Donovan, Kristine A.

Importance Young adults (YAs; ages 18-39 years) diagnosed with cancer face unique psychosocial challenges, including high distress and poor health-related quality of life (HRQOL). There are few efficacious interventions tailored to their needs. Objective To evaluate the efficacy of Bright IDEAS-YA, a problem-solving skills training intervention tailored for YAs, in reducing distress and improving HRQOL. Design, Setting, and Participants This randomized clinical trial was conducted at 3 academic medical centers and enrolled participants between February 2021 and March 2024. Eligible participants were aged 18 to 39 years, within 4 months of a first cancer diagnosis, and undergoing systemic therapy. Participants completed surveys at baseline and 3, 6, 12, and 24 months. Intervention Bright IDEAS-YA is a 6-session, one-on-one intervention that teaches a structured approach to problem-solving. Enhanced usual care (EUC) included standard psychosocial care plus a list of adolescent and YA resources. Main Outcomes and Measures Primary outcomes were depression and anxiety (Patient-Reported Outcomes Measurement Information System Short Forms) and HRQOL (Functional Assessment of Cancer Therapy-General) at 6 months. Problem-solving ability (Social Problem-Solving Inventory-Revised Short Form) was examined as a mediator. Analyses used linear mixed effects models and mediation analysis. Results Of the 1128 YAs screened, 344 YAs (median [IQR] age, 31.27 [25.78-36.38] years; 251 female [62.5%]) enrolled, with 171 allocated to intervention and 173 allocated to control. Overall, 296 YAs (86.0%) and 280 YAs (81.4%) completed 3- and 6-month surveys, respectively. At 6 months, the intervention group showed significantly greater improvements than EUC in depression (effect size estimate, −3.23 points; 95% CI, −4.93 to −1.53 points; P < .001), anxiety (effect size estimate,−2.43 points; 95% CI, −4.05 to −0.81 points; P = .003), and HRQOL (effect size estimate, 3.40 points; 95% CI, 0.34 to 6.45 points; P = .03). These changes were clinically meaningful. Mediation analyses showed that improvements in depression and anxiety were partially due to increased problem-solving ability, particularly reductions in negative problem orientation. Sex and education were moderators of treatment effect, with the treatment effect on anxiety being greater for males (effect size estimate, −5.29 points; 95% CI, −7.97 to −2.60 points) and the treatment effect on anxiety (effect size estimate, −6.94 points; 95% CI, −10.50 to −3.43 points) and depression (effect size estimate, −7.47 points; 95% CI, −11.20 to −3.74 points; P < .001) being greater for those with lower education. Conclusions and Relevance In this randomized clinical trial of Bright IDEAS-YA, intervention participants had significantly reduced distress and improved HRQOL relative to control. These findings suggest that Bright IDEAS-YA may be offered as supportive care for YAs with cancer to improve psychosocial outcomes. Trial Registration ClinicalTrials.gov Identifier: NCT04585269

Abstract Background Breast cancer (BC) survivors frequently experience sleep disturbances, which may persist for many years after treatment. This study aimed to describe trends in sleep-related symptoms over time and identify factors that may be associated with sleep disturbances in BC survivors. Patients and Methods Adult patients from the Mayo Clinic Breast Disease Registry were surveyed annually for up to 7 years post-diagnosis. Sleep disturbance severity was assessed using numeric rating scales for difficulty falling and staying asleep. Data from 3354 unique patients were analyzed, excluding those with metastatic disease or recurrence. Univariable and multivariable analyses were performed at the 1-year survey timepoint to evaluate disease and patient-related factors that were associated with increased sleep-related symptoms, and these factors were also assessed in relationship to sleep-related symptoms over time. Results In multivariable analyses, more trouble falling asleep was associated with financial insecurity, higher clinical stage, more cigarettes smoked per day, and less weekly exercise. More trouble staying asleep was associated with older age, race, advanced education, financial insecurity, and higher clinical stage. Over time, there was a nonsignificant trend toward increased trouble falling asleep and fluctuations in trouble staying asleep. Higher clinical stage and receipt of radiotherapy were associated with decreased severity in trouble falling asleep over time, while more cigarettes smoked per day was linked to increased severity in trouble staying asleep. Conclusions These findings highlight the complex interplay of clinical, lifestyle, and demographic factors in sleep disturbances among BC survivors, underscoring the need for tailored sleep management strategies.

ABSTRACTObjectiveTo conduct an economic evaluation of a group mindfulness program compared to an education support program for breast cancer survivors (BCS).MethodsThe cost‐utility analysis (cost per quality‐adjusted life year [QALY]) was performed from a single‐center randomized controlled trial in the United States. Data from 181 BCS were included in the analysis (91 from the mindfulness‐based stress reduction for breast cancer, MBSR(BC) and 90 from the Breast Cancer Education Support, (BCES)). Analyses were conducted from two perspectives: societal and healthcare system. The EuroQol EQ‐5D‐5L was used to measure quality of life and the Client Service Receipt Inventory (CSRI) was used to measure health services utilization from baseline through 26 weeks. The impact of MBSR(BC) on health services utilization and costs was estimated with generalized linear models.ResultsIn the reference case analyses (societal perspective), the average total cost in the MBSR(BC) group was $5744 compared with $6140 in the BCES group. At the end of follow‐up, the MBSR(BC) group dominated BCES in terms of Incremental Cost Utility Ratio (ICUR), with MBSR(BC) providing an incremental cost of −$541 (95% CI: −$3400, $2318) and a 0.021 QALY (95% CI: −0.014, 0.055). Net monetary benefit (NMB) analysis showed that MBSR(BC) has a higher probability of achieving positive NMB across a range of possible societal willingness‐to‐pay for improving quality of life.ConclusionsOur findings suggest that MBSR(BC) is likely to be cost‐effective for breast cancer survivors over 6 months. Cost savings primarily resulted from reduced ER and hospital admissions and tests.

Abstract Background Despite 40 years of evidence supporting psychosocial interventions as a component of comprehensive cancer care, patients continue to report vast unmet psychosocial needs and distress. Cognitive behavioral therapies for cancer distress (CBT-C) are the most rigorously tested class of psychosocial interventions for cancer care. Purpose To report clinical effectiveness outcomes of cancer-related distress and self-efficacy following implementation of best-evidence CBT-C, adapted for a real-world, billable practice setting. Methods Patients who completed group-delivered, CBT-C (10 intervention hours, 5 sessions) in the practice setting were invited to enroll in a research study to document cancer distress across the year following CBT-C. Participants (n = 65) were primarily middle-aged (mean 50.5 years, 17% were young adults ≤40 years), female, and White. Analyses utilized mixed linear models with intent-to-treat procedures. Given group delivery and social skills training content within CBT-C, social self-efficacy was assessed as a potential treatment mechanism. Results Distress decreased across the year following CBT-C (mean score change of 20 points for YAs, 6 points for non-YAs), with statistically significant age x time effects. Within-person improvements in social self-efficacy scores were related to reductions in cancer distress, including distress subscales of intrusive thoughts, avoidant coping, and hyperarousal. The model explained 76.6% of the total variance in cancer distress. Conclusions This study demonstrates the effective translation of CBT-C from controlled research trials to the practice setting. CBT-C effectiveness within a mixed-cancer population and relatively rural region of the US is also supported. CBT-C can be effectively translated to the practice settings for which it is intended.

12005 Background: Young adults (YAs) diagnosed with cancer between the ages of 18 and 39 face unique psychosocial challenges and are at risk of experiencing significant emotional distress and poor health-related quality of life (HRQOL). This randomized trial evaluated the efficacy of Bright IDEAS-YA, a problem-solving skills training intervention, on reducing distress and improving HRQOL of YAs newly diagnosed with cancer. A secondary aim examined change in problem-solving ability as a potential mediator of treatment effects. Methods: A three-site randomized trial of Bright IDEAS-YA compared with enhanced usual care (EUC) enrolled YA survivors within four months of a first diagnosis of cancer. Participants were randomized 1:1 to Bright IDEAS-YA or EUC (NCT04585269). Bright IDEAS-YA is a 6-session, one-on-one intervention that teaches a systematic approach to overcome personal challenges across any life domain. EUC involved usual psychosocial care plus AYA resources. Participants completed surveys at 0 (baseline), 3, 6, 12, and 24 months, with 6 months as the primary endpoint. Validated measures included the PROMIS Depression Short Form and Anxiety Short Form (primary outcomes), the Functional Assessment of Cancer Therapy – General (FACT-G; primary outcome), and Social Problem-Solving Inventory-Revised Short Form (SPSI-R; mediator). Efficacy was tested using linear mixed effects models, run in R, examining the group x time interaction effects. Mediation was tested using the R multiple mediation analysis. Results: 344 YA (34.2% acceptance rate, M age = 30.3 years, SD = 6.3; 63% female, 37% male, < 1% non-binary) participated (100% planned enrollment), with 86% and 81% completing surveys at 3 and 6 months, respectively. Compared to baseline, the intervention arm showed statistically significant improvements in depression, anxiety, and HRQOL relative to the control group at 6 months. The intervention arm demonstrated an average reduction of 3.2 T-score points reduction in depression (95% CI [-4.9, -1.5], p < 0.001), 2.4 T-score points in anxiety (95% CI [-4.0, -0.81], p = 0.003), and 3.4 points improvement in total FACT-G (95% CI [0.34, 6.5], p = 0.029) relative to the control. These differences reflect clinically meaningful changes per published reports. Across all three models, change in total problem-solving ability (SPSI-R) was shown to mediate treatment effects, primarily due to change in the negative problem-orientation subscale. Conclusions: Bright IDEAS-YA was efficacious in reducing symptoms of depression and anxiety and improving HRQOL compared with enhanced usual care among YAs with cancer. Improvements are attributable to increased problem-solving ability, particularly by reducing the tendency to view problems as significant threats and doubt one’s ability to successfully solve problems. Clinical trial information: NCT04585269 .

12083 Background: Fatigue and sleep disturbance are prevalent during and after cancer treatment; sleep-related symptoms affect 30-50% of patients with cancer, and sleep-wake disruptions persist beyond the immediate post-surgical period in breast cancer (BC) survivors. Identifying demographic- and treatment-related factors associated with sleep-related symptoms during survivorship is critical to inform interventions for those at highest risk of sleep disturbance. Methods: Patients who were seen at least once at Mayo Clinic Rochester following an initial diagnosis of BC at age 18 or older and provided informed consent were prospectively enrolled in the Mayo Clinic Breast Disease Registry. Surveys mailed to this cohort included two 11-point numeric rating scale questions regarding difficulty falling asleep and staying asleep in the past week, with values for each ranging from 0 (no problem) to 10 (as severe as you can imagine). Participants who provided sleep-related information on the Year 1 survey (answered approximately one year after cancer diagnosis) were included. Participants were excluded if they had clinical or pathologic metastatic disease and/or recurrence prior to the Year 1 survey. Associations of sleep-related symptoms with demographic and clinical characteristics were assessed using multivariate linear regression models, fitting the sleep difficulty rating scale as the outcome and clinical and demographic factors as exposures. Results: In total, 3,354 participants met inclusion criteria. The average age at BC diagnosis was 59, and most participants were female (99.3%), White (95.4%), non-Hispanic (96.2%), married (78.1%), had at least some college education (80.4%), did not report financial insecurity (76.2%), did not consume alcohol (60.6%) or smoke tobacco (93.2%), and reported at least some weekly exercise (76,6%). Sixty-two percent of participants had clinical stage 0 or I disease; 50.3% underwent lumpectomy (not mastectomy), 59.2% received radiotherapy, 34.1% received chemotherapy, and 67.2% received endocrine therapy. Overall, sleep-related symptoms were relatively low (mean rating for falling asleep = 2.1, mean rating for staying asleep = 3.1). In multivariate analyses, more difficulty falling asleep was associated with higher clinical stage (p < 0.001), more cigarettes smoked per day (p = 0.012), less moderate and/or strenuous exercise (p = 0.001), and more financial hardship (p < 0.001). More difficulty staying asleep was associated with higher clinical stage (0.003), older age (p < 0.001), more education (p = 0.011), and more financial hardship (p < 0.001). Conclusions: In our cohort of BC survivors, factors associated with both increased difficulty with falling and staying asleep at one year after diagnosis are higher clinical stage and more financial hardship. Future research should explore the course of these symptoms over time and across varied treatment trajectories.

This study aimed to explore contextual elements of the cancer experience that are consistently distressing and/or psychologically traumatic, as well as explore perceptions of Accelerated Resolution Therapy® (ART®) and its influence on the cancer experience. Using a qualitative descriptive design, semi-structured interviews were completed by 12 participants following the completion of ART. Interview data were analyzed using content analysis to identify major themes and patterns. Four themes included: (a) Cancer as the straw that broke the camel’s back, (b) ART® is different from previous therapy, (c) Don’t need to always be looking in the rearview mirror, and (d) Importance of early psychological intervention. Participants perceived that ART® was different and potentially more effective than other types of therapy they had previously received. Results support the diagnosis of cancer and the cumulative effects of previous life events and cancer-related stressors as traumatic events.

ABSTRACTBackgroundAn estimated one‐third of cancer survivors suffer from post‐traumatic stress (PTS) symptoms. PTS is associated with high levels of cancer distress, anxiety, and depression. Few evidence‐based treatments are available for PTS. Accelerated Resolution Therapy (ART) is a form of trauma‐focused psychological therapy that has been found to be both safe and effective at alleviating post‐traumatic stress symptoms, psychological distress, anxiety and depressive symptoms in non‐cancer populations.MethodsThe purpose of this single arm, pilot study was to examine the preliminary efficacy of ART for alleviating post‐traumatic stress symptoms, cancer distress, depressive symptoms and anxiety among cancer survivors, as well as to evaluate baseline characteristics of persons most likely to respond to ART. Participants were provided with five ART sessions and outcome variables were assessed at enrollment, immediately following ART, and 30 days post ART. Paired t‐tests were used to examine differences between scores at each time point. Associations between the PCL‐5 score from baseline to post 30‐day visit were assessed and other variables were examined using univariate linear regression.ResultsIn a sample of 20 cancer survivors, statistically significant decreases in PTS symptoms (p < 0.0001), cancer distress (p < 0.0001), anxiety (p = 0.0002), and depression (p < 0.0001) from pre to post intervention were present. These improvements remained 30 days post‐intervention. Higher baseline PCL‐5 scores, as well as higher scores on two subscales of the cancer distress measure were associated with response to treatment.ConclusionsFindings suggest that ART is an effective therapeutic intervention for reducing PTS symptoms and cancer distress among cancer survivors.

Introduction: The Mindfulness-Based Stress Reduction program for breast cancer survivors (MBSR [BCs]) is a stress-reducing program designed to increase cognitive functioning through four meditational practices. This randomized clinical trial aimed to determine if improvements in cognitive functioning and perceived cognitive abilities achieved from the MBSR(BC) were mediated through increased mindfulness, decreased rumination, and decreased perceived stress. Methods: Breast cancer survivors (BCSs) who met inclusion criteria of stage I, II, or III BC and received either chemotherapy (CT) or both CT and radiation were randomized to either the 6-week MBSR(BC), or Breast Cancer Education Support (BCES) program, or to a usual care (UC) regimen. Analysis of covariance was first implemented to identify potential mediators, followed by a formal mediational analysis to evaluate the effects of MBSR(BC) on 6-, 12-, and 26-week outcomes. Results: After consent, 212 BCS were randomized to MBSR(BC) ( n = 91), BCES ( n = 90), or UC ( n = 31). The mean age was 56.5 and the majority of the BCS, 73.1%, were White and non-Hispanic. Results showed increases in “observing” as part of mindfulness as a potential mediator of MBSR(BC) effects on impairments on quality of life and logical memory at 6 months relative to UC. No mediation effects were identified for outcomes measured at 6 or 12 weeks and also when MBSR(BC) was compared with the BCES program. Discussion: These results partially supported our hypothesis that improvement in cognitive functioning would occur through increased mindfulness. Although few mediating relationships were identified, results showed a relationship between mindfulness and cognitive functioning. Both mediating relationships occurred through increases in “observing,” a subconcept of “mindfulness,” when compared to the MBSR(BC) with UC at 6 months. This study shows that mediators may help “optimize” clinical therapeutic treatment effects, thus contributing to the advancement of science. Trial Registration: ClinicalTrials.gov, www.ClinicalTrials.gov . Registration Number: NCT02786797.