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NCT04197856 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 490

Last updated 2024-07-09

No results posted yet for this study

Summary

This study evaluates if uptake of genetic counselling in high-risk families is increased when patients at cancer genetics clinics are being offered healthcare-assisted disclosure to at-risk relatives compared to current standard care (with family-mediated disclosure).

Patients/families who have undergone a cancer genetic investigation will be invited to participate in the study. All participants will receive standard care. Half of them will in addition be offered a healthcare-assisted disclosure with the service of direct letters to identified at-risk relatives distributed by the healthcare provider. After a year we will compare the proportion of at-risk relatives who have contacted a cancer genetic clinics in each study arm.

Conditions

  • Familial Breast Cancer
  • Familial Colorectal Cancer
  • Hereditary Breast and Ovarian Cancer Syndrome
  • Hereditary Breast Cancer
  • Lynch Syndrome

Interventions

OTHER

Standard care encouraging family-mediated disclosure of hereditary cancer risk

At counseling, eligible at-risk relatives (who may benefit from disclosure of risk information) are listed on a specified protocol in collaboration between health care provider and the participant.

OTHER

Offer of health-care assisted disclosure by sending direct letters to at-risk relatives

The participant is offered that the health care provider at the cancer genetic unit mail a direct letter with personalized family risk information to all at-risk relatives that participant approve contact with.

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER

  • Lund University

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Umeå University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-06
Primary Completion
2023-12-31
Completion
2025-07-01

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04197856 on ClinicalTrials.gov