Sexual Dysfunction in Gynecologic Oncology Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Changes in Sexual Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lidocaine
Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.
干预措施: Lidocaine Topical (Drug)
Placebo
Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in Sexual Function
时间窗: 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
时间窗: 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.
次要结局
- Relationships and Social Support(9 months)
- Self-Esteem(9 months)
- Depressive Symptoms(9 months)
- Anxiety(9 months)
- Posttraumatic Stress Symptoms(9 months)
- Health Status(9 months)
- Adverse Childhood Events(9 months)
- Romantic Relationships(9 months)
研究者
David Bender
Principal Investigator
University of Iowa