Præ-rehabilitering for kvindelige patienter, der gennemgår bækkenstrålebehandling
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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?
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Namita Agrawal, MD
- Telefonnummer: (317)944-2524
- E-mail: agrawaln@indiana.edu
Undersøgelse Kontakt Backup
- Navn: Sarah Dutkevich, RN
- Telefonnummer: (317)278-5618
- E-mail: sdutkevi@iu.edu
Studiesteder
-
-
Indiana
-
Avon, Indiana, Forenede Stater, 46123
- Rekruttering
- IU Health West
-
Kontakt:
- Nikki Barrow
- Telefonnummer: 317-944-1242
- E-mail: nrbarrow@iu.edu
-
Carmel, Indiana, Forenede Stater, 46032
- Rekruttering
- IU Health Schwarz Cancer Center
-
Kontakt:
- John Spittler
- Telefonnummer: 3172740771
- E-mail: ajspittl@iu.edu
-
Indianapolis, Indiana, Forenede Stater, 46202
- Rekruttering
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center
-
Kontakt:
- Sarah Dutkevitch, RN
- Telefonnummer: 317-278-5618
- E-mail: sdutkevi@iu.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Bækkensundhedsvurdering og intervention
|
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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasability of implementation of pre-rehabilitation to radiotherapy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Average score on the Visual Pain Rating Scale.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Namita Agrawal, MD, Indiana University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Smerte
- Neurologiske manifestationer
- Psykiske lidelser
- Sår og skader
- Kønssygdomme, mandlige
- Mandlige urogenitale sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kønssygdomme, kvindelige
- Seksuelle dysfunktioner, psykologiske
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Bækkensmerter
- Dyspareuni
- Seksuel dysfunktion, Fysiologisk
- Strålingsskader
Andre undersøgelses-id-numre
- CTO-IUSCCC-0772
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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