Evaluation of a Technology-Based Survivor Care Plan for Breast Cancer Survivors: Pre-Post Pilot Study.

BACKGROUND: As of 2016, almost 16 million individuals were cancer survivors, including over 3.5 million survivors of breast cancer. Because cancer survivors are living longer and have unique health care needs, the Institute of Medicine proposed a survivor care plan as a way to alleviate the many medical, emotional, and care coordination problems of survivors. OBJECTIVE: This pilot study for breast cancer survivors was undertaken to: (1) examine self-reported changes in knowledge, confidence, and activation from before receipt to after receipt of a survivor care plan; and (2) describe survivor preferences for, and satisfaction with, a technology-based survivor care plan. METHODS: A single group pretest-posttest design was used to study breast cancer survivors in an academic cancer center and a community cancer center during their medical visit after they completed chemotherapy. The intervention was a technology-based survivor care plan. Measures were taken before, immediately after, and 1 month after receipt of the survivor care plan. RESULTS: A total of 38 breast cancer survivors agreed to participate in the study. Compared to baseline levels before receipt of the survivor care plan, participants reported increased knowledge both immediately after its receipt at the academic center (P<.001) and the community center (P<.001) as well as one month later at the academic center (P=.002) and the community center (P<.001). Participants also reported increased confidence immediately following receipt of the survivor care plan at the academic center (P=.63) and the community center (P=.003) and one month later at both the academic center (P=.63) and the community center (P<.001). Activation was increased from baseline to post-survivor care plan at both the academic center (P=.05) and community center (P<.001) as well as from baseline to 1-month follow-up at the academic center (P=.56) and the community center (P<.001). Overall, community center participants had lower knowledge, confidence, and activation at baseline compared with academic center participants. Overall, 22/38 (58%) participants chose the fully functional electronic survivor care plan. However, 12/23 (52%) in the community center group chose the paper version compared to 4/15 (27%) in the academic center group. Satisfaction with the format (38/38 participants) and the content (37/38 participants) of the survivor care plan was high for both groups. CONCLUSIONS: This study provides evidence that knowledge, confidence, and activation of survivors were associated with implementation of the survivor care plan. This research agrees with previous research showing that cancer survivors found the technology-based survivor care plan to be acceptable. More research is needed to determine the optimal approach to survivor care planning to ensure that all cancer survivors can benefit from it.

The Brief Perceived Cognitive Impairment Scale-Korean: A Validation Study.

BACKGROUND: Practical brief measures are needed for clinicians and researchers to identify and effectively manage cognitive impairment in cancer patients. OBJECTIVE: This study evaluated the reliability (ie, internal consistency reliability) and validity (ie, construct, convergent, concurrent, and known-group validity) of the Brief Perceived Cognitive Impairment Scale-Korean (BPCIS-K). METHODS: From a university hospital, 249 cancer patients participated. The BPCIS-K was constructed with 6 items evaluating key aspects of cognitive impairment in cancer patients. For internal consistency reliability, Cronbach's α and item-total correlations were evaluated. For construct validity, confirmatory factor analysis was performed. For convergent validity, Pearson correlations were tested with the Functional Assessment of Cancer Therapy-Cognitive Function. For concurrent validity, Pearson correlations were tested with the Functional Assessment of Chronic Illness Therapy-Fatigue. For known-group validity, t tests were performed. RESULTS: The BPCIS-K showed high internal consistency reliability (Cronbach's α = .92; item-total correlations ranged from 0.76 to 0.81). Factor analysis confirmed the scale is unidimensional. It is highly associated with another validated cognitive impairment measure (r = -0.91, P < .001) and moderately correlated with a fatigue measure (r = -0.52, P < .001). In known-group validity, female and patients undergoing treatment experienced more severe impairment than did male patients and patient awaiting treatment (P = .05, P = .08, respectively). CONCLUSION: The BPCIS-K is valid and reliable for assessing cancer patients' perceived cognitive impairment, particularly in concentration, memory, and executive functions. IMPLICATION FOR PRACTICE: This study introduces a practical brief measure to clinicians and researchers.

Chemotherapy-associated cognitive impairments in Korean cancer patients: Risk factors and functional outcome.

OBJECTIVE: To identify those experiencing significant self-reported cognitive decline over 2 time points during chemotherapy, examine the risk factors for cognitive decline, and examine differences between those with and without significant decline in functional limitations. METHODS: This secondary analysis used data from 163 cancer patients, collected from a Korean University hospital. Significant decline was determined by 15% or more reduction from baseline in the Functional Assessment of Cancer Therapy-Cognitive Function. Multivariate logistic regression was performed to estimate risk factors. Repeated-measures ANOVA and t tests tested differences in groups with and without cognitive decline in cognitive impairment and functional limitation. RESULTS: About 31% (n = 51) experienced significant cognitive decline. Groups with and without decline significantly differed in cognitive-impairment changes over time (F = 238.49, P < .001) and in functional limitations at follow-up (t test, P < .01). Those experiencing increased fatigue over time (odds = 0.94, P < .05) and those who underwent 2 or more cycles between time 1 and 2 (odds = 2.61; P < .05) had higher risk of significant decline over time during chemotherapy. CONCLUSION: Significant cognitive decline occurred during active chemotherapy; attention to cognitive impairment should be given in the early phase of chemotherapy.

Identifying the subtypes of cancer-related fatigue: results from the population-based PROFILES registry.

PURPOSE: Little research has been done to identify possible cancer-related fatigue (CRF) subtypes and to classify cancer survivors accordingly. We aimed to identify CRF subtypes in a large population-based sample of (long term) stage I-III colorectal cancer survivors. We also identified factors associated with the CRF subtypes. METHODS: Respondents completed the Multidimensional Fatigue Inventory and other validated questionnaires on anxiety and reduced positive affect (anhedonia), sleep quality, and lifestyle factors (body mass index and physical activity). Latent class analysis was used to derive the CRF subtypes. Factors associated with the derived CRF subtypes were determined with multinomial logistic regression. RESULTS: Three CRF classes were identified: class 1 (no fatigue and distress, n = 644, 56%), class 2 (low fatigue, moderate distress, n = 256, 22%), and class 3 (high fatigue, moderate distress, n = 256, 22%). Multinomial logistic regression results show that survivors in class 3 were more likely to be female, were treated with radiotherapy, have comorbid diabetes mellitus, and be overweight/obese than survivors in class 1 (reference). Survivors in classes 2 and 3 were also more likely to have comorbid heart condition, report poorer sleep quality, experience anhedonia, and report more anxiety symptoms when compared with survivors in class 1. CONCLUSIONS: Three distinct classes of CRF were identified which could be differentiated with sleep quality, anxiety, anhedonia, and lifestyle factors. IMPLICATIONS FOR CANCER SURVIVORS: The identification of CRF subtypes with distinct characteristics suggests that interventions should be targeted to the CRF subtype.

Phase 2 Study of Weekly Paclitaxel Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma: ECOG-ACRIN Cancer Research Group (E1898) Trial.

INTRODUCTION: This multicenter phase 2 study assessed the combination of estramustine and weekly paclitaxel with metastatic castration-resistant prostate cancer (CRPC). PATIENTS AND METHODS: We enrolled 77 patients who had received no prior chemotherapy for CRPC between 1998 and 2000; a total of 74 subjects were eligible for the study. Each 8-week cycle included paclitaxel 90 mg/m2 provided intravenously weekly for 6 weeks, followed by 2 weeks off therapy and oral estramustine 280 mg twice daily for 3 days beginning 24 hours before the first dose of paclitaxel. The primary end point was rate of objective or prostate-specific antigen (PSA) response at 16 weeks. A 50% response rate was considered of further interest. RESULTS: Eligible patients received a median of 3 cycles (range, 1-10 cycles). The response rate among patients with measurable disease was 34% (95% confidence interval [CI], 19-52). The PSA response rate was 58% (95% CI, 47-70). Clinical benefit rate was 45% (95% CI, 33-57). The median progression-free survival was 5.9 months (95% CI, 4.4-6.7). The median overall survival was 17.6 months (95% CI, 14.6-20.8). The most common clinical grade 3/4 toxicities were fatigue (14%) and sensory neuropathy (7%). Grade 3/4 hematologic toxicities included lymphopenia (21%) and anemia (9%). There was one toxicity-related death. Quality-of-life scores improved by week 8, but the change was not statistically significant. CONCLUSION: The combination has activity defined by PSA declines in CRPC but did not meet the protocol-specified end point for efficacy as defined by objective response rate. Since this study was conducted, more effective, better-tolerated regimens have been developed.

Advancing Symptom Science Through Symptom Cluster Research: Expert Panel Proceedings and Recommendations.

An overview of proceedings, findings, and recommendations from the workshop on "Advancing Symptom Science Through Symptom Cluster Research" sponsored by the National Institute of Nursing Research (NINR) and the Office of Rare Diseases Research, National Center for Advancing Translational Sciences, is presented. This workshop engaged an expert panel in an evidenced-based discussion regarding the state of the science of symptom clusters in chronic conditions including cancer and other rare diseases. An interdisciplinary working group from the extramural research community representing nursing, medicine, oncology, psychology, and bioinformatics was convened at the National Institutes of Health. Based on expertise, members were divided into teams to address key areas: defining characteristics of symptom clusters, priority symptom clusters and underlying mechanisms, measurement issues, targeted interventions, and new analytic strategies. For each area, the evidence was synthesized, limitations and gaps identified, and recommendations for future research delineated. The majority of findings in each area were from studies of oncology patients. However, increasing evidence suggests that symptom clusters occur in patients with other chronic conditions (eg, pulmonary, cardiac, and end-stage renal disease). Nonetheless, symptom cluster research is extremely limited and scientists are just beginning to understand how to investigate symptom clusters by developing frameworks and new methods and approaches. With a focus on personalized care, an understanding of individual susceptibility to symptoms and whether a "driving" symptom exists that triggers other symptoms in the cluster is needed. Also, research aimed at identifying the mechanisms that underlie symptom clusters is essential to developing targeted interventions.

Defining the Symptom Cluster: How Far Have We Come?

OBJECTIVES: To examine the evolution of the concept of the symptom cluster through literature synthesis and identify knowledge gaps. DATA SOURCES: Published literature. CONCLUSION: A robust body of research has developed showing that clusters of symptoms can be identified empirically with modest evidence of convergence across methods. The science would benefit from a coordinated effort of qualitative studies to ensure that appropriate symptoms are evaluated; empirical symptom cluster identification studies building upon qualitative work; and subgroup identification studies based on empirically defined symptom clusters. IMPLICATIONS FOR NURSING PRACTICE: Work is needed to demonstrate the value of symptom cluster identification in guiding symptom assessment and management for cancer patients and survivors.

Post-treatment problems of African American breast cancer survivors.

PURPOSE: African American breast cancer survivors (AABCS) have a lower survival rate across all disease stages (79 %) compared with White survivors (92 %) and often have more aggressive forms of breast cancer requiring multimodality treatment, so they could experience a larger burden of post-treatment quality of life (QOL) problems. This paper reports a comprehensive assessment of the number, severity, and domains of problems faced by AABCS within 5 years after treatment completion and identifies subgroups at risk for these problems. METHODS: A population-based random sample was obtained from the Pennsylvania Cancer Registry of African American females over 18 years of age who completed primary treatment for breast cancer in the past 5 years. A mailed survey was used to document survivorship problems. RESULTS: Two hundred ninety-seven AABCS completed the survey. The median number of survivor problems reported was 15. Exploratory factor analysis of the problem scale revealed four domains: emotional problems, physical problems, lack of resources, and sexuality problems. Across problem domains, younger age, more comorbid conditions, and greater medical mistrust were risk factors for more severe problems. CONCLUSIONS: The results demonstrated that AABCS experienced significant problem burden in the early years after diagnosis and treatment. In addition to emotional and physical problem domains that were documented in previous research, two problem domains unique to AABCS included lack of resources and sexuality concerns. At risk groups should be targeted for intervention. The study results reported in this manuscript will inform future research to address problems of AABCS as they make the transition from cancer patient to cancer survivor.

Validity and Reliability of the Taiwanese Version of the General Fatigue Scale in Cancer Patients.

BACKGROUND: Fatigue has been described as the most frequent and distressing problem of cancer patients undergoing chemotherapy. OBJECTIVE: The aim of this study is to evaluate the validity and reliability of the Taiwanese version of the General Fatigue Scale (GFS-T) and to evaluate the severity of the fatigue among breast cancer patients in Taiwan. METHODS: A cross-sectional research design was used, recruiting breast cancer patients from 2 medical centers in Taiwan. Patients completed the scale exploring their GFS-T, the Brief Fatigue Inventory-Taiwan Form, and the Eastern Cooperative Oncology Group Performance Status. The data were collected between the day before the first chemotherapy (T1) and 1 week after the first chemotherapy (T2). RESULTS: A total of 171 patients participated in this study. Cronbach's α for the GFS-T at both time points both were .94. Factor analysis generated 1 factor that accounted for 73.7% of variance in participants' fatigue. The receiver operating characteristic curve analyses suggested that the GFS-T cut-point of 24 had an adequate combination of sensitivity and specificity to distinguish high and low performance status. The receiver operating characteristic curve is 0.67 (95% confidence interval, 0.59-0.75). CONCLUSIONS: The GFS-T is a reliable and valid instrument for assessing fatigue among cancer patients. Further research is needed to better understand predictors of cancer-related fatigue. IMPLICATIONS FOR PRACTICE: The GFS-T can provide clinical nurses with a useful measure to assess fatigue in cancer patients.

Management of cancer-related fatigue during chemotherapy through telephone motivational interviewing: modeling and randomized exploratory trial.

OBJECTIVE: Fatigue is a common cancer-related symptom and exacerbated by chemotherapy. Psychological interventions for fatigue show promise. One, Beating Fatigue, was adapted for delivery by telephone and evaluated in an exploratory trial. METHODS: Eight patients and 12 professionals contributed to focus groups that guided adaptation of the intervention. The intervention, modified for delivery by telephone using motivational interviewing, was tested in an exploratory trial. Forty-four patients were recruited to the trial and randomized between the intervention (n=23) and control (n=21). Outcome data were collected on fatigue intensity, fatigue distress, fatigue self-efficacy, anxiety and depression at baseline and following completion of chemotherapy. These data were augmented by interviews conducted to inform understanding of the intervention's mechanism, feasibility and acceptability. RESULTS: The intervention was both feasible and acceptable to patients and most reduced fatigue distress (Effect Size ES=0.62). It also reduced fatigue intensity (ES=0.18), fatigue self-efficacy (ES=-0.34), and anxiety (ES=0.31). It did not reduce depression. CONCLUSION: These preliminary data are encouraging and support the delivery of interventions for cancer-related fatigue by telephone. Motivational interviewing appeared key to the intervention's success. A larger definitive RCT is indicated. PRACTICE IMPLICATIONS: Opportunities should be sought to deliver psychologically-based interventions for fatigue by telephone.

Risk and outcomes of chemotherapy-induced diarrhea (CID) among patients with colorectal cancer receiving multi-cycle chemotherapy.

BACKGROUND: Diarrhea is a common toxicity of chemotherapy, but the practice of reporting only severe grades (≥ 3) in clinical trials results in misleading conclusions of significance. Epidemiology remains poorly described, and effects of multi-cycle regimens have not been investigated. To better understand the risks, symptom burden and consequences of CID, we studied patients receiving chemotherapy for colorectal cancer (CRC). METHODS: One hundred and fourteen patients receiving FOLFOX (95 patients, 530 cycles), FOLFOX + monoclonal antibodies (10 patients, 49 cycles) or FOLFIRI (9 patients, 50 cycles) were enrolled. CID was identified from diaries at baseline and daily during up to 8 chemotherapy cycles using supplemental questions on the Oral Mucositis Daily Questionnaire, a valid tool for collecting patient-reported outcomes of regimen-related mucosal injury. Patients scored CID severity from 0 "none" to 10 "worst possible," and quantity from "little" to "severe" on a 5-point scale. Quality of life was measured using the FACT-G, and fatigue using the FACIT fatigue scale. RESULTS: CID occurred in 89% of patients on FOLFIRI, 50% on FOLFOX + monoclonal antibodies and 56% on FOLFOX alone. The risk of a first episode was highest during Cycle 1 (35 %) and dropped to <10% during Cycles 3-5. Patients with CID reported poorer quality of life scores than those without CID (77.1 vs 80.7). CONCLUSIONS: Diarrhea occurs more commonly than typically appreciated during chemotherapy for CRC. Risk is highest during first exposure, suggesting variable susceptibility. Identification of this high-risk subgroup for prophylaxis could improve the quality of life.

Subgroups of cancer patients with unique pain and fatigue experiences during chemotherapy.

CONTEXT: Some cancer patients experience pain and fatigue, whereas others experience only one of the two symptoms. Yet, it is not clear who experiences these unique patterns and why. OBJECTIVES: This study aimed to identify subgroups of cancer patients with unique pain and fatigue experiences in two different chemotherapy cycles to examine how selected factors influenced subgroup membership and identify how subgroups differed in concurrently measured functional limitation outcome. METHODS: The sample included 276 patients with diverse cancer types from four U.S. sites. To investigate subgroups, latent profile analyses were performed. Multinomial logistic regression and one-way analysis of variance-type analyses were conducted to examine the influencing variables of subgroup membership and to examine differences among subgroups in patient outcome. RESULTS: The high-pain/high-fatigue (HPHF) and low-pain/low-fatigue subgroups were found at both time points. The low-pain/high-fatigue subgroup was present only in the first chemotherapy cycle. Pain and fatigue levels significantly differentiated subgroups at each time point (all P<0.05). Across the two time points, experiencing higher depressed mood increased the risk to be in the HPHF subgroup (all P<0.01). The HPHF subgroup had the most serious limitations in activities (all P<0.01). CONCLUSION: This study confirmed the existence of a unique symptom experience of pain and fatigue. This pattern should be acknowledged for symptom assessment and management.

Biological pathways, candidate genes, and molecular markers associated with quality-of-life domains: an update.

BACKGROUND: There is compelling evidence of a genetic foundation of patient-reported quality of life (QOL). Given the rapid development of substantial scientific advances in this area of research, the current paper updates and extends reviews published in 2010. OBJECTIVES: The objective was to provide an updated overview of the biological pathways, candidate genes, and molecular markers involved in fatigue, pain, negative (depressed mood) and positive (well-being/happiness) emotional functioning, social functioning, and overall QOL. METHODS: We followed a purposeful search algorithm of existing literature to capture empirical papers investigating the relationship between biological pathways and molecular markers and the identified QOL domains. RESULTS: Multiple major pathways are involved in each QOL domain. The inflammatory pathway has the strongest evidence as a controlling mechanism underlying fatigue. Inflammation and neurotransmission are key processes involved in pain perception, and the catechol-O-methyltransferase (COMT) gene is associated with multiple sorts of pain. The neurotransmitter and neuroplasticity theories have the strongest evidence for their relationship with depression. Oxytocin-related genes and genes involved in the serotonergic and dopaminergic pathways play a role in social functioning. Inflammatory pathways, via cytokines, also play an important role in overall QOL. CONCLUSIONS: Whereas the current findings need future experiments and replication efforts, they will provide researchers supportive background information when embarking on studies relating candidate genes and/or molecular markers to QOL domains. The ultimate goal of this area of research is to enhance patients' QOL.

Comparison of groups with different patterns of symptom cluster intensity across the breast cancer treatment trajectory.

BACKGROUND: Comparing subgroups with different patterns of change in symptom intensity would assist in sorting out individuals at risk for more severe symptoms and worse functional outcomes. OBJECTIVES: The objectives of this study were to identify and compare subgroups of breast cancer patients with different patterns of change in a psychoneurological symptom cluster intensity across the treatment trajectory. METHODS: This secondary analysis used the data from 160 breast cancer patients undergoing chemotherapy or radiation treatment. Psychoneurological symptom cluster intensity was a composite score of 5 symptoms (depressed mood, cognitive disturbance, fatigue, insomnia, and pain) in a psychoneurological cluster at each of 3 time points (ie, at baseline and at 2 follow-ups after chemotherapy or radiation treatment). RESULTS: Five distinct subgroups representing different patterns of psychoneurological symptom cluster intensity during breast cancer treatment were identified: the gradually increasing pattern subgroup (group 1), the constantly low pattern subgroup (group 2), the start low with dramatic increase and decrease pattern subgroup (group 3), the constantly high pattern subgroup (group 4), and the start high with dramatic decrease and leveling pattern subgroup (group 5). Patients without previous cancer treatment experience, with higher level of education, treated with chemotherapy, and/or with more limitations at the baseline were more likely to follow the pattern group 4. Patients in group 4 had the most serious functional limitations measured at the second follow-up time point. CONCLUSION: The results suggest the need to evaluate interventions for specific subgroups and to examine the causal mechanisms underlying a psychoneurological symptom cluster. IMPLICATION: Clinicians should consider these diverse symptom experiences for assessment/management.

Recommendations for high-priority research on cancer-related fatigue in children and adults.

Over the past decades, some scientific progress has been made in understanding and treating cancer-related fatigue (CRF). However, three major problems have limited further progress: lack of agreement about measurement, inadequate understanding of the underlying biology, and problems in the conduct of clinical trials for CRF. This commentary reports the recommendations of a National Cancer Institute Clinical Trials Planning Meeting and an ongoing National Cancer Institute working group to address these problems so that high-priority research and clinical trials can be conducted to advance the science of CRF and its treatment. Recommendations to address measurement issues included revising the current case definition to reflect more rigorous criteria, adopting the Patient Reported Outcomes Measurement Information System fatigue scales as standard measures of CRF, and linking legacy measures to the scales. With regard to the biology of CRF, the group identified the need for longitudinal research to examine biobehavioral mechanisms underlying CRF and testing mechanistic hypotheses within the context of intervention research. To address clinical trial issues, recommendations included using only placebo-controlled trial designs. setting eligibility to minimize sample heterogeneity or enable subgroup analysis, establishing a CRF severity threshold for participation in clinical trials, conducting dissemination trials of efficacious interventions (such as exercise), and combining nonpharmacologic and pharmacologic interventions to exploit the potential synergy between these approaches. Accomplishing these goals has the potential to advance the science of CRF and improve the clinical management of this troubling symptom.

Cancer-related fatigue and its impact on functioning.

This article presents the contrasting European and American perspectives on cancer-related fatigue (CRF) and its impact on functioning in cancer survivors. The content is presented in 3 sections: state of the art, intervention studies, and future areas of research, followed by a discussion. Gaps identified include a lack of understanding of the etiology, definition, and measurement of CRF. Models to guide the study of CRF, selection of biomarkers, and design of interventions are needed. There is overlap between Europe and the United States concerning the future directions for research and collaboration related to CRF. The authors suggest the need for international consensus regarding the defining features of CRF in cancer survivors to identify phenotypes, a harmonized measurement of CRF outcomes using instruments that have demonstrated measurement equivalence across languages and cultures, and interventions (including exercise, rehabilitation, and psychoeducational) that have been manualized to permit intervention fidelity across diverse contexts. Coordinated intercontinental efforts would increase understanding of the biological, psychological, and social mechanisms underlying CRF and assist in the design of future intervention studies as well as revisions to clinical guidelines.

Predictors of depression in breast cancer patients treated with radiation: role of prior chemotherapy and nuclear factor kappa B.

BACKGROUND: Depression is common during and after breast cancer treatment. However, the role of specific therapeutic modalities and related biologic mechanisms remains unclear. Radiation is an essential component of breast-conserving therapy and may contribute to depression in patients with breast cancer through the activation of inflammatory pathways. METHODS: Depressive symptoms and inflammatory mediators, including nuclear factor kappa B (NF-κB), were assessed at baseline (before radiation), during radiation, and 6 weeks after radiation in 64 women who had stage 0 through IIIA breast cancer. RESULTS: No significant increases in depressive symptoms occurred during or after radiation, although a number of patients exhibited moderate-to-severe depression throughout the study. Multivariate analyses of baseline factors predictive of depression revealed that educational status, perceived stress, prior chemotherapy, and peripheral blood NF-κB DNA binding all were independent predictors of persistent depressive symptoms after radiation (all P < .05). Of these factors, only prior chemotherapy was associated with inflammatory mediators, including NF-κB DNA binding, soluble tumor necrosis factor-alpha receptor 2, and interleukin-6, which, in univariate analyses predicted depressive symptoms after radiation (all P < .05). Chemotherapy-treated patients also exhibited an over-representation of gene transcripts regulated by NF-κB. CONCLUSIONS: Radiation was not associated with increased depressive symptoms in the current study, but of disease and treatment-related factors, prior chemotherapy predicted significant depression after radiation. Longitudinal studies are warranted to investigate the relationship among prior chemotherapy, inflammation, and persistent depression after breast cancer treatment.

Preparing individuals to communicate genetic test results to their relatives: report of a randomized control trial.

This study reports a randomized clinical trial evaluating the efficacy of an intervention to prepare individuals to communicate BRCA1/BRCA2 results to family members. Women aged 18 years and older, who had genetic testing, and who had adult first-degree relatives, were randomly assigned to a communication skills-building intervention or a wellness control session. Primary outcomes were the percentage of probands sharing test results, and the level of distress associated with sharing. The ability of the theory of planned behavior variables to predict the outcomes was explored. Four hundred twenty-two women were enrolled in the study, 219 (intervention) and 203 (control). Data from 137 in the intervention group and 112 in the control group were analyzed. Two hundred forty-nine probands shared test results with 838 relatives (80.1 %). There were no significant differences between study groups in the primary outcomes. Combining data from both arms revealed that perceived control and specific social influence were associated with sharing. Probands were more likely to share genetic test results with their children, female relatives and relatives who they perceived had a favorable opinion about learning the results. The communication skills intervention did not impact sharing of test results. The proband's perception of her relative's opinion of genetic testing and her sense of control in relaying this information influenced sharing. Communication of test results is selective, with male relatives and parents less likely to be informed. Prevalent psychosocial factors play a role in the communication of genetic test results within families.