Effect of the Informative Paper on patients and families in a Oncogenetic Ambulatory :evaluation of information and perception of coercion.

Randomized, double-blind study on the effect of the Informative Paper on patients and families in the Oncogenetic Ambulatory of universitary hospital: evaluation of information and perception of coercion. - FI: FIGIPEC

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-4y59tq

Enrollment

Unknown

Registered

2011-06-30

Start date

2011-09-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Cancer

Interventions

Group 1 (all patients who receive positive diagnosis for hereditary cancer within six months. Estimate: 180 patients) - The Informative Paper will be delivered to patients at diagnosis. At the next ap

other

C00-D48

Eligibility

Inclusion criteria

Inclusion criteria: Will be included all adult patients who receive a positive diagnosis at the Ambulatory of Oncogenetics/Medical Genetics Service of the hospital for six months and agree to participate in the research, documented by the Consent Term. Also included are all adult family members who seek care at the same ambulatory for a fixed period and accept to participate in the research, documenting the acceptance by Consent Term.

Exclusion criteria

Exclusion criteria: Will be excluded under 18 years old,those who do not accept and those familiaries who attend the institution after the deadline.

Design outcomes

Primary

Measure	Time frame
The outcomes will be the perception of coercion of patients to communicate to relatives on the examination result and degree of information as well as the perception of coercion in the search for the exams by relatives. Instruments to measure outcomes: Informative Paper: A Informative Paper on oncogenetics counseling will be developed along the Laboratory of Genomic Medicine of the hospital, and will include items such as diagnostic procedures, therapeutic procedures, benefits, local service. Check List of Information Informative Paper: The Check List will be based on data from the Informative Paper. Perceived Coercion Scale in Patients (Oncogenetics) and Coercion Expression Scale and in Family (Oncogenetics): Scales adapted by the Laboratory of Research in Bioethics and Ethics in Science of the hospital. These scales are derived from the Perceived Coercion Scale and Expression of Coercion Scale, adapted by Taborda, derived from the MacArthur Coercion Study. Will be elaborated four scenarios, where famliares of patients in both subgroups 1 (with or without the Informative Paper) will be classified, by percentage, as information and perceptions of coercion.	—

Measure

Time frame

The outcomes will be the perception of coercion of patients to communicate to relatives on the examination result and degree of information as well as the perception of coercion in the search for the exams by relatives. Instruments to measure outcomes: Informative Paper: A Informative Paper on oncogenetics counseling will be developed along the Laboratory of Genomic Medicine of the hospital, and will include items such as diagnostic procedures, therapeutic procedures, benefits, local service. Check List of Information Informative Paper: The Check List will be based on data from the Informative Paper. Perceived Coercion Scale in Patients (Oncogenetics) and Coercion Expression Scale and in Family (Oncogenetics): Scales adapted by the Laboratory of Research in Bioethics and Ethics in Science of the hospital. These scales are derived from the Perceived Coercion Scale and Expression of Coercion Scale, adapted by Taborda, derived from the MacArthur Coercion Study. Will be elaborated four scenarios, where famliares of patients in both subgroups 1 (with or without the Informative Paper) will be classified, by percentage, as information and perceptions of coercion.

—

Countries

Brazil

Contacts

Public ContactCristina Melnik

Hospital de Clínicas de Porto Alegre

crismelnik@gmail.com33597615

Outcome results

None listed

Source: REBEC (via WHO ICTRP)