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Psychological Counselling in Diagnostic Screening

20. Dezember 2013 aktualisiert von: Malihe Shams, Istituto Oncologico Veneto IRCCS

Management of Anxiety Related to Diagnostic Screenings: an Exploratory Pilot Study

Diagnostic tests have a deep emotional impact on oncology patients. Anxiety and worries can lead people to avoid screening tests, with high risks for health. A single arm, pilot study was organized to evaluate the feasibility and efficacy of psychological counselling for cancer patients who demonstrated anxiety for diagnostic tests. The hypothesis was that taking part in Psychoeducative Training could offer a new modality to reduce anxiety, before and during tests, and also the possibility to reinforce coping strategies.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The Psychoeducative Training was organized in 6 weekly meetings lasting two hours. Each group was composed of 6 participants. The Training follows the cognitive-behavioural model. In the first part of every meeting, theoretical aspects about stress and anxiety were explained, while in the second part some relaxation techniques were taught. During relaxation, we used a selected music that was also going to be used during the diagnostic tests. Since the first meeting, patients experienced these relaxing techniques in order to learn them. In order to support the adaptability, at the end of every meeting the participants received some homework. They had to take notes on how many times they repeated the relaxation exercises and on the anxiety level before and after the training.

For the study, 43 people were recruited. Anxiety was measured with Beck Anxiety Inventory (BAI); it values the seriousness of the physiological behaviour connected with anxiety. This test an "anxiety gauge", which allows us to obtain numerical data on emotional changes. The test is composed of 4 interpretative levels: serious, moderate, small and minimal anxiety.

The coping style was measured with Coping Orientation to Problems Experienced-New Italian Version (COPE-NIV); this test evaluates the way in which people resolve and face traumatic or usual stressful situations.

The research project was approved by the Ethics Committee of Veneto Institute of Oncology.

Every patient signed a written informed consent to process the data for research purposes and to publish it.

Forty-three patients who had to undergo one or more diagnostic tests (PET, TAC, fMRI, Mammography, Endoscopy, Colonoscopy) took part in the study. The average age was 52.4 and 61.5% were married.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

43

Phase

  • Unzutreffend

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

25 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • age: 25 to 65 years cancer patients who must undergo diagnostic tests: TAC, PET, fMRI, Mammography, Endoscopy and Colonoscopy.
  • an anxiety level greater than 5 (in a scale from 0=very calm to 10=very anxious; using a self-reporting instrument created ad hoc)
  • signed informed consent

Exclusion Criteria:

  • healthy people

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: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Pilot group
Forty-three patients who had to undergo one or more diagnostic tests (PET, TAC, fMRI, Mammography, Endoscopy, Colonoscopy) took part in the study. Most of the 43 patients had to undergo only one diagnostic test, and only 6 patients had more than one. They have attended a psychoeducative training.
The Psychological education was inspired by the technique, Systematic Desensitization (SD), a therapeutic procedure that seeks to eliminate fear and avoidance behaviour
Andere Namen:
  • Systematic Desensitization
  • Psychological counseling

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of patients considered drop-outs
Zeitfenster: 6 weeks after recruitment (end of treatment)
The proportion of patients considered drop-outs. A patient is considered a drop-out if he/she does not attend at least 2 out of 6 programmed meetings. This is a feasibility outcome
6 weeks after recruitment (end of treatment)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
median BAI score after intervention
Zeitfenster: 6 weeks after recruitment (end of treatment)
This is an efficacy outcome
6 weeks after recruitment (end of treatment)
median COPE score - Social support score after intervention
Zeitfenster: 6 weeks after recruitment (end of treatment)
This is an efficacy outcome
6 weeks after recruitment (end of treatment)
median COPE score - Avoidance strategies score after intervention
Zeitfenster: 6 weeks after recruitment (end of treatment)
This is an efficacy outcome
6 weeks after recruitment (end of treatment)
median COPE score - Positive attitude score after intervention
Zeitfenster: 6 weeks after recruitment (end of treatment)
This is an efficacy outcome
6 weeks after recruitment (end of treatment)
median COPE score - Problem acceptance score after intervention
Zeitfenster: 6 weeks after recruitment (end of treatment)
This is an efficacy outcome
6 weeks after recruitment (end of treatment)
recruitment time (process)
Zeitfenster: 6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)
mean number of recruited patients per week (process)
Zeitfenster: 6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)
refusal rate among eligible patients (process)
Zeitfenster: 6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)
rate of patients who obviously meet and do not meet the eligibility requirements (process)
Zeitfenster: 6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)
number of questionnaires correctly filled out (process)
Zeitfenster: 6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)
phone lines overloaded or waiting room overcrowded by study participants (management)
Zeitfenster: 6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)

Mitarbeiter und Ermittler

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

Ermittler

  • Hauptermittler: Malihe Shams, Istituto Oncologico Veneto IRCCS

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

1. April 2012

Primärer Abschluss (Tatsächlich)

1. Februar 2013

Studienabschluss (Tatsächlich)

1. Mai 2013

Studienanmeldedaten

Zuerst eingereicht

17. Dezember 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Dezember 2013

Zuerst gepostet (Schätzen)

23. Dezember 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

23. Dezember 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Dezember 2013

Zuletzt verifiziert

1. Dezember 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • IOV-2012 ANXIETY

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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