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Online Video + Counseling for Cancer-Risk Stress
N/A
Recruiting
Led By Karen H Lu
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with breast cancer at age 45 or younger
Have at least one ovary
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial looks at how well an online video with or without phone counseling can help people with cancer-risk stress.
Who is the study for?
This trial is for individuals with triple negative breast cancer who are under 60, have a family history of certain cancers or gene mutations, and haven't had genetic testing. They must be able to understand English, consent to the study, complete questionnaires, and access the internet.Check my eligibility
What is being tested?
The trial examines if an online educational video about genetics and optional telephone counseling can reduce stress related to cancer risk in patients. It compares distress levels with different combinations of education and counseling.See study design
What are the potential side effects?
Since this trial involves educational materials and genetic counseling rather than medication or invasive procedures, there are no direct physical side effects expected from participating.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with breast cancer before turning 46.
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I have at least one ovary.
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I was diagnosed with triple negative breast cancer before age 61.
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A family member has a known genetic mutation linked to cancer.
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I have a relative who had ovarian cancer.
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Two of my relatives on the same side have breast cancer, one was diagnosed before 50.
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I am 30 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean cancer stress scores
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm D (online education, pre-telephone counseling)Experimental Treatment4 Interventions
Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.
Group II: Arm B (online education, post telephone counseling)Experimental Treatment4 Interventions
Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.
Group III: Arm A (online education)Experimental Treatment3 Interventions
Patients watch genetic testing online educational video and receive genetic testing online test results report.
Group IV: Arm C (online education, pre- and post-telephone counselling)Active Control4 Interventions
Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,928,467 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,799,602 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
Karen H LuPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
374 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot read, speak, or understand English.I was diagnosed with breast cancer before turning 46.I have had a bone marrow transplant.I have not had a blood transfusion in the week before my genetic test.I can see a doctor and am willing to share my genetic test results with them.I have at least one ovary.I was diagnosed with triple negative breast cancer before age 61.A family member has a known genetic mutation linked to cancer.I have a relative who had ovarian cancer.I have had ovarian cancer in the past.I have a male relative who has had breast cancer.Two of my relatives on the same side have breast cancer, one was diagnosed before 50.I have an active blood cancer like leukemia or lymphoma.I have undergone genetic testing or counseling for cancer risk.I am 30 years old or older.I am unable to understand and agree to the study's details on my own.I am unwilling to fill out questionnaires.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C (online education, pre- and post-telephone counselling)
- Group 2: Arm D (online education, pre-telephone counseling)
- Group 3: Arm A (online education)
- Group 4: Arm B (online education, post telephone counseling)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the sample size for this investigation?
"Affirmative. Clinicaltrials.gov documents this clinical trial's active recruitment, which began on April 18th 2017 and was last revised June 14th 2022. This study requires 4000 participants across two sites to complete the research project."
Answered by AI
Is enrollment into this experiment currently open?
"Clinicaltrials.gov confirms that this trial, which began enlisting candidates on April 18th 2017, is actively soliciting participants. The latest update was made June 14th 2022."
Answered by AI
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