Dyspareunia, Pelvic Pain, Radiation Toxicity, Sexual Dysfunction
Conditions
Keywords
vaginal dilator, pelvic health physical therapy
Brief summary
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.
Detailed description
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?
Interventions
BEHAVIORALPelvic health therapy
Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education
DEVICEDilator feasability
Patient Adherence to Vaginal Dilation Questionnaire
Sponsors
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female 2. ≥ 18 years old at the time of informed consent 3. Ability to provide written informed consent and HIPAA authorization 4. Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer 5. Candidate for curative pelvic radiation with external beam, with or without brachytherapy, per radiation oncologist's discretion Notes: * Can have prior and/or current modalities of treatment to address diagnosis including surgery and chemotherapy * Can receive radiation at any facility provided patient is able to perform Physical Therapy visits at IUH North/Schwarz Cancer Center
Exclusion criteria
1. Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up. 2. Not a candidate for curative radiation therapy per radiation oncologist's discretion 3. Prior radiation therapy to the pelvis 4. Women who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasability of implementation of pre-rehabilitation to radiotherapy | Baseline | Recording the number of eligible patients for protocol that decline enrollment. The reason(s) for forgoing protocol intervention will be documented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average score on the Visual Pain Rating Scale. | Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation | Visual Analogue Pain Rating Scale 0-10 |
| Evaluate female sexual function based on questionnaire responses | Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation | Female Sexual Function Index questionnaires (Likert scale) |
| Percentage of adherence to dilator use | Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation | Self-reported dilator adherence |
Countries
United States
Contacts
CONTACTNamita Agrawal, MD
CONTACTSarah Dutkevich, RN
PRINCIPAL_INVESTIGATORNamita Agrawal, MD
Indiana University
Outcome results
None listed