Familial Breast CancerDIRECTNCT04197856
Direct Information to At-risk Relatives
A study testing Offer of health-care assisted disclosure by sending direct letters to at-risk relatives in people with Familial Breast Cancer and Familial Colorectal Cancer, run by Umeå University at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Familial Breast Cancer, Familial Colorectal Cancer, Hereditary Breast and Ovarian Cancer Syndrome
- What is being tested?
- Offer of health-care assisted disclosure by sending direct letters to at-risk relatives
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteSweden
- Study dates
- 6 Feb 2020to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Cannot convey personal opinions and preferences by themselves.
- No eligible at-risk relatives living in Sweden.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the 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).
The intervention component is the addition of a healthcare-assisted disclosure procedure. Participants in the intervention arm will be offered the service of sending letters directly to their at-risk relatives.
If the participant approves the offer, letters will be sent to eligible at-risk relatives deemed to be recommended genetic counseling within a year.
The direct letter will inform the at-risk relative that a cancer genetic investigation has been conducted in the family and the implications for him or her, and their blood relatives.
To facilitate access to further information, contact details to the closest cancer genetics unit are included in the letter. The letters are sent with registered mail in neutral envelopes which means that recipients will have to show proof of identity to retrieve the letter from their local delivery service provider.
METHODS FOR ASSESSMENT OF STUDY OUTCOMES
For participants in both study arms, contact details of the at-risk relatives are identified in collaboration between health care provider and the participant. The health care provider records the name, approximate or exact year of birth and postal address of each at-risk relative for follow-up.
At the time of follow-up (t=12 months) the research nurse will check whether the relatives, listed one year before, have contacted a Swedish cancer genetic unit. Primary outcome data is retrieved from the patient data registries at each clinic. The research nurse will also record additional data points from CRFs, enabling analysis of the other pre-specified outcome measures in the intervention arm.
The outcome data are reported back to the national study secretariat as plain numbers without any personal details of the at-risk relatives.
SAMPLE SIZE AND STATISTICAL METHODS
For sample size calculation and statistical methods, see attached documents.
INTERNAL PILOT, AUDIT and PROGRESS CRITERIA
As this protocol has never been tested in Swedish clinical practice an internal pilot phase is included in the outline of the project.
Progress criteria at each study site are evaluated at internal pilot point and thereafter at formal audit at least yearly. Internal pilot point is set to the time when 20 individuals in total (across the 3 pilot study sites) have been included and treated according to protocol.
Continuation of the full-powered study at the specific study site will be determined by considering the criteria filled, the potentially necessary amendments, and the degree of which the amendments deviate from the original piloted study protocol.
The outcomes and process criteria are found in the attached document.
- Conditions
- Familial Breast Cancer, Familial Colorectal Cancer, Hereditary Breast and Ovarian Cancer Syndrome, Hereditary Breast Cancer, Lynch Syndrome
- Being tested
- Standard care encouraging family-mediated disclosure of hereditary cancer risk, Offer of health-care assisted disclosure by sending direct letters to at-risk relatives
- Keywords
- hereditary cancer risk, prevention, family-mediated disclosure, healthcare-assisted disclosure, information disclosure, risk information, genetic risk
- Medical subject headings
- Breast Cancer, Familial, Hereditary Breast and Ovarian Cancer Syndrome, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care encouraging family-mediated disclosure of hereditary cancer riskOther
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.
Offer of health-care assisted disclosure by sending direct letters to at-risk relativesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control / Family-mediated disclosure (standard care) | Active comparator | Genetic counseling according to current clinical practice Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start6 Feb 2020
- Primary completion31 Dec 2023
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Familial Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-centre, parallel assignment, balanced ratio, investigator-blinded, randomised, controlled superiority trail in Sweden.
- Masking
- None (open label)
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University, Lund University, Karolinska Institutet
- Responsible party
- Principal investigator, Anna Rosen, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197856
- Sponsor's protocol ID
- The Swedish DIRECT study
- Other IDs
- 2018-00964, 2020-1107, 2022-02226, 86719, 2018
- Acronym
- DIRECT
- Status last verified
- Jul 2024
- First submitted
- 6 Dec 2019
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to aggregated data may be granted upon reasonable request to the principal investigator.
Publications
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.
PubMed 38105176
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04197856
- Acronym / sponsor ID
- DIRECT / The Swedish DIRECT study
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Göteborg University, Lund University, Karolinska Institutet
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
The intervention component is the addition of a healthcare-assisted disclosure procedure. Participants in the intervention arm will be offered the service of sending letters directly to their at-risk relatives.
If the participant approves the offer, letters will be sent to eligible at-risk relatives deemed to be recommended genetic counseling within a year.
The direct letter will inform the at-risk relative that a cancer genetic investigation has been conducted in the family and the implications for him or her, and their blood relatives.
To facilitate access to further information, contact details to the closest cancer genetics unit are included in the letter. The letters are sent with registered mail in neutral envelopes which means that recipients will have to show proof of identity to retrieve the letter from their local delivery service provider.
METHODS FOR ASSESSMENT OF STUDY OUTCOMES
For participants in both study arms, contact details of the at-risk relatives are identified in collaboration between health care provider and the participant. The health care provider records the name, approximate or exact year of birth and postal address of each at-risk relative for follow-up.
At the time of follow-up (t=12 months) the research nurse will check whether the relatives, listed one year before, have contacted a Swedish cancer genetic unit. Primary outcome data is retrieved from the patient data registries at each clinic. The research nurse will also record additional data points from CRFs, enabling analysis of the other pre-specified outcome measures in the intervention arm.
The outcome data are reported back to the national study secretariat as plain numbers without any personal details of the at-risk relatives.
SAMPLE SIZE AND STATISTICAL METHODS
For sample size calculation and statistical methods, see attached documents.
INTERNAL PILOT, AUDIT and PROGRESS CRITERIA
As this protocol has never been tested in Swedish clinical practice an internal pilot phase is included in the outline of the project.
Progress criteria at each study site are evaluated at internal pilot point and thereafter at formal audit at least yearly. Internal pilot point is set to the time when 20 individuals in total (across the 3 pilot study sites) have been included and treated according to protocol.
Continuation of the full-powered study at the specific study site will be determined by considering the criteria filled, the potentially necessary amendments, and the degree of which the amendments deviate from the original piloted study protocol.
The outcomes and process criteria are found in the attached document.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-centre, parallel assignment, balanced ratio, investigator-blinded, randomised, controlled superiority trail in Sweden.
| Arm | Type | Receives |
|---|---|---|
| Control / Family-mediated disclosure (standard care) | Active comparator | Other: Standard care encouraging family-mediated disclosure of hereditary cancer riskGenetic counseling according to current clinical practice |
| Intervention / Health-care assisted disclosure | Experimental | 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 relativesGenetic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Cannot convey personal opinions and preferences by themselves.
- No eligible at-risk relatives living in Sweden.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard care encouraging family-mediated disclosure of hereditary cancer riskAt 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 | Control / Family-mediated disclosure (standard care), Intervention / Health-care assisted disclosure |
| Offer of health-care assisted disclosure by sending direct letters to at-risk relativesThe 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. | Other | Intervention / Health-care assisted disclosure |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Derived from this study: PubMed 38105176Hawranek 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.
- Individual participant dataSharing planned: Yes. Access to aggregated data may be granted upon reasonable request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Offer of health-care assisted disclosure by sending direct letters to at-risk relatives in people with Familial Breast Cancer and Familial Colorectal Cancer, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04197856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.