Breast cancer survivors with pain: an examination of the relationships between body mass index, physical activity, and symptom burden.

PURPOSE: Overweight and obesity are common for breast cancer survivors and associated with high symptom burden (i.e., pain, fatigue, depressive symptoms). Physical activity may protect breast cancer survivors with higher body mass indexes (BMI) from increased symptoms. However, the role of physical activity in buffering the relationship between higher BMI and greater symptoms is unclear. METHODS: Baseline data from a randomized trial investigating Pain Coping Skills Training among breast cancer survivors (N = 327) with pain were used to examine the relationship between self-reported BMI (kg/m2) and physical activity level (Rapid Assessment of Physical Activity; suboptimal vs. optimal) with pain (Brief Pain Inventory; severity and interference), fatigue (PROMIS-Fatigue short form), and depressive symptoms (Center for Epidemiological Studies Depression Scale). Analyses were conducted in SPSS. Hayes PROCESS macro (Model 1) assessed whether physical activity moderated the relationship between BMI and symptoms. RESULTS: Lower BMI (B = .06, p < .01) and optimal physical activity (B = - .69, p < .01) were independently associated with lower pain interference. Lower BMI was also associated with lower pain severity (B = .04, p < .001). Neither BMI nor physical activity was associated with fatigue or depressive symptoms. Physical activity did not moderate the relationship between BMI and symptoms. CONCLUSIONS: Among breast cancer survivors experiencing pain, higher BMI and being less physically active were related to greater pain (i.e., severity and/or interference). Physical activity did not buffer the relationships between BMI and pain, fatigue, and depressive symptoms, suggesting that physical activity alone may not be sufficient to influence the strength of the relationships between BMI and symptoms.

Cost-Effectiveness Analysis Evaluating Delivery Strategies for Pain Coping Skills Training in Women With Breast Cancer.

Pain coping skills training (PCST) is efficacious in patients with cancer, but clinical access is limited. To inform implementation, as a secondary outcome, we estimated the cost-effectiveness of 8 dosing strategies of PCST evaluated in a sequential multiple assignment randomized trial among women with breast cancer and pain (N = 327). Women were randomized to initial doses and re-randomized to subsequent doses based on their initial response (ie, ≥30% pain reduction). A decision-analytic model was designed to incorporate costs and benefits associated with 8 different PCST dosing strategies. In the primary analysis, costs were limited to resources required to deliver PCST. Quality-adjusted life-years (QALYs) were modeled based on utility weights measured with the EuroQol-5 dimension 5-level at 4 assessments over 10 months. A probabilistic sensitivity analysis was performed to account for parameter uncertainty. Implementation of PCST initiated with the 5-session protocol was more costly ($693-853) than strategies initiated with the 1-session protocol ($288-496). QALYs for strategies beginning with the 5-session protocol were greater than for strategies beginning with the 1-session protocol. With the goal of implementing PCST as part of comprehensive cancer treatment and with willingness-to-pay thresholds ranging beyond $20,000 per QALY, the strategy most likely to provide the greatest number of QALYs at an acceptable cost was a 1-session PCST protocol followed by either 5 maintenance telephone calls for responders or 5 sessions of PCST for nonresponders. A PCST program with 1 initial session and subsequent dosing based on response provides good value and improved outcomes. PERSPECTIVE: This article presents the results of a cost analysis of the delivery of PCST, a nonpharmacological intervention, to women with breast cancer and pain. Results could potentially provide important cost-related information to health care providers and systems on the use of an efficacious and accessible nonmedication strategy for pain management. TRIALS REGISTRATION: ClinicalTrials.gov: NCT02791646, registered 6/2/2016.

Geriatric Assessment Reveals Actionable Impairments in Hematopoietic Stem Cell Transplantation Candidates Age 18 to 80 Years.

Allogeneic hematopoietic stem cell transplantation (HCT) is a potentially curative treatment for both malignant and nonmalignant hematologic diseases; however, reported rates of treatment-related mortality approach 30%. Outcomes are worse in patients who begin HCT with functional impairments. To detect such impairments, a geriatric assessment (GA) is recommended in adults age ≥65 years. Younger HCT candidates also may be impaired because of chemotherapy regimens pre-HCT. Therefore, we hypothesized that GA can be beneficial for adult patients of all ages and subsequently created a clinical pretransplantation optimization program to assess all HCT candidates using a modified GA. One-hundred fifty-seven patients were evaluated in 4 functional domains- physical, cognitive, nutritional, and psychological-at 2 time points prior to HCT-new patient evaluation (NPE) and sign-off (SO)-between October 2017 and January 2020. At NPE, 80.9% of the patients had at least 1 domain with a functional impairment, and physical (P = .006), cognitive (P = .04), and psychological (P = .04) impairments were associated with an increased likelihood of not proceeding to HCT. In addition, patients age 18 to 39 years were more likely than older patients to have a physical function impairment (P = .001). Between NPE and SO, 51.9% of the patients had resolution of 1 or more impairments, and nutritional impairment at SO was predictive of worse overall survival (P = .01). Our study shows that GA can identify functional impairments in patients of all ages. Early identification of impairments could facilitate referrals to supportive care and resolution of impairments prior to HCT, suggesting that GA could be recommended for HCT candidates of all ages.

Social risk factors predicting outcomes of cervical myelopathy surgery.

OBJECTIVE: Combinations of certain social risk factors of race, sex, education, socioeconomic status (SES), insurance, education, employment, and one's housing situation have been associated with poorer pain and disability outcomes after lumbar spine surgery. To date, an exploration of such factors in patients with cervical spine surgery has not been conducted. The objective of the current work was to 1) define the social risk phenotypes of individuals who have undergone cervical spine surgery for myelopathy and 2) analyze their predictive capacity toward disability, pain, quality of life, and patient satisfaction-based outcomes. METHODS: The Cervical Myelopathy Quality Outcomes Database was queried for the period from January 2016 to December 2018. Race/ethnicity, educational attainment, SES, insurance payer, and employment status were modeled into unique social phenotypes using latent class analyses. Proportions of social groups were analyzed for demonstrating a minimal clinically important difference (MCID) of 30% from baseline for disability, neck and arm pain, quality of life, and patient satisfaction at the 3-month and 1-year follow-ups. RESULTS: A total of 730 individuals who had undergone cervical myelopathy surgery were included in the final cohort. Latent class analysis identified 2 subgroups: 1) high risk (non-White race and ethnicity, lower educational attainment, not working, poor insurance, and predominantly lower SES), n = 268, 36.7% (class 1); and 2) low risk (White, employed with good insurance, and higher education and SES), n = 462, 63.3% (class 2). For both 3-month and 1-year outcomes, the high-risk group (class 1) had decreased odds (all p < 0.05) of attaining an MCID score in disability, neck/arm pain, and health-related quality of life. Being in the low-risk group (class 2) resulted in an increased odds of attaining an MCID score in disability, neck/arm pain, and health-related quality of life. Neither group had increased or decreased odds of being satisfied with surgery. CONCLUSIONS: Although 2 groups underwent similar surgical approaches, the social phenotype involving non-White race/ethnicity, poor insurance, lower SES, and poor employment did not meet MCIDs for a variety of outcome measures. This finding should prompt surgeons to proactively incorporate socially conscience care pathways within healthcare systems, as well as to optimize community-based resources to improve outcomes and personalize care for populations at social risk.

Trajectories of fatigue in a population-based sample of older adult breast, prostate, and colorectal cancer survivors: an analysis using the SEER-MHOS data resource.

PURPOSE: Fatigue is one of the most common and distressing symptoms experienced by cancer survivors. Understanding fatigue trajectories from pre- to post-diagnosis could inform fatigue prevention and management strategies. METHODS: We used the Surveillance, Epidemiology and End Results Medicare Health Outcomes Survey (SEER-MHOS) linked data resource to characterize fatigue trajectories and their predictors 1214 older adult survivors of breast, colorectal, or prostate cancer. Fatigue was measured prior to the cancer diagnosis (T0) and at two timepoints after diagnosis (T1: mean = 20 months and T2: mean = 39 months post-diagnosis). Latent growth curve modeling and mixed effects models for repeated measurements were used to investigate fatigue experiences before and after a cancer diagnosis. RESULTS: Overall, mean fatigue T-scores declined (T0 = 50, T1 = 46, and T2 = 45) indicating worsening fatigue over time. Four latent trajectory subgroups were identified: severe fatigue worsening over time (8.2% of sample), severe fatigue persisting over time (14.4%), no fatigue pre-diagnosis and mild fatigue post-diagnosis (44.4%), and not fatigued (33%). Age, cancer stage, comorbidities, and depressed mood predicted membership in the two trajectory groups experiencing severe fatigue that persisted or that worsened post-diagnosis. Older age, advanced cancer stage at diagnosis, and depressed mood were significantly associated with worsening fatigue from T1 to T2 (all p < 0.0001). CONCLUSIONS: Evaluating cancer patients for depressive symptoms and considering prior fatigue levels, age, comorbid conditions, and cancer stage may help providers anticipate fatigue trajectories and implement pre-emptive strategies to lessen fatigue impact.

A System for Assessment of Canine-Human Interaction during Animal-Assisted Therapies.

Animal-assisted therapies (AAT) are becoming increasingly common to help hospitalized patients, especially in oncology units. There is a critical need for methods and technologies that can enable a quantifiable understanding of AAT to objectively demonstrate its efficacy and improve its efficiency. In this paper, we present our preliminary efforts towards the development of wireless sensor systems to simultaneously detect the related behavioral (activity level, movement, stroking) and physiological signals (heart rate/variability) of humans and animals during their interaction. To detect heart rate, we tested two different techniques based on wearable or contactless electrocardiography. In this preliminary evaluation, we were able to assess these parameters successfully and identify the design challenges towards deployment of these systems in larger clinical studies.

Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART.

BACKGROUND/AIMS: Pain is common in cancer patients and results in lower quality of life, depression, poor physical functioning, financial difficulty, and decreased survival time. Behavioral pain interventions are effective and nonpharmacologic. Traditional randomized controlled trials (RCT) test interventions of fixed time and dose, which poorly represent successive treatment decisions in clinical practice. We utilize a novel approach to conduct a RCT, the sequential multiple assignment randomized trial (SMART) design, to provide comparative evidence of: 1) response to differing initial doses of a pain coping skills training (PCST) intervention and 2) intervention dose sequences adjusted based on patient response. We also examine: 3) participant characteristics moderating intervention responses and 4) cost-effectiveness and practicality. METHODS/DESIGN: Breast cancer patients (N=327) having pain (ratings≥5) are recruited and randomly assigned to: 1) PCST-Full or 2) PCST-Brief. PCST-Full consists of 5 PCST sessions. PCST-Brief consists of one 60-min PCST session. Five weeks post-randomization, participants re-rate their pain and are re-randomized, based on intervention response, to receive additional PCST sessions, maintenance calls, or no further intervention. Participants complete measures of pain intensity, interference and catastrophizing. CONCLUSIONS: Novel RCT designs may provide information that can be used to optimize behavioral pain interventions to be adaptive, better meet patients' needs, reduce barriers, and match with clinical practice. This is one of the first trials to use a novel design to evaluate symptom management in cancer patients and in chronic illness; if successful, it could serve as a model for future work with a wide range of chronic illnesses.

Pain coping skills training for African Americans with osteoarthritis (STAART): study protocol of a randomized controlled trial.

BACKGROUND: African Americans bear a disproportionate burden of osteoarthritis (OA), with higher prevalence rates, more severe pain, and more functional limitations. One key barrier to addressing these disparities has been limited engagement of African Americans in the development and evaluation of behavioral interventions for management of OA. Pain Coping Skills Training (CST) is a cognitive-behavioral intervention with shown efficacy to improve OA-related pain and other outcomes. Emerging data indicate pain CST may be a promising intervention for reducing racial disparities in OA symptom severity. However, there are important gaps in this research, including incorporation of stakeholder perspectives (e.g. cultural appropriateness, strategies for implementation into clinical practice) and testing pain CST specifically among African Americans with OA. This study will evaluate the effectiveness of a culturally enhanced pain CST program among African Americans with OA. METHODS/DESIGN: This is a randomized controlled trial among 248 participants with symptomatic hip or knee OA, with equal allocation to a pain CST group and a wait list (WL) control group. The pain CST program incorporated feedback from patients and other stakeholders and involves 11 weekly telephone-based sessions. Outcomes are assessed at baseline, 12 weeks (primary time point), and 36 weeks (to assess maintenance of treatment effects). The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index, and secondary outcomes include self-efficacy, pain coping, pain interference, quality of life, depressive symptoms, and global assessment of change. Linear mixed models will be used to compare the pain CST group to the WL control group and explore whether participant characteristics are associated with differential improvement in the pain CST program. This research is in compliance with the Helsinki Declaration and was approved by the Institutional Review Boards of the University of North Carolina at Chapel Hill, Durham Veterans Affairs Medical Center, East Carolina University, and Duke University Health System. DISCUSSION: This culturally enhanced pain CST program could have a substantial impact on outcomes for African Americans with OA and may be a key strategy in the reduction of racial health disparities. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02560922 , registered 9/22/2015.

Pain catastrophizing in patients with noncardiac chest pain: relationships with pain, anxiety, and disability.

OBJECTIVE: To examine the contributions of chest pain, anxiety, and pain catastrophizing to disability in 97 patients with noncardiac chest pain (NCCP) and to test whether chest pain and anxiety were related indirectly to greater disability via pain catastrophizing. METHODS: Participants completed daily diaries measuring chest pain for 7 days before completing measures of pain catastrophizing, trait anxiety, and disability. Linear path model analyses examined the contributions of chest pain, trait anxiety, and catastrophizing to physical disability, psychosocial disability, and disability in work, home, and recreational activities. RESULTS: Path models accounted for a significant amount of the variability in disability scales (R(2) = 0.35 to 0.52). Chest pain and anxiety accounted for 46% of the variance in pain catastrophizing. Both chest pain (beta = 0.18, Sobel test Z = 2.58, p < .01) and trait anxiety (beta = 0.14, Sobel test Z = 2.11, p < .05) demonstrated significant indirect relationships with physical disability via pain catastrophizing. Chest pain demonstrated a significant indirect relationship with psychosocial disability via pain catastrophizing (beta = 0.12, Sobel test Z = 1.96, p = .05). After controlling for the effects of chest pain and anxiety, pain catastrophizing was no longer related to disability in work, home, and recreational activities. CONCLUSIONS: Chest pain and anxiety were directly related to greater disability and indirectly related to physical and psychosocial disability via pain catastrophizing. Efforts to improve functioning in patients with NCCP should consider addressing pain catastrophizing.