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1.
Clin Genet ; 2018 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-30417332

RESUMO

Telephone disclosure of cancer genetic test results is noninferior to in-person disclosure. However, how patients who prefer in-person communication of results differ from those who agree to telephone disclosure is unclear but important when considering delivery models for genetic medicine. Patients undergoing cancer genetic testing were recruited to a multicenter, randomized, noninferiority trial (NCT01736345) comparing telephone to in-person disclosure of genetic test results. We evaluated preferences for in-person disclosure, factors associated with this preference and outcomes compared to those who agreed to randomization. Among 1178 enrolled patients, 208 (18%) declined randomization, largely given a preference for in-person disclosure. These patients were more likely to be older (P = 0.007) and to have had multigene panel testing (P < 0.001). General anxiety (P = 0.007), state anxiety (P = 0.008), depression (P = 0.011), cancer-specific distress (P = 0.021) and uncertainty (P = 0.03) were higher after pretest counseling. After disclosure of results, they also had higher general anxiety (P = 0.003), depression (P = 0.002) and cancer-specific distress (P = 0.043). While telephone disclosure is a reasonable alternative to in-person disclosure in most patients, some patients have a strong preference for in-person communication. Patient age, distress and complexity of testing are important factors to consider and requests for in-person disclosure should be honored when possible.

2.
J Clin Oncol ; 36(11): 1088-1095, 2018 Apr 10.
Artigo em Inglês | MEDLINE | ID: mdl-29522362

RESUMO

Purpose Chemohormonal therapy with docetaxel and androgen deprivation therapy (ADT+D) for metastatic hormone-sensitive prostate cancer improves overall survival as compared with androgen deprivation therapy (ADT) alone. We compared the quality of life (QOL) between patients with metastatic hormone-sensitive prostate cancer who were treated with ADT+D and those who were treated with ADT alone. Methods Men were randomly assigned to ADT+ D (six cycles) or to ADT alone. QOL was assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P), FACT-Taxane, Functional Assessment of Chronic Illness Therapy-Fatigue, and the Brief Pain Inventory at baseline and at 3, 6, 9, and 12 months. The Wilcoxon signed rank test was used to examine changes over time. Mixed-effect models compared the QOL between arms at each time point. Results Seven hundred ninety men were randomly assigned (ADT+D [n = 397] and ADT[ n = 393]) and completed FACT-P (90% at baseline, 86% at 3 months, 83% at 6 months, 78% at 9 months, and 77% at 12 months). ADT+D patients reported a statistically significant decline in FACT-P at 3 months ( P < .001) but FACT-P did not differ significantly between baseline and 12 months ( P = .38). ADT+D FACT-P scores were significantly lower at 3 months ( P = .02) but significantly higher at 12 months ( P = .04) when compared with ADT FACT-P scores. Differences did not exceed the minimal clinically important difference at any time point. ADT+D patients reported significantly lower Functional Assessment of Chronic Illness Therapy-Fatigue scores at 3 months than did ADT patients ( P < .001). Over time, both arms reported significantly poorer FACT-Taxane scores ( P < .001) when compared with baseline. Brief Pain Inventory scores were similar between arms. Conclusion Although ADT+D was associated with statistically worse QOL at 3 months, QOL was better at 12 months for ADT+D patients than for ADT patients. Both arms reported a similar minimally changed QOL over time, suggesting that ADT+D is not associated with a greater long-term negative impact on QOL.

3.
J Natl Cancer Inst ; 110(9): 985-993, 2018 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-29490071

RESUMO

Background: Germline genetic testing is standard practice in oncology. Outcomes of telephone disclosure of a wide range of cancer genetic test results, including multigene panel testing (MGPT) are unknown. Methods: Patients undergoing cancer genetic testing were recruited to a multicenter, randomized, noninferiority trial (NCT01736345) comparing telephone disclosure (TD) of genetic test results with usual care, in-person disclosure (IPD) after tiered-binned in-person pretest counseling. Primary noninferiority outcomes included change in knowledge, state anxiety, and general anxiety. Secondary outcomes included cancer-specific distress, depression, uncertainty, satisfaction, and screening and risk-reducing surgery intentions. To declare noninferiority, we calculated the 98.3% one-sided confidence interval of the standardized effect; t tests were used for secondary subgroup analyses. Only noninferiority tests were one-sided, others were two-sided. Results: A total of 1178 patients enrolled in the study. Two hundred eight (17.7%) participants declined random assignment due to a preference for in-person disclosure; 473 participants were randomly assigned to TD and 497 to IPD; 291 (30.0%) had MGPT. TD was noninferior to IPD for general and state anxiety and all secondary outcomes immediately postdisclosure. TD did not meet the noninferiority threshold for knowledge in the primary analysis, but it did meet the threshold in the multiple imputation analysis. In secondary analyses, there were no statistically significant differences between arms in screening and risk-reducing surgery intentions, and no statistically significant differences in outcomes by arm among those who had MGPT. In subgroup analyses, patients with a positive result had statistically significantly greater decreases in general anxiety with telephone disclosure (TD -0.37 vs IPD +0.87, P = .02). Conclusions: Even in the era of multigene panel testing, these data suggest that telephone disclosure of cancer genetic test results is as an alternative to in-person disclosure for interested patients after in-person pretest counseling with a genetic counselor.

4.
Genet Med ; 18(1): 25-33, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25834950

RESUMO

PURPOSE: The risks, benefits, and utilities of multiplex panels for breast cancer susceptibility are unknown, and new counseling and informed consent models are needed. We sought to obtain patient feedback and early outcome data with a novel tiered-binned model for multiplex testing. METHODS: BRCA1/2-negative and untested patients completed pre- and posttest counseling and surveys evaluating testing experiences and cognitive and affective responses to multiplex testing. RESULTS: Of 73 patients, 49 (67%) completed pretest counseling. BRCA1/2-negative patients were more likely to proceed with multiplex testing (86%) than those untested for BRCA1/2 (43%; P < 0.01). Many patients declining testing reported concern for uncertainty and distress. Most patients would not change anything about their pre- (76%) or posttest (89%) counseling sessions. Thirty-three patients (72%) were classified as making an informed choice, including 81% of those who proceeded with multiplex testing. Knowledge increased significantly. Anxiety, depression, uncertainty, and cancer worry did not significantly increase with multiplex testing. CONCLUSION: Some patients, particularly those without prior BRCA1/2 testing, decline multiplex testing. Most patients who proceeded with testing did not experience negative psychological responses, but larger studies are needed. The tiered-binned approach is an innovative genetic counseling and informed consent model for further study in the era of multiplex testing.Genet Med 18 1, 25-33.


Assuntos
Neoplasias da Mama/genética , Proteína BRCA1/genética , Proteína BRCA2/genética , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/psicologia , Aconselhamento , Tomada de Decisões , Detecção Precoce de Câncer/métodos , Feminino , Aconselhamento Genético , Predisposição Genética para Doença , Testes Genéticos/métodos , Humanos , Consentimento Livre e Esclarecido , Pessoa de Meia-Idade , Incerteza
5.
JMIR Res Protoc ; 3(4): e49, 2014 Oct 29.
Artigo em Inglês | MEDLINE | ID: mdl-25355401

RESUMO

BACKGROUND: Dissemination of genetic testing for disease susceptibility, one application of "personalized medicine", holds the potential to empower patients and providers through informed risk reduction and prevention recommendations. Genetic testing has become a standard practice in cancer prevention for high-risk populations. Heightened consumer awareness of "cancer genes" and genes for other diseases (eg, cardiovascular and Alzheimer's disease), as well as the burgeoning availability of increasingly complex genomic tests (ie, multi-gene, whole-exome and -genome sequencing), has escalated interest in and demand for genetic risk assessment and the specialists who provide it. Increasing demand is expected to surpass access to genetic specialists. Thus, there is urgent need to develop effective and efficient models of delivery of genetic information that comparably balance the risks and benefits to the current standard of in-person communication. OBJECTIVE: The aim of this pilot study was to develop and evaluate a theoretically grounded and rigorously developed protocol for telephone communication of BRCA1/2 (breast cancer) test results that might be generalizable to genetic testing for other hereditary cancer and noncancer syndromes. METHODS: Stakeholder data, health communication literature, and our theoretical model grounded in Self-Regulation Theory of Health Behavior were used to develop a telephone communication protocol for the communication of BRCA1/2 genetic test results. Framework analysis of selected audiotapes of disclosure sessions and stakeholders' feedback were utilized to evaluate the efficacy and inform refinements to this protocol. RESULTS: Stakeholder feedback (n=86) and audiotapes (38%, 33/86) of telephone disclosures revealed perceived disadvantages and challenges including environmental factors (eg, non-private environment), patient-related factors (eg, low health literacy), testing-related factors (eg, additional testing needed), and communication factors (eg, no visual cues). Resulting modifications to the communication protocol for BRCA1/2 test results included clarified patient instructions, scheduled appointments, refined visual aids, expanded disclosure checklist items, and enhanced provider training. CONCLUSIONS: Analyses of stakeholders' experiences and audiotapes of telephone disclosure of BRCA1/2 test results informed revisions to communication strategies and a protocol to enhance patient outcomes when utilizing telephone to disclose genetic test results.

6.
Clin Genitourin Cancer ; 12(1): 41-9, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24126238

RESUMO

BACKGROUND: The MD Anderson Symptom Inventory (MDASI) is a psychometrically validated patient-reported outcome measure that assesses the severity and impact of multiple symptoms related to cancer and its treatment and has the potential to guide treatment specific to patients with prostate cancer. Although the original MDASI validation study encompassed various cancer types, the instrument's psychometric properties have not been examined in a large homogeneous sample of patients with prostate cancer. PATIENTS AND METHODS: This study involved secondary analysis of data from the nationwide multicenter Eastern Cooperative Oncology Group (ECOG) SOAPP (Symptom Outcomes and Practice Patterns) study, which enrolled patients from 38 ECOG-affiliated institutions, including 6 academic centers and 32 community clinics. Data were used to establish the psychometric properties of the MDASI in a subsample of 320 patients with prostate cancer. The instrument was administered twice, approximately 1 month apart. RESULTS: The MDASI demonstrated good internal consistency and test-retest reliability (with Cronbach alphas of ≥ .84 and intraclass correlations of ≥ 0.76 for all subscales), strong ability to discriminate between clinically different patient groups (by performance status, tumor response, and disease stage), and high sensitivity in detecting symptom change (with respect to patient-reported quality of life [QOL] between the baseline and 1-month follow-up visits). CONCLUSION: The MDASI is a valid, reliable, and sensitive symptom-assessment instrument that can be used with confidence in descriptive and clinical studies of symptom status in patients with prostate cancer.


Assuntos
Avaliação de Resultados (Cuidados de Saúde) , Neoplasias da Próstata/psicologia , Qualidade de Vida/psicologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Humanos , Masculino , Pessoa de Meia-Idade , Padrões de Prática Médica , Neoplasias da Próstata/tratamento farmacológico , Neoplasias da Próstata/radioterapia , Psicometria , Inquéritos e Questionários , Resultado do Tratamento
7.
Clin Breast Cancer ; 13(5): 325-34, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23816985

RESUMO

BACKGROUND: The M. D. Anderson Symptom Inventory (MDASI) is a psychometrically validated patient-reported outcome measurement that assesses the severity and impact of multiple symptoms related to cancer and its treatment. With the MDASI, patients rate 13 common "core" symptoms and 6 items that reflect symptom interference with functioning. Several MDASI modules (core symptom and interference items plus additional symptoms specific to a particular cancer type or treatment modality) have been developed. Although the original MDASI validation study encompassed various cancer types, the instrument's psychometric properties have not been examined in a homogenous sample of patients with breast cancer in a national multicenter study. MATERIALS AND METHODS: We performed a secondary analysis of data from an Eastern Cooperative Oncology Group study to establish the reliability, validity, and sensitivity of the MDASI in a large sample of patients with breast cancer (n = 1544), 78% of whom were receiving treatment. The instrument was administered twice, approximately 1 month apart. RESULTS: Internal consistency and test-retest reliability were adequate, with Cronbach α values ≥ 0.85 and intraclass correlations ≥ 0.76 for all subscales. Known-group validity was evaluated by using performance status, tumor response, and disease stage. Sensitivity to change in patient-reported quality of life was established. CONCLUSION: The MDASI is a valid, reliable, and sensitive symptom-assessment instrument that can enhance descriptive and clinical studies of symptom status in patients with breast cancer. Future studies might include cognitive debriefing and qualitative interviews to identify additional disease-specific items for inclusion in a MDASI breast cancer module.


Assuntos
Neoplasias da Mama/diagnóstico , Inquéritos e Questionários , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Neoplasias da Mama/epidemiologia , Neoplasias da Mama Masculina/diagnóstico , Neoplasias da Mama Masculina/epidemiologia , Lista de Checagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prática Profissional/estatística & dados numéricos , Prognóstico , Psicometria , Reprodutibilidade dos Testes , Adulto Jovem
9.
Psychosom Med ; 64(4): 612-20, 2002 Jul-Aug.
Artigo em Inglês | MEDLINE | ID: mdl-12140351

RESUMO

OBJECTIVE: Tamoxifen therapy preserves BMD of the lumbar spine and increases levels of SHBG. We assessed whether trait anxiety, a factor linked with a reactive endocrine system, is associated with differential changes in BMD and SHBG levels in response to tamoxifen therapy. METHODS: Postmenopausal women (N= 140) with axillary-node-negative breast cancer participated in a 2-year randomized, double-blind, placebo-controlled trial of tamoxifen (10 mg twice a day). Levels of BMD and SHBG were assessed at baseline and at 3, 6, 12, 18, and 24 months. RESULTS: Trait anxiety predicted tamoxifen-induced changes in lumbar spine BMD; high levels of trait anxiety were associated with significantly greater lumbar spine BMD at 3, 12, and 24 months (p values <.05) for women on tamoxifen therapy. High anxiety also was associated with lower levels of SHBG for women using tamoxifen at 3, 12, 18, and 24 months (p values <.05). CONCLUSIONS: Trait anxiety is associated with greater preservation of lumbar spine BMD in response to tamoxifen and with a suppression of tamoxifen-induced increases in SHBG. Trait anxiety and other affective traits may serve as indicators of underlying physiological processes that moderate the effects of estrogen receptor modulators (such as tamoxifen) in clinical trials. Such data may help to elucidate the physiological mechanisms responsible for some of the variation in individual responses to treatment.


Assuntos
Antineoplásicos/farmacologia , Antineoplásicos/uso terapêutico , Transtornos de Ansiedade/diagnóstico , Densidade Óssea/efeitos dos fármacos , Neoplasias da Mama/tratamento farmacológico , Globulina de Ligação a Hormônio Sexual/metabolismo , Tamoxifeno/farmacologia , Tamoxifeno/uso terapêutico , Transtornos de Ansiedade/psicologia , Índice de Massa Corporal , Método Duplo-Cego , Feminino , Humanos , Vértebras Lombares/efeitos dos fármacos , Pessoa de Meia-Idade , Pós-Menopausa/fisiologia , Valor Preditivo dos Testes , Índice de Gravidade de Doença , Inquéritos e Questionários
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