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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Umeå University
- Enrollment
- 490
- Locations
- 1
- Primary Endpoint
- Uptake of genetic counselling among the patient's at-risk relatives
Study Overview
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.
Detailed Description
(When the formal study protocol is published, this section will instead refer to the published study protocol).
This study is a multi-centre open label, prospective, randomized controlled superiority trial comparing an intervention of healthcare-assisted disclosure with standard care of family-mediated disclosure of hereditary cancer risk information in high-risk families in Sweden.
SUBJECTS AND METHODS
Patients/families will be enrolled and allocated in parallel to intervention or standard care.
All participants receive standard genetic counseling and information summarizing the results of their family investigation. They are informed about preventive measures when applicable, and are encouraged to inform their at-risk relatives (t=0 months).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •Cannot convey personal opinions and preferences by themselves.
- •No eligible at-risk relatives living in Sweden.
Arms & Interventions
Control / Family-mediated disclosure (standard care)
Genetic counseling according to current clinical practice
Intervention: Standard care encouraging family-mediated disclosure of hereditary cancer risk (Other)
Intervention / Health-care assisted disclosure
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.
Intervention: Standard care encouraging family-mediated disclosure of hereditary cancer risk (Other)
Intervention / Health-care assisted disclosure
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.
Intervention: Offer of health-care assisted disclosure by sending direct letters to at-risk relatives (Other)
Outcomes
Primary Outcomes
Uptake of genetic counselling among the patient's at-risk relatives
Time Frame: 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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Anna Rosen
Principal investigator, MD, PhD, Specialist in Clinical genetics
Umeå University