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Prospective Study Assessing Emotional, Sexual and Quality of Life Concerns Of Women Undergoing Removal of the Cervix Versus Removal of the Uterus,Ovaries and Fallopian Tubes For Treatment Of Early Stage Cervical Cancer

30. november 2010 opdateret af: Memorial Sloan Kettering Cancer Center

A Prospective Study Assessing the Emotional, Sexual and Quality of Life Concerns Of Women Undergoing Radical Trachelectomy Versus Radical Hysterectomy For Treatment Of Early Stage Cervical Cancer

The purpose of this study is to will help us understand how two treatments impact women with early stage cervical cancer: a radical hysterectomy, which removes the entire uterus, the ovaries, and fallopian tubes versus a radical trachelectomy which removes the cervix, which is the bottom part of the uterus. The second leaves the rest of the uterus, the ovaries, and fallopian tubes. This means that there is a chance that the woman might be able to get pregnant in the future with this type of treatment. We believe that these two operations need further study to see how they impact women. This study will look at emotions and issues of fertility. The study will also ask about quality of life and sexual functioning. What we learn from this study will help us give better information to women considering these treatments.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This project will prospectively assess and describe the emotional, sexual and quality of life impact of radical trachelectomy in comparison to the standard treatment of radical hysterectomy in women with early stage cervical cancer over a two year time period. Women being considered for radical trachelectomy with laparoscopic pelvic lymphadenectomy or radical hysterectomy (abdominal, laparoscopic or schauta) will be approached for study participation prior to undergoing surgery. After providing informed consent, participants will be given a survey questionnaire pre-operatively and asked to complete follow-up surveys post-operatively at follow up medical appointments at 3 months, 6 months, 12 months, 18 months and 24 months. We will assess the following domains in these women; mood, sexual functioning, and quality of life in addition to issues of fertility and treatment choice. The survey will take approximately 30 minutes to complete. The findings will be used to provide additional information to women considering these procedures and enable future interventions to be designed to meet any identified needs. In addition, the findings of this study will also be presented for consideration of a multi-center feasibility study.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

72

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan Kettering Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Women with early stage cervical cancer undergoing either radical trachelectomy or radical hysterectomy

Beskrivelse

Inclusion Criteria:

  • Patients should be suitable surgical candidates and completed the surgical consenting process with their gynecologic oncology surgeon.
  • Confirmed invasive cervical cancer: squamous, adeno, or adenosquamous.
  • FIGO Stage IA1 with lymph-vascular space involvement or stage IA2-IB2).
  • Consented for a radical trachelectomy (vaginal/abdominal) or radical hysterectomy (laparoscopic/abdominal).
  • Have not started or completed childbearing.
  • Strong desire to preserve fertility (trachelectomy group only).
  • At least 18 years of age and not older than 45 years at the time of treatment.
  • Able to read/ speak the English language.
  • Able to provide informed conse

Exclusion Criteria:

  • Inability to participate in an informed consent process.
  • Patients with a psychiatric disorder precluding response to the survey.
  • Patients that are upstaged at the time of surgery and will require adjuvant therapy.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
1
Women with early stage cervical cancer undergoing radical trachelectomy
2
Women with early stage cervical cancer undergoing radical hysterectomy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Assess emotional, sexual and quality of life of women with early stage cervical cancer undergoing radical trachelectomy and to compare same between women undergoing radical trachelectomy versus standard radical hysterectomy (all forms).
Tidsramme: 12 months
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Memorial Sloan Kettering Cancer Center

Efterforskere

  • Ledende efterforsker: Jeanne Carter, PhD, Memorial Sloan Kettering Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2004

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

19. december 2007

Først indsendt, der opfyldte QC-kriterier

19. december 2007

Først opslået (Skøn)

24. december 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. december 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. november 2010

Sidst verificeret

1. november 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 03-148

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner