Longitudinal Changes in Women's Pelvic Health and Sexual Function After Pelvic Radiation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in vulvovaginal symptoms
研究概览
简要总结
This study investigates changes in physical measures of pelvic health and patient-reported outcomes of sexual function, intimate relationship, and quality of life over time in women undergoing radiation therapy for pelvic cancer. Evaluating vaginal changes prior to and after a course of radiation and collecting patient reported outcomes of sexual function, partner communication, and intimacy may help researchers may help researchers better understand physical changes and symptoms over time.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate changes in objective physical exam findings from baseline to the end of radiation and through two years follow-up for women with pelvic cancer.
II. To examine changes in sexual, relational and quality of life outcomes from baseline to the end of radiation and through one year follow-up for women with pelvic cancer using the patient reported outcome measures.
III. To compare physical exam and patient-reported outcome trajectories over time.
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any patient with anal, rectal, cervical, endometrial, vaginal, or vulvar cancer receiving external beam radiation alone, brachytherapy alone, or both external beam radiation and brachytherapy
- •Concurrent or prior chemotherapy is allowed, including those participating in Ohio State University (OSU)-16166
- •Any prior gynecologic surgery is permitted
- •Rectal surgery, including lower anterior resection and abdominoperineal resection, is permitted
排除标准
- •Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded
- •Patients who have received prior pelvic radiation
研究组 & 干预措施
Supportive Care (pelvic exam, survey)
Patients undergo standard of care pelvic exam at baseline and 1, 3, 6, 12, and 24 month follow ups. Patients also complete patient reported outcome measures at baseline and 1, 3, 6, 12, 18, and 12 month follow ups.
干预措施: Pelvic Examination (Procedure)
Supportive Care (pelvic exam, survey)
Patients undergo standard of care pelvic exam at baseline and 1, 3, 6, 12, and 24 month follow ups. Patients also complete patient reported outcome measures at baseline and 1, 3, 6, 12, 18, and 12 month follow ups.
干预措施: Survey (Other)
结局指标
主要结局
Change in vulvovaginal symptoms
时间窗: Baseline up to 2 year after RT
The Vaginal Assessment Scale (VAS) and Vulvar Assessment Scale (VuAS) are tools to identify vulvovaginal symptoms over the past 4 weeks including vaginal dryness, soreness, irritation, and dyspareunia. Items are scored 0 (none) to 3 (severe) and a composite score is calculated by taking the mean of the items. Will first test bivariate correlations between patient reported outcomes and categorical sociodemographic factors using ANOVA. Will then test bivariate correlations between patient-reported outcomes and continuous sociodemographic factors using Pearson's correlation. Will employ one-tailed paired sample t-test to assess the effects of radiation by comparing patient-reported outcomes at each time point to baseline. Will also report 95% confidence intervals and effect sizes. Will utilize mixed-effects modeling to demonstrate changes in each outcome variable over time adjusting for demographic/clinical characteristics.
Change in physical exam findings
时间窗: Baseline up to 2 years after radiation therapy (RT)
Vaginal Health Assessment (VHA) tool; vaginal length and diameter will be reported as categorical variables (Eaton et al., 2017). Estimates will be \<2.5, 2.5, 3.0, 3.5, 4.0 or \>4 cm. Vaginal length will be estimated based on manual exam. Estimates will be \<4cm, 4-6cm, and \>6cm. We will first test bivariate correlations between physical exam outcomes and categorical sociodemographic factors using Fisher's exact test at each time point. The study team will test bivariate correlations between physical exam outcomes and continuous sociodemographic factors using ANOVA at each time point. Next, the study team will employ one-tailed Wilcoxon signed-rank test to assess the effects of radiation by comparing 1-month, 3-month, 6-month, 12-month and 24-month physical exam outcomes to baseline.
Change in sexual function
时间窗: Baseline up to 2 year after RT
Female Sexual Functioning Index (FSFI) is a 19 item self -reported instrument measuring six domains of sexual functioning including arousal, orgasm, satisfaction and pain. The maximum score is 36 and a score of ≤ 26.0 indicates sexual dysfunction. Will first test bivariate correlations between patient reported outcomes and categorical sociodemographic factors using ANOVA. Will then test bivariate correlations between patient-reported outcomes and continuous sociodemographic factors using Pearson's correlation. Will employ one-tailed paired sample t-test to assess the effects of radiation by comparing patient-reported outcomes at each time point to baseline. Will also report 95% confidence intervals and effect sizes. Will utilize mixed-effects modeling to demonstrate changes in each outcome variable over time adjusting for demographic/clinical characteristics.
次要结局
- Change in vaginal microbiome(Baseline up to 2 year after RT)
研究者
Elizabeth Arthur
Principal Investigator
Ohio State University Comprehensive Cancer Center