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Effectiveness of an Individualized Symptom Education Program (ISEP)

25. mai 2006 oppdatert av: University of Toronto

Effectiveness of an Individualized Symptom Education Program (ISEP) on the Symptom Distress of Women Receiving Radiation for Gynecological Cancer.

The purpose of this study is to examine whether an Individualized Symptom Education Program (ISEP) is helpful to women to manage their symptoms when they are receiving radiation therapy for gynecological cancer.

It is expected that women who participate in the ISEP program will be better able to manage their symptoms and exprience less distress than women who receive usual care.

Studieoversikt

Detaljert beskrivelse

Women who have radiation therapy for gynecological cancer may experience a number of symptoms including fatigue, pain, nausea, pelvic symptoms (urgent and frequent urination and bowel movements, vaginal discharge, vaginal itching, skin irritation), anxiety and depression. We know that individualized education programs have helped people with other types of cancer to better manage their symptoms, and we would like to find out whether such interventions are helpful to women with gynecological cancers.

This study will compare two types of education: 1) the symptom education program currently in place (usual care), and 2) an individualized symptom education program (ISEP). This study is being conducted because we do not know if one type of education in patients who receive radiation for gynecological cancers is better than the other. Both types of education are are described below.

Usual care: Usual symptom education during radiation treatment consists of receiving verbal and written education from a radiation oncologist, nurse and radiation therapist, and other members of the interdisciplinary team. The radiation therapist will see the patient everyday during her radiation treatment and her doctor and nurse will see her on a weekly basis. The patient will also see other members of the team, such as a dietitian and social worker as required.

Individualized symptom education: Individualized symptom education will include usual symptom education and also an education program that focuses on symptom management. The patient will meet with an advanced practice nurse on a weekly basis for six sessions of about 30 minutes each. The advanced practice nurse will ask about the symptoms the paient is experiencing and those that are most bothersome to her. She will be given information about specific strategies to manage those symptoms, including written education materials. These strategies will be based on published best practice guidelines.

Data on symptom experience will be collected at 3 points: at baseline, after completion of the education program (end of external beam treatment), and at 3 months following completion of the education program (3 months following completion of external radiation treatment).

Studietype

Intervensjonell

Registrering

144

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

    • Ontario
      • Toronto, Ontario, Canada
        • Princess Margaret Hospital; Toronto Sunnybrook Reginal Cancer Centre

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:

  • First time diagnosis of cancer of the uterus, cervix, vagina, or vulva
  • Beginning first time radical radiation therapy to the pelvis of at least 4000cGy (with or without brachytherapy after external beam treatment and with or without concurrent chemotherapy)
  • At least 18 years of age and over
  • Able to speak and understand English

Exclusion Criteria:

  • Receiving palliative cancer treatment
  • Receiving split course radiation treatment
  • Ovarian cancer

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Hva måler studien?

Primære resultatmål

Resultatmål
Symptom distress - measured by the Symptom Distress Scale (SDS) at baseline, end of treatment, and three (3) months post treatment.

Sekundære resultatmål

Resultatmål
All secondary outcomes measured at baseline, end of treatment, and three (3) months post treatment.
Pain - measured by the Brief Pain Inventory-Short Form (BPI-SF)
Fatigue - measured by the Brief Fatigue Inventory (BFI).
Nausea - measured by the nausea subscale (items 4, 5, 7) on the Rhodes Index of Nausea and Vomiting (INVR)
Mood symptoms - measured by the Hospital Anxiety and Depression Scale (HADS).
Pelvic symptoms - measured by the Pelvic Symptom Index (PSI)

Samarbeidspartnere og etterforskere

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

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Karima Velji, RN, MSc, AOCN, PhD(C), University of Toronto

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

1. juli 2003

Studiet fullført

1. februar 2006

Datoer for studieregistrering

Først innsendt

10. januar 2006

Først innsendt som oppfylte QC-kriteriene

10. januar 2006

Først lagt ut (Anslag)

11. januar 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. mai 2006

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mai 2006

Sist bekreftet

1. januar 2006

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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