AYA Access Study: An Enhanced eHealth and Chat-Bot Enabled Delivery Model for Clinical Genetic Services in Community AYA Cancer Patients
Summary
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.
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.
Arms & interventions
- OtherTelemedicine
Undergo telehealth visit with genetic counselor for pretest genetic education
- OtherGenetic Testing
Complete standard of care genetic testing
- OtherTelemedicine
Undergo telehealth visit with genetic counselor for disclosure of results
- OtherInternet-Based Intervention
Receive access to Genetic Journey Chatbot
- OtherEducational Intervention
Complete digital pre-test genetic education
- BehavioralPatient Navigation
Utilize chatbot to answer questions, assess barriers, and provide reminders for next steps during the testing period
- OtherInterview
Complete interview
- OtherSurvey Administration
Ancillary studies
Outcome measures
Primary
Uptake of genetic counseling
Defined as a binary outcome of whether an adolescent or young adult (AYA) underwent genetic counseling within 6 months post completion of the baseline survey. Will be compared between randomized arms using Cochran-Mantel-Haenszel (CMH) tests stratified by gender and a Bonferroni correction will be applied to control family-wise type I error.
Time frame: Within 6 months of baseline
Uptake of genetic testing
Defined as a binary outcome of whether an AYA underwent genetic testing within 6 months post completion of the baseline survey. Will be compared between randomized arms using CMH tests stratified by gender and a Bonferroni correction will be applied to control family-wise type I error.
Time frame: Within 6 months of baseline
Secondary
Knowledge of genetic disease
Time frame: Up to 42 months post registration
Test result recall
Time frame: Up to 42 months post registration
Perceptions of genetic disease
Time frame: Up to 42 months post registration
Anxiety
Time frame: Up to 42 months post registration
Depression
Time frame: Up to 42 months post registration
Disease-specific distress
Time frame: Up to 42 months post registration
Impact of cancer risk
Time frame: Up to 42 months post registration
Satisfaction with genetic services
Time frame: Up to 30 months post registration
Attitude toward genetic testing
Time frame: Up to 24 months post registration
Lifestyle behaviors
Time frame: Up to 42 months post registration
Health behaviors
Time frame: Up to 42 months post registration
Communication to at-risk relatives
Time frame: Up to 42 months post registration
Genetic counselor time
Time frame: Up to 24 months post registration
Testing costs
Time frame: Up to 36 months post registration
Costs of the intervention
Time frame: Up to 42 months post registration
Eligibility criteria
Study locations (231)
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Katmai Oncology Group
Anchorage, Alaska, 99508
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
CARTI Cancer Center
Little Rock, Arkansas, 72205
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Mercy Cancer Center - Carmichael
Carmichael, California, 95608
Mercy San Juan Medical Center
Carmichael, California, 95608
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
Mercy Cancer Center
Merced, California, 95340
Providence Queen of The Valley
Napa, California, 94558
Mercy Cancer Center - Rocklin
Rocklin, California, 95765
Mercy Cancer Center - Sacramento
Sacramento, California, 95816
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, 95403
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, 95405
Saint Joseph's Medical Center
Stockton, California, 95204
Woodland Memorial Hospital
Woodland, California, 95695
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
CommonSpirit Cancer Center Mercy
Durango, Colorado, 81301
Mercy Medical Center
Durango, Colorado, 81301
CommonSpirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado, 80228
Longmont United Hospital
Longmont, Colorado, 80501
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004
Saint Anthony North Hospital
Westminster, Colorado, 80023
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Nemours Children's Hospital
Orlando, Florida, 32827
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
Augusta University Medical Center
Augusta, Georgia, 30912
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Illinois CancerCare-Canton
Canton, Illinois, 61520
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
SIH Cancer Institute
Carterville, Illinois, 62918
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Centralia Oncology Clinic
Centralia, Illinois, 62801
Saint Mary's Hospital
Centralia, Illinois, 62801
Carle at The Riverfront
Danville, Illinois, 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Carle BroMenn Medical Center
Normal, Illinois, 61761
Carle Cancer Institute Normal
Normal, Illinois, 61761
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Illinois CancerCare-Peru
Peru, Illinois, 61354
Valley Radiation Oncology
Peru, Illinois, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Springfield Clinic
Springfield, Illinois, 62702
Springfield Memorial Hospital
Springfield, Illinois, 62781
Carle Cancer Center
Urbana, Illinois, 61801
Illinois CancerCare - Washington
Washington, Illinois, 61571
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Greater Regional Medical Center
Creston, Iowa, 50801
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Broadlawns Medical Center
Des Moines, Iowa, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
UI Healthcare Mission Cancer and Blood - Pella
Pella, Iowa, 50219
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266
The Iowa Clinic PC
West Des Moines, Iowa, 50266
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
Mercy Hospital Pittsburg
Pittsburg, Kansas, 66762
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
Saint Joseph Hospital
Lexington, Kentucky, 40504
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504
Saint Joseph Hospital East
Lexington, Kentucky, 40509
Saint Joseph London
London, Kentucky, 40741
Saint Joseph Mount Sterling
Mount Sterling, Kentucky, 40353
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Mercy Hospital
Coon Rapids, Minnesota, 55433
Fairview Southdale Hospital
Edina, Minnesota, 55435
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Monticello Cancer Center
Monticello, Minnesota, 55362
New Ulm Medical Center
New Ulm, Minnesota, 56073
Fairview Northland Medical Center
Princeton, Minnesota, 55371
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Lakeview Hospital
Stillwater, Minnesota, 55082
Ridgeview Medical Center
Waconia, Minnesota, 55387
Rice Memorial Hospital
Willmar, Minnesota, 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Cox Cancer Center Branson
Branson, Missouri, 65616
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Freeman Health System
Joplin, Missouri, 64804
Mercy Hospital Joplin
Joplin, Missouri, 64804
Lake Regional Hospital
Osage Beach, Missouri, 65065
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Mercy Hospital Springfield
Springfield, Missouri, 65804
CoxHealth South Hospital
Springfield, Missouri, 65807
Mercy Infusion Center - Chippewa
St Louis, Missouri, 63109
Mercy Hospital South
St Louis, Missouri, 63128
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
Mercy Hospital Washington
Washington, Missouri, 63090
Community Hospital of Anaconda
Anaconda, Montana, 59711
Billings Clinic Cancer Center
Billings, Montana, 59101
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Great Falls Clinic
Great Falls, Montana, 59405
Hi-Line Sletten Cancer Center
Havre, Montana, 59501
Benefis Helena Specialty Center
Helena, Montana, 59601
Logan Health Medical Center
Kalispell, Montana, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Community Medical Center
Missoula, Montana, 59804
CHI Health Saint Francis
Grand Island, Nebraska, 68803
CHI Health Good Samaritan
Kearney, Nebraska, 68847
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130
Creighton University Medical Center
Omaha, Nebraska, 68131
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Novant Health Cancer Institute - Huntersville
Huntersville, North Carolina, 28078
Novant Health Presbyterian Medical Center Huntersville
Huntersville, North Carolina, 28078
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284
Matthews Radiation Oncology Center
Matthews, North Carolina, 28105
Novant Health Cancer Institute - Matthews
Matthews, North Carolina, 28105
Novant Health Cancer Institute - Mooresville
Mooresville, North Carolina, 28117
Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina, 27030
Novant Health Cancer Institute - Rowan
Salisbury, North Carolina, 28144
Rowan Regional Medical Center
Salisbury, North Carolina, 28144
Novant Health Cancer Institute - Thomasville
Thomasville, North Carolina, 27360
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Bethesda North Hospital
Cincinnati, Ohio, 45242
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Saint Charles Health System
Bend, Oregon, 97701
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Bay Area Hospital
Coos Bay, Oregon, 97420
Providence Hood River Memorial Hospital
Hood River, Oregon, 97031
Providence Newberg Medical Center
Newberg, Oregon, 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Saint Charles Health System-Redmond
Redmond, Oregon, 97756
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
VCU Community Memorial Health Center
South Hill, Virginia, 23970
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Providence Regional Cancer Partnership
Everett, Washington, 98201
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
Skagit Regional Health Cancer Care Center
Mount Vernon, Washington, 98274
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711
Swedish Medical Center-First Hill
Seattle, Washington, 98122
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
Saint Joseph Medical Center Hematology and Oncology - Silverdale
Silverdale, Washington, 98383
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202
Cancer Care Northwest-Valley
Spokane, Washington, 99216
Cancer Care Northwest-North Spokane
Spokane, Washington, 99218
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081
Sheboygan Physicians Group
Sheboygan, Wisconsin, 53081
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
Memorial Hospital of Laramie County
Cheyenne, Wyoming, 82001
Billings Clinic-Cody
Cody, Wyoming, 82414