Anita Y. Kinney

Randomized Noninferiority Trial of Telephone Versus In-Person Genetic Counseling for Hereditary Breast and Ovarian Cancer

PURPOSE Although guidelines recommend in-person counseling before BRCA1/BRCA2 gene testing, genetic counseling is increasingly offered by telephone. As genomic testing becomes more common, evaluating alternative delivery approaches becomes increasingly salient. We tested whether telephone delivery of BRCA1/2 genetic counseling was noninferior to in-person delivery. PATIENTS AND METHODS Participants (women age 21 to 85 years who did not have newly diagnosed or metastatic cancer and lived within a study site catchment area) were randomly assigned to usual care (UC; n = 334) or telephone counseling (TC; n = 335). UC participants received in-person pre- and post-test counseling; TC participants completed all counseling by telephone. Primary outcomes were knowledge, satisfaction, decision conflict, distress, and quality of life; secondary outcomes were equivalence of BRCA1/2 test uptake and costs of delivering TC versus UC. RESULTS TC was noninferior to UC on all primary outcomes. At 2 weeks after pretest counseling, knowledge (d = 0.03; lower bound of 97.5% CI, -0.61), perceived stress (d = -0.12; upper bound of 97.5% CI, 0.21), and satisfaction (d = -0.16; lower bound of 97.5% CI, -0.70) had group differences and confidence intervals that did not cross their 1-point noninferiority limits. Decision conflict (d = 1.1; upper bound of 97.5% CI, 3.3) and cancer distress (d = -1.6; upper bound of 97.5% CI, 0.27) did not cross their 4-point noninferiority limit. Results were comparable at 3 months. TC was not equivalent to UC on BRCA1/2 test uptake (UC, 90.1%; TC, 84.2%). TC yielded cost savings of

Hypoxia-regulated protein expression, patient characteristics, and preoperative imaging as predictors of survival in adults with glioblastoma multiforme

114 per patient. CONCLUSION Genetic counseling can be effectively and efficiently delivered via telephone to increase access and decrease costs.

Investigating efficacy of two brief mind–body intervention programs for managing sleep disturbance in cancer survivors: a pilot randomized controlled trial

Regions of hypoxia within glioblastoma multiforme (GBM) are common and may influence a tumors aggressiveness, response to treatment, and the patients overall survival. In this study, the authors examined 4 markers of hypoxia (hypoxia‐inducible factor 1 [HIF‐1α], glucose transporter 1 [GLUT‐1], vascular endothelial growth factor [VEGF], and carbonic anhydrase 9 [CA IX]), cellular proliferation and microvascular density (MVD) indices, extent of surgical resection, and preoperative imaging characteristics and compared them with the overall survival rates of adults with GBM.

Preoperative dynamic contrast-enhanced MRI correlates with molecular markers of hypoxia and vascularity in specific areas of intratumoral microenvironment and is predictive of patient outcome

PurposeAfter completing treatment, cancer survivors may suffer from a multitude of physical and mental health impairments, resulting in compromised quality of life. This exploratory study investigated whether two mind–body interventions, i.e., Mind–Body Bridging (MBB) and Mindfulness Meditation (MM), could improve posttreatment cancer survivors’ self-reported sleep disturbance and comorbid symptoms, as compared to sleep hygiene education (SHE) as an active control.MethodsThis randomized controlled trial examined 57 cancer survivors with clinically significant self-reported sleep disturbance, randomly assigned to receive MBB, MM, or SHE. All interventions were conducted in three sessions, once per week. Patient-reported outcomes were assessed via the Medical Outcomes Study Sleep Scale and other indicators of psychosocial functioning relevant to quality of life, stress, depression, mindfulness, self-compassion, and well-being.ResultsMixed effects model analysis revealed that mean sleep disturbance symptoms in the MBB (p = .0029) and MM (p = .0499) groups were lower than in the SHE group, indicating that both mind–body interventions improved sleep. In addition, compared with the SHE group, the MBB group showed reductions in self-reported depression symptoms (p = .040) and improvements in overall levels of mindfulness (p = .018), self-compassion (p = .028), and well-being (p = .019) at postintervention.ConclusionsThis study provides preliminary evidence that brief sleep-focused MBB and MM are promising interventions for sleep disturbance in cancer survivors. Integrating MBB or MM into posttreatment supportive plans should enhance care of cancer survivors with sleep disturbance. Because MBB produced additional secondary benefits, MBB may serve as a promising multipurpose intervention for posttreatment cancer survivors suffering from sleep disturbance and other comorbid symptoms.Implications for Cancer SurvivorsTwo brief sleep-focused mind–body interventions investigated in the study were effective in reducing sleep disturbance and one of them further improved other psychosocial aspects of the cancer survivors’ life. Management of sleep problems in survivors is a high priority issue that demands more attention in cancer survivorship.

Expanding Access to BRCA1/2 Genetic Counseling with Telephone Delivery: A Cluster Randomized Trial

BACKGROUND Measures of tumor vascularity and hypoxia have been correlated with glioma grade and outcome. Dynamic contrast-enhanced (DCE) MRI can noninvasively map tumor blood flow, vascularity, and permeability. In this prospective observational cohort pilot study, preoperative imaging was correlated with molecular markers of hypoxia, vascularity, proliferation, and progression-free and overall patient survival. METHODS Pharmacokinetic modeling methods were used to generate maps of tumor blood flow, extraction fraction, permeability-surface area product, transfer constant, washout rate, interstitial volume, blood volume, capillary transit time, and capillary heterogeneity from preoperative DCE-MRI data in human glioma patients. Tissue was obtained from areas of peritumoral edema, active tumor, hypoxic penumbra, and necrotic core and evaluated for vascularity, proliferation, and expression of hypoxia-regulated molecules. DCE-MRI parameter values were correlated with hypoxia-regulated protein expression at tissue sample sites. RESULTS Patient survival correlated with DCE parameters in 2 cases: capillary heterogeneity in active tumor and interstitial volume in areas of peritumoral edema. Statistically significant correlations were observed between several DCE parameters and tissue markers. In addition, MIB-1 index was predictive of overall survival (P = .044) and correlated with vascular endothelial growth factor expression in hypoxic penumbra (r = 0.7933, P = .0071) and peritumoral edema (r = 0.4546). Increased microvessel density correlated with worse patient outcome (P = .026). CONCLUSIONS Our findings suggest that DCE-MRI may facilitate noninvasive preoperative predictions of areas of tumor with increased hypoxia and proliferation. Both imaging and hypoxia biomarkers are predictive of patient outcome. This has the potential to allow unprecedented prognostic decisions and to guide therapies to specific tumor areas.

Implementation intention and planning interventions in Health Psychology: Recommendations from the Synergy Expert Group for research and practice

BACKGROUND The growing demand for cancer genetic services underscores the need to consider approaches that enhance access and efficiency of genetic counseling. Telephone delivery of cancer genetic services may improve access to these services for individuals experiencing geographic (rural areas) and structural (travel time, transportation, childcare) barriers to access. METHODS This cluster-randomized clinical trial used population-based sampling of women at risk for BRCA1/2 mutations to compare telephone and in-person counseling for: 1) equivalency of testing uptake and 2) noninferiority of changes in psychosocial measures. Women 25 to 74 years of age with personal or family histories of breast or ovarian cancer and who were able to travel to one of 14 outreach clinics were invited to participate. Randomization was by family. Assessments were conducted at baseline one week after pretest and post-test counseling and at six months. Of the 988 women randomly assigned, 901 completed a follow-up assessment. Cluster bootstrap methods were used to estimate the 95% confidence interval (CI) for the difference between test uptake proportions, using a 10% equivalency margin. Differences in psychosocial outcomes for determining noninferiority were estimated using linear models together with one-sided 97.5% bootstrap CIs. RESULTS Uptake of BRCA1/2 testing was lower following telephone (21.8%) than in-person counseling (31.8%, difference = 10.2%, 95% CI = 3.9% to 16.3%; after imputation of missing data: difference = 9.2%, 95% CI = -0.1% to 24.6%). Telephone counseling fulfilled the criteria for noninferiority to in-person counseling for all measures. CONCLUSIONS BRCA1/2 telephone counseling, although leading to lower testing uptake, appears to be safe and as effective as in-person counseling with regard to minimizing adverse psychological reactions, promoting informed decision making, and delivering patient-centered communication for both rural and urban women.

Risk reduction behaviors and provider communication following genetic counseling and BRCA1 mutation testing in an African American kindred.

The current article details a position statement and recommendations for future research and practice on planning and implementation intentions in health contexts endorsed by the Synergy Expert Group. The group comprised world-leading researchers in health and social psychology and behavioural medicine who convened to discuss priority issues in planning interventions in health contexts and develop a set of recommendations for future research and practice. The expert group adopted a nominal groups approach and voting system to elicit and structure priority issues in planning interventions and implementation intentions research. Forty-two priority issues identified in initial discussions were further condensed to 18 key issues, including definitions of planning and implementation intentions and 17 priority research areas. Each issue was subjected to voting for consensus among group members and formed the basis of the position statement and recommendations. Specifically, the expert group endorsed statements and recommendations in the following areas: generic definition of planning and specific definition of implementation intentions, recommendations for better testing of mechanisms, guidance on testing the effects of moderators of planning interventions, recommendations on the social aspects of planning interventions, identification of the preconditions that moderate effectiveness of planning interventions and recommendations for research on how people use plans.

A Randomized Trial Comparing the Effect of Two Phone-Based Interventions on Colorectal Cancer Screening Adherence

Little is known about the impact of cancer genetic counseling and testing on health behaviors in racial and ethnic subgroups. This prospective observational study examined use of risk reduction strategies following BRCA1 counseling and testing. Participants were female members of an African American kindred who received genetic education, counseling and testing (n = 40) and completed a 1-year follow-up interview. Mutation carriers were more likely to opt for breast (100%, 7/7) and ovarian (25%; 1 of 4) cancer surveillance than prophylactic surgery. Following genetic counseling, 71% (5/7) of the BRCA1 carriers who opted for surveillance reported having a mammogram within the year following receipt of their genetic test results. Ovarian cancer screening among mutation carriers increased from 0% at baseline to 25% (one of four) at 1 year. Compared to noncarriers (23%, 7/30), carriers (70%, 7/10) were more likely to discuss their BRCA1 test results with their primary health care providers. Surveillance for breast cancer was preferred to prophylactic surgery and chemoprevention as a way to reduce risk for these cancers. Our data indicate that patient-provider communication about BRCA1 test results is suboptimal.

Colorectal Cancer Surveillance Behaviors Among Members of Typical and Attenuated FAP Families

BackgroundEarly-stage diagnosis of colorectal cancer is associated with high survival rates; screening prevalence, however, remains suboptimal.PurposeThis study seeks to test the hypothesis that participants receiving telephone-based tailored education or motivational interviewing had higher colorectal cancer screening completion rates compared to usual care.MethodsPrimary care patients not adherent with colorectal cancer screening and with no personal or family history of cancer (n = 515) were assigned by block randomization to control (n = 169), tailored education (n = 168), or motivational interview (n = 178). The response rate was 70%; attrition was 24%.ResultsHighest screening occurred in the tailored education group (23.8%, p < .02); participants had 2.2 times the odds of completing a post-intervention colorectal cancer screening than did the control group (AOR = 2.2, CI = 1.2−4.0). Motivational interviewing was not associated with significant increase in post-intervention screening.ConclusionsTailored education showed promise as a feasible strategy to increase colorectal cancer screening.

Rural vs Urban Residence Affects Risk-Appropriate Colorectal Cancer Screening

OBJECTIVES:Although enhanced colorectal surveillance is recommended for members of familial adenomatous polyposis (FAP) families, little is known about individual-level adherence behavior. This study examined factors associated with recent use of colorectal cancer (CRC) surveillance among FAP patients and their at-risk relatives.METHODS:This cross-sectional study conducted a computer-assisted telephone survey among 150 members of 71 extended families with classic (FAP) or attenuated adenomatous polyposis (AFAP). Participants were enrolled in a university-based hereditary CRC registry or were first-degree relatives of enrollees. Both qualitative and quantitative data were collected and analyzed.RESULTS:Surveillance behavior varied by disease status. Fifty-four percent of 71 participants with a personal history of FAP and 42% of 79 at-risk relatives reported recent use of CRC surveillance recommendations. In multiple logistic regression analysis, lack of patient recall of provider recommendation for an endoscopic examination of the colon (OR 4.8, 95% CI 1.8–13.1), lack of health insurance or no reimbursement for CRC surveillance (OR 3.6, 95% CI 1.2–10.5), and/or the belief that their relative risk of CRC is not increased (OR 3.1, 95% CI 1.2–7.1) were independently associated with not having had a recent colonoscopy or sigmoidoscopy.CONCLUSIONS:Despite the known benefits of CRC surveillance, a substantial proportion of FAP family members did not have a recent colonoscopy or endoscopy. Interventions targeted at both clinicians and patients are needed to improve surveillance behavior. These data are also important in designing decision support tools to assist clinicians in identifying and managing high-risk patients.