Study protocol for Young &amp; Strong: a cluster randomized design to increase attention to unique issues faced by young women with newly diagnosed breast cancer

Greaney, Mary L.; Sprunck-Harrild, Kim; Ruddy, Kathryn J.; Ligibel, Jennifer A.; Barry, William T.; Baker, Emily; Meyer, Meghan E.; Emmons, Karen M.; Partridge, Ann H.

doi:10.1186/s12889-015-1346-9

Cited by 50 publications

(52 citation statements)

References 42 publications

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“…The findings suggest that preferences were driven in part by the young age of these women at the time of diagnosis; young age may involve different life factors and stressors (e.g., young children, education, working) than those facing women diagnosed at an older age (Greaney et al. ). In addition, because young women are more likely to get aggressive cancer treatments than older women, their experiences of these treatments may differ, potentially influencing these views on what information would be valuable at what times and how capable they would have been of handling that information.…”

Section: Resultsmentioning

confidence: 98%

How, who, and when: preferences for delivery of genome sequencing results among women diagnosed with breast cancer at a young age

Kaphingst

Ivanovich

Elrick

et al. 2016

Mol Genet Genomic Med

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BackgroundThe increasing use of genome sequencing with patients raises a critical communication challenge: return of secondary findings. While the issue of what sequencing results should be returned to patients has been examined, much less attention has been paid to developing strategies to return these results in ways that meet patients' needs and preferences. To address this, we investigated delivery preferences (i.e., who, how, when) for individual genome sequencing results among women diagnosed with breast cancer at age 40 or younger.MethodsWe conducted 60 semistructured, in‐person individual interviews to examine preferences for the return of different types of genome sequencing results and the reasons underlying these preferences. Two coders independently coded interview transcripts; analysis was conducted using NVivo 10.ResultsThe major findings from the study were that: (1) many participants wanted sequencing results as soon as possible, even at the time of breast cancer diagnosis; (2) participants wanted an opportunity for an in‐person discussion of results; and (3) they put less emphasis on the type of person delivering results than on the knowledge and communicative skills of that person. Participants also emphasized the importance of a results return process tailored to a patient's individual circumstances and one that she has a voice in determining.ConclusionsA critical goal for future transdisciplinary research including clinicians, patients, and communication researchers may be to develop decision‐making processes to help patients make decisions about how they would like various sequencing results returned.

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Section: Resultsmentioning

confidence: 98%

How, who, and when: preferences for delivery of genome sequencing results among women diagnosed with breast cancer at a young age

Kaphingst

Ivanovich

Elrick

et al. 2016

Mol Genet Genomic Med

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“…Cluster-randomization trials (CRTs), by contrast, are better suited for digital solutions supporting group efforts (e.g. solutions supporting tumor board meetings 39 ), and this approach has been increasingly adopted by public health researchers [40][41][42] . CRTs are often used in situations when contamination may occur; for example, where individuals in the same cluster have been randomized to different intervention groups, or for logistic, feasibility or ethical reasons 43 .…”

Section: Surveys and Interviewsmentioning

confidence: 99%

Challenges for the evaluation of digital health solutions—A call for innovative evidence generation approaches

et al. 2020

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The field of digital health, and its meaning, has evolved rapidly over the last 20 years. For this article we followed the most recent definition provided by FDA in 2020. Emerging solutions offers tremendous potential to positively transform the healthcare sector. Despite the growing number of applications, however, the evolution of methodologies to perform timely, cost-effective and robust evaluations have not kept pace. It remains an industry-wide challenge to provide credible evidence, therefore, hindering wider adoption. Conventional methodologies, such as clinical trials, have seldom been applied and more pragmatic approaches are needed. In response, several academic centers such as researchers from the Institute of Global Health Innovation at Imperial College London have initiated a digital health clinical simulation test bed to explore new approaches for evidence gathering relevant to solution type and maturity. The aim of this article is to: (1) Review current research approaches and discuss their limitations; (2) Discuss challenges faced by different stakeholders in undertaking evaluations; and (3) Call for new approaches to facilitate the safe and responsible growth of the digital health sector.

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“…Baseline assessment often occurred at the first medical oncology visit for the participants. Details on the trial can be found in previous publications [27,28].…”

Section: Study Populationmentioning

confidence: 99%

Prospective evaluation of the impact of stress, anxiety, and depression on household income among young women with early breast cancer from the Young and Strong trial

et al. 2020

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Background Young women with breast cancer tend to report lower quality of life and higher levels of stress than older women with breast cancer, and this may have implications for other psychosocial factors including finances. We sought to determine if stress, anxiety, and depression at diagnosis were associated with changes in household income over 12-months in young women with breast cancer in the United States. Methods This study was a prospective, longitudinal cohort study comprised of women enrolled in the Young and Strong trial. Of the 467 women aged 18–45 newly diagnosed with early-stage breast cancer enrolled in the Young and Strong trial from 2012 to 2013, 356 (76%) answered income questions. Change in household income from baseline to 12 months was assessed and women were categorized as having lost, gained, maintained the same household income <$100,000, or maintained household income ≥$100,000. Patient-reported stress, anxiety, and depression were assessed close to diagnosis at trial enrollment. Adjusted multinomial logistic regression models were used to compare women who lost, gained, or maintained household income ≥$100,000 to women who maintained the same household income <$100,000. Results Although most women maintained household income ≥$100,000 (37.1%) or the same household income <$100,000 (32.3%), 15.4% lost household income and 15.2% gained household income. Stress, anxiety, and depression were not associated with gaining or losing household income compared to women maintaining household incomes <$100,000. Women with household incomes <$50,000 had a higher risk of losing household income compared to women with household incomes ≥$50,000. Women who maintained household incomes ≥$100,000 were less likely to report financial or insurance problems. Among women who lost household income, 56% reported financial problems and 20% reported insurance problems at 12 months. Conclusions Baseline stress, anxiety, and depression were not associated with household income changes for young women with breast cancer. However, lower baseline household income was associated with losing household income. Some young survivors encounter financial and insurance problems in the first year after diagnosis, and further support for these women should be considered. Trial registration Clinicaltrials.gov, NCT01647607; date registered: July 23, 2012.

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Study protocol for Young & Strong: a cluster randomized design to increase attention to unique issues faced by young women with newly diagnosed breast cancer

Cited by 50 publications

References 42 publications

How, who, and when: preferences for delivery of genome sequencing results among women diagnosed with breast cancer at a young age

How, who, and when: preferences for delivery of genome sequencing results among women diagnosed with breast cancer at a young age

Challenges for the evaluation of digital health solutions—A call for innovative evidence generation approaches

Prospective evaluation of the impact of stress, anxiety, and depression on household income among young women with early breast cancer from the Young and Strong trial

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