Family Communications After Genetic Testing
Purpose
This clinical trial compares patient (proband)-mediated communication to provider-mediated communication for improving genetic testing in first-degree relatives of patients with newly diagnosed colorectal cancer. It is estimated that 30% of cases of colorectal cancer have a genetic basis and about 15% of these patients have a disease-causing (pathogenic) inherited (germline) variant in a cancer susceptibility gene. Most individuals carrying a pathogenic germline variant are unaware of their cancer risk and may not meet guidelines for genetic testing. Identifying pathogenic germline variants or hereditary cancer syndromes in cancer patients has important implications for their at-risk relatives who may not know that they are at high risk for cancer. The burden of communicating this risk to first-degree relatives often falls on the patients, who may lack sufficient knowledge to correctly share and explain their genetic test results. Receiving provider-mediated communication of genetic testing results may be more effective at communicating genetic risk to first-degree relatives than the usual practice of proband-mediated communication.
Conditions
- Colon Adenocarcinoma
- Colorectal Adenocarcinoma
- Rectal Adenocarcinoma
- Stage I Colon Cancer AJCC v8
- Stage I Colorectal Cancer AJCC v8
- Stage I Rectal Cancer AJCC v8
- Stage II Colon Cancer AJCC v8
- Stage II Colorectal Cancer AJCC v8
- Stage II Rectal Cancer AJCC v8
- Stage III Colon Cancer AJCC v8
- Stage III Colorectal Cancer AJCC v8
- Stage III Rectal Cancer AJCC v8
- Stage IV Colon Cancer AJCC v8
- Stage IV Colorectal Cancer AJCC v8
- Stage IV Rectal Cancer AJCC v8
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- STEP 1 PROBANDS: Age >= 18 years - STEP 1 PROBANDS: Patients with a newly diagnosed (within 3 months of registration), primary colorectal adenocarcinoma, stage I to IV - Histologically proven stage I to IV colon or rectal adenocarcinoma (any T or N, M+). Tumors deemed to originate in the colon can extend into/involve the small bowel (e.g., those at the ileocecal valve). Tumors will be regarded as originating in the colon if the entire tumor is in the colon. In the case of rectal involvement, the cancer will be considered a rectal primary - Patients with more than one primary colon adenocarcinoma are eligible - STEP 1 PROBANDS: No patients with stage 0 or in-situ colorectal cancer - STEP 1 PROBANDS: Patients who have had prior malignancies are eligible, including non-invasive cancers - STEP 1 PROBANDS: Patients with synchronous second malignancies are eligible - STEP 1 PROBANDS: Have not received germline testing in the 2 years prior to enrollment or known hereditary colon cancer syndromes - STEP 1 PROBANDS: Patients must have at least 2 living FDRs who meet the eligibility criteria, with whom the patient is willing to share their cancer diagnosis - STEP 1 PROBANDS: In order to complete the mandatory patient-completed measures and view the video and receive genetic education and counseling, participants must be able to speak and read English or Spanish - STEP 1 PROBANDS: No known diagnosis of dementia or cognitive impairment. Persons with impaired decision-making capacity are ineligible as they need to be able to understand genetic test results, its implications for the patient and family, and explain genetic test results to their family members * No persons with a known psychiatric or documented developmental disorder that affects cognitive or emotional functions to the extent that the capacity for judgment and reason is significantly diminished, such that they cannot participate based on the judgment of the treating physician - STEP 2 PROBANDS: Probands positive for a pathogenic germline variant (PGV) in a cancer susceptibility gene - FDRs: Age >= 18 years - FDRs: Have not previously received germline genetic testing or known hereditary colon cancer syndromes - FDRs: FDRs must reside within the United States, as genetic testing from LabCorp is only available to United States (U.S.) residents - FDRs: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish
Exclusion Criteria
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Screening
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Step 1 (biospecimen collection, genetic testing) |
Probands undergo collection of blood samples and genetic testing on study. |
|
|
Active Comparator Step 2, Arm A (proband-mediated) |
FDRs receive proband-mediated communication about the proband's genetic testing results. |
|
|
Experimental Step 2, Arm B (provider-mediated) |
FDRs receive provider-mediated communication about the proband's genetic testing results. |
|
Recruiting Locations
Anchorage, Alaska 98508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Fairbanks, Alaska 99701
Phoenix, Arizona 85004
Fort Smith, Arkansas 72903
Site Public Contact
800-378-9373
Little Rock, Arkansas 72205
Arroyo Grande, California 93420
Burbank, California 91505
Carmichael, California 95608
Carmichael, California 95608
Elk Grove, California 95758
Merced, California 95340
Napa, California 94558
Site Public Contact
707-521-3830
Rocklin, California 95765
Sacramento, California 95816
San Luis Obispo, California 93401
Santa Maria, California 93444
Santa Rosa, California 95403
Site Public Contact
707-521-3830
Santa Rosa, California 95405
Site Public Contact
707-521-3830
St. Helena, California 94574
Site Public Contact
707-967-3698
Stockton, California 95204
Site Public Contact
209-461-5257
Woodland, California 95695
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80923
Durango, Colorado 81301
Durango, Colorado 81301
Lakewood, Colorado 80228
Longmont, Colorado 80501
Pueblo, Colorado 81004
Westminster, Colorado 80023
Fort Lauderdale, Florida 33308
Boise, Idaho 83706
Boise, Idaho 83712
Caldwell, Idaho 83605
Coeur d'Alene, Idaho 83814
Fruitland, Idaho 83619
Meridian, Idaho 83642
Meridian, Idaho 83642
Nampa, Idaho 83687
Nampa, Idaho 83687
Post Falls, Idaho 83854
Sandpoint, Idaho 83864
Twin Falls, Idaho 83301
Alton, Illinois 62002
Site Public Contact
618-463-5623
Bloomington, Illinois 61704
Canton, Illinois 61520
Carbondale, Illinois 62902
Carterville, Illinois 62918
Carthage, Illinois 62321
Centralia, Illinois 62801
Danville, Illinois 61832
Decatur, Illinois 62526
Decatur, Illinois 62526
Dixon, Illinois 61021
Site Public Contact
815-285-7800
Effingham, Illinois 62401
Effingham, Illinois 62401
Eureka, Illinois 61530
Galesburg, Illinois 61401
Kewanee, Illinois 61443
Macomb, Illinois 61455
Mattoon, Illinois 61938
Mount Vernon, Illinois 62864
Normal, Illinois 61761
Normal, Illinois 61761
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Ottawa, Illinois 61350
Pekin, Illinois 61554
Peoria, Illinois 61615
Peoria, Illinois 61636
Peru, Illinois 61354
Peru, Illinois 61354
Site Public Contact
815-664-4141
Princeton, Illinois 61356
Rockford, Illinois 61108
Site Public Contact
815-227-2633
Springfield, Illinois 62702
Site Public Contact
217-545-7929
Springfield, Illinois 62702
Site Public Contact
800-444-7541
Springfield, Illinois 62781
Urbana, Illinois 61801
Washington, Illinois 61571
Garden City, Kansas 67846
Great Bend, Kansas 67530
Pittsburg, Kansas 66762
Site Public Contact
888-446-3729
Topeka, Kansas 66606
Site Public Contact
785-270-4939
Bardstown, Kentucky 40004
Corbin, Kentucky 40701
Lexington, Kentucky 40504
Lexington, Kentucky 40504
Lexington, Kentucky 40509
London, Kentucky 40741
Mount Sterling, Kentucky 40353
Baltimore, Maryland 21215
Site Public Contact
410-601-9083
Randallstown, Maryland 21133
Towson, Maryland 21204
Westminster, Maryland 21157
Site Public Contact
410-871-6400
Alma, Michigan 48801
Alpena, Michigan 49707
Ann Arbor, Michigan 48106
Brighton, Michigan 48114
Brighton, Michigan 48114
Canton, Michigan 48188
Canton, Michigan 48188
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Clarkston, Michigan 48346
Detroit, Michigan 48236
East China Township, Michigan 48054
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Gladwin, Michigan 48624
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Lansing, Michigan 48912
Livonia, Michigan 48154
Macomb, Michigan 48044
Macomb, Michigan 48044
Midland, Michigan 48670
Mount Pleasant, Michigan 48858
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Saginaw, Michigan 48601
Tawas City, Michigan 48764
Warren, Michigan 48093
Warren, Michigan 48093
Warren, Michigan 48093
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48197
Aitkin, Minnesota 56431
Baxter, Minnesota 56425
Site Public Contact
218-828-2880
Brainerd, Minnesota 56401
Burnsville, Minnesota 55337
Chaska, Minnesota 55318
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Crosslake, Minnesota 56442
Site Public Contact
218-692-1010
Deer River, Minnesota 56636
Detroit Lakes, Minnesota 56501
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Edina, Minnesota 55435
Edina, Minnesota 55435
Ely, Minnesota 55731
Site Public Contact
218-365-7900
Fosston, Minnesota 56542
Hibbing, Minnesota 55746
Site Public Contact
218-786-3308
International Falls, Minnesota 56649
Site Public Contact
218-283-9431
Maple Grove, Minnesota 55369
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Moose Lake, Minnesota 55767
Site Public Contact
218-485-4481
New Ulm, Minnesota 56073
Park Rapids, Minnesota 56470
Pequot Lakes, Minnesota 56472
Site Public Contact
218-568-4416
Pine River, Minnesota 56474
Site Public Contact
218-587-4416
Princeton, Minnesota 55371
Robbinsdale, Minnesota 55422
Saint Louis Park, Minnesota 55416
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55102
Sandstone, Minnesota 55072
Shakopee, Minnesota 55379
Staples, Minnesota 56479
Site Public Contact
218-894-7870
Stillwater, Minnesota 55082
Virginia, Minnesota 55792
Waconia, Minnesota 55387
Willmar, Minnesota 56201
Woodbury, Minnesota 55125
Wyoming, Minnesota 55092
Ballwin, Missouri 63011
Site Public Contact
888-446-3729
Bolivar, Missouri 65613
Branson, Missouri 65616
Site Public Contact
417-269-4520
Cape Girardeau, Missouri 63703
Site Public Contact
888-446-3729
Cape Girardeau, Missouri 63703
Farmington, Missouri 63640
Site Public Contact
314-996-5569
Joplin, Missouri 64804
Joplin, Missouri 64804
Osage Beach, Missouri 65065
Rolla, Missouri 65401
Site Public Contact
573-458-6379
Rolla, Missouri 65401
Saint Joseph, Missouri 64506
Sainte Genevieve, Missouri 63670
Site Public Contact
314-996-5569
Springfield, Missouri 65804
Site Public Contact
417-269-4520
Springfield, Missouri 65807
Site Public Contact
417-269-4520
St Louis, Missouri 63109
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888-446-3729
St Louis, Missouri 63128
St Louis, Missouri 63131
Site Public Contact
314-996-5569
St Louis, Missouri 63141
Site Public Contact
314-251-7066
Sullivan, Missouri 63080
Site Public Contact
314-996-5569
Sunset Hills, Missouri 63127
Site Public Contact
314-996-5569
Washington, Missouri 63090
Site Public Contact
636-390-1600
Anaconda, Montana 59711
Billings, Montana 59101
Bozeman, Montana 59715
Great Falls, Montana 59405
Great Falls, Montana 59405
Havre, Montana 59501
Helena, Montana 59601
Kalispell, Montana 59901
Missoula, Montana 59802
Missoula, Montana 59804
Grand Island, Nebraska 68803
Kearney, Nebraska 68847
Omaha, Nebraska 68122
Omaha, Nebraska 68124
Omaha, Nebraska 68130
Gastonia, North Carolina 28054
Lincolnton, North Carolina 28092
Site Public Contact
704-671-7031
Fargo, North Dakota 58103
Jamestown, North Dakota 58401
Alliance, Ohio 44601
Site Public Contact
330-363-1250
Canton, Ohio 44710
Cincinnati, Ohio 45219
Cincinnati, Ohio 45220
Cincinnati, Ohio 45242
Cincinnati, Ohio 45247
Cincinnati, Ohio 45255
West Chester, Ohio 45069
Oklahoma City, Oklahoma 73120
Site Public Contact
405-752-3402
Baker City, Oregon 97814
Bend, Oregon 97701
Clackamas, Oregon 97015
Coos Bay, Oregon 97420
Hood River, Oregon 97031
Newberg, Oregon 97132
Ontario, Oregon 97914
Oregon City, Oregon 97045
Portland, Oregon 97213
Portland, Oregon 97225
Redmond, Oregon 97756
Site Public Contact
541-706-2909
Allentown, Pennsylvania 18103
Bethlehem, Pennsylvania 18017
East Stroudsburg, Pennsylvania 18301
Hazleton, Pennsylvania 18201
Rapid City, South Dakota 57701
Aberdeen, Washington 98520
Bellingham, Washington 98225
Centralia, Washington 98531
Edmonds, Washington 98026
Everett, Washington 98201
Issaquah, Washington 98029
Kennewick, Washington 99336
Lacey, Washington 98503
Longview, Washington 98632
Mount Vernon, Washington 98274
Seattle, Washington 98107
Seattle, Washington 98122-5711
Seattle, Washington 98122
Sedro-Woolley, Washington 98284
Silverdale, Washington 98383
Spokane, Washington 99202
Spokane, Washington 99216
Spokane, Washington 99218
Vancouver, Washington 98664
Walla Walla, Washington 99362
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Hayward, Wisconsin 54843
Hayward, Wisconsin 54843
Site Public Contact
218-568-4416
New Richmond, Wisconsin 54017
Spooner, Wisconsin 54801
Superior, Wisconsin 54880
Site Public Contact
701-364-6272
Cheyenne, Wyoming 82001
Cody, Wyoming 82414
More Details
- Status
- Recruiting
- Sponsor
- Alliance for Clinical Trials in Oncology
Detailed Description
PRIMARY OBJECTIVES: I. To compare the proportion of first-degree relatives (FDRs) of probands with Lynch Syndrome who undergo germline testing in the provider-mediated arm (Arm B) versus the proband-mediated (Arm A) at 6 months. II. To compare the proportion of FDRs of proband with a non-Lynch pathogenic germline variant who undergo germline testing in the provider-mediated arm (Arm B) versus the proband-mediated arm (Arm A) at 6 months. SECONDARY OBJECTIVE: I. To compare the proportion of FDRs with a pathogenic germline variant (PGV) who underwent disease prevention efforts at 12 months between the provider-mediated arm (Arm B) and the proband-mediated cascade testing arm (Arm A). EXPLORATORY OBJECTIVES: I. To assess differences in percentages of cascade genetic testing within the following proband subgroups: race/ethnicity (non-Hispanic whites; other race/ethnicities), sex (females; males), age (>= 50; < 50), tumor location (colon; rectal), tumor stage (stage I-II; stage III-IV), geographic location (urban; rural), and receipt of medical care in an academic versus (vs.) community setting. III. To determine the prevalence and spectrum of pathogenic germline variants in cancer susceptibility genes by analysis of results of upfront germline testing in a multi-site cancer cooperative group study population with newly diagnosed CRC. IV. Assess the pattern of accrual of demographic patient subgroups including racial/ethnic minority and rural individuals at the initial 50% of accrual enrolled and at the end of the trial. V. To compare disease-free survival (DFS) of the proband at 3 years between the direct-contact arm (Arm B) and the proband-directed cascade testing arm (Arm A). V. To evaluate the completion rate of a Social Determinants of Health questionnaire with patient directed questions . OUTLINE: STEP 1: Patients (probands) undergo collection of blood samples and genetic testing on study. STEP 2: Probands with pathogenic or likely pathogenic germline variants and their FDRs are randomized to 1 of 2 arms. ARM A: FDRs receive proband-mediated communication about the proband's genetic testing results. ARM B: FDRs receive provider-mediated communication about the proband's genetic testing results. Probands are followed for up to 3 years and FDRs are followed for up to 1 year