Direct Information to At-risk Relatives

NCT04197856 | Active Not Recruiting

• 5 other identifiers: The Swedish DIRECT study2018-009642020-11072022-0222686719
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hereditary cancer risk; prevention; family-mediated disclosure; healthcare-assisted disclosure; information disclosure; risk information; genetic risk

Outcome Measures

Primary Outcomes (1)

• Uptake of genetic counselling among the patient's at-risk relatives

  Number of potential at-risk relatives who have contacted a Swedish cancer genetic unit out of the total number of potential at-risk relatives for each patient.

  One year (12 months) following the first counselling session when implications of the cancer genetic investigation for the patient´s at-risk relatives is discussed, hence 12 months after t=0.

Other Outcomes (5)

• Proportion of first-degree ARRs contacting a cancer genetics clinic

  One year (12 months) following the first counselling session when implications of the cancer genetic investigation for the patient´s at-risk relatives is discussed, hence 12 months after t=0.

• Proportion of distant ARRs contacting a cancer genetics clinic

  One year (12 months) following the first counselling session when implications of the cancer genetic investigation for the patient´s at-risk relatives is discussed, hence 12 months after t=0.

• Intervention - Acceptance to offer (only intervention group)

  One year (12 months) following the first counselling session when implications of the cancer genetic investigation for the patient´s at-risk relatives is discussed, hence 12 months after t=0.

Study Arms (2)

Control / Family-mediated disclosure (standard care)

ACTIVE COMPARATOR

Genetic counseling according to current clinical practice

Other: Standard care encouraging family-mediated disclosure of hereditary cancer risk

Intervention / Health-care assisted disclosure

EXPERIMENTAL

Genetic counseling according to current clinical practice with the addition of an offer from health care provider to mail letters directly to eligible at-risk relatives.

Other: Standard care encouraging family-mediated disclosure of hereditary cancer risk; Other: Offer of health-care assisted disclosure by sending direct letters to at-risk relatives

Interventions

Standard care encouraging family-mediated disclosure of hereditary cancer risk OTHER

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.

Control / Family-mediated disclosure (standard care); Intervention / Health-care assisted disclosure

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

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.

Intervention / Health-care assisted disclosure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient being offered a cancer genetic investigation for hereditary breast, ovarian or colorectal cancer.
• Written consent to participate the study,
• Belonging to a family with; a) familial breast cancer, b) familial colorectal cancer, c) pathogenic variant in PALB2, BRCA1/2 (Hereditary breast cancer, hereditary breast and ovarian cancer), MLH1, MSH2, MSH6, PMS2 (Lynch syndrome) and
• Having at least one eligible at-risk relative (family member deemed to be an ARR recommended genetic counseling within a year).

You may not qualify if:

• Cannot convey personal opinions and preferences by themselves.
• No eligible at-risk relatives living in Sweden.

Sponsors & Collaborators

• Umeå University: lead
• Göteborg University: collaborator
• Lund University: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Cancergenetisk mottagning

Umeå, 90185, Sweden

Location

Related Publications (1)

• Hawranek C, Ehrencrona H, Ofverholm A, Hellquist BN, Rosen A. Direct letters to relatives at risk of hereditary cancer-study protocol for a multi-center randomized controlled trial of healthcare-assisted versus family-mediated risk disclosure at Swedish cancer genetics clinics (DIRECT-study). Trials. 2023 Dec 17;24(1):810. doi: 10.1186/s13063-023-07829-5.

  PMID: 38105176 DERIVED

MeSH Terms

Conditions

Breast Cancer, Familial; Hereditary Breast and Ovarian Cancer Syndrome; Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Since the intervention in this trial is an offer of sending physical direct letters to at-risk relatives, neither the health care providers nor the study participant can be blinded to the allocation. However, the final data analysis will be performed by a statistician blinded to the study arm allocations and subgroups.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, PhD, Specialist in Clinical genetics

Model Details: Multi-centre, parallel assignment, balanced ratio, investigator-blinded, randomised, controlled superiority trail in Sweden.

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 13, 2019
• Study Start: February 6, 2020
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: As requested by the publisher (peer reviewed journal).
• Access Criteria: According to access to the peer reviewed journal.

Locations

SE (1)