Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-50
SponsorDuke University
About this trial
The goal of this study is to develop an educational aid about hormone replacement therapy that physicians can share with patients as part of their pre-surgical counseling for a risk-reducing salpingo-oophorectomy (RRSO).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BRCA1 or BRCA2 germline mutation
scheduled for a risk-reducing salpingo-oophorectomy (RRSO) by Duke Gynecologic Oncologist
premenopausal
Disqualifiers
personal history of cancer
postmenopausal
>50 years old
unable to provide informed consent in English
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental Arm
BehavioralParticipants will be randomized to SOC plus the video.
SOC Arm
BehavioralParticipants will be randomized to SOC counseling.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Standard of CarePlacebo comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Decisional Conflict pre-randomization
The Decisional Conflict Scale ranges from 16 to 80 with a higher score indicating greater conflict with the decision.
Time frame
Baseline, pre-randomization2
Decisional Conflict post-intervention
Decisional conflict will be reassessed preoperatively after all materials have been reviewed. The Decisional Conflict Scale ranges from 16 to 80 with a higher score indicating greater conflict with the decision.
Time frame
Immediately after the intervention3
Decisional Conflict post-operatively
Decisional conflict will be reassessed postoperatively. The Decisional Conflict Scale ranges from 16 to 80 with a higher score indicating greater conflict with the decision.
Time frame
2-6 weeks post op4
Satisfaction with Counseling
a Likert-scale questionnaire to assess their satisfaction with their preoperative counseling.
Time frame
2-6 weeks post opSecondary outcomes
1
Number of participants who decide to take HRT
Number of participants who decide to take HRT
Time frame
3-6 months post op2
Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication
Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication
Time frame
3-6 months post opSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov