History of Cancer
Conditions
Keywords
Personal genomics, Genome Sequencing Results, 12-167
Brief summary
This study uses new methods called genome sequencing that allow the investigators to study part or all of a person's genome. The genome is the collection of all of a person's genes. Genes carry the instructions that our bodies need to develop and function. Genes are passed on from one generation to the next. Genome sequencing can study all of a person's genome (whole genome sequencing) or just parts of their genome (whole exome sequencing). In the study, the investigators refer to all these research methods as 'genome sequencing'. Genome sequencing typically shows a large number of gene changes, known as variants. Some (but not all) of these genetic variants may be linked to increased risks of diseases other than cancer. The purpose of this study is to learn what kinds of genetic variants the patient wants to learn about from their genome.
Interventions
BEHAVIORALqualitative interviews
A week before the participants return to the clinic to learn of their results, the RSA will call each participant to complete the Hospital Anxiety & Depression Scale (HADS), revised Impact of Events Scale (IES-R), & a questionnaire about their health behaviors, to establish baseline distress levels & health behaviors. A week later, participants will return to the Clinical Genetics Service to review their results with the genetics provider & discuss resultant therapeutic & management recommendations for the participants & their relatives. A week later, the RSA will call each participant to complete the HADS, IES-R again, to establish the safety of receiving these results. Participants will also be asked to complete the revised Multidimensional Impact of Cancer Risk Assessment (MICRA) measure. The RSA will also invite participants to complete an in-depth telephone interview.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Cancer survivors (sample #1): * Consented individuals with a personal history of cancer enrolled on protocols 09-068 or 96-051 who have indicated their interest in participating in future research or learning their results, defined as either: * For samples #1-2: checking yes to the re-contact question in their consent form; or, * checking I wish to know these results in their consent form. Unaffected Relatives (sample #2): * Consented individuals with no personal history of cancer enrolled on protocols 09-068 and 96-051 (parents or siblings of probands) who have indicated their interest in participating in future research or learning their results, defined as either: * checking yes to the re-contact question in their consent form or, * checking I wish to know these results in their consent form Focus group participants (sample #3- hypothetical group): * Individuals with or without a personal history of cancer
Exclusion criteria
* Non-English speakers; or, * Individuals \< 18 years of age; or * Individuals unable to complete the follow-up assessments (e.g., unavailable to complete questionnaires over the 12-month study period). * For samples #1-2: Individuals who indicate in their consent form that they do not want to * checking no to the re-contact question in their consent form; or, * checking I prefer not to know these results in their consent form * Cases where it is unclear whether individuals' are interested in participating in future research or learning their results, defined as: * Not answering the re-contact question in their consent form (i.e., left blank); or, * Not answering the re-contact question because it did not exist in the version of the consent form that was originally signed (i.e., re-contact question missing).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychological distress | 2 years | of receiving incidentally identified disease risk results from whole genome/exome sequencing. Safety is defined as no more than 20% of participants experiencing clinically meaningful levels of distress at 1 week follow-up, as measured by the Hospital Anxiety & Depression Scale (HADS; score \> or = to 8 on the anxiety sub-scale). Patients will be considered evaluable for the primary outcome if they are not distressed at baseline and have completed the 1 week follow-up assessment. |
Countries
United States
Outcome results
None listed