to 6 weeks
Title
Weight (kilograms)
Description
Participants weight will be measured
Time Frame
from study enrollment to the final dose of brachytherapy, up to 6 weeks
Title
Radiation Dose Administered (Gy)
Description
Amount of radiation administered to the patient will be measured.
Time Frame
At each dose from study enrollment to the final dose of brachytherapy, up to 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyoti Mayadev, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moores UC San Diego Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video
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