- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04573088
Acceptance-based Intervention at Colorectal Cancer Patients (ABICOL)
Impact of Perioperative Acceptance-based Intervention on Early Psychological and Fanctional Recovery of Colorectal Cancer Patients
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Introduction: Uncertainty, fears and anxiety are common reactions to an upcoming colectomy for colorectal cancer patients and are related not only to cancer disease, but also to the inevitable change in colon anatomy, affecting their preoperative psychological and functional condition and their postsurgical recovery.
Purpose: We aim to evaluate the psychological and functional recovery of colorectal cancer patients, who undergo colectomy, after an acceptance-based nursing intervention. The scope of this brief preoperative intervention is to enable patients to cope more efficiently with the upcoming surgery and their health status, as it is expected to reduce anxiety and have positive effect on postsurgical psychological and functional recovery.
Methods: The study includes histologically diagnosed patients with colorectal cancer, regardless of stage, who are scheduled to undergo colectomy. Patients will be divided into two groups-the experimental and the control group-by simple randomization. Both groups are going to complete a set of same questionnaires regarding quality of life, sleep, anxiety, depression and functional status. Patients in the control arm will then receive treatment-as-usual while patients in the experimental arm will also receive an acceptance-based intervention before surgery. Postoperatively, for both groups, apart from the self-reported symptoms, we will assess objective recovery factors, such as postoperative complications
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Athens, Grækenland, 11528
- Rekruttering
- NKUAthens
-
Kontakt:
- George Theodoropoulos
- Telefonnummer: 6945463593
- E-mail: georgetheocrs@live.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with histologically proven colorectal adenocarcinoma
- Age > 18 years
Exclusion Criteria:
- Metastasis at time of diagnosis
- Recurrence at time of diagnosis
- History of other malignancies
- Mental retardation
- Deafness
- Illiteracy
- ASA score>3
- Poor performance status
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: ABICOL
24 hours prior to surgery the patients undergo acceptance-based intervention, incorporating questions about their subjective perception about the surgery, the domains of their lives that have been affected, and on their own expectations from surgery and its effects on their lives.
They will be asked to express their fears and worries about their condition and they will be discussed about the likelihood of experiencing postoperative pain.
|
24 hours prior to surgery the patients undergo acceptance-based intervention, incorporating questions about their subjective perception about the surgery, the domains of their lives that have been affected, and on their own expectations from surgery and its effects on their lives.
They will be asked to express their fears and worries about their condition and they will be discussed about the likelihood of experiencing postoperative pain.
|
Ingen indgriben: CONTROL
No acceptance-based intervention or other discussion related to the patients' fears and worries will be applied.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Postoperative pain as measured by VAS score
Tidsramme: Third postoperative day
|
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.The most simple VAS is a straight horizontal line of fixed length, usually 100 mm.
The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst) to the right (best).
|
Third postoperative day
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Functional status as measured by "Maintain Function" Scale (MFS)
Tidsramme: Third postoperative day
|
"Maintain function" scale is a validated 5-item summative.
Each item begins with the stem, "How confidant are you that you know or can," and assesses an aspect of daily life-function, such as work and social activities.
The responses are a 5-level Likert scale from 0 = "not at all confident" to 4 = "completely confident."
We did not include a "not applicable" response option.
The self-efficacy scores range between 0 and 20, with a higher score indicating better self-efficacy to maintain function.
|
Third postoperative day
|
Anxiety and depression measured by Brief Illness Perception Questionnaire (Brief IPQ)
Tidsramme: Third postoperative day
|
The Brief Illness Perception Questionnaire (Brief IPQ) is a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness.
The Brief IPQ uses a single-item scale approach to assess perception on a 0-10 response scale.
The Brief IBQ comprises 5 items on cognitive representation of illness perception: consequences, timeline, personal control, treatment control, and identity.
There are 2 items on emotional representation: concern and emotions.
One item is on illness comprehensibility.
The last item is on perceived cause of illness, in which respondents list the three most important causal factors in their illness.
|
Third postoperative day
|
Anxiety and depression measured by State-Trait Anxiety (STAI) questionnaire
Tidsramme: Third postoperative day
|
The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis.
The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic.
Higher scores are positively correlated with higher levels of anxiety.
|
Third postoperative day
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: George E Theodoropoulos, Associate Professor of Surgery
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Smerte
- Neurologiske manifestationer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Smerte, Procedurel
Andre undersøgelses-id-numre
- IRB6/26-2-2019
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 Kolorektale neoplasmer
-
Guangzhou First People's HospitalAfsluttet
-
University of ArkansasAktiv, ikke rekrutterendeColorectal cancer og inflammatorisk tarmsygdomForenede Stater
-
University Health Network, TorontoAstraZenecaAktiv, ikke rekrutterendeAdenocarcinom i bugspytkirtlen | Leiomyosarkom | Mismatch Reparation Proficient Colorectal CancerCanada
-
Tianjin Medical University Cancer Institute and...RekrutteringMSI-H Advanced Colorectal CancerKina
-
Bristol-Myers SquibbAktiv, ikke rekrutterendeMikrosatellit stabil kolorektal cancer | Mismatch Reparation Proficient Colorectal Cancer | Mikrosatellit ustabil kolorektal cancer | Mismatch Reparation Manglende tyktarmskræftForenede Stater, Australien, Belgien, Canada, Irland, Italien, Spanien, Frankrig
-
Syndax PharmaceuticalsMerck Sharp & Dohme LLCAfsluttetMelanom | Ikke-småcellet lungekræft | Mismatch Reparation-Proficient Colorectal CancerForenede Stater
Kliniske forsøg med ACCEPTANCE-BASED INTERVENTION
-
University of PaviaUniversità degli Studi di BresciaAfsluttetMentalt velværeItalien
-
Stockholm UniversityKarolinska Institutet; Region Stockholm; Centrum för kompetensutveckling... og andre samarbejdspartnereAktiv, ikke rekrutterende
-
Washington University School of MedicineSpinal Cord Injury/Disease Research ProgramAfsluttet
-
University of Nevada, Las VegasIkke rekrutterer endnuPost traumatisk stress syndrom
-
University of California, Los AngelesBrown University; Asociación Civil Impacta Salud y Educación, Peru; The Fenway...Afsluttet
-
Necmettin Erbakan UniversityAfsluttetVaccine tøven | BarndomsvaccinationKalkun
-
University of SheffieldPrincess Nourah Bint Abdulrahman UniversityAfsluttetSpiseforstyrrelse symptom og kropsbillede utilfredshedSaudi Arabien
-
Albert Einstein College of MedicineHealth Resources and Services Administration (HRSA); The New SchoolAfsluttetVold i hjemmet | BørnemishandlingForenede Stater
-
Stanford UniversityAnonymous DonorRekrutteringAutismespektrumforstyrrelse | Autisme | ASDForenede Stater