Clinical trial NCT04428710: Assessment Psychological Distress for Cancer Heredity Test
Official title: Cancer Genetic Counseling and Emotional Response in Spanish Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Psychological Distress
Hereditary Diseases
Genetic Counseling
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determinate the prevalence of psychological distress of patients studied of the different hereditary cancer syndromes attended at Cancer Genetic Counseling Unit
timeFrame: Data collection for two years
measure: To determinate cáncer worry of patients studied of the different hereditary cancer syndromes attended at Cancer Genetic Counseling Unit
timeFrame: Data collection for two years
measure: To determinate the prevalence of psychological morbidity of patients studied of the different hereditary cancer syndromes attended at Cancer Genetic Counseling Unit
timeFrame: Data collection for two years
Secondary outcomes:
measure: Find out differences on psychological distress regarding the hereditary syndrome studied at the cancer genetic counseling.
timeFrame: Data collection for two years
measure: Identify differences in cancer worry regarding the hereditary syndrome studied at the cancer genetic counseling.
timeFrame: Data collection for two years
measure: Psychometric analysis of the questionnaires used to assess psychological distress and cancer worry
timeFrame: Data collection for two years
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
References:
citation: 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.
citation: 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.