Psychological Counselling in Diagnostic Screening

NCT02018471 | Completed

• 1 other identifier: IOV-2012 ANXIETY
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer

Keywords

anxiety; psychoeducational training; coping; relaxation

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (11)

• median BAI score after intervention

  6 weeks after recruitment (end of treatment)

• median COPE score - Social support score after intervention

  6 weeks after recruitment (end of treatment)

• median COPE score - Avoidance strategies score after intervention

  6 weeks after recruitment (end of treatment)

• median COPE score - Positive attitude score after intervention

  6 weeks after recruitment (end of treatment)

• median COPE score - Problem acceptance score after intervention

  6 weeks after recruitment (end of treatment)

Study Arms (1)

Pilot group

EXPERIMENTAL

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.

Behavioral: Psychoeducative training

Interventions

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

Also known as: Systematic Desensitization, Psychological counseling

Pilot group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• healthy people

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Malihe Shams

  Istituto Oncologico Veneto IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: April 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 23, 2013

Record last verified: 2013-12