Assessment Psychological Distress for Cancer Heredity Test

NCT04428710 | Unknown

• 1 other identifier: Cancer Genetic Counseling.PSI
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Psychological Distress; Hereditary Diseases; Genetic Counseling

Outcome Measures

Primary Outcomes (3)

• To determinate the prevalence of psychological distress of patients studied of the different hereditary cancer syndromes attended at Cancer Genetic Counseling Unit

  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

  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

  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 Outcomes (3)

• Find out differences on psychological distress regarding the hereditary syndrome studied at the cancer genetic counseling.

  Data collection for two years

• Identify differences in cancer worry regarding the hereditary syndrome studied at the cancer genetic counseling.

  Data collection for two years

• Psychometric analysis of the questionnaires used to assess psychological distress and cancer worry

  Data collection for two years

Study Arms (1)

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

Interventions

assessment with psychometric questionnaire OTHER

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.

patients admitted to cancer genetic counseling test

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (1)

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

Related Publications (2)

• Costa-Requena G, Garcia-Garijo M, Richart-Aznar P, Segura-Huerta A. Comparison of psychological distress for breast, ovarian and colorectal cancer predisposition in a Spanish sample at high risk of hereditary cancer. Eur J Cancer Prev. 2022 Sep 1;31(5):482-486. doi: 10.1097/CEJ.0000000000000734. Epub 2021 Dec 15.

  PMID: 36165038 DERIVED

• Costa-Requena G, Garcia-Garijo M, Richart-Aznar P, Segura-Huerta A. Psychiatric symptoms in a Spanish sample with hereditary cancer risk. J Community Genet. 2022 Jun;13(3):339-346. doi: 10.1007/s12687-022-00580-5. Epub 2022 Feb 8.

  PMID: 35133604 DERIVED

MeSH Terms

Conditions

Neoplasms; Genetic Diseases, Inborn

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Clinical psychologist

Study Record Dates

• First Submitted: May 30, 2020
• First Posted: June 11, 2020
• Study Start: October 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

ES (1)