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Trial record 1 of 1 for:    NCT04197856
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Direct Information to At-risk Relatives (DIRECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04197856
Recruitment Status : Enrolling by invitation
First Posted : December 13, 2019
Last Update Posted : March 25, 2020
Sponsor:
Collaborators:
Göteborg University
Lund University
Karolinska Institutet
Information provided by (Responsible Party):
Anna Rosen, Umeå University

Brief Summary:

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

600 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 unit in each study arm.


Condition or disease Intervention/treatment Phase
Familial Breast Cancer Familial Colorectal Cancer Hereditary Breast and Ovarian Cancer Syndrome Hereditary Breast Cancer Lynch Syndrome 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, parallel assignment, balanced ratio, investigator-blinded, randomised, controlled superiority trail in Sweden.
Masking: Single (Investigator)
Masking Description:

The primary outcome data will be assessed locally at each study site, documented by the research nurses in trial CRF's and submitted for aggregation to the national study office. Outcomes will be entered into a study database and coded by third party staff. Original data analysis will thus be performed by investigators unaware of the study arm allocations.

Secondary outcomes are only related to the intervention group.

Primary Purpose: Screening
Official Title: Direct Information to At-risk Relatives - a Randomized Controlled Multicentre Trial of Healthcare-assisted Versus Family-mediated Disclosure of Hereditary Cancer Risk Information in High-risk Families in Sweden
Actual Study Start Date : February 6, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025


Arm Intervention/treatment
Active Comparator: Control / Family-mediated disclosure (standard care)
Genetic counseling according to current clinical practice
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.

Experimental: 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.
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.




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Intervention - Acceptance to offer (only intervention group) [ 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 that proband allowed contact with, compared to total number of potential at-risk relatives for that specific patient. [proportion]

  2. Intervention - Distribution of letters (only intervention group) [ 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 at-risk relatives that proband allowed contact with and where contact data allowed distribution of direct letter, compared to total number of potential at-risk relatives for that specific patient. [proportion]

  3. Intervention - Collection of letters (only intervention group) [ 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 at-risk relatives that proband allowed contact with, contact data was sufficient and the registered letter was collected from the post-office within 12 months, compared to total number of potential at-risk relatives for that specific patient. [proportion]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, EPCAM (Lynch syndrome) and
  4. Having at least one at-risk relative who have not previously received written information about potential genetic cancer risk in the family.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197856


Locations
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Sweden
Cancergenetisk mottagning
Umeå, Sweden, 90185
Sponsors and Collaborators
Umeå University
Göteborg University
Lund University
Karolinska Institutet
  Study Documents (Full-Text)

Documents provided by Anna Rosen, Umeå University:
Statistical Analysis Plan  [PDF] December 11, 2019

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Responsible Party: Anna Rosen, Principal investigator, MD, PhD, Specialist in Clinical genetics, Umeå University
ClinicalTrials.gov Identifier: NCT04197856    
Other Study ID Numbers: The Swedish DIRECT study
Ref. no: 2018-00964 ( Other Grant/Funding Number: FORTE (https://forte.se/en) )
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Supporting study materials and appropriate IPD data sets will be made available according to journal publication requirements before publication of results.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: As requested by the publisher (peer reviewed journal).
Access Criteria: According to access to the peer reviewed journal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Rosen, Umeå University:
hereditary cancer risk
prevention
family-mediated disclosure
healthcare-assisted disclosure
information disclosure
risk information
genetic risk
Additional relevant MeSH terms:
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Breast Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Hereditary Breast and Ovarian Cancer Syndrome
Syndrome
Disease
Pathologic Processes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Ovarian Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases