- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02018471
Psychological Counselling in Diagnostic Screening
Management of Anxiety Related to Diagnostic Screenings: an Exploratory Pilot Study
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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.
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The Psychological education was inspired by the technique, Systematic Desensitization (SD), a therapeutic procedure that seeks to eliminate fear and avoidance behaviour
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Proportion of patients considered drop-outs
Aikaikkuna: 6 weeks after recruitment (end of treatment)
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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
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6 weeks after recruitment (end of treatment)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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median BAI score after intervention
Aikaikkuna: 6 weeks after recruitment (end of treatment)
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This is an efficacy outcome
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6 weeks after recruitment (end of treatment)
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median COPE score - Social support score after intervention
Aikaikkuna: 6 weeks after recruitment (end of treatment)
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This is an efficacy outcome
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6 weeks after recruitment (end of treatment)
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median COPE score - Avoidance strategies score after intervention
Aikaikkuna: 6 weeks after recruitment (end of treatment)
|
This is an efficacy outcome
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6 weeks after recruitment (end of treatment)
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median COPE score - Positive attitude score after intervention
Aikaikkuna: 6 weeks after recruitment (end of treatment)
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This is an efficacy outcome
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6 weeks after recruitment (end of treatment)
|
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median COPE score - Problem acceptance score after intervention
Aikaikkuna: 6 weeks after recruitment (end of treatment)
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This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
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recruitment time (process)
Aikaikkuna: 6 weeks after recruitment (end of treatment)
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This is a feasibility outcome
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6 weeks after recruitment (end of treatment)
|
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mean number of recruited patients per week (process)
Aikaikkuna: 6 weeks after recruitment (end of treatment)
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This is a feasibility outcome
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6 weeks after recruitment (end of treatment)
|
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refusal rate among eligible patients (process)
Aikaikkuna: 6 weeks after recruitment (end of treatment)
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This is a feasibility outcome
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6 weeks after recruitment (end of treatment)
|
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rate of patients who obviously meet and do not meet the eligibility requirements (process)
Aikaikkuna: 6 weeks after recruitment (end of treatment)
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This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
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number of questionnaires correctly filled out (process)
Aikaikkuna: 6 weeks after recruitment (end of treatment)
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This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
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phone lines overloaded or waiting room overcrowded by study participants (management)
Aikaikkuna: 6 weeks after recruitment (end of treatment)
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This is a feasibility outcome
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6 weeks after recruitment (end of treatment)
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Malihe Shams, Istituto Oncologico Veneto IRCCS
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
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- IOV-2012 ANXIETY
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