- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01866228
Clinical Trial of the Impact of Treatment Consultation Recordings on Cancer Patient Outcomes
19. februar 2018 opdateret af: Dr. Tom Hack, University of Manitoba
Impact of Treatment Consultation Recordings on Cancer Patient Outcomes: A Prospective, Parallel, Randomized Controlled Trial
The time period from diagnosis through to the end of treatment is challenging for patients.
Patients need information, assistance with decision making, and emotional and social support to help cope with their diagnosis and treatment.
The first meeting with the cancer doctor is especially anxiety-provoking for patients who will learn, for the first time, their treatment options and likelihood of being cured.
This anxiety causes many patients to have difficulty remembering the important pieces of information that their cancer doctor tells them during this consultation.
The main goal of this study is to demonstrate the benefits of giving cancer patients an audio-recording of their first consultation with their cancer doctor.
The investigators will include newly diagnosed patients from cancer centres in Winnipeg and Calgary.
The types of cancer that will be included in this study are brain and neuroendocrine.
Patients with these types of cancer are more likely to have confused thinking, and therefore may have the most to gain from receiving their consultation recordings.
The study will include 244 patients, and those who sign consent forms to participate will be assigned by chance to either receive their treatment consultation recording or not.
Patients will receive their recording immediately after their consultation, and will be able to listen to the recording at any time either alone, or with family and friends.
To figure out whether the consultation recording provides patients with benefits, the investigators will administer some questionnaires to patients at 1 week after the consultation, and again at 3 and 6 months after the consultation.
These questionnaires will assess the following patient outcomes: i) anxiety and depression, ii) perception of being informed about the disease and treatment, iii) satisfaction with cancer care, iv) satisfaction with the doctor, and v) the extent to which patients are satisfied with their degree of involvement in treatment decision making.
The investigators hypothesize that patients who receive their consultation recording will experience more benefits than patients who do not receive their consultation recording.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
140
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- British Columbia Cancer Agency
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 0V9
- Cancer Care Manitoba
-
-
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
Alle
Beskrivelse
Inclusion Criteria:
- presenting with a primary diagnosis of non-recurrent or metastatic brain, or neuroendocrine cancer
- 18 years of age or older
- able to read and communicate using the English language
- access to a computer to enable consultation playback
Exclusion Criteria:
- deemed by a treating clinician (or primary nurse for the treating clinician) to have any severe psychiatric condition or cognitive dysfunction that precludes provision of free and informed consent to participate
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: No Consultation Recording
Participant does not receive consultation recording
|
|
Eksperimentel: Consultation Recording
Participant receives consultation recording
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change from Baseline in Control Preferences Scale at 1-week post-consultation
Tidsramme: 1-week post-consultation
|
Subjective report of actual role played in decision making.
|
1-week post-consultation
|
Change from Baseline in Control Preferences Scale at 3-months post-consultation
Tidsramme: 3-months post-consultation
|
Subjective report of actual role played in decision making.
|
3-months post-consultation
|
Change from Baseline in Control Preferences Scale at 6-months post-consultation
Tidsramme: 6-months post-consultation
|
Subjective report of actual role played in decision making.
|
6-months post-consultation
|
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 1-week post-consultation
Tidsramme: 1-week post-consultation
|
1-week post-consultation
|
|
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 3-months post-consultation
Tidsramme: 3-months post-consultation
|
3-months post-consultation
|
|
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 6-months post-consultation
Tidsramme: 6-months post-consultation
|
6-months post-consultation
|
|
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 1-week post-consultation
Tidsramme: 1-week post-consultation
|
1-week post-consultation
|
|
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 3-months post-consultation
Tidsramme: 3-months post-consultation
|
3-months post-consultation
|
|
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 6-months post-consultation
Tidsramme: 6-months post-consultation
|
6-months post-consultation
|
|
Change from Baseline in Hospital Anxiety and Depression Scale at 1-week post-consultation
Tidsramme: 1-week post-consultation
|
1-week post-consultation
|
|
Change from Baseline in Hospital Anxiety and Depression Scale at 3-months post-consultation
Tidsramme: 3-months post-consultation
|
3-months post-consultation
|
|
Change from Baseline in Hospital Anxiety and Depression Scale at 6-months post-consultation
Tidsramme: 6-months post-consultation
|
6-months post-consultation
|
|
Change from Baseline in Perception of Being Informed Scale at 1-week post-consultation
Tidsramme: 1- week post-consultation
|
1- week post-consultation
|
|
Change from Baseline in Perception of Being Informed Scale at 3-months post-consultation
Tidsramme: 3-months post-consultation
|
3-months post-consultation
|
|
Change from Baseline in Perception of Being Informed Scale at 6-months post-consultation
Tidsramme: 6-months post-consultation
|
6-months post-consultation
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Thomas F Hack, PhD, University of Manitoba
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.
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. juni 2013
Primær færdiggørelse (Faktiske)
1. februar 2017
Studieafslutning (Faktiske)
1. december 2017
Datoer for studieregistrering
Først indsendt
16. april 2013
Først indsendt, der opfyldte QC-kriterier
27. maj 2013
Først opslået (Skøn)
31. maj 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. februar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. februar 2018
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Adenocarcinom
- Karcinom
- Neoplasmer, kirtel og epitel
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neoplasmer i centralnervesystemet
- Neoplasmer i nervesystemet
- Neuroendokrine tumorer
- Neoplasmer i hjernen
- Karcinom, neuroendokrin
Andre undersøgelses-id-numre
- H2013:085
- 126049 (Andet bevillings-/finansieringsnummer: Canadian Institutes of Health Research/126049)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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 .
Kliniske forsøg med Hjerne svulst
-
Assistance Publique Hopitaux De MarseilleUkendt
-
National Institute of Mental Health (NIMH)AfsluttetKÆLEDYR | Brain Imaging | Cannabinoid | CB1Forenede Stater
-
GE HealthcareAfsluttetBrain Imaging | Billedbehandling af hele kroppenForenede Stater
-
Mayo ClinicTilmelding efter invitationBrain Imaging | Billedbehandling af hele kroppenForenede Stater
-
Tang-Du HospitalIkke rekrutterer endnuPsykisk lidelse | Sociale medier | Brain Imaging
-
University Hospital TuebingenAfsluttetFunktionel dyspepsi | Mad | Brain ImagingTyskland
-
University of MichiganAfsluttetÆndringer i Brain Network ConnectivityForenede Stater
-
School of Health Sciences GenevaUniversity of Lausanne Hospitals; University of Geneva, SwitzerlandRekrutteringMR scanning | Opførsel | Funktionel magnetisk resonansbilleddannelse | Musik | Udvikling, barn | Brain Imaging | Executive funktioner | Hjerneplasticitet | Interventioner | Kunst | Strukturel hjerneforbindelseSchweiz
-
Rigshospitalet, DenmarkLundbeck Foundation; Filadelfia Epilepsy Hospital; Lennart Grams Mindefond...AfsluttetKirurgi | Refraktær epilepsi | Elektroencefalografi | Brain ImagingDanmark
-
Sándor BeniczkyHospital del Mar; Centro Hospitalar e Universitário de Coimbra, E.P.E.; Motol... og andre samarbejdspartnereAktiv, ikke rekrutterendeKirurgi | Refraktær epilepsi | Elektroencefalografi | Brain ImagingSpanien, Portugal, Østrig, Tjekkiet, Danmark, Tyskland, Italien, Rumænien
Kliniske forsøg med Consultation Recording
-
Saint John's Cancer InstituteTrukket tilbageKræft | Omsorgspersoner | Kliniske forsøgForenede Stater
-
Boninger, Michael, MDNational Institute of Neurological Disorders and Stroke (NINDS); Ripple...RekrutteringAmputation | Amputation; Traumatisk, HåndForenede Stater
-
Hackensack Meridian HealthAmerican Music Therapy AssociationRekrutteringSkizofrenispektrum og andre psykotiske lidelser | Maniodepressiv | Angst lidelse | Psykiske problemer | DepressivForenede Stater
-
American Institutes for ResearchWisconsin Center for Education Research; University of Nebraska College...RekrutteringFølelsesmæssige forstyrrelserForenede Stater
-
Anna HooverNational Institute of Environmental Health Sciences (NIEHS)RekrutteringDesinfektionsbiprodukterForenede Stater
-
University of FloridaAfsluttetAldring | Ændring af kognitiv funktionForenede Stater
-
VA Office of Research and DevelopmentCase Western Reserve UniversityAfsluttetRygmarvsskader | Tetraplegi | QuadriplegiForenede Stater
-
The University of Texas Health Science Center,...UkendtSelvforsømmelseForenede Stater
-
Esin Merve Erol KoçAfsluttetLivskvalitet | Ufrivillig vandladning | Angst under graviditet (lidelse)Kalkun
-
Koç UniversityIkke rekrutterer endnuLivskvalitet | Inkontinens, Urge | Inkontinens Stress