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Psychological Counselling in Diagnostic Screening

20 décembre 2013 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

43

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

25 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Autres noms:
  • Systematic Desensitization
  • Psychological counseling

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of patients considered drop-outs
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
median BAI score after intervention
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 6 weeks after recruitment (end of treatment)
This is an efficacy outcome
6 weeks after recruitment (end of treatment)
recruitment time (process)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 6 weeks after recruitment (end of treatment)
This is a feasibility outcome
6 weeks after recruitment (end of treatment)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Malihe Shams, Istituto Oncologico Veneto IRCCS

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2012

Achèvement primaire (Réel)

1 février 2013

Achèvement de l'étude (Réel)

1 mai 2013

Dates d'inscription aux études

Première soumission

17 décembre 2013

Première soumission répondant aux critères de contrôle qualité

20 décembre 2013

Première publication (Estimation)

23 décembre 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

23 décembre 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 décembre 2013

Dernière vérification

1 décembre 2013

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • IOV-2012 ANXIETY

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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