Miscellaneous Neoplasm, Nos, Non-Neoplastic Condition, Nos
Conditions
Brief 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.
Interventions
OTHERTelemedicine
Undergo telehealth visit with genetic counselor for pretest genetic education
OTHERGenetic Testing
Complete standard of care genetic testing
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
Sponsors
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of genetic counseling | Within 6 months of baseline | 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. |
| Uptake of genetic testing | Within 6 months of baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of genetic disease | Up to 42 months post registration | Obtained from the KnowGene scale. Will be compared using non-inferiority testing with the equivalent of a 0.3 standard deviation (SD) non-inferiority margin. The lower limit of the one-sided 97.5% confidence limit for the difference in means will be compared with the non-inferiority margin and non-inferiority will be concluded if the interval fully lies above -0.3 SD. Longitudinal analyses will include model based analysis using generalized linear models of endpoints over time with link function determined by distribution of the endpoint being modeled and adjusting for baseline patient and disease characteristics. |
| Test result recall | Up to 42 months post registration | Measured via the Test Result Recall scale. Will be compared using non-inferiority testing with the equivalent of a 0.3 SD non-inferiority margin. The lower limit of the one-sided 97.5% confidence limit for each secondary endpoint at T2 (the primary time point of interest for the secondary analyses) will be compared with the non-inferiority margin and non-inferiority will be concluded if the interval fully lies above -0.3 SD. Longitudinal analyses will include model based analysis using generalized linear models of endpoints over time with link function determined by distribution of the endpoint being modeled and adjusting for baseline patient and disease characteristics. |
| Perceptions of genetic disease | Up to 42 months post registration | Measured via the Perceived Risk scale. Will be compared using non-inferiority testing with the equivalent of a 0.3 SD non-inferiority margin. The lower limit of the one-sided 97.5% confidence limit for the difference in means will be compared with the non-inferiority margin and non-inferiority will be concluded if the interval fully lies above -0.3 SD. Longitudinal analyses will include model based analysis using generalized linear models of endpoints over time with link function determined by distribution of the endpoint being modeled and adjusting for baseline patient and disease characteristics. |
| Anxiety | Up to 42 months post registration | Measured via Patient Reported Outcome Measurement Information System (PROMIS) anxiety score. Will be compared using non-inferiority testing with the equivalent of a 0.3 SD non-inferiority margin. The lower limit of the one-sided 97.5% confidence limit for the difference in means will be compared with the non-inferiority margin and non-inferiority will be concluded if the interval fully lies above -0.3 SD. Longitudinal analyses will include model based analysis using generalized linear models of endpoints over time with link function determined by distribution of the endpoint being modeled and adjusting for baseline patient and disease characteristics. |
| Depression | Up to 42 months post registration | Measured via PROMIS Depression score. Will be compared using non-inferiority testing with the equivalent of a 0.3 SD non-inferiority margin. The lower limit of the one-sided 97.5% confidence limit for the difference in means will be compared with the non-inferiority margin and non-inferiority will be concluded if the interval fully lies above -0.3 SD. Longitudinal analyses will include model based analysis using generalized linear models of endpoints over time with link function determined by distribution of the endpoint being modeled and adjusting for baseline patient and disease characteristics. |
| Disease-specific distress | Up to 42 months post registration | Measured via the Revised Impact of Events Scale score. Will be compared using non-inferiority testing with the equivalent of a 0.3 SD non-inferiority margin. The lower limit of the one-sided 97.5% confidence limit for the difference in means will be compared with the non-inferiority margin and non-inferiority will be concluded if the interval fully lies above -0.3 SD. Longitudinal analyses will include model based analysis using generalized linear models of endpoints over time with link function determined by distribution of the endpoint being modeled and adjusting for baseline patient and disease characteristics. |
| Impact of cancer risk | Up to 42 months post registration | Measured via the Multi-dimensional Impact of Cancer Risk Assessment score. Will be compared using non-inferiority testing with the equivalent of a 0.3 SD non-inferiority margin. The lower limit of the one-sided 97.5% confidence limit or each secondary endpoint at T2 (the primary time point of interest for the secondary analyses) will be compared with the non-inferiority margin and non-inferiority will be concluded if the interval fully lies above -0.3 SD. Longitudinal analyses will include model based analysis using generalized linear models of endpoints over time with link function determined by distribution of the endpoint being modeled and adjusting for baseline patient and disease characteristics |
| Satisfaction with genetic services | Up to 30 months post registration | Measured via the Satisfaction with Genetic Services scale. Will be compared using non-inferiority testing with the equivalent of a 0.3 SD non-inferiority margin. The lower limit of the one-sided 97.5% confidence limit or each secondary endpoint at T2 (the primary time point of interest for the secondary analyses) will be compared with the non-inferiority margin and non-inferiority will be concluded if the interval fully lies above -0.3 SD. |
| Attitude toward genetic testing | Up to 24 months post registration | Measured via Attitudes Toward Genetic Testing scale. Will be compared using non-inferiority testing with the equivalent of a 0.3 SD non-inferiority margin. The lower limit of the one-sided 97.5% confidence limit or each secondary endpoint at T2 (the primary time point of interest for the secondary analyses) will be compared with the non-inferiority margin and non-inferiority will be concluded if the interval fully lies above -0.3 SD. |
| Lifestyle behaviors | Up to 42 months post registration | Will be compared using non-inferiority testing with the equivalent of a 0.3 SD non-inferiority margin. The lower limit of the one-sided 97.5% confidence limit for the difference in means will be compared with the non-inferiority margin and non-inferiority will be concluded if the interval fully lies above -0.3 SD. Longitudinal analyses will include model based analysis using generalized linear models of endpoints over time with link function determined by distribution of the endpoint being modeled and adjusting for baseline patient and disease characteristics. |
| Health behaviors | Up to 42 months post registration | Measured via the Screening Health behaviors score. Will be compared using non-inferiority testing with the equivalent of a 0.3 SD non-inferiority margin. The lower limit of the one-sided 97.5% confidence limit for the difference in means will be compared with the non-inferiority margin and non-inferiority will be concluded if the interval fully lies above -0.3 SD. Longitudinal analyses will include model based analysis using generalized linear models of endpoints over time with link function determined by distribution of the endpoint being modeled and adjusting for baseline patient and disease characteristics. |
| Communication to at-risk relatives | Up to 42 months post registration | Will be compared using non-inferiority testing with the equivalent of a 0.3 SD non-inferiority margin. The lower limit of the one-sided 97.5% confidence limit for the difference in means will be compared with the non-inferiority margin and non-inferiority will be concluded if the interval fully lies above -0.3 SD. Longitudinal analyses will include model based analysis using generalized linear models of endpoints over time with link function determined by distribution of the endpoint being modeled and adjusting for baseline patient and disease characteristics. |
| Genetic counselor time | Up to 24 months post registration | o Will be compared using non-inferiority testing with the equivalent of a 0.3 SD non-inferiority margin. The lower limit of the one-sided 97.5% confidence limit for the difference in means will be compared with the non-inferiority margin and non-inferiority will be concluded if the interval fully lies above -0.3 SD. Longitudinal analyses will include model based analysis using generalized linear models of endpoints over time with link function determined by distribution of the endpoint being modeled and adjusting for baseline patient and disease characteristics. |
| Testing costs | Up to 36 months post registration | Measured by 2 patient reported items |
| Costs of the intervention | Up to 42 months post registration | o Will be estimated from a societal perspective, including direct medical and nonmedical costs. These include intervention and chatbot hosting, telecommunication services, personnel and patient time. Information to estimate intervention costs collected from study billing and payment records (e.g. website hosting, chatbot usage and time, videoconferencing and phone usage) and telegenetic staff logs (personnel time). The cost of personnel time will be based on institution-specific salaries, including fringe benefits. In sensitivity analysis, will substitute site-specific salary information with national average wage rates for the relevant occupational categories. Information about other out-of-pocket costs for testing (e.g. copayments) will be obtained through participant surveys. Patient time costs will be valued using national average wage rates for participant-specified occupations. |
Countries
United States
Contacts
CONTACTRachel Wills
STUDY_CHAIRAngela Bradbury, MD
Alliance for Clinical Trials in Oncology
Outcome results
None listed