Testing an Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing in Young Adults With Cancer
Purpose
This phase III trial compares the use of a digital chatbot enabled intervention to standard remote genetic services for increasing uptake of genetic counseling and testing among adolescents and young adult (AYA) cancer patients. Genetic testing for cancer predisposition syndromes has become standard evidence-based practice and can inform enhanced screening and risk reducing measures to reduce cancer morbidity and mortality. Despite this, many AYAs are not receiving recommended genetic counseling and testing. Offering remote telehealth services can address access barriers and chatbots and texting interventions could enhance patient outcomes and reduce provider and staff time. The use of a digital chatbot enabled intervention may be equally as effective as standard remote genetic services in AYA cancer patients undergoing genetic testing.
Conditions
- Miscellaneous Neoplasm, Nos
- Non-Neoplastic Condition, Nos
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Criteria
- PATIENTS: Age ≥ 18 years and ≤ 39 years at the time of enrollment
- PATIENTS: AYA cancer patients and survivors. This includes patients at any stage of
diagnosis (e.g., newly diagnosed, in treatment, in survivorship) and a cancer
diagnosis (including pediatric cancers) at any age ≤ 39 years old. Given targeted
therapies for BRCA+ and microsatellite instability (MSI)-high/Lynch Syndrome
patients and benefit to relatives, patients with metastatic cancer are included. Any
history of cancer, regardless of being in treatment or not
- PATIENTS: Language: In order to complete the mandatory patient-completed measures
and receive genetic education and counseling, participants must be able to speak and
read English or Spanish
- PATIENTS: 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
- PATIENTS: 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
- PATIENTS: Participants must meet National Comprehensive Cancer Network (NCCN)
guidelines for genetic testing assessment provided by Penn Telegenetics by the
Eligibility Verification Assessment (EVA) chatbot, or paper forms and genetic
counselor's review
- NON-PATIENT PARTICIPANT: Non-patient participants eligible for this study include:
oncology providers, members of the care team and clinic staff, genetic counselors,
and insurers (i.e., people who work in financial services and/or for insurance
companies) who participate in oncology care among AYA in community for this study
- NON-PATIENT PARTICIPANT: Age ≥ 18 years
- NON-PATIENT PARTICIPANT: Non-patient participants must be able to speak and read
English or Spanish in order to participate in the key informant interviews
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Arm I (standard remote genetic services) |
Patients attend a standard of care telehealth visit with a genetic counselor for pretest genetic education. Patients then undergo standard of care genetic testing and attend a telehealth visit with a genetic counselor for disclosure of results. |
|
|
Experimental Arm II (Genetic Journey Chatbot) |
Patients receive access to the Genetic Journey Chatbot and choose to complete digital pre-test genetic education via the digital tool or via telehealth visit with a genetic counselor. Via the chatbot, patients may request a telehealth visit with a genetic counselor at any time to answer unresolved questions. Patients then undergo standard of care genetic testing and attend a telehealth visit with a genetic counselor for disclosure of results. The chatbot remains available to answer questions, assess barriers, and provide reminders for next steps during the testing period. |
|
Recruiting Locations
Anchorage, Alaska 98508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
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
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
Wilmington, Delaware 19803
Orlando, Florida 32806
Orlando, Florida 32827
Pensacola, Florida 32504
Boise, Idaho 83712
Coeur d'Alene, Idaho 83814
Fruitland, Idaho 83619
Meridian, Idaho 83642
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
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
Ankeny, Iowa 50023
Site Public Contact
515-241-3305
Carroll, Iowa 51401
Clive, Iowa 50325
Site Public Contact
515-241-3305
Clive, Iowa 50325
Site Public Contact
515-241-3305
Creston, Iowa 50801
Site Public Contact
515-241-3305
Des Moines, Iowa 50309
Site Public Contact
515-241-6727
Des Moines, Iowa 50309
Site Public Contact
515-241-3305
Des Moines, Iowa 50314
Site Public Contact
515-282-2200
Des Moines, Iowa 50314
Site Public Contact
515-241-3305
Des Moines, Iowa 50314
Site Public Contact
515-241-3305
Fort Dodge, Iowa 50501
Pella, Iowa 50219
Waukee, Iowa 50263
Site Public Contact
515-241-3305
West Des Moines, Iowa 50266
Site Public Contact
515-241-3305
West Des Moines, Iowa 50266
Site Public Contact
515-875-9815
Garden City, Kansas 67846
Great Bend, Kansas 67530
Pittsburg, Kansas 66762
Site Public Contact
888-446-3729
Bardstown, Kentucky 40004
Corbin, Kentucky 40701
Lexington, Kentucky 40504
Lexington, Kentucky 40504
Lexington, Kentucky 40509
London, Kentucky 40741
Mount Sterling, Kentucky 40353
Escanaba, Michigan 49829
Burnsville, Minnesota 55337
Coon Rapids, Minnesota 55433
Edina, Minnesota 55435
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Monticello, Minnesota 55362
New Ulm, Minnesota 56073
Princeton, Minnesota 55371
Robbinsdale, Minnesota 55422
Saint Louis Park, Minnesota 55416
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55102
Shakopee, Minnesota 55379
Stillwater, Minnesota 55082
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
Site Public Contact
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
Omaha, Nebraska 68131
Charlotte, North Carolina 28204
Huntersville, North Carolina 28078
Huntersville, North Carolina 28078
Kernersville, North Carolina 27284
Matthews, North Carolina 28105
Matthews, North Carolina 28105
Mooresville, North Carolina 28117
Mount Airy, North Carolina 27030
Salisbury, North Carolina 28144
Salisbury, North Carolina 28144
Thomasville, North Carolina 27360
Wilmington, North Carolina 28401
Site Public Contact
910-342-3000
Winston-Salem, North Carolina 27103
Cincinnati, Ohio 45220
Cincinnati, Ohio 45242
Cincinnati, Ohio 45247
Cincinnati, Ohio 45255
Oklahoma City, Oklahoma 73120
Site Public Contact
405-752-3402
Bend, Oregon 97701
Clackamas, Oregon 97015
Coos Bay, Oregon 97420
Hood River, Oregon 97031
Newberg, Oregon 97132
Oregon City, Oregon 97045
Portland, Oregon 97213
Portland, Oregon 97225
Redmond, Oregon 97756
Site Public Contact
541-706-2909
Charleston, South Carolina 29425
San Antonio, Texas 78229
Mechanicsville, Virginia 23116
Midlothian, Virginia 23114
Richmond, Virginia 23226
Richmond, Virginia 23235
Richmond, Virginia 23298
South Hill, Virginia 23970
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
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
New Richmond, Wisconsin 54017
Oconto Falls, Wisconsin 54154
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Sturgeon Bay, Wisconsin 54235-1495
Cheyenne, Wyoming 82001
Cody, Wyoming 82414
More Details
- Status
- Recruiting
- Sponsor
- Alliance for Clinical Trials in Oncology
Detailed Description
The primary and secondary objectives of the study: PRIMARY OBJECTIVES: I. To evaluate the efficacy of an enhanced eHealth and chatbot enabled delivery model to increase uptake of genetic counseling. II. To evaluate the efficacy of an enhanced eHealth and chatbot enabled delivery model to increase uptake of genetic testing. SECONDARY OBJECTIVE: I. To evaluate the efficacy of an enhanced eHealth and chatbot enabled delivery model to provide non-inferior short-term and longitudinal cognitive (e.g. knowledge), affective (e.g. distress), and behavioral outcomes (e.g. cancer screening and communication to relatives) and costs. EXPLORATORY OBJECTIVES: I. To test for moderators of uptake of counseling and testing (primary objectives). II. To test for moderators of short-term and longitudinal patient outcomes (secondary objectives). III. To identify facilitators and barriers to implementation of the enhanced eHealth and chatbot enabled delivery model and standard remote services. OUTLINE: Patients are randomized to 1 of 2 arms. Non-patient participants are assigned to arm 3. ARM I: Patients attend a standard of care telehealth visit with a genetic counselor for pretest genetic education. Patients then undergo standard of care genetic testing and attend a telehealth visit with a genetic counselor for disclosure of results. ARM II: Patients receive access to the Genetic Journey Chatbot and choose to complete digital pre-test genetic education via the digital tool or via telehealth visit with a genetic counselor. Via the chatbot, patients may request a telehealth visit with a genetic counselor at any time to answer unresolved questions. Patients then undergo standard of care genetic testing and attend a telehealth visit with a genetic counselor for disclosure of results. The chatbot remains available to answer questions, assess barriers, and provide reminders for next steps during the testing period. ARM III: Non-patient participants complete an interview on study. After completion of study intervention, patients are followed up at 6 and 12 months.