Duloxetine and Cognitive Behavioral Therapy with Phone-based Support for the Treatment of Chronic Musculoskeletal Pain: Study Protocol of the PRECICE Randomized Control Trial.

Background: Chronic musculoskeletal pain (CMP) is the most common, disabling, and costly of all pain conditions. While evidence exists for the efficacy of both duloxetine and web-based cognitive behavioral therapy (CBT) as monotherapy, there is a clear need to consider study of treatment components that may complement each other. In addition, given the reported association between patient's adherence and treatment outcomes, strategies are needed to enhance participant's motivation to adopt and maintain continued use of newly learned pain coping skills from CBT. Methods: Two hundred eighty participants will be recruited from the primary care clinics of a large academic health care system in North Carolina. Participants with CMP will be randomized to one of 3 treatment arms: (1) combination treatment (duloxetine + web-based self-guided CBT) with phone-based motivational interviewing (MI), (2) combination treatment without phone-based MI and (3) duloxetine monotherapy. Participants will be in the study for 24 weeks and will be assessed at baseline, week 13, and week 25. The primary outcome is the Brief Pain Inventory (BPI)-Global Pain Severity score, which combines BPI pain severity and BPI pain interference. Secondary measures include between-group comparisons in mean BPI pain severity and BPI pain interference scores. Data collection and outcome assessment will be blinded to treatment group assignment. Discussion: This randomized controlled trial (RCT) will determine if combination treatment with duloxetine and web-based CBT is superior to duloxetine monotherapy for the management of CMP. Furthermore, this RCT will determine the effectiveness of phone-based motivational interviewing in promoting the continued practice of pain coping skills; thereby, enhancing treatment outcomes. Trial Registration: NCT04395001. Registered in ClinicalTrials.gov on May 15, 2020.

Duloxetine and cognitive behavioral therapy with phone-based support for the treatment of chronic musculoskeletal pain: study protocol of the PRECICE randomized control trial.

BACKGROUND: Chronic musculoskeletal pain (CMP) is the most common, disabling, and costly of all pain conditions. While evidence exists for the efficacy of both duloxetine and web-based cognitive behavioral therapy (CBT) as monotherapy, there is a clear need to consider study of treatment components that may complement each other. In addition, given the reported association between patient's adherence and treatment outcomes, strategies are needed to enhance participant's motivation to adopt and maintain continued use of newly learned pain coping skills from CBT. METHODS: Two hundred eighty participants will be recruited from the primary care clinics of a large academic health care system in North Carolina. Participants with CMP will be randomized to one of three treatment arms: (1) combination treatment (duloxetine + web-based self-guided CBT) with phone-based motivational interviewing (MI), (2) combination treatment without phone-based MI, and (3) duloxetine monotherapy. Participants will be in the study for 24 weeks and will be assessed at baseline, week 13, and week 25. The primary outcome is the Brief Pain Inventory (BPI)-Global Pain Severity score, which combines BPI pain severity and BPI pain interference. Secondary measures include between-group comparisons in mean BPI pain severity and BPI pain interference scores. Data collection and outcome assessment will be blinded to treatment group assignment. DISCUSSION: This randomized controlled trial (RCT) will determine if combination treatment with duloxetine and web-based CBT is superior to duloxetine monotherapy for the management of CMP. Furthermore, this RCT will determine the effectiveness of phone-based motivational interviewing in promoting the continued practice of pain coping skills, thereby enhancing treatment outcomes. TRIAL REGISTRATION: NCT04395001 ClinicalTrials.gov. Registered on May 15, 2020.

Examining sociodemographic and health-related characteristics as moderators of an mHealth intervention on physical activity outcomes in young adult cancer survivors.

PURPOSE: This study explored whether sociodemographic and health-related characteristics moderated mHealth PA intervention effects on total and moderate-to-vigorous physical activity (MVPA) at 6 months, relative to a self-help condition among young adult cancer survivors (YACS). METHODS: We conducted exploratory secondary analyses of data from a randomized controlled trial among 280 YACS. All participants received digital tools; intervention participants also received lessons, adaptive goals, tailored feedback, text messages, and Facebook prompts. Potential moderators were assessed in baseline questionnaires. PA was measured at baseline and 6 months with accelerometers. Linear model repeated measures analyses examined within- and between-group PA changes stratified by levels of potential moderator variables. RESULTS: Over 6 months, the intervention produced MVPA increases that were ≥ 30 min/week compared with the self-help among participants who were males (28.1 vs. -7.7, p = .0243), identified with racial/ethnic minority groups (35.2 vs. -8.0, p = .0006), had baseline BMI of 25-30 (25.4 vs. -7.2, p = .0034), or stage III/IV cancer diagnosis (26.0 vs. -6.8, p = .0041). Intervention participants who were ages 26-35, college graduates, married/living with a partner, had a solid tumor, or no baseline comorbidities had modest MVPA increases over 6 months compared to the self-help (ps = .0163-.0492). Baseline characteristics did not moderate intervention effects on total PA. CONCLUSIONS: The mHealth intervention was more effective than a self-help group at improving MVPA among subgroups of YACS defined by characteristics (sex, race, BMI, cancer stage) that may be useful for tailoring PA interventions. IMPLICATIONS FOR CANCER SURVIVORS: These potential moderators can guide future optimization of PA interventions for YACS. GOV IDENTIFIER: NCT03569605.

Measuring perceived utility of genomic sequencing: Development and validation of the GENEtic Utility (GENE-U) scale for pediatric diagnostic testing.

INTRODUCTION: Measuring effects of genomic sequencing (GS) on patients and families is critical for translational research. We aimed to develop and validate an instrument to assess parents' perceived utility of pediatric diagnostic GS. METHODS: Informed by a five-domain conceptual model, the study comprised five steps: (1) item writing, (2) cognitive testing, (3) pilot testing and item reduction, (4) psychometric testing, and (5) evaluation of construct validity. Parents of pediatric patients who had received results of clinically indicated GS participated in structured cognitive interviews and two rounds of surveys. After eliminating items based on theory and quantitative performance, we conducted an exploratory factor analysis and calculated Pearson correlations with related instruments. RESULTS: We derived the 21-item Pediatric Diagnostic version of the GENEtic Utility (GENE-U) scale, which has a two-factor structure that includes an Informational Utility subscale (16 items, α = 0.91) and an Emotional Utility subscale (5 items, α = 0.71). Scores can be summed to calculate a Total scale score (α = 0.87). The Informational Utility subscale was strongly associated with empowerment and personal utility of GS, and the Emotional Utility subscale was moderately associated with psychosocial impact and depression and anxiety. DISCUSSION: The Pediatric Diagnostic GENE-U scale demonstrated good psychometric performance in this initial evaluation and could be a useful tool for translational genomics researchers, warranting additional validation.

Medical Advocacy among Latina Women Diagnosed with Breast Cancer.

Medical advocacy has continued to significantly impact quality of life and survivorship outcomes among Latina breast cancer survivors in the United States. However, little is known about the unique experiences of Latina survivors, including the perceived value, process, and context in which they practice medical advocacy. To help address this gap, we conducted a qualitative, secondary analysis of semi-structured focus groups with 18 Latina breast cancer survivors from Chicago, Illinois. Eligible women had to self-identify as (1) female, (2) Latina, (3) 18 years or older, and (4) having a breast cancer diagnosis 5 years ago or more. In total, 61% of participants were 50-59 years old, 83% were born in Mexico, and 100% spoke Spanish. The three emergent themes from the focus groups were (1) the cultural need for Latina advocates and support groups; (2) the process and experiences of becoming a community advocate within Latine culture; and (3) the cultural contexts for advocacy by Latina breast cancer survivors. Latina survivor advocates share strengths of receiving ongoing health education, peer support, and access to resources when being linked to a support group furthering their exposure to role models, increasing their awareness of opportunities in medical advocacy, and providing an entry to participate in medical advocacy.

Measuring health-related quality of life in children with suspected genetic conditions: validation of the PedsQL proxy-report versions.

PURPOSE: Measuring health-related quality of life (HRQoL) of children with suspected genetic conditions is important for understanding the effect of interventions such as genomic sequencing (GS). The Pediatric Quality of Life Inventory (PedsQL) is a widely used generic measure of HRQoL in pediatric patients, but its psychometric properties have not yet been evaluated in children undergoing diagnostic GS. METHODS: In this cross-sectional study, we surveyed caregivers at the time of their child's enrollment into GS research studies as part of the Clinical Sequencing Evidence Generating Research (CSER) consortium. To evaluate structural validity of the PedsQL 4.0 Generic Core Scales and PedsQL Infant Scales parent proxy-report versions, we performed a confirmatory factor analysis of the hypothesized factor structure. To evaluate convergent validity, we examined correlations between caregivers' reports of their child's health, assessed using the EQ VAS, and PedsQL scores by child age. We conducted linear regression analyses to examine whether age moderated the association between caregiver-reported child health and PedsQL scores. We assessed reliability using Cronbach's alpha. RESULTS: We analyzed data for 766 patients across all PedsQL age group versions (1-12 months through 13-18 years). Model fit failed to meet criteria for good fit, even after modification. Neither age group (categorical) nor age (continuous) significantly moderated associations between PedsQL scores and caregiver-reported child health. Cronbach's alphas indicated satisfactory internal consistency for most PedsQL scales. CONCLUSION: The PedsQL Generic Core Scales and Infant Scales may be appropriate to measure HRQoL in pediatric patients with suspected genetic conditions across a wide age range. While we found evidence of acceptable internal consistency and preliminary convergent validity in this sample, there were some potential problems with structural validity and reliability that require further attention.

The Parent PrU: A measure to assess personal utility of pediatric genomic results.

PURPOSE: We aimed to adapt and validate an existing patient-reported outcome measure, the personal-utility (PrU) scale, for use in the pediatric genomic context. METHODS: We adapted the adult version of the PrU and obtained feedback from 6 parents whose child had undergone sequencing. The resulting measure, the Parent PrU, was administered to parents of children in 4 pediatric cohorts of the Clinical Sequencing Evidence-Generating Research consortium after they received their children's genomic results. We investigated the measure's structural validity and internal consistency. RESULTS: We conducted a principal-axis factor analysis with oblimin rotation on data from 755 participants to determine structural validity. These analyses yielded a 3-factor solution, accounting for 76% of the variance in the 16 items. We used Cronbach's α to assess the internal consistency of each factor: (1) child benefits (α = .95), (2) affective parent benefits (α = .90), and (3) parent control (α = .94). CONCLUSION: Our evidence suggests that the Parent PrU scale has potential as a measure for assessing parent-reported personal utility of their children's genomic results. Additional research is needed to further validate the Parent PrU scale, including by comparing its findings with utility assessments reported by clinicians and children themselves.

Intervening in the Cancer Care System: An Analysis of Equity-Focused Nurse Navigation and Patient-Reported Outcomes.

BACKGROUND: Nurse navigation can improve quality of cancer care and reduce racial disparities in care outcomes. Addressing persistent structurally-rooted disparities requires research on strategies that support patients by prompting structural changes to systems of care. We applied a novel conceptualization of social support to an analysis of racial equity-focused navigation and patient-reported outcomes. METHOD: We applied an antiracism lens to create a theory-informed definition of system-facing social support: intervening in a care system on a patient's behalf. Participants were adults with early-stage breast or lung cancer, who racially identified as Black or White, and received specialized nurse navigation (n = 155). We coded navigators' clinical notes (n = 3,251) to identify instances of system-facing support. We then estimated models to examine system-facing support in relation to race, perceived racism in health care settings, and mental health. RESULTS: Twelve percent of navigators' clinical notes documented system-facing support. Black participants received more system-facing support than White participants, on average (b = 0.78, 95% confidence interval [CI]: [0.25, 1.31]). The interaction of race*system-facing support was significant in a model predicting perceived racism in health care settings at the end of the study controlling for baseline scores (b = 0.05, 95% CI [0.01, 0.09]). Trends in simple slopes indicated that among Black participants, more system-facing support was associated with slightly more perceived racism; no association among White participants. DISCUSSION: The term system-facing support highlights navigators' role in advocating for patients within the care system. More research is needed to validate the construct system-facing support and examine its utility in interventions to advance health care equity.

Greater Social Isolation and Social Constraints Prior to Hematopoietic Stem Cell Transplant Are Associated with Greater Anxiety and Depressive Symptoms.

BACKGROUND: Hematopoietic stem cell transplantation (hereafter "HCT") is a physically and psychologically difficult treatment for patients with hematological cancers. This study examined relationships among patients' reports of pre-transplant social isolation, social constraints, and psychological distress. METHOD: We used baseline data from a multisite randomized controlled trial evaluating the effects of expressive helping writing to reduce physical and emotional symptoms in HCT patients. We collected data prior to randomization and before either allogenic or autologous HCT using validated scales to assess social constraints, social isolation, anxiety, and depressive symptoms. We analyzed data using bivariate analysis and multivariate linear regression. We also explored whether social isolation mediated the effect of social constraints on both of our outcomes: anxiety and depressive symptoms. RESULTS: Among 259 adults recruited prior to transplant, 43.6% were women (mean age = 57.42 years, SD = 12.34 years). In multivariate analysis controlling for relevant covariates, both social isolation (ß = 0.24, p < 0.001) and social constraints (ß = 0.28, p < 0.001) were associated with anxiety. When both social constraints and social isolation were in the model, only greater social isolation (ß = 0.79, p < 0.001) was associated with depressive symptoms. Social isolation fully mediated the association between social constraints and anxiety and depressive symptoms. CONCLUSION: For patients awaiting either allogenic or autologous HCT, the negative association between social constraints and anxiety and depressive symptoms may be related, in part, to the mechanism of perceived social isolation. Interventions prior to and during HCT are needed to support patients' psychological health and sense of social connectedness.

Mechanisms to enhance racial equity in health care: Developing a model to facilitate translation of the ACCURE intervention.

Background: As medical and public health professional organizations call on researchers and policy makers to address structural racism in health care, guidance on evidence-based interventions to enhance health care equity is needed. The most promising organizational change interventions to reduce racial health disparities use multilevel approaches and are tailored to specific settings. This study examines the Accountability for Cancer Care through Undoing Racism and Equity (ACCURE) intervention, which changed systems of care at two U.S. cancer centers and eliminated the Black-White racial disparity in treatment completion among patients with early-stage breast and lung cancer. Purpose: We aimed to document key characteristics of ACCURE to facilitate translation of the intervention in other care settings. Methods: We conducted semi-structured interviews with participants who were involved in the design and implementation of ACCURE and analyzed their responses to identify the intervention's mechanisms of change and key components. Results: Study participants (n = 18) described transparency and accountability as mechanisms of change that were operationalized through ACCURE's key components. Intervention components were designed to enhance either institutional transparency (e.g., a data system that facilitated real-time reporting of quality metrics disaggregated by patient race) or accountability of the care system to community values and patient needs for minimally biased, tailored communication and support (e.g., nurse navigators with training in antiracism and proactive care protocols). Conclusions: The antiracism principles transparency and accountability may be effective change mechanisms in equity-focused health services interventions. The model presented in this study can guide future research aiming to adapt ACCURE and evaluate the intervention's implementation and effectiveness in new settings and patient populations.

Decision support training for advanced cancer family caregivers: Study protocol for the CASCADE factorial trial.

BACKGROUND: Patients with advanced cancer face numerous decisions when diagnosed and often receive decision support from family caregivers. The CASCADE (CAre Supporters Coached to be Adept DEcision partners) factorial trial intervention aims to train caregivers in skills to provide effective decision support to patients and identify most effective intervention components. METHODS: This is a 2-site, single-blind, 24 factorial trial to test components of the CASCADE decision support training intervention for family caregivers of patients with newly-diagnosed advanced cancer delivered by specially-trained, telehealth, palliative care lay coaches over 24 weeks. Family caregivers (target N = 352) are randomly assigned to one of 16 combinations of four components with two levels each: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision support communication training (1 session vs. none); 3) Ottawa Decision Guide training (1 session vs. none) and 4) monthly follow-up (1 call vs. calls for 24 weeks). The primary outcome is patient-reported decisional conflict at 24 weeks. Secondary outcomes include patient distress, healthcare utilization, caregiver distress, and quality of life. Mediators and moderators (e.g., sociodemographics, decision self-efficacy, social support) will be explored between intervention components and outcomes. Results will be used to build two versions of CASCADE: one with only effective components (d ≥ 0.30) and another optimized for scalability and cost. DISCUSSION: This protocol describes the first factorial trial, informed by the multiphase optimization strategy, of a palliative care decision-support intervention for advanced cancer family caregivers and will address the field's need to identify effective components that support serious illness decision-making. TRIAL REGISTRATION: NCT04803604.

Physical activity maintenance among young adult cancer survivors in an mHealth intervention: Twelve-month outcomes from the IMPACT randomized controlled trial.

BACKGROUND: Most physical activity (PA) interventions in young adult cancer survivors (YACS) have focused on short-term outcomes without evaluating longer-term outcomes and PA maintenance. This study examined the effects of an mHealth PA intervention at 12 months, after 6 months of tapered contacts, relative to a self-help group among 280 YACS. METHODS: YACS participated in a 12-month randomized trial that compared self-help and intervention groups. All participants received an activity tracker, smart scale, individual videochat session, and access to a condition-specific Facebook group. Intervention participants also received lessons, tailored feedback, adaptive goal setting, text messages, and Facebook prompts for 6 months, followed by tapered contacts. Accelerometer-measured and self-reported PA (total [primary outcome], moderate-to-vigorous [MVPA], light, steps, sedentary behaviors) were collected at baseline, 6, and 12 months. Generalized estimating equation analyses evaluated group effects on outcomes from baseline to 12 months. RESULTS: From baseline to 12 months, there were no between- or within-group differences in accelerometer-measured total PA min/week, while increases in self-reported total PA were greater in the intervention versus self-help group (mean difference = +55.8 min/week [95% CI, 6.0-105.6], p = 0.028). Over 12 months, both groups increased accelerometer-measured MVPA (intervention: +22.5 min/week [95% CI, 8.8-36.2] vs. self-help: +13.9 min/week [95% CI, 3.0-24.9]; p = 0.34), with no between-group differences. Both groups maintained accelerometer-measured and self-reported PA (total, MVPA) from 6 to 12 months. At 12 months, more intervention participants reported meeting national PA guidelines than self-help participants (47.9% vs. 33.1%, RR = 1.45, p = 0.02). CONCLUSION: The intervention was not more effective than the self-help group at increasing accelerometer-measured total PA over 12 months. Both groups maintained PA from 6 to 12 months. Digital approaches have potential for promoting sustained PA participation in YACS, but additional research is needed to identify what strategies work for whom, and under what conditions.

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.

BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use. METHODS: As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment. DISCUSSION: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services. TRIAL REGISTRATION: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020.

Role, race, and place: Prostate cancer disparities in Patients' and Partners' health outcomes and psychosocial factors.

PURPOSE: This study aimed to examine the effects of participant role (patient vs. partner), race (white vs. non-white), and place (less vs. more neighborhood deprivation) on health outcomes (quality of life [QOL] and symptoms) and stress-coping-related psychosocial factors (appraisals of illness and coping resources). METHODS: This descriptive study included 273 patients and their partners (dyads) who transitioned from PCa treatment to self-management. We used established, psychometrically sound measures to assess health outcomes and psychosocial factors and conducted multilevel modeling analyses. RESULTS: Compared to partners, patients reported worse physical QOL; less frequent anxiety; less pain and fatigue; less bothersome hormonal problems; more bothersome urinary and sexual problems; greater self-efficacy; and more instrumental support. Compared to their white counterparts, non-white dyads reported better overall, emotional, and functional QOL; less depression; more positive appraisals, and greater self-efficacy. Compared to dyads in low ADI neighborhoods, dyads in high ADI (more deprived) neighborhoods reported worse social QOL; more bothersome urinary, sexual, and hormonal symptoms; and less interpersonal support. White patients reported the highest emotional support among all groups, while white partners reported the lowest emotional support. CONCLUSION: Our findings underscore the need to consider social determinants of health at multiple levels when investigating PCa disparities. Considering neighborhood-level socioeconomic factors, in addition to race and role, improves our understanding of the PCa disparities in QOL, symptoms, and psychosocial factors among patients and partners. Targeted multilevel supportive care interventions should tailor to the needs of racially diverse PCa patients and partners residing in deprived neighborhoods are needed.

Question prompt lists and caregiver question asking in pediatric specialty appointments: A randomized controlled trial.

OBJECTIVE: Question prompt lists (QPLs) have been effective at increasing patient involvement and question asking in medical appointments, which is critical for shared decision making. We investigated whether pre-visit preparation (PVP), including a QPL, would increase question asking among caregivers of pediatric patients with undiagnosed, suspected genetic conditions. METHODS: Caregivers were randomized to receive the PVP before their appointment (n = 59) or not (control, n = 53). Appointments were audio-recorded. Transcripts were analyzed to determine questions asked. RESULTS: Caregivers in the PVP group asked more questions (MeanPVP = 4.36, SDPVP = 4.66 vs. Meancontrol = 2.83, SDcontrol = 3.03, p = 0.045), including QPL questions (MeanPVP = 1.05, SDPVP = 1.39 vs. Meancontrol = 0.36, SDcontrol = 0.81, p = 0.002). Caregivers whose child had insurance other than Medicaid in the PVP group asked more total and QPL questions than their counterparts in the control group (ps = 0.005 and 0.002); there was no intervention effect among caregivers of children with Medicaid or no insurance (ps = 0.775 and 0.166). CONCLUSION: The PVP increased question asking but worked less effectively among traditionally underserved groups. Additional interventions, including provider-focused efforts, may be needed to promote engagement of underserved patients. PRACTICE IMPLICATIONS: Patient/family-focused interventions may not be beneficial for all populations. Providers should be aware of potential implicit and explicit biases and encourage question asking to promote patient/family engagement.

Diagnostic yield and psychological outcomes among women pursuing trio-exome sequencing: Do women with recurrent anomalous fetal phenotypes experience more negative psychological outcomes?

PURPOSE: To describe psychological outcomes among people with recurrent anomalous pregnancies pursuing trio-exome sequencing (exome sequencing (ES)) compared to those with one affected. METHODS: We analyzed data from a prospective ES cohort, enrolling patients with major fetal anomaly and normal microarray. Participants completed validated scales before and after ES. We (1) compared responses of those with multiple anomalous pregnancies to those with one affected and (2) conducted linear regression to examine associations between multiple affected pregnancies and post-ES constructs. RESULTS: Of 166 trios, 61 (37%) received results from ES. Forty (24%) had more than one affected pregnancy and 45% of those received a result explaining the fetal phenotype. All participants had clinically significant presequencing generalized psychological distress. For the 93 who completed the post-ES surveys, those with multiple affected pregnancies had higher psychological adaptation scores but worse test related distress scores (9.3 (6.2) versus 7.1(5.6), p = 0.12) and (14.3 (1.5) versus 15.4 (1.4), p = 0.01). In linear regression models, there were no significant differences in post-ES constructs after adjusting for clinically relevant covariates. CONCLUSIONS: All individuals experienced significant generalized psychological distress in the pre-ES period, extending our knowledge of how pregnancy history contributes to parental sequencing outcomes.

Motivating Weight Loss Among Black Adults in Relationships: Recommendations for Weight Loss Interventions.

BACKGROUND: Black men and women have the highest rates of obesity in the United States. Behavioral weight loss programs incorporating intimate partners may be effective in combating obesity among this population. Yet, current participation in these programs is low. Identifying motivations and triggers to weight loss may provide insight in designing programs to increase participation. AIM: To determine triggers and motivations for weight loss among Black men and women in committed relationships to inform development of weight loss interventions. METHOD: Twenty semi-structured interviews, based on an integrated theoretical framework of interdependence and communal coping and the social cognitive theory, were conducted among Black heterosexual couples where one or both individuals intentionally lost ≥5% of their body weight in the last 6 months in a metropolitan region in a southern state. Interviews were transcribed and coded. Themes were identified following multi-rater coding and direct and conventional content analysis. Recommendations were developed from emergent themes. RESULTS: Among individuals with recent weight loss, personal relevancy and awareness (health awareness and self-awareness) were identified as personal triggers for weight loss initiation. Health concerns and appearance were general motivations among the total sample. CONCLUSION: Emphasizing the impact of weight on daily functioning and quality of life, and increasing awareness of personal weight status and health consequences, may increase weight loss initiation and participation in weight loss programs among Black men and women in committed relationships. Findings also highlight strategies to improve recruitment and retention and guide intervention development and implementation for this population.

The Burden of COVID-19 on Caregivers of Children with Suspected Genetic Conditions: A Therapeutic Odyssey.

AIMS: Children with disabilities and rare or undiagnosed conditions and their families have faced numerous hardships of living during the COVID-19 pandemic. For those with undiagnosed conditions, the diagnostic odyssey can be long, expensive, and marked by uncertainty. We, therefore, sought to understand whether and how COVID-19 impacted the trajectory of children's care. METHODS: We conducted semi-structured qualitative interviews with 25 caregivers who, prior to the pandemic, were on a diagnostic odyssey for their children. RESULTS: Most caregivers did not report any interruptions to their child's diagnostic odyssey. The greatest impact was access to therapy services, including the suspension or loss of their child's in-person therapeutic care and difficulties with virtual therapies. This therapy gap caused caregivers to fear that their children were not making progress. CONCLUSION: Although much has been written about the challenges of diagnostic odysseys for children and their families, this study illustrates the importance of expanding the focus of these studies to include therapeutic odysseys. Because therapeutic odysseys continue regardless of whether diagnoses are made, future research should investigate how to support caregivers through children's therapies within and outside of the COVID-19 context.

Stem Cell Transplant Experiences Among Hispanic/Latinx Patients: A Qualitative Analysis.

BACKGROUND: Hispanic/Latinx (H/L) patients with cancer treated with stem cell transplant are vulnerable to adverse outcomes, including higher mortality. This study explored their unmet transplant needs, barriers, and facilitators. METHODS: Eighteen English- or Spanish-speaking H/L patients (M age = 59.2) who had a transplant in the past year were interviewed about their transplant experience and rated their interest in receiving information about transplant topics (0 = not at all to 10 = extremely). RESULTS: Content analysis revealed five main themes: (1) pre-transplant barriers and concerns; (2) complex relationships with medical teams; (3) informational mismatch; (4) impacts on daily life after transplant; and (5) methods of coping. Participants were most interested in information about ways of coping with transplant (M = 9.11, SD = 1.45) and words of hope and encouragement (M = 9.05, SD = 1.80). At just above the scale's midpoint, they were least interested in information about side effects and unintended consequences of transplant (M = 5.61, SD = 3.85). CONCLUSIONS: Cultural factors, social determinants, and structural inequalities give rise to unique needs in this growing patient population. Healthcare team members and researchers can better meet the needs of H/L transplant recipients through attention to described considerations, such as financial barriers, communication difficulties, family dynamics, and coping styles.

Effect of an mHealth intervention on physical activity outcomes among young adult cancer survivors: The IMPACT randomized controlled trial.

BACKGROUND: Physical inactivity is common in young adult cancer survivors (YACS), but evidence regarding effects of physical activity (PA) interventions among YACS is limited. The IMproving Physical Activity after Cancer Treatment (IMPACT) trial evaluated a theory-based mobile PA intervention on total PA minutes/week (primary) and secondary outcomes (moderate-to-vigorous PA [MVPA], light PA, steps, sedentary behaviors) at 6 months in YACS. METHODS: YACS (N = 280) were randomized to an intervention group or self-help group. All participants received digital tools (activity tracker, smart scale, access to arm-specific Facebook group) and an individual video chat session. Intervention participants also received a 6-month program with behavioral lessons, adaptive goal-setting, tailored feedback, tailored text messages, and Facebook prompts. PA was assessed via accelerometry and questionnaires at baseline and 6 months. Generalized estimating equation analyses tested between-group differences in changes over time. RESULTS: Of 280 YACS, 251 (90%) completed the 6-month accelerometry measures. Accelerometer-measured total PA minutes/week changed from 1974.26 at baseline to 2024.34 at 6 months in the intervention (mean change, 55.14 [95% CI, -40.91 to 151.19]) and from 1814.93 to 1877.68 in the self-help group (40.94 [95% CI, -62.14 to 144.02]; between-group p = .84). Increases in MVPA were +24.67 minutes/week (95% CI, 14.77-34.57) in the intervention versus +11.41 minutes/week in the self-help (95% CI, 1.44-21.38; between-group p = .07). CONCLUSION: Although the intervention did not result in significant differences in total PA, the increase in MVPA relative to the self-help group might be associated with important health benefits. Future research should examine moderators to identify for whom, and under what conditions, the intervention might be effective. CLINICALTRIALS: gov Identifier: NCT03569605. PLAIN LANGUAGE SUMMARY: Physical inactivity is common in young adult cancer survivors. However, few interventions have focused on helping young adult cancer survivors to get more physical activity. The IMproving Physical Activity after Cancer Treatment trial compared a mobile health physical activity intervention with a self-help group on total amount of physical activity at 6 months in a nationwide sample of young adult cancer survivors. Intervention participants did not improve their total amount of physical activity, but they did increase their moderate-to-vigorous intensity physical activity by twice as much as the self-help participants. This increase in activity may be associated with health benefits.