Communication About Sexual Health in Gynecologic Cancer
ConditionGynecologic Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFox Chase Cancer Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years old
Diagnosed with any stage (I-IV) gynecologic cancer
Receiving treatment for gynecologic cancer or completed active treatment less than 10 years ago
Attending visits in follow-up care at Fox Chase Cancer Center
Disqualifiers
Not able to speak English
Not willing to have clinic visit audio recorded
Eastern Cooperative Oncology Group (ECOG) score > 2
Overt cognitive dysfunction or psychiatric disturbance
Trial design
Design model
Parallel
Treatments tested in this trial
Starting the Conversation
BehavioralStarting 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.
Sexual Health Resources
BehavioralThe 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Enhanced Care-as-Usual (Sexual Health Resources Alone)Active comparator 1 intervention
Group B: Sexual Health Resources + Starting the Conversation Video/WorkbookExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Clinical Communication - Raise Topic of Sexual Health
Number of patients who raise the topic of sexual health concerns in a clinic visit.
Time frame
2 weeks2
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 weeks3
Clinical Communication - Express a Concern about Sexual Health
Number of patients who express a sexual health concern in a clinic visit.
Time frame
2 weeksSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fox Chase Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov