Clinical trial NCT02018471: Psychological Counselling in Diagnostic Screening
Official title: Management of Anxiety Related to Diagnostic Screenings: an Exploratory Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: anxiety
psychoeducational training
coping
relaxation
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 43
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients considered drop-outs
timeFrame: 6 weeks after recruitment (end of treatment)
Secondary outcomes:
measure: median BAI score after intervention
timeFrame: 6 weeks after recruitment (end of treatment)
measure: median COPE score - Social support score after intervention
timeFrame: 6 weeks after recruitment (end of treatment)
measure: median COPE score - Avoidance strategies score after intervention
timeFrame: 6 weeks after recruitment (end of treatment)
measure: median COPE score - Positive attitude score after intervention
timeFrame: 6 weeks after recruitment (end of treatment)
measure: median COPE score - Problem acceptance score after intervention
timeFrame: 6 weeks after recruitment (end of treatment)
measure: recruitment time (process)
timeFrame: 6 weeks after recruitment (end of treatment)
measure: mean number of recruited patients per week (process)
timeFrame: 6 weeks after recruitment (end of treatment)
measure: refusal rate among eligible patients (process)
timeFrame: 6 weeks after recruitment (end of treatment)
measure: rate of patients who obviously meet and do not meet the eligibility requirements (process)
timeFrame: 6 weeks after recruitment (end of treatment)
measure: number of questionnaires correctly filled out (process)
timeFrame: 6 weeks after recruitment (end of treatment)
measure: phone lines overloaded or waiting room overcrowded by study participants (management)
timeFrame: 6 weeks after recruitment (end of treatment)
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Oncologico Veneto IRCCS
name: Malihe Shams
role: PRINCIPAL_INVESTIGATOR
References: