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The purpose of this study is to examine the feasibility of adding pre-rehabilitation pelvic health physical therapy to standard of care radiation therapy treatment plan for female patients who have been diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer and are a candidate for curative pelvic radiation with external beam. Participants will receive education on using a vaginal dilator for use during treatment and complete questionnaires looking at pain and sexual function.
Because of the increasing survivorship rate, there is a need for research addressing the post-treatment side effects of pelvic pain and dyspareunia, due to the significant impact these side effects have on patients' quality of life. Current best practice from trained pelvic health physical therapists for addressing dyspareunia and pelvic pain due to vaginal stenosis after radiation therapy, is vaginal dilation. Vaginal dilators are cone shaped durable medical equipment that are inserted into the vagina with lubricant, to assist in patency of the vaginal canal and stretching of the pelvic floor muscles.
The primary objective of this pilot clinical trial is to assess the feasibility of implementing a collaborative, coordinated, and multidisciplinary initiative between radiation oncology and pelvic health physical therapy to answer the following questions: 1) What are the barriers and facilitators to the implementation of a pre-rehabilitation service for gynecological and female anal cancer patients undergoing pelvic radiation and 2) What is the potential clinical value of adding pre-rehabilitative pelvic health services, with an emphasis on vaginal dilator education and use, to the gynecological and female anal cancer radiation setting, in collaboration with radiation oncology staff, as a means of reducing pelvic pain and dyspareunia?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic health Assessment and Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic health therapy | Behavioral | Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education |
| Measure | Description | Time Frame |
|---|---|---|
| Feasability of implementation of pre-rehabilitation to radiotherapy | Recording the number of eligible patients for protocol that decline enrollment. The reason(s) for forgoing protocol intervention will be documented. | Baseline |
| Feasability of implementation of pre-rehabilitation to radiotherapy | The number of eligible patients that were not identified for protocol enrollment will be recorded and potential gaps in the screening process will be analyzed. | Baseline |
| Feasability of implementation of pre-rehabilitation to radiotherapy | The number of eligible patients identified, but not screened, for eligibility or not consented if eligible will be recorded. | Baseline |
| Feasability of implementation of pre-rehabilitation to radiotherapy | The duration of time from initial clinical presentation to being offered information of clinical study will be recorded. | Baseline |
| Feasability of implementation of pre-rehabilitation to radiotherapy | The duration of time from enrollment on clinical study to being seen by physical therapy will be recorded. | Baseline to 6 weeks |
| Feasability of implementation of pre-rehabilitation to radiotherapy | The number of Female Sexual Function Index questionnaires will be recorded as completed, incomplete or not attempted. Reasons for submitting incomplete questionnaires or not submitting a questionnaire will be recorded. | Baseline to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Average score on the Visual Pain Rating Scale. | Visual Analogue Pain Rating Scale 0-10 | Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation |
| Evaluate female sexual function based on questionnaire responses |
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Inclusion Criteria:
Notes:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Namita Agrawal, MD | Contact | (317)944-2524 | agrawaln@indiana.edu | |
| Sarah Dutkevich, RN | Contact | (317)278-5618 | sdutkevi@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Namita Agrawal, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health West | Recruiting | Avon | Indiana | 46123 | United States |
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| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| D017699 | Pelvic Pain |
| D012735 | Sexual Dysfunction, Physiological |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Dilator feasability | Device | Patient Adherence to Vaginal Dilation Questionnaire |
|
Female Sexual Function Index questionnaires (Likert scale) |
| Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation |
| Percentage of adherence to dilator use | Self-reported dilator adherence | Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation |
| IU Health Schwarz Cancer Center | Recruiting | Carmel | Indiana | 46032 | United States |
|
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |