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Acceptance-based Intervention at Colorectal Cancer Patients (ABICOL)

1. Oktober 2020 aktualisiert von: George Theodoropoulos, National and Kapodistrian University of Athens

Impact of Perioperative Acceptance-based Intervention on Early Psychological and Fanctional Recovery of Colorectal Cancer Patients

Taking into account the unavoidable effect of a major oncologic surgery commonly required for colorectal cancer patients and the recognized psychological and functional sequelae of the surgical treatment on their status, we will evaluate the influence of a psychological intervention, known as acceptance-based intervention, offered to those patients at the preoperative setting. Reduction of anxiety and assessmemt of indices of post-intervention psychological and functional recovery will be the primary goals of the study.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: ACCEPTANCE-BASED INTERVENTION
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.
Kein Eingriff: CONTROL
No acceptance-based intervention or other discussion related to the patients' fears and worries will be applied.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Postoperative pain as measured by VAS score
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Functional status as measured by "Maintain Function" Scale (MFS)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National and Kapodistrian University of Athens

Ermittler

  • Hauptermittler: George E Theodoropoulos, Associate Professor of Surgery

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

22. Juni 2020

Primärer Abschluss (Voraussichtlich)

22. Juni 2021

Studienabschluss (Voraussichtlich)

20. Januar 2022

Studienanmeldedaten

Zuerst eingereicht

16. September 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Oktober 2020

Zuerst gepostet (Tatsächlich)

5. Oktober 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Oktober 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Oktober 2020

Zuletzt verifiziert

1. Oktober 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB6/26-2-2019

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Sharing clinical trial data with other professional organizations and researchers will be important element to support best practice principles in our clinical trial.

IPD-Sharing-Zeitrahmen

At completion of study and analysis of results

IPD-Sharing-Zugriffskriterien

If requested for universal prospective registration If requested by journals for publication If requested by researchers running similar clinical trials

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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