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Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer

14. november 2019 opdateret af: University of Wisconsin, Madison

Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer

This randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with gynecologic cancer. Discussing sexual outcomes and counseling options with patients may help improve sexual outcomes and/or anxiety after primary gynecologic cancer treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVES:

I. To evaluate the feasibility of patient recruitment, including time required to consent, enroll and retain the necessary number of participants.

II. To determine the distribution of candidate primary patient-reported outcome measures, including time to resumption of sexual activity, global satisfaction with sex life, sexual function and anxiety in this particular population.

III. To establish the prevalence of patient recall of the intervention to determine the most effective time at which to deliver the intervention.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit.

ARM II: Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit.

ARM III: Patients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit.

ARM IV: Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin, Madison

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Patients with a new suspected or confirmed gynecologic malignancies
  • Patients plan to have primary surgery at either the University of Chicago Hospital or the University of Wisconsin Hospital
  • Patients must be English speaking

Exclusion Criteria:

  • Previous treatment of any cancer excluding skin cancer
  • Patients with a suspected benign gynecologic process
  • Patients who are prisoners or incarcerated

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm I (standard counseling)
Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit.
Andet: spørgeskemaadministration
Hjælpestudier
Andet: counseling intervention
Given standard counseling
Andre navne:
  • rådgivning og kommunikationsstudier
Eksperimentel: Arm II (standard counseling, scripted intervention)
Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit.
Andet: spørgeskemaadministration
Hjælpestudier
Andet: counseling intervention
Given standard counseling
Andre navne:
  • rådgivning og kommunikationsstudier
Andet: informational intervention
Given scripted intervention
Eksperimentel: Arm III (standard counseling, scripted intervention)
Patients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit.
Andet: spørgeskemaadministration
Hjælpestudier
Andet: counseling intervention
Given standard counseling
Andre navne:
  • rådgivning og kommunikationsstudier
Andet: informational intervention
Given scripted intervention
Eksperimentel: Arm IV (standard counseling, scripted intervention)
Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.
Andet: spørgeskemaadministration
Hjælpestudier
Andet: counseling intervention
Given standard counseling
Andre navne:
  • rådgivning og kommunikationsstudier
Andet: informational intervention
Given scripted intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of patient recruitment
Tidsramme: Up to 9 months
To inform possible issues in recruitment for a large-scale randomized controlled trial, the ratio of enrolled subjects to total eligible potential subjects as well as the time necessary to recruit those subjects will be tracked.
Up to 9 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Resumption of sexual activity after cancer surgery
Tidsramme: Up to 9 months
Resumption of sexual activity after cancer surgery will be measured using items adapted from a previous national, multi-site study of sexual outcomes following an acute myocardial infarction.
Up to 9 months
Retention
Tidsramme: Up to 9 months
The percentage of subjects completing the final assessment from the total number of subjects enrolled will be calculated.
Up to 9 months
Satisfaction with sex life independent of specific sexual function measured by Patient Reported Outcomes Measurement Information System (PROMIS) Global Satisfaction with Sex Life questionnaire
Tidsramme: Up to 9 months
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
Up to 9 months
PROMIS Sexual Function Profile
Tidsramme: Up to 9 months
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
Up to 9 months
Recall of intervention
Tidsramme: Up to 9 months
Subjects will be queried to learn whether they recall receiving physician counseling about sexual health outcomes after surgery with follow up questions regarding whether or not the patient has spoken with other healthcare providers about sexual concerns.
Up to 9 months
Patient-reported anxiety measured by PROMIS Anxiety 4a short form
Tidsramme: Up to 6 months
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
Up to 6 months
Rate of referral acceptance
Tidsramme: Up to 9 months
The rate of acceptance of sexual health clinic referrals as well as rates of utilization of these referrals will be tracked using medical record abstraction.
Up to 9 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Wisconsin, Madison

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: David Kushner, University of Wisconsin, Madison

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. september 2014

Primær færdiggørelse (Faktiske)

1. juni 2015

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

21. marts 2014

Først indsendt, der opfyldte QC-kriterier

21. marts 2014

Først opslået (Skøn)

26. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. november 2019

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UW13080 (Anden identifikator: University of Wisconsin Carbone Cancer Center)
  • P30CA014520 (U.S. NIH-bevilling/kontrakt)
  • A532820 (Anden identifikator: UW Madison)
  • SMPH/OBSTET & GYNECOL/OBSTET (Anden identifikator: UW Madison)
  • NCI-2014-00471 (Registry Identifier: NCI Trial ID)
  • 2014-0122 (Anden identifikator: Institutional Review Board)

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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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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