Gynecologic Cancers
Conditions
Keywords
sexual health
Brief summary
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
Interventions
BEHAVIORALStarting the Conversation
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.
BEHAVIORALSexual Health Resources
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.
Sponsors
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Score of at least 3 on a sexual concerns screener question
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Communication - Raise Topic of Sexual Health | 2 weeks | Number of patients who raise the topic of sexual health concerns in a clinic visit. |
| Clinical Communication - Ask a Question about Sexual Health | 2 weeks | Number of patients who ask a question about sexual health concerns in a clinic visit. |
| Clinical Communication - Express a Concern about Sexual Health | 2 weeks | Number of patients who express a sexual health concern in a clinic visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Sexual Function | Baseline, 2 weeks, 3 months, 6 months | 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. |
| Self-Reported Sexual Activity | Baseline, 2 weeks, 3 months, 6 months | 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. |
| Self-Reported Anxiety Symptoms | Baseline, 2 weeks, 3 months, 6 months | 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. |
| Self-Reported Depressive Symptoms | Baseline, 2 weeks, 3 months, 6 months | 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. |
Countries
United States
Contacts
CONTACTJennifer B Reese, PhD
CONTACTKristen A Sorice
Outcome results
None listed