Psychological Counselling in Diagnostic Screening

Cancer Clinical Trial

Official title:

Management of Anxiety Related to Diagnostic Screenings: an Exploratory Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018471
• Other study ID #: IOV-2012 ANXIETY
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: December 20, 2013
• Start date: April 2012
• Est. completion date: May 2013

Study information

• Verified date: December 2013
• Source: Istituto Oncologico Veneto IRCCS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Psychoeducative training
The Psychological education was inspired by the technique, Systematic Desensitization (SD), a therapeutic procedure that seeks to eliminate fear and avoidance behaviour

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Oncologico Veneto IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients considered drop-outs	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)	No
Secondary	median BAI score after intervention	This is an efficacy outcome	6 weeks after recruitment (end of treatment)	No
Secondary	median COPE score - Social support score after intervention	This is an efficacy outcome	6 weeks after recruitment (end of treatment)	No
Secondary	median COPE score - Avoidance strategies score after intervention	This is an efficacy outcome	6 weeks after recruitment (end of treatment)	No
Secondary	median COPE score - Positive attitude score after intervention	This is an efficacy outcome	6 weeks after recruitment (end of treatment)	No
Secondary	median COPE score - Problem acceptance score after intervention	This is an efficacy outcome	6 weeks after recruitment (end of treatment)	No
Secondary	recruitment time (process)	This is a feasibility outcome	6 weeks after recruitment (end of treatment)	No
Secondary	mean number of recruited patients per week (process)	This is a feasibility outcome	6 weeks after recruitment (end of treatment)	No
Secondary	refusal rate among eligible patients (process)	This is a feasibility outcome	6 weeks after recruitment (end of treatment)	No
Secondary	rate of patients who obviously meet and do not meet the eligibility requirements (process)	This is a feasibility outcome	6 weeks after recruitment (end of treatment)	No
Secondary	number of questionnaires correctly filled out (process)	This is a feasibility outcome	6 weeks after recruitment (end of treatment)	No
Secondary	phone lines overloaded or waiting room overcrowded by study participants (management)	This is a feasibility outcome	6 weeks after recruitment (end of treatment)	No