Sexual Dysfunction in Gynecologic Oncology Patients

Gynecologic Cancer Clinical Trial

Official title:

Sexual Dysfunction in Gynecologic Oncology Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03801031
• Other study ID #: 201609770
• Status: Terminated
• Phase: Phase 4
• Start date: June 6, 2019
• Est. completion date: November 3, 2021

Study information

• Verified date: November 2022
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gynecologic Cancer
• Sexual Dysfunction

Intervention

Drug:
• Lidocaine Topical
Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.
• Placebo
Placebo solution intervention used to validate the effects of the lidocaine solution usage.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
David Bender

Country where clinical trial is conducted

United States, 

References & Publications (1)

Abbott-Anderson K, Kwekkeboom KL. A systematic review of sexual concerns reported by gynecological cancer survivors. Gynecol Oncol. 2012 Mar;124(3):477-89. doi: 10.1016/j.ygyno.2011.11.030. Epub 2011 Nov 28. Erratum In: Gynecol Oncol. 2012 Sep;126(3):501-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Sexual Function	Sexual function measured by the Female Sexual Function Index (FSFI) survey, a 19-item self-report survey measuring sexual function. Item responses are on a 5-point scale and the total scores range 2 to 36 points, considering that the higher the score obtained, the better the sexual function of the woman.	9 months
Primary	Changes in Pain	Pain is measured by using the visual analog scale for pain, which is a scale of 0-10, utilizing numbers and face illustrations to describe pain level. Pain level is measured on a 0-10 point scale, 0 indicating no pain and 10 indicating the worst pain possible.	9 months
Secondary	Depressive Symptoms	Mean Change in Patient Health Questionnaire 9 (PHQ-9), a 9-item self-report instrument to screen for depression. Responses range from 0-3 and the scores range from 0-27, the higher total score indicates more depression.	9 months
Secondary	Anxiety	Mean change in Generalized Anxiety Disorder 7-item scale (GAD-7), a brief self-report instrument of 7 items to assess generalized anxiety disorder. Responses range from 0-3 and the scores range from 0-21, the higher total score indicates more anxiety.	9 months
Secondary	Relationships and Social Support	Mean change in Social Provisions Scale, a 24-item self-reported survey measuring perceived social support to assess confounders on sexual function. Responses range from 1-4 and higher total scores indicate greater social connection.	9 months
Secondary	Self-Esteem	Mean change of Rosenberg's Body Self-Esteem Index, a 10-item self-report survey assessing global self-worth by measuring both positive and negative feelings about the self. Total scores range between 0 and 40; higher scores indicate better self-esteem.	9 months
Secondary	Posttraumatic Stress Symptoms	Scores of Severity of Posttraumatic Stress Symptoms-Adult survey, a 9-item self-report instrument that assesses severity of posttraumatic stress disorder following a particular event or experience. Responses range from 0-4, 0 indicating no distress and 4 indicating extreme distress. Each item is measured on a 5-point scale (0=not at all; 4=extremely). Total score can range from 0-36 or averaged for 0-5. The higher scores indicate more severe PTS distress.	9 months
Secondary	Adverse Childhood Events	Presence, Severity, or Mean Change in Adverse Childhood Events Index, a 10-item self-report scale measuring types of physical, verbal, and emotional childhood trauma. Items are responded with yes or no. The total score is the sum of yes responses and range from 0-10. Higher total scores indicate more adverse childhood experiences.	9 months
Secondary	Health Status	Mean Change in SF-12, a 12-item self-report measure of perceived general health status and disability. Responses include yes or no or ranges on 5- or 6-point scales. Higher total scores indicate more disability.	9 months
Secondary	Romantic Relationships	Mean Change in Dyadic Adjustment Scale (DAS), a 32-item self-report measure of couple satisfaction. Responses are 5- or 6-point scales or yes or no. Total scores range from 0 to 151. Higher total scores indicate higher adjustment and satisfaction in intimate relationships.	9 months