CancerNCT02018471
Psychological Counselling in Diagnostic Screening
A study testing Psychoeducative training in people with Cancer, run by Istituto Oncologico Veneto IRCCS.
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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Cancer
- What is being tested?
- Psychoeducative training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- healthy people
About this study
Official title: Management of Anxiety Related to Diagnostic Screenings: an Exploratory Pilot Study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Psychoeducative training
- Keywords
- anxiety, psychoeducational training, coping, relaxation
- Medical subject headings
- Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducative trainingBehavioural
Also called Systematic Desensitization, Psychological counseling
The Psychological education was inspired by the technique, Systematic Desensitization (SD), a therapeutic procedure that seeks to eliminate fear and avoidance behaviour
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Psychoeducative training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks after recruitment (end of treatment)
Secondary outcomes (11)
median BAI score after intervention
This is an efficacy outcome
Measured: 6 weeks after recruitment (end of treatment)
median COPE score - Social support score after intervention
This is an efficacy outcome
Measured: 6 weeks after recruitment (end of treatment)
median COPE score - Avoidance strategies score after intervention
This is an efficacy outcome
Measured: 6 weeks after recruitment (end of treatment)
median COPE score - Positive attitude score after intervention
This is an efficacy outcome
Measured: 6 weeks after recruitment (end of treatment)
median COPE score - Problem acceptance score after intervention
This is an efficacy outcome
Measured: 6 weeks after recruitment (end of treatment)
recruitment time (process)
This is a feasibility outcome
Measured: 6 weeks after recruitment (end of treatment)
mean number of recruited patients per week (process)
This is a feasibility outcome
Measured: 6 weeks after recruitment (end of treatment)
refusal rate among eligible patients (process)
This is a feasibility outcome
Measured: 6 weeks after recruitment (end of treatment)
rate of patients who obviously meet and do not meet the eligibility requirements (process)
This is a feasibility outcome
Measured: 6 weeks after recruitment (end of treatment)
number of questionnaires correctly filled out (process)
This is a feasibility outcome
Measured: 6 weeks after recruitment (end of treatment)
phone lines overloaded or waiting room overcrowded by study participants (management)
This is a feasibility outcome
Measured: 6 weeks after recruitment (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startApr 2012
- Primary completionFeb 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malihe Shams, Istituto Oncologico Veneto IRCCS
- Investigators
- Malihe Shams, Principal investigator, Istituto Oncologico Veneto IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018471
- Sponsor's protocol ID
- IOV-2012 ANXIETY
- Status last verified
- Dec 2013
- First submitted
- 17 Dec 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Anxiety Related to Diagnostic Screenings: an Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT02018471
- Acronym / sponsor ID
- IOV-2012 ANXIETY
- Conditions
- Cancer
- Keywords
- anxiety, psychoeducational training, coping, relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot group | Experimental | Behavioral: Psychoeducative trainingForty-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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- healthy people
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducative trainingAlso: Systematic Desensitization, Psychological counselingThe Psychological education was inspired by the technique, Systematic Desensitization (SD), a therapeutic procedure that seeks to eliminate fear and avoidance behaviour | Behavioural | Pilot group |
Primary outcome
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
11 secondary outcomes
median BAI score after intervention
Time frame: 6 weeks after recruitment (end of treatment)
median COPE score - Social support score after intervention
Time frame: 6 weeks after recruitment (end of treatment)
median COPE score - Avoidance strategies score after intervention
Time frame: 6 weeks after recruitment (end of treatment)
median COPE score - Positive attitude score after intervention
Time frame: 6 weeks after recruitment (end of treatment)
median COPE score - Problem acceptance score after intervention
Time frame: 6 weeks after recruitment (end of treatment)
recruitment time (process)
Time frame: 6 weeks after recruitment (end of treatment)
mean number of recruited patients per week (process)
Time frame: 6 weeks after recruitment (end of treatment)
refusal rate among eligible patients (process)
Time frame: 6 weeks after recruitment (end of treatment)
rate of patients who obviously meet and do not meet the eligibility requirements (process)
Time frame: 6 weeks after recruitment (end of treatment)
number of questionnaires correctly filled out (process)
Time frame: 6 weeks after recruitment (end of treatment)
phone lines overloaded or waiting room overcrowded by study participants (management)
Time frame: 6 weeks after recruitment (end of treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malihe Shams principal investigator
Istituto Oncologico Veneto IRCCS
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducative training in people with Cancer, run by Istituto Oncologico Veneto IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients considered drop-outs (time frame: 6 weeks after recruitment (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2013.