Human Subjects Protection: An Event Monitoring Committee for Research Studies of Girls From Breast Cancer Families

Harris, Diana; Patrick‐Miller, Linda; Schwartz, Lisa A.; Lantos, John D.; Daugherty, C. K.; Daly, Mary B.; Andrulis, Irene L.; Buys, Saundra S.; Chung, Wendy K.; Frost, Caren J.; John, Esther M.; Keegan, Theresa H.M.; Knight, Julia A.; Terry, Mary Beth; Bradbury, Angela R.

doi:10.1016/j.jadohealth.2014.03.007

Cited by 5 publications

(3 citation statements)

References 26 publications

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“…Although this percentage and overall levels of distress were relatively low, this is a young cohort, and perceived risk may increase as girls progress through adolescence. 23,45 Additionally, higher perceived risk was associated with higher breast cancer–specific distress. This is particularly important because distress and externalizing problems have been associated with risk-taking behaviors among youth.…”

Section: Discussionmentioning

confidence: 96%

Psychosocial Adjustment in School-age Girls With a Family History of Breast Cancer

et al. 2015

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OBJECTIVE Understanding how young girls respond to growing up with breast cancer family histories is critical given expansion of genetic testing and breast cancer messaging. We examined the impact of breast cancer family history on psychosocial adjustment and health behaviors among >800 girls in the multicenter LEGACY Girls Study. METHODS Girls aged 6 to 13 years with a family history of breast cancer or familial BRCA1/2 mutation (BCFH+), peers without a family history (BCFH−), and their biological mothers completed assessments of psychosocial adjustment (maternal report for 6- to 13-year-olds, self-report for 10- to 13-year-olds), breast cancer–specific distress, perceived risk of breast cancer, and health behaviors (10- to 13-year-olds). RESULTS BCFH+ girls had better general psychosocial adjustment than BCFH− peers by maternal report. Psychosocial adjustment and health behaviors did not differ significantly by self-report among 10- to 13-year-old girls. BCFH+ girls reported higher breast cancer–specific distress (P = .001) and were more likely to report themselves at increased breast cancer risk than BCFH− peers (38.4% vs 13.7%, P < .001), although many girls were unsure of their risk. In multivariable analyses, higher daughter anxiety was associated with higher maternal anxiety and poorer family communication. Higher daughter breast cancer–specific distress was associated with higher maternal breast cancer-specific distress. CONCLUSIONS Although growing up in a family at risk for breast cancer does not negatively affect general psychosocial adjustment among preadolescent girls, those from breast cancer risk families experience greater breast cancer–specific distress. Interventions to address daughter and mother breast cancer concerns and responses to genetic or familial risk might improve psychosocial outcomes of teen daughters.

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Section: Discussionmentioning

confidence: 96%

Psychosocial Adjustment in School-age Girls With a Family History of Breast Cancer

et al. 2015

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“…Additionally, an external, five-member Event Monitoring Committee (EMC) [79,80] has been convened to provide additional, independent study oversight and protection of the psychosocial wellbeing of pediatric participants. The EMC has multidisciplinary expertise relevant to the study (e.g., experts in adolescent health, bioethics, and pediatric genetics) and will work with the study team to address and prevent adverse events.…”

Section: Psychosocial Supportmentioning

confidence: 99%

Pediatric reporting of genomic results study (PROGRESS): a mixed-methods, longitudinal, observational cohort study protocol to explore disclosure of actionable adult- and pediatric-onset genomic variants to minors and their parents

Savatt¹,

Wagner

Joffe

et al. 2020

BMC Pediatr

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Background Exome and genome sequencing are routinely used in clinical care and research. These technologies allow for the detection of pathogenic/likely pathogenic variants in clinically actionable genes. However, fueled in part by a lack of empirical evidence, controversy surrounds the provision of genetic results for adult-onset conditions to minors and their parents. We have designed a mixed-methods, longitudinal cohort study to collect empirical evidence to advance this debate. Methods Pediatric participants in the Geisinger MyCode® Community Health Initiative with available exome sequence data will have their variant files assessed for pathogenic/likely pathogenic variants in 60 genes designated as actionable by MyCode. Eight of these genes are associated with adult-onset conditions (Hereditary Breast and Ovarian Cancer Syndrome (HBOC), Lynch syndrome, MUTYH-associated polyposis, HFE-Associated Hereditary Hemochromatosis), while the remaining genes have pediatric onset. Prior to clinical confirmation of results, pediatric MyCode participants and their parents/legal guardians will be categorized into three study groups: 1) those with an apparent pathogenic/likely pathogenic variant in a gene associated with adult-onset disease, 2) those with an apparent pathogenic/likely pathogenic variant in a gene associated with pediatric-onset disease or with risk reduction interventions that begin in childhood, and 3) those with no apparent genomic result who are sex- and age-matched to Groups 1 and 2. Validated and published quantitative measures, semi-structured interviews, and a review of electronic health record data conducted over a 12-month period following disclosure of results will allow for comparison of psychosocial and behavioral outcomes among parents of minors (ages 0–17) and adolescents (ages 11–17) in each group. Discussion These data will provide guidance about the risks and benefits of informing minors and their family members about clinically actionable, adult-onset genetic conditions and, in turn, help to ensure these patients receive care that promotes physical and psychosocial health. Trial registration ClinicalTrials.gov Identifier: NCT03832985. Registered 6 February 2019

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“…Another mechanism we are using is an event monitoring committee (EMC) to provide independent oversight and monitor for psychosocial harms specific to our study 23 . EMCs are explicitly designed for social or behavioral intervention trials where the potential risks are primarily psychosocial rather than physical and where traditional data safety monitoring boards might not be applicable or suitable.…”

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confidence: 99%

Balancing External Validity and Concern for Psychosocial Harms in Translational Genetic Research

Meyer¹,

Rahm²,

O’Dell³

et al. 2021

Ethics & Human Research

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Human Subjects Protection: An Event Monitoring Committee for Research Studies of Girls From Breast Cancer Families

Cited by 5 publications

References 26 publications

Psychosocial Adjustment in School-age Girls With a Family History of Breast Cancer

Psychosocial Adjustment in School-age Girls With a Family History of Breast Cancer

Pediatric reporting of genomic results study (PROGRESS): a mixed-methods, longitudinal, observational cohort study protocol to explore disclosure of actionable adult- and pediatric-onset genomic variants to minors and their parents

Balancing External Validity and Concern for Psychosocial Harms in Translational Genetic Research

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