- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04839874
Health Seeking Behaviour in Women Diagnosed With Gynaecological Cancer: Can it be Modified to Improve Patient Outcomes?
Studie Overzicht
Gedetailleerde beschrijving
The study will explore the research questions using qualitative semi-structured interviews with women diagnosed with gynaecological cancer. A study information sheet, reply slip and a reply-paid envelope will be sent to eligible patients by their secondary care clinician, with reminders sent after two weeks. Recruitment and interviewing will take place until data saturation occurs (three interviews with no new shared beliefs) on the main themes. Interviews will take place at a mutually convenient time and place, ideally face to face but could be conducted over the telephone if preferred by the interviewee or if social distancing measures are still in place due to Covid-19. Further verbal and written information regarding the study will be provided prior to interview commencement and participants will be given the opportunity to ask questions. Those agreeing to take part in a face to face interview will sign a consent form in duplicate (one for the participant and one copy for the research team). Those participating in a telephone interview will be read each point of the consent form and asked to agree to each one. This will be recorded, transcribed and used as evidence of consent. Interviews will be conducted flexibly allowing for shorter interviews where necessary and participants will be reminded that the interviews can be terminated at any time. The participant can withdraw from the study at any time: data already collected with consent will be retained and used in the study. No further data will be collected, or any other research procedures carried out on or in relation to the participant. All interviews will be digitally audio recorded and transcribed verbatim by the CI or NHSG approved transcription service. The data will be stored and managed using NVivo software. Interviews will follow a semi-structured topic guide based on the COM-B behaviour change model concepts of capability, opportunity and motivation. Changes can be made to the topic guide as interviews are conducted. Data familiarisation will be by reading and rereading transcripts and by listening to the recorded interviews. Data will be analysed using iterative deductive and inductive methods combining Framework analysis and thematic analysis.
A contact will be provided for patients should they become distressed because of contact by or participation in the study. Although all data collected will stored and analysed with the strictest of confidence in line with the General Data Protection Regulations (2018), if details of any improper conduct or poor practice are disclosed the research team may be obliged to report this. The participant's GP will not be informed. Study participants will have any travel costs reimbursed.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Aberdeen City
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Aberdeen, Aberdeen City, Verenigd Koninkrijk
- NHS Grampian
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Clinical diagnosis of gynaecological cancer
Exclusion Criteria:
- Non-English speaking participants
- Cognitive impairment
- Terminal stage of illness
- Diagnosis through screening programmes
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Description of the facilitators and barriers to health seeking behaviour in women diagnosed with gynaecological cancer using semi-structured qualitative interviews.
Tijdsspanne: 2 years
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Semi-structured interviews will be used to explore the facilitators and barriers to health seeking behaviour in women who have been diagnosed with a gynaecological cancer.
Analysis will be narrative using both framework and thematic analysis Framework analysis will use the constructs of capability, opportunity and motivation of the COM-B behaviour tool model.
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2 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Description of the perceptions of pelvic examination in women diagnosed with gynaecological cancer using semi-structured interviews.
Tijdsspanne: 2 years
|
Semi-structured interviews will be used to explore the perceptions to pelvic examination in women who have been diagnosed with a gynaecological cancer.
Analysis will be narrative using both framework and thematic analysis Framework analysis will use the constructs of capability, opportunity and motivation of the COM-B behaviour tool model.
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2 years
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Pauline Williams, University of Aberdeen
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NHS Grampian
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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