Educational Materials for Genetic Testing in Cancer
(IMAGINE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to develop easy-to-understand educational materials about genetic testing for cancer patients from diverse backgrounds. Genetic testing can reveal gene changes that might impact cancer treatment options. Participants will review and provide feedback on these materials to help improve them. This trial suits individuals diagnosed with breast, ovarian, pancreatic, or prostate cancer who speak English, Haitian Creole, or Spanish fluently. As an unphased trial, participants can contribute to creating valuable resources that may enhance understanding and decision-making for future patients.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on developing educational materials about genetic testing, so it's unlikely that your current medications would be affected.
What prior data suggests that these educational materials are safe for diverse cancer patients?
Research has shown that the LCAM method for genetic testing is generally easy for people to handle. Studies indicate that this method helps individuals from various cultural and educational backgrounds feel more at ease with genetic testing. No reports have indicated negative psychological effects in those who received important genetic information through this care. Overall, the process is considered safe and does not harm participants.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to create new educational materials tailored specifically for a diverse group of cancer patients considering genetic testing. Unlike standard genetic counseling, which often involves generic pre-test and post-test information, this new approach includes personalized educational content and utilizes a "literacy screener" to better match communication to each patient's understanding. Additionally, the integration of clinical communication materials adapted to individual needs promises to enhance the overall genetic counseling experience, potentially making it more effective and accessible for patients from various backgrounds.
What evidence suggests that this trial's educational materials could be effective for diverse cancer patients?
Research has shown that the LCAM intervention model, which participants in this trial may receive, helps patients make better decisions and feel more satisfied with genetic testing. It aids patients in understanding their options and making informed choices. Studies suggest this approach is particularly beneficial for individuals from diverse cultural and educational backgrounds. The goal is to ensure more patients can access genetic testing and have a positive experience. This model is part of ongoing efforts to make genetic testing easier and more accessible for all cancer patients.12346
Who Is on the Research Team?
Jada Hamilton, PhD, MPH
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Formative Research
Conduct formative research including transcreation and cognitive interviewing to adapt educational materials for the LCAM model
Phase 2: Randomized Clinical Trial
Conduct a randomized clinical trial to test and evaluate effects of the LCAM model for hereditary cancer MGPT compared to standard-of-care
Follow-up
Participants are monitored for decision satisfaction and psychosocial outcomes after genetic testing
What Are the Treatments Tested in This Trial?
Interventions
- Developing New Educational Materials About Genetic Testing for a Diverse Group of Cancer Patients
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
There is no treatment or intervention for Phase 1 of this study. Participants will be asked to participate in a cognitive interview. This section will be amended to include the Phase 2 intervention information once the Phase 1 portion of the study is complete. The Phase 1 materials developed, and results obtained, will directly be part of and inform the intervention for Phase 2.Phase 2: participants will be randomized to the standard-of-care arm or the LCAM intervention arm.
Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics
Participants will receive adapted pretest educational materials from study staff and/or clinical staff and have testing ordered by their oncologist, followed by post-test genetic counseling via telegenetics with a health and genetic "literacy screener" and adapted clinical communication materials.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Citations
Developing New Educational Materials About Genetic ...
The central hypothesis is that this LCAM genetic testing model will lead to better patient decision-making, psychosocial, and behavioral outcomes than a ...
LCAM for Hereditary Cancer Screening in Patients ...
LCAM may help patients from diverse cultural and educational backgrounds have better access to genetic testing and feel satisfied with their experience.
Clinical Studies - NIH RePORTER
The objective of this study is to develop, test, and evaluate a mainstreaming model for hereditary cancer multigene panel testing among cancer patients of many ...
4.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT04751435/developing-new-educational-materials-about-genetic-testing-for-a-diverse-group-of-cancer-patientsDeveloping New Educational Materials About Genetic ...
The objective of this proposal is to develop, test and evaluate a mainstreaming (LCAM) model for hereditary cancer multigene panel testing (MGPT) ...
IMProving Care After Inherited Cancer Testing (IMPACT ...
Our highly innovative and practice-changing study is designed to shift the paradigm by which individuals with P/LP variants and VUS in inherited cancer genes ...
The Clinical and Psychosocial Outcomes for Women Who ...
There were no adverse psychological outcomes amongst women who received clinically actionable germline information through a model of 'genome-first' care.
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