- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03899441
Multimedia Aid Gynecologic Counseling and Consent
10. august 2020 opdateret af: UNC Lineberger Comprehensive Cancer Center
Does Multimedia Perioperative Teaching Improve Patient Experience in the Treatment of Endometrial Cancer
This is an interventional trial to introduce two short animated videos into preoperative counseling/consent and to compare patient comprehension and satisfaction with a multimedia approach compared to standard of care currently.
The investigators anticipate that patients will retain more information about their surgery and peri-operative care and will be more satisfied with a multimedia approach.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
The investigators plan a pilot study where patients will be randomized to receiving standard consent and teaching prior to their planned surgery for endometrial cancer or standard consent and multimedia video aid with targeted teaching.
This video will be an adjunct to the standard consent process and supplement the pre and post-operative teaching that is currently not formalized.
The primary outcome is patient satisfaction.
The secondary outcomes include patient understanding and physician satisfaction.
The investigators hypothesize that patients will be more satisfied when their consent for surgery is done in conjunction with this multimedia aid.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
87
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- Univeristy of North Carolina at Chapel Hill
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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
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- English-speaking
- Has diagnosis of endometrial cancer
- Planned minimally invasive surgical treatment with hysterectomy and sentinel lymph node biopsy
Exclusion Criteria:
- Non-English speaking
- Pregnant
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Control
Patients in the control arm will have pre-operative teaching from their physician and sign consent for surgery, as is the current standard of care at the investigators' institution.
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Eksperimentel: Video arm
Patients in the intervention arm will watch two short animated video about minimally-invasive endometrial cancer surgery followed by focused pre-operative teaching from their physician.
They will then sign consent for surgery.
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Two short animated videos - one that reviews minimally-invasive surgery and sentinel lymph node mapping and biopsy for endometrial cancer treatment.
This video as reviews possible complications.
The second video reviews peri-operative instructions.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Patient satisfaction
Tidsramme: 1 day (assessed at first visit)
|
Patient satisfaction with the clinic visit (either new patient visit where they are consented for surgery or a pre-operative visit).
Patient satisfaction will be measured using two survey tools: a single question to assess global satisfaction with the clinic visit (on a scale from 1-10) and an 8 question validated satisfaction survey (Client Satisfaction Questionnaire-8 or CSQ-8).
Patient satisfaction will be compared between the control and intervention groups.
For the single question satisfaction question, answers are on a scale from 1-10, the higher numbers indicating higher satisfaction.
The CSQ8 survey contains 8 questions that all have answers ranging from 1 to 4, with higher numbers indicating higher satisfaction.
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1 day (assessed at first visit)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Patient comprehension
Tidsramme: 6-8 weeks (assessed at 3 time points - first clinic visit, inpatient at time of surgery, and at follow-up visit 4-6 weeks after surgery)
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Patient comprehension (of the surgery, its complication, and peri-operative instructions) will be measured using a 9 question survey developed by the study investigators.
This survey was developed to assess patient understanding on key information reviewed either in the study videos or by physicians during pre-operative counseling.
Patient comprehension will be assessed at three different time points (using the same survey) to compare comprehension immediately after watching the video or undergoing standard physician counseling and again during the patient's hospital stay and at the follow-up visit.
Comprehension scores will be compared between the control and intervention groups.
The comprehension surveys questions will all be awarded points for correct answers, with higher answers indicating more comprehension of topics relating to the surgery.
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6-8 weeks (assessed at 3 time points - first clinic visit, inpatient at time of surgery, and at follow-up visit 4-6 weeks after surgery)
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Physician satisfaction
Tidsramme: 1 day (assessed at first visit)
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Physician satisfaction with new patient or pre-operative visit.
Physician satisfaction will be measured using a single question to assess global satisfaction with the clinic visit (on a scale from 1-10, with higher numbers indicating higher satisfaction).
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1 day (assessed at first visit)
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Visit length
Tidsramme: 1 day (assessed during first visit)
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Time of new patient or pre-operative visit.
The length of visits will be recorded (from the time the physician first enters the patient room until the visit is complete and the patient is leaving the clinic room).
Appointment times will be compared between the control and intervention group, for pre-operative visits and new patient visits.
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1 day (assessed during first visit)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Katherine Tucker, MD, UNC Hospital
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 (Faktiske)
1. oktober 2018
Primær færdiggørelse (Faktiske)
1. april 2020
Studieafslutning (Faktiske)
1. april 2020
Datoer for studieregistrering
Først indsendt
1. marts 2019
Først indsendt, der opfyldte QC-kriterier
29. marts 2019
Først opslået (Faktiske)
2. april 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. august 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2020
Sidst verificeret
1. august 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LCCC 1821
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