Cancer
Conditions
Brief summary
To address the gap in access to genetic services, this study will evaluate the effectiveness of an adapted model of remote delivery of genetic services to increase the uptake of recommended genetic assessment and testing in childhood cancer survivors.
Detailed description
As childhood cancer survivors receive care locally from PCPs, the in-home, collaborative PCP model is designed to increase access to genetic services and uptake of genetic testing in childhood cancer survivors. In this model, individual survivors can access remote telegenetic services and genetic counselors will partner with PCPs to order genetic testing. This study comprises of a 3-arm randomized Hybrid 1 Effectiveness and Implementation study in 360 CCSS survivors to evaluate the effectiveness of our in-home, collaborative PCP model of remote telegenetic services to increase uptake of cancer genetic testing in childhood cancer survivors compared to usual care options for genetic testing. Aims are as follows: To evaluate the effectiveness of our in-home, collaborative PCP model of remote telegenetic services to increase uptake of genetic testing at 6 months as compared to usual care among childhood cancer survivors who meet criteria for cancer genetic testing. Our primary outcome will be a composite variable indicating whether a person had pre-test counseling or genetic testing. To evaluate the effectiveness of remote videoconferencing to provide greater increase in knowledge and decrease in distress and depression as compared to remote phone services, to examine the moderators of patient outcomes with remote telegenetic services, and to estimate intervention costs and incremental cost-effectiveness of the three study arms. To conduct a multi-stakeholder, mixed-methods process evaluation to understand patient, provider and system factors associated with uptake of counseling and testing in our adapted in-home, collaborative PCP model and facilitators and barriers to uptake to provide recommendations for future implementation.
Interventions
BEHAVIORALRemote Telegenetic Counseling by Phone
Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor by Telephone.
BEHAVIORALRemote Telegenetic Counseling by Videoconferencing
Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor using Videoconferencing Technology.
BEHAVIORALUsual Care Arm
Participants in the usual care arm will receive usual care services depending on which referral method they choose and if they initiate services. After a 6 month status survey, if they have not had genetic services through usual care they will be offered services and re-randomized to ARM A/ARM B.
Sponsors
University of Chicago
University of Pennsylvania
St. Jude Children's Research Hospital
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able to understand and communicate in English or Spanish * Currently residing in the US * Childhood Cancer Survivor Study Participant survivors of the following primary cancers: * CNS tumor * Sarcoma (except Ewing sarcoma) * Hepatoblastoma * Leukemia * Childhood Cancer Survivor Study Participant with a family history of a child with cancer: * 2 or more malignancies in childhood (age 18 or younger) * A first degree relative (parent or sibling) with cancer aged 45 or younger * 2 or more second degree relatives with cancer aged 45 or younger (same side of family) * Parents of the child with cancer are related (consanguinity) * Other family history that meets NCCN criteria * Able to communicate remotely through remote telegenetic platforms (phone or videoconference) with genetic counselors
Exclusion criteria
* Uncorrected or uncompensated speech defects that would lead to the participant being unable to communicate effectively with genetic counselor * Currently residing in a US state or territory where genetic counselors are not licensed to provide care * Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and task * Participants who have already completed and received a clinically appropriate multi-gene panel genetic testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received Genetic Services | Assessed at 6 Months for ARMS A/B/C | Primary composite outcome collected via remote services records-Yes/No |
| Genetic Knowledge Scale | Average time from baseline to disclosure was 152.3 days (standard deviation=150.0). (ARMS A/B only) | Change in knowledge. Score range=0-16, and increased change score indicates increase in knowledge (better). |
| Impact of Events Scale (IES) | Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days.(ARMS A/B only) | Change in Cancer Specific Distress. Raw Score Range = 0-40. Decreased score change indicates a decrease in distress (better). |
| Patient-Reported Outcomes Measurement Information System (PROMIS) | Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days.(ARMS A/B only) | Change in Depression. Score Range = 4-20. Decreased score change indicates a decrease in depression (better). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of Genetic Counseling and Testing | 6 month status survey (ARMS A/B/C) | The uptake of genetic services was obtained through available GC records for the telehealth genetic services arms. The 6-month post-enrollment survey was used for the usual care arm and for the telehealth genetic services arms when GC records did not indicate completion. |
| Patient Reported Outcomes Measurement Information Systems (PROMIS) Anxiety | Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only) | Change in Anxiety. Score Range = 4-20. Decreased score change indicates a decrease in anxiety (better). |
| Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) Uncertainty | Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only) | Change in Uncertainty. Score Range = 0-85. Decreased score change indicates a decrease in uncertainty (better). |
| Change in Health Behaviors: Change in Number of Wine/Beer/Mixed Drinks Per Day Among Those With Genetic Testing | Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only) | Change in performance of risk reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses. |
| Change in Health Behaviors: Change in Minutes of Vigorous Exercise Per Week Among Those With Genetic Testing | Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only) | Change in performance of risk reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses. |
| Change in Health Behaviors: Change in Minutes of Moderate Exercise Per Week Among Those With Genetic Testing | Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only) | Change in performance of ris k reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses. |
| Change in Health Behaviors: New Sigmoidoscopy or Colonoscopy Among Those Who Did Not Have One Within a Year of the Baseline Visit | Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only) | Change in performance of risk reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses. |
| Change in Health Behaviors: New Mammogram Within One Year at 6 Months Among Those Who Did Not Have One Within a Year at Baseline | Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only) | Change in performance of risk reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTara O Henderson, MD, MPH
University of Chicago
PRINCIPAL_INVESTIGATORAngela Bradbury, MD
University of Pennsylvania
Participant flow
Recruitment details
Participants were recruited by the Childhood Cancer Survivorship Study (CCSS) Coordinating Center at St. Jude between August 2021 and July 2023. Recruitment methods included emails, texts, phone calls, and mailings.
Pre-assignment details
511 participants were consented and enrolled.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 44.2 years STANDARD_DEVIATION 9.8 |
| First-degree/second-degree relative with cancer | 1.9 Relatives with cancer STANDARD_DEVIATION 1.8 |
| Race/Ethnicity, Customized Black | 12 Participants |
| Race/Ethnicity, Customized Other/Missing | 34 Participants |
| Race/Ethnicity, Customized White | 128 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 188 | 0 / 198 | 0 / 129 |
| other Total, other adverse events | 0 / 188 | 0 / 198 | 0 / 129 |
| serious Total, serious adverse events | 0 / 188 | 0 / 198 | 0 / 129 |
Outcome results
None listed