Sexual Dysfunction in Gynecologic Oncology Patients
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 1/16/2019 |
| Start Date: | February 2019 |
| End Date: | July 2020 |
| Contact: | Erika Holm-Brown |
| Email: | cancer-information@uiowa.edu |
| Phone: | 1-800-237-1225 |
This project will evaluate sexual dysfunction in women who have had surgery for gynecologic
cancer. The subjects will complete a set of questionnaires about health, daily living, sexual
encounters, and pain before their surgery and three times following. Each subject will be
randomized to receive either lidocaine or a placebo that is applied vaginally immediately
prior to any sexual encounters for approximately 6 months while maintaining a journal of
sexual encounters and pain. The subjects and healthcare providers will be blinded to the
treatment randomization until intervention and data collection is complete. Total
participation will last up to one year from the date of enrollment. Subjects will visit the
clinic at the same time as regular cancer care visits, receive the blinded intervention and
complete the surveys.
cancer. The subjects will complete a set of questionnaires about health, daily living, sexual
encounters, and pain before their surgery and three times following. Each subject will be
randomized to receive either lidocaine or a placebo that is applied vaginally immediately
prior to any sexual encounters for approximately 6 months while maintaining a journal of
sexual encounters and pain. The subjects and healthcare providers will be blinded to the
treatment randomization until intervention and data collection is complete. Total
participation will last up to one year from the date of enrollment. Subjects will visit the
clinic at the same time as regular cancer care visits, receive the blinded intervention and
complete the surveys.
Once consented, subjects will complete nine short surveys (The Female Sexual Function Index,
The PHQ-9, the GAD-7, the Social Provision Score (SPS), Rosenberg's Body Self-Esteem Index,
the Severity of Posttraumatic Stress (PTS) Symptoms Scale, the Adverse Childhood Events
Index, the Short Form (SF)-12, and the Dyadic Adjustment Scale) at their initial visit,
assessing physical, psychological, and social elements related to sexuality.
Subjects will then have the tumor reduction surgery.
Twelve weeks after her surgery, each subject will be asked to complete the same nine-survey
packet.
Once the second packet is completed, subjects will be randomized to receive either aqueous
lidocaine (4%) or placebo with instructions to apply the solution to three cotton balls and
place them on the perineum/vaginal introitus for one minute prior to sexual intercourse.
Subjects will be educated on the use of this blinded intervention and be asked to keep a
diary of sexual encounters, including a simple pictorial pain scale for each encounter.
Subjects and providers are blinded to the assigned intervention.
Once subjects complete three months of perineal intervention, they will be asked at a
follow-up visit (12 weeks following randomization) to complete the survey packet for a third
time.
Subjects will then continue their perineal intervention, keep a diary of sexual encounters
with the pain scale and return after another three-month interval for a fourth completion of
the survey packet. Sexual encounter diaries and pain scale assessments will be collected and
their participation in the trial will conclude. Also at the time of this concluding follow-up
visit in the Gynecologic Oncology Clinic, patients will receive counseling by a gynecologic
oncologist regarding education about sexual dysfunction, the possibility of experiencing
sexual dysfunction, and a potential referral for further treatment of sexual dysfunction. The
subject will remain blinded to the randomized intervention until the conclusion of the study.
Subjects will be unblinded and informed of assigned intervention at the conclusion of the
study via a letter sent to their home address from the researchers.
The PHQ-9, the GAD-7, the Social Provision Score (SPS), Rosenberg's Body Self-Esteem Index,
the Severity of Posttraumatic Stress (PTS) Symptoms Scale, the Adverse Childhood Events
Index, the Short Form (SF)-12, and the Dyadic Adjustment Scale) at their initial visit,
assessing physical, psychological, and social elements related to sexuality.
Subjects will then have the tumor reduction surgery.
Twelve weeks after her surgery, each subject will be asked to complete the same nine-survey
packet.
Once the second packet is completed, subjects will be randomized to receive either aqueous
lidocaine (4%) or placebo with instructions to apply the solution to three cotton balls and
place them on the perineum/vaginal introitus for one minute prior to sexual intercourse.
Subjects will be educated on the use of this blinded intervention and be asked to keep a
diary of sexual encounters, including a simple pictorial pain scale for each encounter.
Subjects and providers are blinded to the assigned intervention.
Once subjects complete three months of perineal intervention, they will be asked at a
follow-up visit (12 weeks following randomization) to complete the survey packet for a third
time.
Subjects will then continue their perineal intervention, keep a diary of sexual encounters
with the pain scale and return after another three-month interval for a fourth completion of
the survey packet. Sexual encounter diaries and pain scale assessments will be collected and
their participation in the trial will conclude. Also at the time of this concluding follow-up
visit in the Gynecologic Oncology Clinic, patients will receive counseling by a gynecologic
oncologist regarding education about sexual dysfunction, the possibility of experiencing
sexual dysfunction, and a potential referral for further treatment of sexual dysfunction. The
subject will remain blinded to the randomized intervention until the conclusion of the study.
Subjects will be unblinded and informed of assigned intervention at the conclusion of the
study via a letter sent to their home address from the researchers.
Inclusion criteria
- Female
- Age 18-99
- Planned to undergo primary surgical treatment at the University of Iowa Hospitals and
Clinics for a suspected or proven diagnosis of ovarian, fallopian tube, peritoneal,
endometrial, or cervical cancer
- Able to give informed consent and follow study procedures
- No previous reactions to lidocaine applications
- Performance Status of 0 or 1
- Reports having engaged in vaginal intercourse at least once in the last 12 months
Exclusion criteria:
- Failure to confirm invasive ovarian, fallopian tube, peritoneal, endometrial or
cervical cancer by pathology from primary biopsy or surgery (subjects will not be
eligible to continue the trial beyond the initial completion of the questionnaires)
- Diagnosis of another malignancy within the past five years, excluding basal cell
carcinoma of the skin
- Patients undergoing primary or adjuvant external pelvic radiation (excluding adjuvant
vaginal brachytherapy)
- Previous reactions to lidocaine applications
- Previous reactions to lidocaine for the subjects' sexual partner(s)
We found this trial at
1
site
University of Iowa With just over 30,000 students, the University of Iowa is one of...
Click here to add this to my saved trials
