골반 방사선 치료를 받는 여성 환자의 사전 재활
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.
연구 개요
상세 설명
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?
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Namita Agrawal, MD
- 전화번호: (317)944-2524
- 이메일: agrawaln@indiana.edu
연구 연락처 백업
- 이름: Sarah Dutkevich, RN
- 전화번호: (317)278-5618
- 이메일: sdutkevi@iu.edu
연구 장소
-
-
Indiana
-
Avon, Indiana, 미국, 46123
- 모병
- IU Health West
-
연락하다:
- Nikki Barrow
- 전화번호: 317-944-1242
- 이메일: nrbarrow@iu.edu
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Carmel, Indiana, 미국, 46032
- 모병
- IU Health Schwarz Cancer Center
-
연락하다:
- John Spittler
- 전화번호: 3172740771
- 이메일: ajspittl@iu.edu
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Indianapolis, Indiana, 미국, 46202
- 모병
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center
-
연락하다:
- Sarah Dutkevitch, RN
- 전화번호: 317-278-5618
- 이메일: sdutkevi@iu.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Female
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer
- 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:
- 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.
- Not a candidate for curative radiation therapy per radiation oncologist's discretion
- Prior radiation therapy to the pelvis
- Women who are pregnant or nursing
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 골반 건강 평가 및 중재
|
Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education Patient Adherence to Vaginal Dilation Questionnaire |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasability of implementation of pre-rehabilitation to radiotherapy
기간: Baseline
|
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
기간: Baseline
|
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
기간: Baseline
|
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
기간: Baseline
|
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
기간: Baseline to 6 weeks
|
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
기간: Baseline to 4 months
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Average score on the Visual Pain Rating Scale.
기간: 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
|
Visual Analogue Pain Rating Scale 0-10 |
4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
|
|
Evaluate female sexual function based on questionnaire responses
기간: 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
|
Female Sexual Function Index questionnaires (Likert scale) |
4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
|
|
Percentage of adherence to dilator use
기간: 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
|
Self-reported dilator adherence |
4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Namita Agrawal, MD, Indiana University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CTO-IUSCCC-0772
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
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