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Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)

Primary Purpose

BARD1 Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Genetic Counseling
Genetic Counseling
Laboratory Biomarker Analysis
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for BARD1 Gene Mutation

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 30 or older. Note: Participants must meet each of Criteria 1-4.
  • Have access to a healthcare provider and be willing to share genetic results with that provider
  • Have at least one ovary
  • Have a valid United States mailing address for receipt of saliva kit
  • Participants must meet any one of the following 6 criteria:
  • Diagnosed with breast cancer at age 45 or younger
  • Diagnosed with triple negative (negative for estrogen receptor, progesterone receptor and not human epidermal growth factor receptor 2 [Her2] amplified) breast cancer at 60 or younger
  • Have one blood relative with a mutation in BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2
  • Have one relative with ovarian cancer
  • Have at least 2 relatives with breast cancer on the same side of the family, one of which is =< 50 years of age
  • Have one male relative with breast cancer

Exclusion Criteria:

  • Personal history of ovarian cancer
  • Unable to read, speak, and understand English
  • Unable to provide informed consent
  • Unwilling to complete baseline and follow-up questionnaires
  • Unable to access the internet
  • Previous genetic testing or counseling regarding cancer risk
  • Previous bone marrow transplant
  • Previous blood transfusion (7 days prior to genetic testing)
  • Active hematologic malignancy (cancer that begins in blood-forming tissue, such as leukemia or lymphoma)

Sites / Locations

  • M D Anderson Cancer CenterRecruiting
  • University of Washington Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Arm Label

Arm A (online education)

Arm B (online education, post telephone counseling)

Arm C (online education, pre- and post-telephone counselling)

Arm D (online education, pre-telephone counseling)

Arm Description

Patients watch genetic testing online educational video and receive genetic testing online test results report.

Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.

Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.

Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.

Outcomes

Primary Outcome Measures

Mean cancer stress scores
Mean cancer stress scores are measured on the Impact of Events Scale (IES), a 15-item self-report measure that assesses subjective distress caused by traumatic events, which may include a positive genetic test result.There are two subscales, Intrusion and Avoidance, used to calculate a total. The range for Intrusion is 0-35 and the range for Avoidance is 0-40. The range of the total score is 0-75. Higher scores reflect more stressful impact, and therefore, a worse outcome. Subscales are summed to compute the total score.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2016
Last Updated
July 19, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02993068
Brief Title
Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
Official Title
Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
April 18, 2024 (Anticipated)
Study Completion Date
April 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized clinical trial studies how well online genetics educational video with or without pre- and/or post-telephone genetics counseling works in assessing cancer-risk distress in patients with triple negative breast cancer. Online genetic education and telephone genetic counseling may help the doctors learn the stress a person feels about their risk of cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To test the effects of online genetic education versus telephone genetic counseling on cancer-risk distress. SECONDARY OBJECTIVES: I. To test the effects of online genetic education versus telephone genetic counseling on testing completion rates. II. To evaluate the role of psychological and social variables in women's reactions to genetic testing for ovarian cancer risk with variable education strategies. III. To consider the effects of variations of genetic education/counseling on genetic knowledge, satisfaction with the decision to undergo testing, and family communication. OUTLINE: Patients are randomized into 1 of 4 arms. ARM A: Patients watch genetic testing online educational video and receive genetic testing online test results report. ARM B: Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling. ARM C: Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling. ARM D: Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BARD1 Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRIP1 Gene Mutation, Estrogen Receptor Negative, HER2/Neu Negative, MLH1 Gene Mutation, MSH2 Gene Mutation, MSH6 Gene Mutation, PALB2 Gene Mutation, PMS2 Gene Mutation, Progesterone Receptor Negative, RAD51C Gene Mutation, RAD51D Gene Mutation, Triple-Negative Breast Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (online education)
Arm Type
Experimental
Arm Description
Patients watch genetic testing online educational video and receive genetic testing online test results report.
Arm Title
Arm B (online education, post telephone counseling)
Arm Type
Experimental
Arm Description
Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.
Arm Title
Arm C (online education, pre- and post-telephone counselling)
Arm Type
Active Comparator
Arm Description
Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.
Arm Title
Arm D (online education, pre-telephone counseling)
Arm Type
Experimental
Arm Description
Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Watch genetic testing online educational video
Intervention Type
Other
Intervention Name(s)
Genetic Counseling
Intervention Description
Receive post-telephone genetic counseling
Intervention Type
Other
Intervention Name(s)
Genetic Counseling
Intervention Description
Receive pre-telephone genetic counseling
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Mean cancer stress scores
Description
Mean cancer stress scores are measured on the Impact of Events Scale (IES), a 15-item self-report measure that assesses subjective distress caused by traumatic events, which may include a positive genetic test result.There are two subscales, Intrusion and Avoidance, used to calculate a total. The range for Intrusion is 0-35 and the range for Avoidance is 0-40. The range of the total score is 0-75. Higher scores reflect more stressful impact, and therefore, a worse outcome. Subscales are summed to compute the total score.
Time Frame
Up to 4 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 30 or older. Note: Participants must meet each of Criteria 1-4. Have access to a healthcare provider and be willing to share genetic results with that provider Have at least one ovary Have a valid United States mailing address for receipt of saliva kit Participants must meet any one of the following 6 criteria: Diagnosed with breast cancer at age 45 or younger Diagnosed with triple negative (negative for estrogen receptor, progesterone receptor and not human epidermal growth factor receptor 2 [Her2] amplified) breast cancer at 60 or younger Have one blood relative with a mutation in BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2 Have one relative with ovarian cancer Have at least 2 relatives with breast cancer on the same side of the family, one of which is =< 50 years of age Have one male relative with breast cancer Exclusion Criteria: Personal history of ovarian cancer Unable to read, speak, and understand English Unable to provide informed consent Unwilling to complete baseline and follow-up questionnaires Unable to access the internet Previous genetic testing or counseling regarding cancer risk Previous bone marrow transplant Previous blood transfusion (7 days prior to genetic testing) Active hematologic malignancy (cancer that begins in blood-forming tissue, such as leukemia or lymphoma)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen H. Lu, MD
Phone
713-745-7877
Email
magenta@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen H Lu
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen H. Lu
Phone
713-745-8902
First Name & Middle Initial & Last Name & Degree
Karen H. Lu
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth M. Swisher
Email
swishere@u.washington.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth M. Swisher

12. IPD Sharing Statement

Citations:
PubMed Identifier
36155347
Citation
Coffin T, Bowen D, Lu K, Swisher EM, Rayes N, Norquist B, Blank SV, Levine DA, Bakkum-Gamez JN, Fleming GF, I Olopade O, Romero I, D'Andrea A, Nebgen DR, Peterson C, Munsell MF, Gavin K, Crase J, Polinsky D, Lechner R. Using Social Media to Facilitate Communication About Women's Testing: Tool Validation Study. JMIR Form Res. 2022 Sep 26;6(9):e35035. doi: 10.2196/35035.
Results Reference
derived
PubMed Identifier
31266460
Citation
Rayes N, Bowen DJ, Coffin T, Nebgen D, Peterson C, Munsell MF, Gavin K, Lechner R, Crase J, Polinsky D, Romero I, Blank SV, Levine DA, Norquist BM, Swisher EM, Lu KH. MAGENTA (Making Genetic testing accessible): a prospective randomized controlled trial comparing online genetic education and telephone genetic counseling for hereditary cancer genetic testing. BMC Cancer. 2019 Jul 2;19(1):648. doi: 10.1186/s12885-019-5868-x.
Results Reference
derived
Links:
URL
https://magenta.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)

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