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Psychological Counselling in Diagnostic Screening

20 december 2013 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

43

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

25 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of patients considered drop-outs
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
median BAI score after intervention
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 6 weeks after recruitment (end of treatment)
This is an efficacy outcome
6 weeks after recruitment (end of treatment)
recruitment time (process)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Malihe Shams, Istituto Oncologico Veneto IRCCS

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2012

Primaire voltooiing (Werkelijk)

1 februari 2013

Studie voltooiing (Werkelijk)

1 mei 2013

Studieregistratiedata

Eerst ingediend

17 december 2013

Eerst ingediend dat voldeed aan de QC-criteria

20 december 2013

Eerst geplaatst (Schatting)

23 december 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

23 december 2013

Laatste update ingediend die voldeed aan QC-criteria

20 december 2013

Laatst geverifieerd

1 december 2013

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • IOV-2012 ANXIETY

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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