The goal of this clinical trial is to learn if an educational video and workbook can help gynecologic cancer patients talk to their cancer providers about sexual health concerns. The main questions it aims to answer are: 1. Do gynecologic cancer patients who take part in the educational program and get a resource booklet talk to their cancer clinicians more about sexual health concerns than patients who get a resource booklet alone? 2. Do gynecologic cancer patients who take part in the educational program and get a resource booklet have better sexual function and less anxiety and depression than patients who get a resource booklet alone? Researchers will compare those who get the educational program and the resource booklet to those who get the resource booklet alone along with their usual care. Participants will: 1. Fill out a consent form and survey 2. Have their next clinic visit audio recorded 3. Fill out another survey right after their clinic visit 4. Fill out a final survey 6 months after their clinic visit
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
200
Starting the Conversation includes a 25-minute video with information about sexual health and gynecologic cancer and tips about how to talk to their cancer care team about sexual health concerns. Participants will also fill out a workbook with activities to help them practice communication skills.
The sexual health resource guide includes institutional resources for patients with sexual concerns (for example, the Women's Survivorship Clinic) and links to reputable websites with information about sexual health after gynecologic cancer.
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
RECRUITINGClinical Communication - Raise Topic of Sexual Health
Number of patients who raise the topic of sexual health concerns in a clinic visit.
Time frame: 2 weeks
Clinical Communication - Ask a Question about Sexual Health
Number of patients who ask a question about sexual health concerns in a clinic visit.
Time frame: 2 weeks
Clinical Communication - Express a Concern about Sexual Health
Number of patients who express a sexual health concern in a clinic visit.
Time frame: 2 weeks
Self-Reported Sexual Function
Patients' self-reported sexual function will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) SexFS Brief Profile Version 2.0. Four domains (lubrication, vaginal discomfort, satisfaction, and interest) will be scored. Domains are scored using T-scores, with higher scores signifying better sexual function for the lubrication, satisfaction, and interest domains. Lower scores in the vaginal discomfort range signify better sexual function.
Time frame: Baseline, 2 weeks, 3 months, 6 months
Self-Reported Sexual Activity
Patients' self-reported sexual activity will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Activity screener. Number of participants reporting any sexual activity will be reported.
Time frame: Baseline, 2 weeks, 3 months, 6 months
Self-Reported Anxiety Symptoms
Patients' self-reported anxiety symptoms will be measured using the Hospital Anxiety and Depression Scale (HADS). The anxiety subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of anxiety.
Time frame: Baseline, 2 weeks, 3 months, 6 months
Self-Reported Depressive Symptoms
Patients' self-reported depressive symptoms will be measured using the Hospital Anxiety and Depression Scale (HADS). The depression subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of depressive symptoms.
Time frame: Baseline, 2 weeks, 3 months, 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.