- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Athens, Grecia, 11528
- Reclutamento
- NKUAthens
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Contatto:
- George Theodoropoulos
- Numero di telefono: 6945463593
- Email: georgetheocrs@live.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
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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.
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Nessun intervento: CONTROL
No acceptance-based intervention or other discussion related to the patients' fears and worries will be applied.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Postoperative pain as measured by VAS score
Lasso di tempo: Third postoperative day
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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).
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Third postoperative day
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Functional status as measured by "Maintain Function" Scale (MFS)
Lasso di tempo: Third postoperative day
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"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.
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Third postoperative day
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Anxiety and depression measured by Brief Illness Perception Questionnaire (Brief IPQ)
Lasso di tempo: Third postoperative day
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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.
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Third postoperative day
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Anxiety and depression measured by State-Trait Anxiety (STAI) questionnaire
Lasso di tempo: Third postoperative day
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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.
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Third postoperative day
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Collaboratori e investigatori
Investigatori
- Investigatore principale: George E Theodoropoulos, Associate Professor of Surgery
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Neoplasie
- Neoplasie per sede
- Dolore
- Manifestazioni neurologiche
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie gastrointestinali
- Malattie del colon
- Malattie intestinali
- Neoplasie intestinali
- Malattie del retto
- Neoplasie colorettali
- Dolore, Procedurale
Altri numeri di identificazione dello studio
- IRB6/26-2-2019
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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