- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02018471
Psychological Counselling in Diagnostic Screening
Management of Anxiety Related to Diagnostic Screenings: an Exploratory Pilot Study
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Proportion of patients considered drop-outs
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
median BAI score after intervention
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 6 weeks after recruitment (end of treatment)
|
This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
recruitment time (process)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 6 weeks after recruitment (end of treatment)
|
This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Malihe Shams, Istituto Oncologico Veneto IRCCS
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- IOV-2012 ANXIETY
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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