骨盤放射線療法を受ける女性患者のプレリハビリテーション
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.
調査の概要
詳細な説明
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?
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Namita Agrawal, MD
- 電話番号：(317)944-2524
- メール：agrawaln@indiana.edu
研究連絡先のバックアップ
- 名前：Sarah Dutkevich, RN
- 電話番号：(317)278-5618
- メール：sdutkevi@iu.edu
研究場所
-
-
Indiana
-
Avon、Indiana、アメリカ、46123
- 募集
- IU Health West
-
コンタクト：
- Nikki Barrow
- 電話番号：317-944-1242
- メール：nrbarrow@iu.edu
-
Carmel、Indiana、アメリカ、46032
- 募集
- IU Health Schwarz Cancer Center
-
コンタクト：
- John Spittler
- 電話番号：3172740771
- メール：ajspittl@iu.edu
-
Indianapolis、Indiana、アメリカ、46202
- 募集
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center
-
コンタクト：
- Sarah Dutkevitch, RN
- 電話番号：317-278-5618
- メール：sdutkevi@iu.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：骨盤の健康状態の評価と介入
|
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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasability of implementation of pre-rehabilitation to radiotherapy
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Average score on the Visual Pain Rating Scale.
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Namita Agrawal, MD、Indiana University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CTO-IUSCCC-0772
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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