Evaluating Cascade Communication Methods (NCT04428736) | Clinical Trial Compass
CompletedNot Applicable
Evaluating Cascade Communication Methods
United States52 participantsStarted 2020-02-19
Plain-language summary
Hereditary cancer programs face challenges with respect to effective communication of genetic test results within families and uptake of genetic testing by relatives. This study aims to determine if a "disclosure toolkit" provided to the index participant (carrier of cancer risk gene mutation) contributes to sharing genetic test results with relatives, if there are preferred disclosure methods, and whether toolkit use contributes towards at-risk relatives pursuing genetic testing.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age and older
* Proband must be carrier of a high risk cancer predisposition gene
* Relative must be established relative of respective proband participant and deemed "at-risk" for familial gene mutation and eligible genetic testing candidate as per study team determination
* Participants must be able to understand and read English
* Participants must be able to provide informed verbal or written consent
Exclusion Criteria:
* \<18 years of age
* Individuals who are mutation negative for high risk cancer predisposition genes
* Individuals who are carriers of a variant of uncertain significance in any gene
* Individuals who test positive for more than 1 high risk cancer predisposition gene
* Individuals who cannot speak and read English
* Individuals who do not have any at-risk relatives (eligible for familial gene mutation testing) as per study team determination
* Major psychiatric illness or cognitive impairment that in the judgement of the study investigators or study staff would preclude study participation
* Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff
* No available family members for cascade opportunity (adoption, estrangement, etc.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Impact of Toolkit use on sharing genetic test results with at-risk relatives
Timeframe: 1 year
2
Impact of Toolkit use on at-risk relatives pursuing genetic testing