Gynecologic Cancer
Conditions
Brief summary
This study seeks to find out if an early intervention of providing directed sexual health education and treatment for gynecologic cancer patients will improve patient outcomes as compared to routine clinic visits.
Detailed description
Participants will be randomly placed to one of two groups. This random placement allows our research study to be more significant when the study team checks the results. In one group, the control group, participants will attend their usual clinic visits with their provider every 3 months for a year. At each clinic visit participants will be asked to fill out 3 short surveys (each takes less than 3 minutes). Participants will have a gynecologic exam like they routinely would for cancer surveillance, and confidential notes will be made regarding their exam to assess for improvement or worsening over time. In the other group, the intervention group, participants will attend one focused Sexual Health Clinic visit, where a provider specialized in sexual health for cancer patients will review a focused history and physical, and will provide education, as well as recommend any helpful treatments. This provider may or may not recommend follow up with her again after this initial visit. Participants will otherwise continue the usual every 3 month clinic visits with their Gynecologic Oncologist for a year. At each clinic visit participants will be asked to fill out 3 short surveys (each takes less than 3 minutes). Participants will have a gynecologic exam like they routinely would for cancer surveillance, and confidential notes will be made regarding their exam to assess for improvement or worsening over time. Participants will not need any additional blood draws or procedures. During their gynecologic exam, a swab will be collected to test participants vaginal pH - a test to see the health of their vaginal flora. In brief, participants will have their usual 4 clinic visits: one at 3 months, 6 months, 9 months, and 12 months. At each visit, participants will fill out 3 surveys and have a gynecologic exam performed as they usually would, but with a vaginal swab for vaginal pH. This swab will be assessed in the clinic by their provider as the swab will change colors to show pH at the time of exam. This result will be noted in the participants' chart and the swab will be discarded.
Interventions
BEHAVIORALdedicated sexual health clinic appointment
Intervention will consist of a dedicated sexual health clinic appointment with a physician provider focused on sexual health in this population. This provider will perform a focused history and physical, and will then determine need for appropriate treatment and management, which may consist of recommendations for medications, psychosocial counseling, physical therapy, and/or dilator use, but are not required.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to consent * Screening positive for sexual health dysfunction as per baseline FSFI * Diagnosed with any gynecologic malignancy It is acceptable to have received treatment prior to or during enrollment, including prior surgery, chemotherapy, radiation, hormonal therapy, or clinical trial.
Exclusion criteria
* Unable to speak English * Patients unable to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sexual dysfunction as measured by FSFI | At 3, 6, 9, and 12 months from start of treatment | Change in sexual function as measured by FSFI, a 19-question, standardized scale of female sexual function, validated in cancer survivors as compared to start of study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sexual distress as measured by FSDS | At 3, 6, 9, and 12 months from start of treatment | Change in sexual distress score as measured by FSDS, a 13-question, validated questionnaire assessing sexually related personal distress in women with female sexual dysfunction. This questionnaire will be used for follow up visits to help assess the level of distress participants are enduring related to their sexual dysfunction. |
| Change in psychologic distress as measured by Kessler K10 Scale | At 3, 6, 9, and 12 months from start of treatment | Change in psychologic distress as measured by Kessler K10 Scale, a 10-question, validated questionnaire assessing psychological distress. This survey will be used at follow up visits to help determine baseline psychological distress unrelated to sexual distress for a more global picture of the participants' coping throughout their illness. Scores range from 10 to 50 with higher scores indicating worse distress symptoms. |
| Change in clinical assessment of vaginal symptoms as measured by VAS | At 3, 6, 9, and 12 months from start of treatment | Change in vaginal symptoms as measured by VAS, a 4-item validated clinical measure of vaginal health, with scores ranging from 0-12 and higher scores indicating worse symptoms. |
| Change in clinical assessment of vulvar symptoms as measured by VuAS | At 3, 6, 9, and 12 months from start of treatment | Change in vulvar symptoms as measured by VAS, a 4-item validated clinical measure of vulvar health with scores ranging from 0-12 and higher scores indicating worse symptoms. |
Countries
United States
Outcome results
None listed