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Psychological Counselling in Diagnostic Screening

20 dicembre 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

43

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 25 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Altri nomi:
  • Systematic Desensitization
  • Psychological counseling

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of patients considered drop-outs
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
median BAI score after intervention
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6 weeks after recruitment (end of treatment)
This is an efficacy outcome
6 weeks after recruitment (end of treatment)
recruitment time (process)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Malihe Shams, Istituto Oncologico Veneto IRCCS

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2012

Completamento primario (Effettivo)

1 febbraio 2013

Completamento dello studio (Effettivo)

1 maggio 2013

Date di iscrizione allo studio

Primo inviato

17 dicembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

20 dicembre 2013

Primo Inserito (Stima)

23 dicembre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

23 dicembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 dicembre 2013

Ultimo verificato

1 dicembre 2013

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • IOV-2012 ANXIETY

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

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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