Skip to main content
OpenTrials
Completed

NCT Number: NCT02018471

Psychological Counselling in Diagnostic Screening

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducative training

Behavioral

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

Other names: Systematic Desensitization, Psychological counseling

Primary outcomes

  1. Proportion of patients considered drop-outs

    Time frame: 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

Secondary outcomes

  1. median BAI score after intervention

    Time frame: 6 weeks after recruitment (end of treatment)

    This is an efficacy outcome

  2. median COPE score - Social support score after intervention

    Time frame: 6 weeks after recruitment (end of treatment)

    This is an efficacy outcome

  3. median COPE score - Avoidance strategies score after intervention

    Time frame: 6 weeks after recruitment (end of treatment)

    This is an efficacy outcome

  4. median COPE score - Positive attitude score after intervention

    Time frame: 6 weeks after recruitment (end of treatment)

    This is an efficacy outcome

  5. median COPE score - Problem acceptance score after intervention

    Time frame: 6 weeks after recruitment (end of treatment)

    This is an efficacy outcome

  6. recruitment time (process)

    Time frame: 6 weeks after recruitment (end of treatment)

    This is a feasibility outcome

  7. mean number of recruited patients per week (process)

    Time frame: 6 weeks after recruitment (end of treatment)

    This is a feasibility outcome

  8. refusal rate among eligible patients (process)

    Time frame: 6 weeks after recruitment (end of treatment)

    This is a feasibility outcome

  9. rate of patients who obviously meet and do not meet the eligibility requirements (process)

    Time frame: 6 weeks after recruitment (end of treatment)

    This is a feasibility outcome

  10. number of questionnaires correctly filled out (process)

    Time frame: 6 weeks after recruitment (end of treatment)

    This is a feasibility outcome

  11. phone lines overloaded or waiting room overcrowded by study participants (management)

    Time frame: 6 weeks after recruitment (end of treatment)

    This is a feasibility outcome

Sponsors and collaborators

Lead sponsor

Istituto Oncologico Veneto IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 23, 2013
Registry last updated
Dec 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.