Gynecologic Cancer, Sexual Dysfunction
Conditions
Brief 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.
Detailed 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.
Interventions
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.
DRUGPlacebo
Placebo solution intervention used to validate the effects of the lidocaine solution usage.
Sponsors
David Bender
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Sexual Function | 9 months | 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. |
| Changes in Pain | 9 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationships and Social Support | 9 months | 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. |
| Self-Esteem | 9 months | 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. |
| Posttraumatic Stress Symptoms | 9 months | 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. |
| Depressive Symptoms | 9 months | 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. |
| Health Status | 9 months | 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. |
| Romantic Relationships | 9 months | 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. |
| Adverse Childhood Events | 9 months | 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. |
| Anxiety | 9 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
Subjects will complete nine short surveys at their initial visit, assessing physical, psychological, and social elements related to sexuality. Subjects will then have the tumor reduction surgery. Twelve weeks after 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 the lidocaine solution or a placebo using permuted block technique based on cancer origin.
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.
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. | 3 |
| Placebo Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.
Placebo: Placebo solution intervention used to validate the effects of the lidocaine solution usage. | 1 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Unable to comply | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | Lidocaine |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 2 Participants |
| Age, Continuous | 52 years | 55 years | 56 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | 4 participants | 3 participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 1 / 1 |
| other Total, other adverse events | 0 / 3 | 0 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 |
Outcome results
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.
Time frame: 9 months
Population: Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
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.
Time frame: 9 months
Population: Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
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.
Time frame: 9 months
Population: Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
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.
Time frame: 9 months
Population: Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
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.
Time frame: 9 months
Population: Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
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.
Time frame: 9 months
Population: Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
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.
Time frame: 9 months
Population: Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
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.
Time frame: 9 months
Population: Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
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.
Time frame: 9 months
Population: Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
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.
Time frame: 9 months
Population: Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.