Clinical trial · Interventional
Direct Information to At-risk Relatives
Direct Letters to Relatives at Risk of Hereditary Cancer- a Multi-centre Randomised Controlled Trial of Healthcare-assisted Versus Family-mediated Risk Disclosure at Swedish Cancer Genetics Clinics (DIRECT-study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Familial Breast Cancer | — | UNRESOLVED | — |
| Familial Colorectal Cancer | — | UNRESOLVED | — |
| Hereditary Breast and Ovarian Cancer Syndrome | — | UNRESOLVED | — |
| Hereditary Breast Cancer | Hereditary Breast Carcinoma | ALIAS | 0.90 |
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Offer of health-care assisted disclosure by sending direct letters to at-risk relatives | Other | — | UNRESOLVED |
| Standard care encouraging family-mediated disclosure of hereditary cancer risk | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control / Family-mediated disclosure (standard care)
- description
- Genetic counseling according to current clinical practice
- interventionNames
- Other: Standard care encouraging family-mediated disclosure of hereditary cancer risk
- type
- EXPERIMENTAL
- label
- Intervention / Health-care assisted disclosure
- description
- 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.
- interventionNames
- 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
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria 1. Patient being offered a cancer genetic investigation for hereditary breast, ovarian or colorectal cancer. 2. Written consent to participate the study, 3. 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 4. Having at least one eligible at-risk relative (family member deemed to be an ARR recommended genetic counseling within a year). Exclusion Criteria: 1. Cannot convey personal opinions and preferences by themselves. 2. No eligible at-risk relatives living in Sweden.
References
Publications (1)
- DERIVEDHawranek 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