Pré-réadaptation pour les patientes subissant une radiothérapie pelvienne
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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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?
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Namita Agrawal, MD
- Numéro de téléphone: (317)944-2524
- E-mail: agrawaln@indiana.edu
Sauvegarde des contacts de l'étude
- Nom: Sarah Dutkevich, RN
- Numéro de téléphone: (317)278-5618
- E-mail: sdutkevi@iu.edu
Lieux d'étude
-
-
Indiana
-
Avon, Indiana, États-Unis, 46123
- Recrutement
- IU Health West
-
Contact:
- Nikki Barrow
- Numéro de téléphone: 317-944-1242
- E-mail: nrbarrow@iu.edu
-
Carmel, Indiana, États-Unis, 46032
- Recrutement
- IU Health Schwarz Cancer Center
-
Contact:
- John Spittler
- Numéro de téléphone: 3172740771
- E-mail: ajspittl@iu.edu
-
Indianapolis, Indiana, États-Unis, 46202
- Recrutement
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center
-
Contact:
- Sarah Dutkevitch, RN
- Numéro de téléphone: 317-278-5618
- E-mail: sdutkevi@iu.edu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Évaluation et intervention de la santé pelvienne
|
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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasability of implementation of pre-rehabilitation to radiotherapy
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Average score on the Visual Pain Rating Scale.
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Namita Agrawal, MD, Indiana University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- La douleur
- Manifestations neurologiques
- Les troubles mentaux
- Blessures et Blessures
- Maladies génitales, sexe masculin
- Maladies urogénitales masculines
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies génitales, femme
- Dysfonctions sexuelles, psychologiques
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Douleur pelvienne
- Dyspareunie
- Dysfonction sexuelle, physiologique
- Blessures par rayonnement
Autres numéros d'identification d'étude
- CTO-IUSCCC-0772
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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