Cancer
Conditions
Keywords
anxiety, psychoeducational training, coping, relaxation
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.
Interventions
BEHAVIORALPsychoeducative training
The Psychological education was inspired by the technique, Systematic Desensitization (SD), a therapeutic procedure that seeks to eliminate fear and avoidance behaviour
Sponsors
Istituto Oncologico Veneto IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients considered drop-outs | 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
| Measure | Time frame | Description |
|---|---|---|
| median COPE score - Social support score after intervention | 6 weeks after recruitment (end of treatment) | This is an efficacy outcome |
| median COPE score - Avoidance strategies score after intervention | 6 weeks after recruitment (end of treatment) | This is an efficacy outcome |
| median COPE score - Positive attitude score after intervention | 6 weeks after recruitment (end of treatment) | This is an efficacy outcome |
| median COPE score - Problem acceptance score after intervention | 6 weeks after recruitment (end of treatment) | This is an efficacy outcome |
| recruitment time (process) | 6 weeks after recruitment (end of treatment) | This is a feasibility outcome |
| median BAI score after intervention | 6 weeks after recruitment (end of treatment) | This is an efficacy outcome |
| refusal rate among eligible patients (process) | 6 weeks after recruitment (end of treatment) | This is a feasibility outcome |
| rate of patients who obviously meet and do not meet the eligibility requirements (process) | 6 weeks after recruitment (end of treatment) | This is a feasibility outcome |
| number of questionnaires correctly filled out (process) | 6 weeks after recruitment (end of treatment) | This is a feasibility outcome |
| phone lines overloaded or waiting room overcrowded by study participants (management) | 6 weeks after recruitment (end of treatment) | This is a feasibility outcome |
| mean number of recruited patients per week (process) | 6 weeks after recruitment (end of treatment) | This is a feasibility outcome |
Outcome results
None listed