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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
511
Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor by Telephone.
Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor using Videoconferencing Technology.
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.
University of Chicago Medical Center
Chicago, Illinois, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
St Jude Children's Research Hospital
Memphis, Tennessee, United States
Number of Participants Who Received Genetic Services
Primary composite outcome collected via remote services records-Yes/No
Time frame: Assessed at 6 Months for ARMS A/B/C
Genetic Knowledge Scale
Change in knowledge. Score range=0-16, and increased change score indicates increase in knowledge (better).
Time frame: Average time from baseline to disclosure was 152.3 days (standard deviation=150.0). (ARMS A/B only)
Impact of Events Scale (IES)
Change in Cancer Specific Distress. Raw Score Range = 0-40. Decreased score change indicates a decrease in distress (better).
Time frame: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days.(ARMS A/B only)
Patient-Reported Outcomes Measurement Information System (PROMIS)
Change in Depression. Score Range = 4-20. Decreased score change indicates a decrease in depression (better).
Time frame: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days.(ARMS A/B only)
Uptake of Genetic Counseling and Testing
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.
Time frame: 6 month status survey (ARMS A/B/C)
Patient Reported Outcomes Measurement Information Systems (PROMIS) Anxiety
Change in Anxiety. Score Range = 4-20. Decreased score change indicates a decrease in anxiety (better).
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Time frame: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) Uncertainty
Change in Uncertainty. Score Range = 0-85. Decreased score change indicates a decrease in uncertainty (better).
Time frame: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)
Change in Health Behaviors: Change in Number of Wine/Beer/Mixed Drinks Per Day Among Those With Genetic Testing
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.
Time frame: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)
Change in Health Behaviors: Change in Minutes of Vigorous Exercise Per Week Among Those With Genetic Testing
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.
Time frame: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)
Change in Health Behaviors: Change in Minutes of Moderate Exercise Per Week Among Those With Genetic Testing
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.
Time frame: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)
Change in Health Behaviors: New Sigmoidoscopy or Colonoscopy Among Those Who Did Not Have One Within a Year of the Baseline Visit
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.
Time frame: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)
Change in Health Behaviors: New Mammogram Within One Year at 6 Months Among Those Who Did Not Have One Within a Year at Baseline
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.
Time frame: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)