Clinical trial · Observational
Changes in Pelvic Health, Sexual Function, and Quality of Life in Women With Pelvic Cancer Undergoing Radiation Therapy
Longitudinal Changes in Women's Pelvic Health and Sexual Function After Pelvic Radiation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Carcinoma | Anal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Carcinoma | Endometrial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Pelvic Neoplasm | Malignant Pelvic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Rectal Carcinoma | Rectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Vaginal Carcinoma | Vaginal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Vulvar Carcinoma | Vulvar Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pelvic Examination | Procedure | — | UNRESOLVED |
| Survey | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Supportive Care (pelvic exam, survey)
- description
- 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.
- interventionNames
- Procedure: Pelvic Examination
- Other: Survey
Primary outcomes (3)
- measure
- Change in physical exam findings
- timeFrame
- Baseline up to 2 years after radiation therapy (RT)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded * Patients who have received prior pelvic radiation
References
Publications (0)
Data not yet available