Investigating psychological mechanisms linking pain severity to depression symptoms in women cancer survivors at a cancer center with a rural catchment area.

PURPOSE: Women cancer survivors, especially those in rural areas, with high levels of depression may be acutely susceptible to pain due to the ways they think, feel, and behave. The current study seeks to elucidate the relationship between symptoms of depression and pain severity in women cancer survivors, by examining the putative mediators involved in this relationship, specifically their self-efficacy for managing their health, how overwhelmed they were from life's responsibilities, and relational burden. METHODS: Self-report data were collected from 183 cancer survivors of breast, cervical, ovarian, or endometrial/uterine cancer, who were between 6 months and 3 years post-active therapy. RESULTS: Women cancer survivors with higher (vs. lower) symptoms of depression had more severe pain. Individual mediation analyses revealed that survivors with higher levels of depression felt more overwhelmed by life's responsibilities and had lower self-efficacy about managing their health, which was associated with greater pain severity. When all mediators were simultaneously entered into the same model, feeling overwhelmed by life's responsibilities significantly mediated the link between survivors' symptoms of depression and their pain severity. CONCLUSIONS: The relationship between symptoms of depression and pain severity in women cancer survivors may be attributed in part to their self-efficacy and feeling overwhelmed by life's responsibilities. Early and frequent assessment of psychosocial factors involved in pain severity for women cancer survivors may be important for managing their pain throughout the phases of cancer survivorship.

Cancer Screening and Treatment Delays During the COVID-19 Pandemic and the Role of Health Literacy in Care Re-engagement: Findings from an NCI-Designated Comprehensive Cancer Center sample.

The COVID-19 pandemic has led to numerous delays in cancer-related care and cancer-specific screening, but the extent is not fully understood. For those that experience a delay or disruption in care, health related self-management is required to re-engage in care pathways and the role of health literacy in this pathway has not been explored. The purpose of this analysis is to (1) report the frequency of self-reported delays in cancer treatment and preventative screening services at an academic, NCI-designated center during the COVID-19 pandemic and (2) investigate cancer-related care and screening delays among those with adequate and limited health literacy. A cross-sectional survey was administered from an NCI-designated Cancer Center with a rural catchment area during November 2020 through March 2021. A total of 1,533 participants completed the survey, and nearly 19 percent of participants were categorized as having limited health literacy. Twenty percent of those with a cancer diagnosis reported a delay in cancer-related care; and 23-30% of the sample reported a delay in cancer screening. In general, the proportions of delays among those with adequate and limited health literacy were similar with the exception of colorectal cancer screening. There was also a notable difference in the ability to re-engage in cervical cancer screening among those with adequate and limited health literacy. Thus, there is a role for those engaged in cancer-related education and outreach to offer additional navigation resources for those at risk to cancer-related care and screening disruptions. Future study is warranted to investigate the role of health literacy on cancer care engagement.

Spatial analysis of colorectal cancer outcomes and socioeconomic factors in Virginia.

BACKGROUND: Colorectal cancer (CRC) disparities vary by country and population group, but often have spatial features. This study of the United States state of Virginia assessed CRC outcomes, and identified demographic, socioeconomic and healthcare access contributors to CRC disparities. METHODS: County- and city-level cross-sectional data for 2011-2015 CRC incidence, mortality, and mortality-incidence ratio (MIR) were analyzed for geographically determined clusters (hotspots and cold spots) and their correlates. Spatial regression examined predictors including proportion of African American (AA) residents, rural-urban status, socioeconomic (SES) index, CRC screening rate, and densities of primary care providers (PCP) and gastroenterologists. Stationarity, which assesses spatial equality, was examined with geographically weighted regression. RESULTS: For incidence, one CRC hotspot and two cold spots were identified, including one large hotspot for MIR in southwest Virginia. In the spatial distribution of mortality, no clusters were found. Rurality and AA population were most associated with incidence. SES index, rurality, and PCP density were associated with spatial distribution of mortality. SES index and rurality were associated with MIR. Local coefficients indicated stronger associations of predictor variables in the southwestern region. CONCLUSIONS: Rurality, low SES, and racial distribution were important predictors of CRC incidence, mortality, and MIR. Regions with concentrations of one or more factors of disparities face additional hurdles to improving CRC outcomes. A large cluster of high MIR in southwest Virginia region requires further investigation to improve early cancer detection and support survivorship. Spatial analysis can identify high-disparity populations and be used to inform targeted cancer control programming.

Examining the feasibility, acceptability, and potential utility of mobile distress screening in adult cancer patients.

OBJECTIVE: A common method of distress monitoring in cancer patients relies on static and retrospective data collected in-person at the time of a health care provider appointment. Relatively little work has examined the potential usefulness of mobile distress monitoring using cancer patients' smartphones. The current study deployed longitudinal distress monitoring using secure text messaging. METHODS: In an observational study, a total of 52 cancer patients receiving active cancer treatment (Mage  = 58, 62% female) received a text message once a week for 4 weeks. Text messages contained a secure link to complete online the Patient Health Questionnaire-4 (PHQ-4), a commonly used distress screener. RESULTS: Cancer patients completed a distress screener 75% of the time they received a text message. On average, it took less than a minute to complete each mobile distress screener. Geolocation data indicated that cancer patients completed distress screeners across a range of locations. Analyses of model fit of distress scores indicated significant heterogeneity in variability of distress scores over time and across cancer patients (AIC = 630.5). Quantitative feedback from cancer patients at the end of the study indicated high ease of use, ease of learning, and satisfaction of completing mobile distress screeners. CONCLUSIONS: These findings support the use of secure text messaging to monitor longitudinal, out of clinic, distress in cancer patients. Findings also highlight the importance of mobile-based approaches to distress screening in order to maximize opportunities to intervene.

Addressing Stigma Through a Virtual Community for People Living with HIV: A Mixed Methods Study of the PositiveLinks Mobile Health Intervention.

Stigma has negative consequences for quality of life and HIV care outcomes. PositiveLinks is a mobile health intervention that includes a secure anonymous community message board (CMB). We investigated discussion of stigma and changes in stigma scores. Of 77 participants in our pilot, 63% were male, 49% Black, and 72% had incomes below the federal poverty level. Twenty-one percent of CMB posts (394/1834) contained stigma-related content including negative (experiencing stigma) and positive (overcoming stigma) posts addressing intrapersonal and interpersonal stigma. Higher baseline stigma was positively correlated with stress and negatively correlated with HIV care self-efficacy. 12-month data showed a trend toward more improved stigma scores for posters on the CMB versus non-posters (- 4.5 vs - 0.63) and for posters of stigma-related content versus other content (- 5.1 vs - 3.3). Preliminary evidence suggests that a supportive virtual community, accessed through a clinic-affiliated smartphone app, can help people living with HIV to address stigma.

Social Support in a Virtual Community: Analysis of a Clinic-Affiliated Online Support Group for Persons Living with HIV/AIDS.

Social support can improve outcomes for people living with HIV (PLWH) and could be provided through online support groups. The Positive Links smartphone app is a multicomponent intervention that allows users to interact in a clinic-affiliated anonymous online support group. We investigated how social support was exchanged in a group of 55 participants over 8 months, using an adaptation of the Social Support Behavior Code. Participant interviews assessed their experiences and perceptions of the app. Of 840 posts analyzed, 115 (14 %) were coded as eliciting social support and 433 (52 %) as providing social support. Messages providing support were predominantly emotional (41 %), followed by network (27 %), esteem (24 %), informational (18 %), and instrumental (2 %) support. Participants perceived connection and support as key benefits of the app. Technical issues and interpersonal barriers limited some participants in fully using the app. Mobile technology offers a useful tool to reach populations with barriers to in-person support and may improve care for PLWH.

Impact of Urban Neighborhood Disadvantage on Late Stage Breast Cancer Diagnosis in Virginia.

Research suggests that residents of inner-city urban neighborhoods have higher rates of late stage cancer diagnosis. Identifying urban neighborhoods with high rates of both concentrated disadvantage and late stage cancer diagnosis may assist health care providers to target screening interventions to reduce disparities. The purposes of this study were to (1) create an index to evaluate concentrated disadvantage (CD) using non-racial measures of poverty, (2) determine the impact of neighborhood CD on late stage breast cancer diagnosis in US cities, and (3) to understand the role of obesity on this relationship. We used census block group- (CBG) level poverty indicators from five Virginia cities to develop the index. Breast cancer cases of women aged 18-65 who lived in the five cities were identified from the 2000-2012 Virginia Cancer Registry. A logistic regression model with random intercept was used to evaluate the impact of disadvantage on late stage breast cancer diagnosis. CBG-level maps were developed to geographically identify neighborhoods with both high rates of CD and late breast cancer staging. Over 900 CBGs and 6000 breast cases were included. Global fit of the concentrated disadvantage model was acceptable. The effect of disadvantage on late stage was significant (OR = 1.0083, p = 0.032). Inner-city poverty impacts risk of late stage breast cancer diagnosis. Area-level obesity is highly correlated with neighborhood poverty (ρ = 0.74, p < 0.0001) but the mediating direct and indirect effects are non-significant. Intervening in these high poverty neighborhoods may help combat disparities in late stage diagnosis for urban poor and for minorities living in these underserved neighborhoods, but more study is needed to understanding the complex relationship between concentrated neighborhood poverty, obesity, and late stage diagnosis.

Content Analysis and User Characteristics of a Smartphone-Based Online Support Group for People Living with HIV.

BACKGROUND: Although there is growing interest in mobile applications and online support groups to enhance chronic disease self-management, little is known about their potential impact for people living with HIV (PLWH). INTRODUCTION: We developed an innovative online support group delivered through a community message board (CMB) within a clinic-affiliated smartphone application Positive Links (PL). We analyzed characteristics of posters and nonposters to the CMB and evaluated content posted to the CMB. MATERIALS AND METHODS: For this study, 38 HIV-infected patients received cell phones with the PL application that included the opportunity to interact with other users on a CMB. Logistic regressions investigated associations between participant characteristics and posting. CMB messages were downloaded and analyzed qualitatively. RESULTS: 24 participants posted to the CMB; 14 did not. Participants had lower odds of posting if they were white (p = 0.028) and had private insurance (p = 0.003). Participants had higher odds of posting if they had unsuppressed viral loads (p = 0.034). Of the 840 CMB messages over 8 months, 62% had psychosocial content, followed by community chat (29%), and biomedical content (10%). DISCUSSION: Psychosocial content was most prevalent on this CMB, in contrast to other online forums dominated by informational content. Participants who posted expressed support for each other, appreciation for the community, and a perception that the app played a positive role in their HIV self-management. CONCLUSIONS: This CMB on a clinic-affiliated mobile application may reach vulnerable populations, including racial/ethnic minorities and those of lower socioeconomic status, and provide psychosocial support to PLWH.

Evaluating the impact of patients' psychological and physical problems on their interest in participating in research at a cancer center with a rural catchment area.

BACKGROUND: Cancer patients' participation in research trials is essential to improving their care and treatment. In a large sample of adults recently diagnosed with cancer, the aim of the current study is to investigate the relationship between cancer patients' interest in research and the psychological and physical problems they experience resulting from their cancer diagnosis. METHOD: We analyzed data from 906 cancer patients collected during routine clinical care. Correlational analyses focused on the relationship between patients' psychological and physical problems and their interest in research. Hierarchical binary logistic regression analyses tested whether patients' psychological/physical problems as a block predicted their interest in research, above and beyond their sociodemographic characteristics. RESULTS: Higher levels of patients' anxiety, fear of cancer treatment, difficulty managing emotions, worry, suicidal/homicidal ideation, fatigue, problems related to physical appearance, sleep difficulty, and changes to weight/appetite, were associated with a greater interest in research. Patients' psychological/physical problems, as a block, incrementally predicted their interest in research (Δχ2 = 24.34, df = 14, p = .04, Δr2=0.05), though none of the individual psychological/physical problems were found to be significant predictors. A higher level of education was significantly positively associated with an increased likelihood of being interested in research (OR = 1.26, 95%CI = 1.09, 1.46, p = .001). CONCLUSION: Cancer patients' problems stemming from their diagnosis can be important factors in their decision to participate in research. Depending on the needs of the trial in question, researchers may want to account for patients' level of symptom burden in deciding who to approach for enrollment in a research trial.

The lived experience during the peri-diagnostic period of breast cancer: A scoping review.

OBJECTIVES: The aim of this scoping review is to provide an overview of the existing research that investigates the lived experience during the peri-diagnostic period of breast cancer. METHODS: Nine databases were searched for relevant literature between January 2007 and April 2019. Data were extracted and categorized using deductive and inductive approaches. RESULTS: A majority of the 66 studies included used qualitative methods to retrospectively explore the treatment decision making process of female breast cancer patients. Patients experienced uncertainty, emotional distress, and a need for more information from providers and relied on social support and family guidance during this period. CONCLUSIONS: The results of this review show that the burdens experienced during the peri-diagnostic period parallel those in later periods of cancer care. However, these burdens are prompted by different circumstances. More research is needed to explore the lived experience during this period through the use of mixed-methods and by recruiting a diverse sample with regards to role in the breast cancer experience, age, gender, race, and ethnicity. PRACTICE IMPLICATIONS: Interventions positioned at earlier points in the breast cancer experience should provide informational support, which could be delivered through shared decision making models. Additional support could be facilitated by patient navigation programs and health information technology.

Challenges to accrual predictions to phase III cancer clinical trials: a survey of study chairs and lead statisticians of 248 NCI-sponsored trials.

BACKGROUND: Research on barriers to accrual has typically emphasized factors influencing participation after trial activation. PURPOSE: We sought to identify factors influencing trial design and accrual predictions prior to trial activation associated with sufficient accrual. METHODS: A 30-question web-based survey was sent to the study chair and lead statistician for all 248 phase III trials open in 1993-2002 by five Clinical Trials Cooperative Groups. Questions addressed prior trial experience, trial design elements, accrual predictions, and perceived accrual influences. Accrual sufficiency categorization was derived from Clinical Trials Cooperative Group records: sufficient accrual included trials closed with complete accrual or at interim analysis, insufficient accrual included trials closed with inadequate accrual. Responses were analyzed by respondent role (study chair/lead statistician) and accrual sufficiency. RESULTS: Three hundred and nine eligible responses were included (response rate, 63%; lead statisticians, 81%; and study chairs, 45%), representing trials with sufficient (63%) and insufficient accruals (37%). Study chair seniority or lead statistician experience was not linked to accrual sufficiency. Literature review, study chair's personal experience, and expert opinion within Clinical Trials Cooperative Group most commonly influenced control arm selection. Clinical Trials Cooperative Group experience most influenced accrual predictions. These influences were not associated with accrual sufficiency. Among respondents citing accrual difficulties (41%), factors negatively influencing accrual were not consistently identified. Respondents credited three factors with positively influencing accrual: clinical relevance of study, lack of competing trials, and protocol paralleling normal practice. LIMITATIONS: Perceptions of lead statisticians and study chairs may not accurately reflect accrual barriers encountered by participating physicians or patients. Survey responses may be subject to recall bias. CONCLUSION: Consistent factors explaining poor accrual were not identified, suggesting reasons for poor accrual are not well understood and warrant further study. Alternate strategies for accrual prediction are needed since Clinical Trials Cooperative Group experience is linked to successful and unsuccessful accrual.

Health disparities between Appalachian and non-Appalachian counties in Virginia USA.

UNLABELLED: The examination of health disparities among people within Appalachian counties compared to people living in other counties is needed to find ways to strategically target improvements in community health in the United States of America (USA). METHODS: A telephone survey of a random sample of adults living in households within communities of all counties of the state of Virginia (VA) in the USA was conducted. FINDINGS: Health status was poorer among those in communities within Appalachian counties in VA and health insurance did not make a difference. Health perception was significantly worse in residents within communities in Appalachian counties compared to non-Appalachian community residents (30.5 vs. 17.4% rated their health status as poor/fair), and was worse even among those with no chronic diseases. Within communities in Appalachian counties, black residents report significantly better health perception than do white residents. CONCLUSION: Residents living in communities in Appalachian counties in VA are not receiving adequate health care, even among those with health insurance. More research with a larger ethnic minority sample is needed to investigate the racial/ethnic disparities in self-reported health and health care utilization within communities.

An Implementation Strategy to Expand Mobile Health Use in HIV Care Settings: Rapid Evaluation Study Using the Consolidated Framework for Implementation Research.

BACKGROUND: Mobile health (mHealth) apps can provide support to people living with a chronic disease by offering resources for communication, self-management, and social support. PositiveLinks (PL) is a clinic-deployed mHealth app designed to improve the health of people with HIV. In a pilot study, PL users experienced considerable improvements in care engagement and viral load suppression. To promote its expansion to other HIV clinics, we developed an implementation strategy consisting of training resources and on-demand program support. OBJECTIVE: The objective of our study was to conduct an interim analysis of the barriers and facilitators to PL implementation at early adopting sites to guide optimization of our implementation strategy. METHODS: Semistructured interviews with stakeholders at PL expansion sites were conducted. Analysis of interviews identified facilitators and barriers that were mapped to 22 constructs of the Consolidated Framework for Implementation Research (CFIR). The purpose of the analysis was to identify the facilitators and barriers to PL implementation in order to adapt the PL implementation strategy. Four Ryan White HIV clinics were included. Interviews were conducted with one health care provider, two clinic managers, and five individuals who coordinated site PL activities. RESULTS: Ten common facilitators and eight common barriers were identified. Facilitators to PL implementation included PL's fit with patient and clinic needs, PL training resources, and sites' early engagement with their information technology personnel. Most barriers were specific to mHealth, including access to Wi-Fi networks, maintaining patient smartphone access, patient privacy concerns, and lack of clarity on how to obtain approvals for mHealth use. CONCLUSIONS: The CFIR is a useful framework for evaluating mHealth interventions. Although PL training resources were viewed favorably, we identified important barriers to PL implementation in a sample of Ryan White clinics. This enabled our team to expand guidance on identifying information technology stakeholders and procuring and managing mobile resources. Ongoing evaluation results continue to inform improvements to the PL implementation strategy, facilitating PL access for future expansion sites.

A Novel Mobile Phone App Intervention With Phone Coaching to Reduce Symptoms of Depression in Survivors of Women's Cancer: Pre-Post Pilot Study.

BACKGROUND: Psychological distress is a major issue among survivors of women's cancer who face numerous barriers to accessing in-person mental health treatments. Mobile phone app-based interventions are scalable and have the potential to increase access to mental health care among survivors of women's cancer worldwide. OBJECTIVE: This study aimed to evaluate the acceptability and preliminary efficacy of a novel app-based intervention with phone coaching in a sample of survivors of women's cancer. METHODS: In a single-group, pre-post, 6-week pilot study in the United States, 28 survivors of women's cancer used iCanThrive, a novel app intervention that teaches skills for coping with stress and enhancing well-being, with added phone coaching. The primary outcome was self-reported symptoms of depression (Center for Epidemiologic Studies Depression Scale). Emotional self-efficacy and sleep disruption were also assessed at baseline, 6-week postintervention, and 4 weeks after the intervention period. Feedback obtained at the end of the study focused on user experience of the intervention. RESULTS: There were significant decreases in symptoms of depression and sleep disruption from baseline to postintervention. Sleep disruption remained significantly lower at 4-week postintervention compared with baseline. The iCanThrive app was launched a median of 20.5 times over the intervention period. The median length of use was 2.1 min. Of the individuals who initiated the intervention, 87% (20/23) completed the 6-week intervention. CONCLUSIONS: This pilot study provides support for the acceptability and preliminary efficacy of the iCanThrive intervention. Future work should validate the intervention in a larger randomized controlled study. It is important to develop scalable interventions that meet the psychosocial needs of different cancer populations. The modular structure of the iCanThrive app and phone coaching could impact a large population of survivors of women's cancer.

Use of Mental Health Apps by Patients With Breast Cancer in the United States: Pilot Pre-Post Study.

BACKGROUND: Nearly half of the patients with breast cancer experience clinically significant mental distress within the first year of receiving their cancer diagnosis. There is an urgent need to identify scalable and cost-efficient ways of delivering empirically supported mental health interventions to patients with breast cancer. OBJECTIVE: The aim of this study was to evaluate the feasibility of in-clinic recruitment for a mobile phone app study and to evaluate the usability and preliminary impact of a suite of mental health apps (IntelliCare) with phone coaching on psychosocial distress symptoms in patients recently diagnosed with breast cancer. METHODS: This pilot study adopted a within-subject, 7-week pre-post study design. A total of 40 patients with breast cancer were recruited at a US National Cancer Institute-designated clinical cancer center. Self-reported distress (Patient Health Questionnaire-4) and mood symptoms (Patient-Reported Outcomes Measurement Information System depression and anxiety scales) were assessed at baseline and postintervention. App usability was assessed at postintervention. RESULTS: The minimum recruitment threshold was met. There was a significant decrease in general distress symptoms, as well as symptoms of depression and anxiety, from baseline to postintervention. Overall, participants reported high levels of ease of app use and learning. Scores for app usefulness and satisfaction were reinforced by some qualitative feedback suggesting that tailoring the apps more for patients with breast cancer could enhance engagement. CONCLUSIONS: There is a dire need for scalable, supportive interventions in cancer. The results from this study inform how scalable mobile phone-delivered programs with additional phone support can be used to support patients with breast cancer. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/11452.

Long term impact of PositiveLinks: Clinic-deployed mobile technology to improve engagement with HIV care.

BACKGROUND: PositiveLinks (PL) is a smartphone-based platform designed in partnership with people living with HIV (PLWH) to improve engagement in care. PL provides daily medication reminders, check-ins about mood and stress, educational resources, a community message board, and an ability to message providers. The objective of this study was to evaluate the impact of up to 24 months of PL use on HIV viral suppression and engagement in care and to examine whether greater PL use was associated with improved outcomes. SETTING: This study occurred between September 2013 and March 2017 at a university-based Ryan White HIV clinic. METHODS: We assessed engagement in care and viral suppression from study baseline to the 6-, 12-, 18- and 24-month follow-up time periods and compared trends among high vs. low PL users. We compared time to viral suppression, proportion of days virally suppressed, and time to engagement in care in patients with high vs. low PL use. RESULTS: 127 patients enrolled in PL. Engagement in care and viral suppression improved significantly after 6 months of PL use and remained significantly improved after 24 months. Patients with high PL use were 2.09 (95% CI 0.64-6.88) times more likely to achieve viral suppression and 1.52 (95% CI 0.89-2.57) times more likely to become engaged in care compared to those with low PL use. CONCLUSION: Mobile technology, such as PL, can improve engagement in care and clinical outcomes for PLWH. This study demonstrates long-term acceptability of PL over two years and provides evidence for long-term improvement in engagement in care and viral suppression associated with PL use.

A Case-Control Study to Add Volumetric or Clinical Mammographic Density into the Tyrer-Cuzick Breast Cancer Risk Model.

BACKGROUND: Accurate breast cancer risk assessment for women attending routine screening is needed to guide screening and preventive interventions. We evaluated the accuracy of risk predictions from both visual and volumetric mammographic density combined with the Tyrer-Cuzick breast cancer risk model. METHODS: A case-control study (474 patient participants and 2243 healthy control participants) of women aged 40-79 years was performed using self-reported classical risk factors. Breast density was measured by using automated volumetric software and Breast Imaging and Reporting Data System (BI-RADS) density categories. Odds ratios (95% CI) were estimated by using logistic regression, adjusted for age, demographic factors, and 10-year risk from the Tyrer-Cuzick model, for a change from the 25th to 75th percentile of the adjusted percent density distribution in control participants (IQ-OR). RESULTS: After adjustment for classical risk factors in the Tyrer-Cuzick model, age, and body mass index (BMI), BI-RADS density had an IQ-OR of 1.55 (95% CI = 1.33 to 1.80) compared with 1.40 (95% CI = 1.21 to 1.60) for volumetric percent density. Fibroglandular volume (IQ-OR = 1.28, 95% CI = 1.12 to 1.47) was a weaker predictor than was BI-RADS density (Pdiff = 0.014) or volumetric percent density (Pdiff = 0.065). In this setting, 4.8% of women were at high risk (8% + 10-year risk), using the Tyrer-Cuzick model without density, and 7.1% (BI-RADS) compared with 6.8% (volumetric) when combined with density. CONCLUSION: The addition of volumetric and visual mammographic density measures to classical risk factors improves risk stratification. A combined risk could be used to guide precision medicine, through risk-adapted screening and prevention strategies.

Use of Mental Health Apps by Breast Cancer Patients and Their Caregivers in the United States: Protocol for a Pilot Pre-Post Study.

BACKGROUND: Over one-third of cancer patients experience clinically significant mental distress, and distress in caregivers can exceed that of the cancer patients for whom they care. There is an urgent need to identify scalable and cost-efficient ways of delivering mental health interventions to cancer patients and their loved ones. OBJECTIVE: The aim of this study is to describe the protocol to pilot a mobile app-based mental health intervention in breast cancer patients and caregivers. METHODS: The IntelliCare mental health apps are grounded in evidence-based research in psychology. They have not been examined in cancer populations. This pilot study will adopt a within-subject, pre-post study design to inform a potential phase III randomized controlled trial. A target sample of 50 individuals (with roughly equal numbers of patients and caregivers) at least 18 years of age and fluent in English will be recruited at a US National Cancer Institute designated clinical cancer center. Consent will be obtained in writing and a mobile phone will be provided if needed. Self-report surveys assessing mental health outcomes will be administered at a baseline session and after a 7-week intervention. Before using the apps, participants will receive a 30-min coaching call to explain their purpose and function. A 10-min coaching call 3 weeks later will check on user progress and address questions or barriers to use. Self-report and semistructured interviews with participants at the end of the study period will focus on user experience and suggestions for improving the apps and coaching in future studies. RESULTS: This study is ongoing, and recruitment will be completed by the end of 2018. CONCLUSIONS: Results from this study will inform how scalable mobile phone-delivered programs can be used to support breast cancer patients and their loved ones. TRIAL REGISTRATION: ClinicalTrials.gov NCT03488745; https://clinicaltrials.gov/ct2/show/NCT03488745. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11452.

Risk factors for poor health-related quality of life in cancer survivors with multiple chronic conditions: exploring the role of treatment burden as a mediator.

PURPOSE: The purpose of this study was to identify risk factors for poor health-related quality of life (HRQL) in multi-morbid adult cancer survivors and explore whether perceived treatment and self-management burden mediate any of these relationships. METHODS: Ninety-one multi-morbid cancer survivors (median age: 65 years) completed surveys at baseline and 6 months. Demographic, psychosocial, and health care-related factors were assessed as were perceived treatment burden and general HRQL (physical and mental health). Data on medical diagnoses and cancer treatment were extracted from the medical record. Bivariate correlations screened for associations between predictors and outcomes, with significant predictors entered into multivariable linear regressions to identify unique risk factors for greater treatment burden and poorer HRQL. Follow-up regressions examined whether treatment burden mediated any of the risk factor-outcome relationships. RESULTS: Factors that correlated with higher baseline treatment burden included: having more diagnoses, less formal education, having seen more physicians in the past 6 months, having a mental health diagnosis, not having a set routine for one's self-management, low health literacy, low self-efficacy for self-management, and low social support (Ps <0.05). Among these, factors that also correlated with worse 6-month HRQL outcome included: having more diagnoses, having seen more physicians in the past 6 months, having a mental health diagnosis, not having a set routine for one's self-management, low health literacy, low self-efficacy, and low social support (Ps <0.05). Multivariable regressions showed that some of these factors independently predicted higher treatment burden and/or worse HRQL. Low self-efficacy was the most robust independent risk factor for poor HRQL (bs: 0.34-0.49, Ps <0.005), with evidence supporting that the relationships were partially mediated by treatment burden. CONCLUSION: Monitoring of psychosocial and health care-related risk factors for high treatment burden and poor HRQL can identify multi-morbid cancer survivors in need of extra support and could inform a more personalized treatment approach.

"Are you at risk for hereditary breast cancer?": development of a personal risk assessment tool for hereditary breast and ovarian cancer.

Identification of risk for the hereditary breast and ovarian cancer syndrome (HBOC) is important, as research has demonstrated the benefits of risk-reducing interventions for women with or at risk for this disorder. Knowledge among women regarding risk factors for hereditary breast cancer and the existence of cancer genetics services appears limited. The goal of this project was to develop a tool to broaden women's awareness regarding their potential risk for HBOC. A formal instructional design process was used to develop a brochure to facilitate recognition of HBOC risk among women attending a no-cost breast and cervical cancer screening clinic. Brochure development was guided by gathering feedback from potential users early and often. The resulting brochure included four parts: (1) a brief description of the impact of hereditary breast cancer risk on one's health; (2) a personal and family history collection table; (3) a series of questions enabling the user to self-assess HBOC risk; (4) a list of resources for women at risk for HBOC. User feedback indicated that the brochure was easy to use. The project demonstrated that women can self-evaluate their risk for HBOC. Future work will evaluate this tool among a broader population of women.