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 5879400, Alaska 5879092 98508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Phoenix 5308655, Arizona 5551752 85004
Fort Smith 4111410, Arkansas 4099753 72903
Site Public Contact
800-378-9373
Little Rock 4119403, Arkansas 4099753 72205
Arroyo Grande 5324802, California 5332921 93420
Burbank 5331835, California 5332921 91505
Carmichael 5334336, California 5332921 95608
Carmichael 5334336, California 5332921 95608
Elk Grove 5346111, California 5332921 95758
Merced 5372253, California 5332921 95340
Napa 5376095, California 5332921 94558
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707-521-3830
Rocklin 5388319, California 5332921 95765
Sacramento 5389489, California 5332921 95816
San Luis Obispo 5392323, California 5332921 93401
Santa Maria 5393180, California 5332921 93444
Santa Rosa 5393287, California 5332921 95403
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707-521-3830
Santa Rosa 5393287, California 5332921 95405
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707-521-3830
Stockton 5399020, California 5332921 95204
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209-461-5257
Woodland 5410430, California 5332921 95695
Colorado Springs 5417598, Colorado 5417618 80907
Colorado Springs 5417598, Colorado 5417618 80907
Colorado Springs 5417598, Colorado 5417618 80923
Durango 5420241, Colorado 5417618 81301
Durango 5420241, Colorado 5417618 81301
Lakewood 5427946, Colorado 5417618 80228
Longmont 5579276, Colorado 5417618 80501
Pueblo 5435464, Colorado 5417618 81004
Westminster 5443910, Colorado 5417618 80023
Wilmington 4145381, Delaware 4142224 19803
Orlando 4167147, Florida 4155751 32806
Orlando 4167147, Florida 4155751 32827
Pensacola 4168228, Florida 4155751 32504
Boise 5586437, Idaho 5596512 83712
Fruitland 5593708, Idaho 5596512 83619
Meridian 5600685, Idaho 5596512 83642
Nampa 5601933, Idaho 5596512 83687
Twin Falls 5610810, Idaho 5596512 83301
Alton 4232679, Illinois 4896861 62002
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618-463-5623
Bloomington 4885164, Illinois 4896861 61704
Canton 4831990, Illinois 4896861 61520
Carbondale 4235193, Illinois 4896861 62902
Carterville 4235311, Illinois 4896861 62918
Carthage 4886716, Illinois 4896861 62321
Centralia 4235587, Illinois 4896861 62801
Decatur 4236895, Illinois 4896861 62526
Decatur 4236895, Illinois 4896861 62526
Dixon 4889959, Illinois 4896861 61021
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815-285-7800
Effingham 4237727, Illinois 4896861 62401
Eureka 4891310, Illinois 4896861 61530
Galesburg 4893392, Illinois 4896861 61401
Kewanee 4898433, Illinois 4896861 61443
Macomb 4900817, Illinois 4896861 61455
Mount Vernon 4245152, Illinois 4896861 62864
O'Fallon 4245926, Illinois 4896861 62269
O'Fallon 4245926, Illinois 4896861 62269
Ottawa 4905006, Illinois 4896861 61350
Pekin 4905599, Illinois 4896861 61554
Peoria 4905687, Illinois 4896861 61615
Peoria 4905687, Illinois 4896861 61636
Peru 4905770, Illinois 4896861 61354
Peru 4905770, Illinois 4896861 61354
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815-664-4141
Princeton 4906818, Illinois 4896861 61356
Springfield 4250542, Illinois 4896861 62702
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217-545-7929
Springfield 4250542, Illinois 4896861 62702
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800-444-7541
Springfield 4250542, Illinois 4896861 62781
Washington 4915545, Illinois 4896861 61571
Ankeny 4846960, Iowa 4862182 50023
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515-241-3305
Carroll 4850478, Iowa 4862182 51401
Clive 4852065, Iowa 4862182 50325
Clive 4852065, Iowa 4862182 50325
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515-241-3305
Creston 4853078, Iowa 4862182 50801
Des Moines 4853828, Iowa 4862182 50309
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515-241-6727
Des Moines 4853828, Iowa 4862182 50309
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515-241-3305
Des Moines 4853828, Iowa 4862182 50314
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515-282-2200
Des Moines 4853828, Iowa 4862182 50314
Des Moines 4853828, Iowa 4862182 50314
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515-241-3305
Fort Dodge 4857486, Iowa 4862182 50501
Pella 4870915, Iowa 4862182 50219
Waukee 4880981, Iowa 4862182 50263
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515-241-3305
West Des Moines 4881346, Iowa 4862182 50266
West Des Moines 4881346, Iowa 4862182 50266
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515-875-9815
Garden City 5445439, Kansas 4273857 67846
Great Bend 4272340, Kansas 4273857 67530
Pittsburg 4277241, Kansas 4273857 66762
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888-446-3729
Bardstown 4283133, Kentucky 6254925 40004
Corbin 4288656, Kentucky 6254925 40701
Lexington 4297983, Kentucky 6254925 40504
Lexington 4297983, Kentucky 6254925 40504
Lexington 4297983, Kentucky 6254925 40509
London 4298960, Kentucky 6254925 40741
Mount Sterling 4301683, Kentucky 6254925 40353
Escanaba 4992232, Michigan 5001836 49829
Burnsville 5019767, Minnesota 5037779 55337
Coon Rapids 5022025, Minnesota 5037779 55433
Edina 5025264, Minnesota 5037779 55435
Maple Grove 5036493, Minnesota 5037779 55369
Maplewood 5036588, Minnesota 5037779 55109
Maplewood 5036588, Minnesota 5037779 55109
Minneapolis 5037649, Minnesota 5037779 55407
Minneapolis 5037649, Minnesota 5037779 55415
Monticello 5038045, Minnesota 5037779 55362
Princeton 5042360, Minnesota 5037779 55371
Robbinsdale 5043439, Minnesota 5037779 55422
Saint Louis Park 5045021, Minnesota 5037779 55416
Saint Paul 5045360, Minnesota 5037779 55101
Saint Paul 5045360, Minnesota 5037779 55102
Shakopee 5046997, Minnesota 5037779 55379
Stillwater 5048814, Minnesota 5037779 55082
Waconia 5051640, Minnesota 5037779 55387
Willmar 5052916, Minnesota 5037779 56201
Woodbury 5053358, Minnesota 5037779 55125
Wyoming 5053526, Minnesota 5037779 55092
Ballwin 4375663, Missouri 4398678 63011
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Bolivar 4377835, Missouri 4398678 65613
Branson 4378219, Missouri 4398678 65616
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417-269-4520
Cape Girardeau 4379966, Missouri 4398678 63703
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Cape Girardeau 4379966, Missouri 4398678 63703
Farmington 4386289, Missouri 4398678 63640
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314-996-5569
Joplin 4392768, Missouri 4398678 64804
Joplin 4392768, Missouri 4398678 64804
Osage Beach 4402040, Missouri 4398678 65065
Rolla 4406282, Missouri 4398678 65401
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573-458-6379
Rolla 4406282, Missouri 4398678 65401
Saint Joseph 4407010, Missouri 4398678 64506
Sainte Genevieve 4407294, Missouri 4398678 63670
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Springfield 4409896, Missouri 4398678 65804
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Springfield 4409896, Missouri 4398678 65807
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St Louis 4407066, Missouri 4398678 63109
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St Louis 4407066, Missouri 4398678 63128
St Louis 4407066, Missouri 4398678 63131
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St Louis 4407066, Missouri 4398678 63141
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Sullivan 4410669, Missouri 4398678 63080
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Sunset Hills 4410836, Missouri 4398678 63127
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314-996-5569
Washington 4413621, Missouri 4398678 63090
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636-390-1600
Missoula 5666639, Montana 5667009 59802
Grand Island 5069297, Nebraska 5073708 68803
Kearney 5071348, Nebraska 5073708 68847
Omaha 5074472, Nebraska 5073708 68122
Omaha 5074472, Nebraska 5073708 68124
Omaha 5074472, Nebraska 5073708 68130
Omaha 5074472, Nebraska 5073708 68131
Charlotte 4460243, North Carolina 4482348 28204
Huntersville 4472370, North Carolina 4482348 28078
Huntersville 4472370, North Carolina 4482348 28078
Matthews 4478334, North Carolina 4482348 28105
Matthews 4478334, North Carolina 4482348 28105
Mooresville 4480125, North Carolina 4482348 28117
Salisbury 4489985, North Carolina 4482348 28144
Salisbury 4489985, North Carolina 4482348 28144
Cincinnati 4508722, Ohio 5165418 45220
Cincinnati 4508722, Ohio 5165418 45242
Cincinnati 4508722, Ohio 5165418 45247
Cincinnati 4508722, Ohio 5165418 45255
Oklahoma City 4544349, Oklahoma 4544379 73120
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405-752-3402
Bend 5713587, Oregon 5744337 97701
Clackamas 5719308, Oregon 5744337 97015
Coos Bay 5720495, Oregon 5744337 97420
Hood River 5731777, Oregon 5744337 97031
Newberg 5742726, Oregon 5744337 97132
Oregon City 5744253, Oregon 5744337 97045
Portland 5746545, Oregon 5744337 97213
Portland 5746545, Oregon 5744337 97225
Redmond 5747882, Oregon 5744337 97756
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541-706-2909
Charleston 4574324, South Carolina 4597040 29425
San Antonio 4726206, Texas 4736286 78229
Mechanicsville 4772566, Virginia 6254928 23116
Midlothian 4772943, Virginia 6254928 23114
Richmond 4781708, Virginia 6254928 23226
Aberdeen 5785243, Washington 5815135 98520
Bellingham 5786899, Washington 5815135 98225
Centralia 5789683, Washington 5815135 98531
Edmonds 5793427, Washington 5815135 98026
Everett 5793933, Washington 5815135 98201
Issaquah 5798487, Washington 5815135 98029
Kennewick 5799610, Washington 5815135 99336
Lacey 5800112, Washington 5815135 98503
Longview 5801617, Washington 5815135 98632
Mount Vernon 5804127, Washington 5815135 98274
Seattle 5809844, Washington 5815135 98107
Seattle 5809844, Washington 5815135 98122-5711
Seattle 5809844, Washington 5815135 98122
Sedro-Woolley 5809902, Washington 5815135 98284
Silverdale 5810490, Washington 5815135 98383
Spokane 5811696, Washington 5815135 99202
Spokane 5811696, Washington 5815135 99216
Spokane 5811696, Washington 5815135 99218
Vancouver 5814616, Washington 5815135 98664
Walla Walla 5814916, Washington 5815135 99362
Green Bay 5254962, Wisconsin 5279468 54301
Green Bay 5254962, Wisconsin 5279468 54303
New Richmond 5264475, Wisconsin 5279468 54017
Oconto Falls 5265522, Wisconsin 5279468 54154
Sheboygan 5272893, Wisconsin 5279468 53081
Sheboygan 5272893, Wisconsin 5279468 53081
Sturgeon Bay 5274867, Wisconsin 5279468 54235-1495
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.