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Pre-rehabilitering for kvinnelige pasienter som gjennomgår bekkenstrålebehandling

15. september 2026 oppdatert av: Namita Agrawal, Indiana University

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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?

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Sarah Dutkevich, RN
  • Telefonnummer: (317)278-5618
  • E-post: sdutkevi@iu.edu

Studiesteder

  • Forente stater
    • Indiana
      • Avon, Indiana, Forente stater, 46123
        • Rekruttering
        • IU Health West
        • Ta kontakt med:
      • Carmel, Indiana, Forente stater, 46032
        • Rekruttering
        • IU Health Schwarz Cancer Center
        • Ta kontakt med:
      • Indianapolis, Indiana, Forente stater, 46202
        • Rekruttering
        • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Bekkenhelsevurdering og intervensjon
Atferdsmessig: Pelvic health therapy

Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education

Enhet: Dilator feasability

Patient Adherence to Vaginal Dilation Questionnaire

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Indiana University

Etterforskere

  • Hovedetterforsker: Namita Agrawal, MD, Indiana University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. januar 2024

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. juli 2027

Datoer for studieregistrering

Først innsendt

22. september 2023

Først innsendt som oppfylte QC-kriteriene

22. september 2023

Først lagt ut (Faktiske)

28. september 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CTO-IUSCCC-0772

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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