Assessment Psychological Distress for Cancer Heredity Test

February 8, 2021 updated by: Gemma Costa Requena, Hospital Universitario La Fe

Cancer Genetic Counseling and Emotional Response in Spanish Population

The study of hereditary cancer related syndromes allows reducing the risk of suffering in cancer to patients and close relatives. The objective of this study will be to evaluate the prevelance of psychological morbidity in patients attended at cancer genetic counselling unit, and to determine the socio-demographic and clinical factors that influence it.

A descriptive cross-sectional study will be carried out. Patients attented at the cancer genetic counselling unit, who have criteria for conducting a genetic syndrome test related to hererditary cancer, will be consecutively evaluated.

To knowing the psychological morbidity it is relevant to providing care for these patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Nowadays several familial cancer syndromes that confer a high lifetime risk of cancer can be identified with genetic testing. The psychological impact of genetic testing and the rates of psychological distress in patients undergoing genetic testing vary between 6 to 65% depending on socio-demographic or clinical characteristics.

The effect of baseline distress on post-testing assessments tended to decrease or show little change over time, it may be important to target patients with high baseline distress for additional counseling or intervention both pre-testing and over time.The most robust predictor of future distress is baseline distress, additional factors were associated with cancer risk perception considering family history of cancer, patient's affected or unaffected with cancer, etc...

It is relevant to developing and providing care for these patients, it has been demonstrated that enhanced genetic counseling with clinical psychologist to facilitate decision-making process, managing family concerns promoting their communication with and involvement of family members, and attending their emotional distress, can be beneficial. Also, cancer genetic counseling may promote patient use of personal resources and enhance patient health literacy about their syndrome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants were recruited from all consecutive patients referred to the Cancer Genetic Program at the Hospital Universitari i Politècnic la Fe.

Description

Inclusion Criteria:

  • Age between 18 and 80 years
  • Factors presumed predictive for hereditary cáncer
  • They agreed to participate in the research.

Exclusion Criteria:

  • Patients with cognitive impairment
  • Patients with difficulties to read and understand Spanish language.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients admitted to cancer genetic counseling test
Participants were recruited from all consecutive patients referred to the Cancer Genetic Program at the Hospital Universitari i Politècnic la Fe.
Other: assessment with psychometric questionnaire

At the initial genetic consultation patients are informed about hereditary cancer risk and the genetic testing process. At the second genetic counseling appointment, after patients done tests, all participants were informed about the study purpose, and they signed the informed consent before the psychometric assessment. Those patients who agreed to participate, they were given the questionnaires to fill in. Also, background characteristics were reported including age, marital relationship, level of education, psychiatric antecedents.

The time for completion the self-report measures was about 10 minutes. The psychometric assessment was occurred prior to delivering the results of genetic testing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To determinate the prevalence of psychological distress of patients studied of the different hereditary cancer syndromes attended at Cancer Genetic Counseling Unit
Time Frame: Data collection for two years
The Hospital Anxiety and Depression Scale (HADS), it is consisting of two subscales with seven items respectively, anxiety (HADS-A) and depression (HADS-D) symptomatology. The questionnaire is used to evaluate psychological distress in non-psychiatric settings. In general medical outpatients the optimal cut-off point for the screening for psychiatric morbidity seems to be 12, for screening depressive symptomatology seems to be 5 score and 8 (range 7-10) for screening anxiety symptomatology. In Spanish population the HADS demonstrated a good internal consistency and optimal psychometric properties.
Data collection for two years
To determinate cáncer worry of patients studied of the different hereditary cancer syndromes attended at Cancer Genetic Counseling Unit
Time Frame: Data collection for two years
Cancer Worry Scale. (CWS), consists of the six-item scale measures concerns about developing cancer, and the impact of these concerns on performing daily tasks among patients at risk for hereditary cancer. The questionnaire are rated on a 4-point Likert scale ranging from "never" to "almost always", with a total value ranging from 6 (minimal worry) to 24 (maximum worry). CWS presented good reliability coefficient in Spanish samples at risk for hereditary cancer.
Data collection for two years
To determinate the prevalence of psychological morbidity of patients studied of the different hereditary cancer syndromes attended at Cancer Genetic Counseling Unit
Time Frame: Data collection for two years
The General Health Questionnaire (GHQ-28), measures psychological distress, which is consisting of social functioning, somatic symptoms, anxiety/sleep disturbances, and depression. Each item was scored from 0 to 3. Higher scores indicating greater psychological morbidity, with a cutting score of 5/6 to identify psychiatric morbidity. The Spanish version of the GHQ-28 had adequate psychometric properties.
Data collection for two years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Find out differences on psychological distress regarding the hereditary syndrome studied at the cancer genetic counseling.
Time Frame: Data collection for two years
Psychometric questionnaire. Hospital Anxiety and Depresion Scale (HADS) , it is consisting of two subscales with seven items respectively, anxiety (HADS-A) and depression (HADS-D) symptomatology. The questionnaire is used to evaluate psychological distress in non-psychiatric settings. The optimal cut-off point for screening psychiatric morbidity seems to be 12, for screening depressive symptomatology seems to be 5 score and 8 (range 7-10) score for screening anxiety symptomatology. In Spanish population the HADS demonstrated a good internal consistency and optimal psychometric properties.
Data collection for two years
Identify differences in cancer worry regarding the hereditary syndrome studied at the cancer genetic counseling.
Time Frame: Data collection for two years
Cancer Worry Scale (CWS). this questionnaire consists of the six-item measures concerns about developing cancer and the impact of these concerns on performing daily tasks among patients at risk for hereditary cancer. The questionnaire are rated on a 4-point Likert scale ranging from "never" to "almost always", with a total value ranging from 6 (minimal worry) to 24 (maximum worry). CWS presented good reliability coefficient in Spanish samples at risk for hereditary cancer.
Data collection for two years
Psychometric analysis of the questionnaires used to assess psychological distress and cancer worry
Time Frame: Data collection for two years
Impact of Event Scale (IES), is a self-report measure for distress in relation to a stressful life event, which in our study is cancer risk. IES is using 15 items to measures psychological distress on two subscaless, with intrusion (the extent to which patients are overwhelmed by thoughts and feelings about cancer) and avoidance (tendency to avoid thoughts and feelings about cancer). The intrusion subscale has seven items, the avoidance subscale eight items. Each item is scored from 0 to 5. The psychometric properties of IES are good in samples with increased risk for hereditary breast cancer.
Data collection for two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Universitario La Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Cancer Genetic Counseling.PSI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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