Implementing a Clinical Pathway for Needs Assessment and Supportive Care Interventions.

Despite advances in clinical cancer care, cancer survivors frequently report a range of persisting issues, unmet needs, and concerns that limit their ability to participate in life roles and reduce quality of life. Needs assessment is recognized as an important component of cancer care delivery, ideally beginning during active treatment to connect patients with supportive services that address these issues in a timely manner. Despite the recognized importance of this process, many health care systems have struggled to implement a feasible and sustainable needs assessment and management system. This article uses an implementation science framework to guide pragmatic implementation of a needs assessment clinical system in cancer care. According to this framework, successful implementation requires four steps including (1) choosing a needs assessment tool; (2) carefully considering the provider level, clinic level, and health care system-level strengths and barriers to implementation and creating a pilot system that addresses these factors; (3) making the assessment system actionable by matching needs with clinical workflow; and (4) demonstrating the value of the system to support sustainability.

Trends and predictors of Quality of Life in lung cancer survivors.

INTRODUCTION: Health-related quality of life (HR-QoL) is often impaired in lung cancer survivors. To inform personalized survivorship care, we identified associations between HR-QoL scores and patient-, tumor-, and treatment-factors over time. MATERIALS AND METHODS: We evaluated HR-QoL scores provided at diagnosis, 6 months, 1 year, and 2 years from the Yale Lung Cancer Biorepository. HR-QoL was measured via the Functional Assessment of Cancer Therapy - Lung (FACT-L) instrument and available for a subset of patients (n = 513). Analyses were stratified by early-stage (I-II; n = 355) non-small cell lung cancer (NSCLC), advanced stage NSCLC (III-IV; n = 158), and small cell lung cancer (SCLC, n = 21). We used mixed effects modeling and multivariable analysis with covariate adjustment to examine changes in FACT-L from diagnosis to follow-up. Sensitivity analysis was performed including patients with early-stage disease and complete FACT-L scores at both baseline and year 2 (n = 91). RESULTS: The average FACT-L scores at diagnosis in early-stage NSCLC, advanced stage NSCLC, and SCLC were 121.0 (standard deviation (SD) 11.4), 109.2 (18.7), and 98.7 (20.2) respectively. At all timepoints, HR-QoL was higher in patients with early-stage NSCLC (vs advanced-stage disease). In patients with early- and advanced-stage NSCLC, HR-QoL was higher at years 1 and 2 than at diagnosis, though the changes did not meet clinical significance. At NSCLC diagnosis, higher HR-QoL was associated with older age, better performance status, participating in physical activity, adenocarcinoma histology, and (in advanced stage NSCLC) anticipated treatment with chemotherapy. At NSCLC follow-up, HR-QoL was higher in patients with higher BMI and better performance status. DISCUSSION: In patients with newly diagnosed NSCLC, HR-QoL scores are impacted by patient factors, tumor factors, and treatment factors. HR-QoL is higher in patients with early-stage disease. In patients surviving 2 years, HR-QoL was higher at follow-up, though the change did not meet clinical significance. To optimize HR-QoL, lung cancer survivorship teams should prioritize comorbidity management, physical activity, healthy weight maintenance, and treatment-related side effects.

Roadmap for Connecting Cancer Rehabilitation With Survivorship to Improve Patient Outcomes and Clinical Efficiency.

ABSTRACT: An evolved model of comprehensive cancer care is needed that begins at cancer diagnosis to proactively manage cancer treatment toxicities and optimize patient health, function, and well-being. Building new care models requires connecting oncology, primary care, and specialized clinicians from many disciplines including cancer rehabilitation. Having a vision for an evolved standard of comprehensive cancer care is a requirement, but it is not enough to bring an innovative clinical program to life and sustain it over the long term. To inform the development of new clinical programs, two example programs are presented that successfully integrate cancer rehabilitation services along with details of a three-step process these programs used to facilitate their success and build robust business models that ensure their sustainability. Following the roadmap for growth presented here, gaining input from stakeholders and ensuring their buy-in, leveraging existing programmatic priorities, as well as developing a strategic growth plan can help clinical innovators ensure that new programs anticipate and continually meet the needs of oncology, primary care, subspecialty care, and programs, while addressing the business needs of administrators and improving the experience for patients.

Depression, Inflammation, and Intestinal Permeability: Associations with Subjective and Objective Cognitive Functioning throughout Breast Cancer Survivorship.

About one-in-three breast cancer survivors have lingering cognitive complaints and objective cognitive impairment. Chronic inflammation and intestinal permeability (i.e., leaky gut), two risk factors for cognitive decline, can also fuel depression-another vulnerability for cognitive decline. The current study tested whether depression accompanied by high levels of inflammation or intestinal permeability predicted lower subjective and objective cognitive function in breast cancer survivors. We combined data from four breast cancer survivor studies (n = 613); some had repeated measurements for a total of 1015 study visits. All participants had a blood draw to obtain baseline measures of lipopolysaccharide binding protein-a measure of intestinal permeability, as well as three inflammatory markers that were incorporated into an inflammatory index: C-reactive protein, interleukin-6, and tumor necrosis factor-α. They reported depressive symptoms on the Center for Epidemiological Studies depression scale (CES-D), and a binary variable indicated clinically significant depressive symptoms (CES-D ≥ 16). The Kohli (749 observations) and the Breast Cancer Prevention Trial (591 observations) scales assessed subjective cognitive function. Objective cognitive function tests included the trail-making test, Hopkins verbal learning test, Conners continuous performance test, n-back test, FAS test, and animal-naming test (239-246 observations). Adjusting for education, age, BMI, cancer treatment type, time since treatment, study visit, and fatigue, women who had clinically elevated depressive symptoms accompanied by heightened inflammation or intestinal permeability reported poorer focus and marginally poorer memory. However, poorer performance across objective cognitive measures was not specific to inflammation-associated depression. Rather, there was some evidence of lower verbal fluency; poorer attention, verbal learning and memory, and working memory; and difficulties with visuospatial search among depressed survivors, regardless of inflammation. By themselves, inflammation and intestinal permeability less consistently predicted subjective or objective cognitive function. Breast cancer survivors with clinically significant depressive symptoms accompanied by either elevated inflammation or intestinal permeability may perceive greater cognitive difficulty, even though depression-related objective cognitive deficits may not be specific to inflammation- or leaky-gut-associated depression.

The Evaluation and Management of Visceral Complications in Radiation Fibrosis Syndrome Part 1.

Abstract: External beam ionizing radiation is a fundamental component of cancer treatment and is incorporated into approximately 50% of cancer treatments. Radiation therapy causes cell death directly by apoptosis and indirectly by disruption of mitosis. Purpose of Review: This study aims to inform rehabilitation clinicians of the visceral toxicities of radiation fibrosis syndrome and how to detect and diagnose these complications. Recent Findings: Latest research indicates that radiation toxicity is primarily related to radiation dose, patient co-morbidity, and concomitant use of chemotherapies and immunotherapies for the treatment of cancer. While cancer cells are the primary target, surrounding normal cells and tissues are also affected. Radiation toxicity is dose dependent, and tissue injury develops from inflammation that may progress to fibrosis. Thus, radiation dosing in cancer therapy is often limited by tissue toxicity. Although newer radiotherapeutic modalities aim to limit delivery of radiation to non-cancerous tissues, many patients continue to experience toxicity. Summary: To ensure early recognition of radiation toxicity and fibrosis, it is imperative that all clinicians are aware of the predictors, signs, and symptoms of radiation fibrosis syndrome. Here, we present part 1 of the visceral complications of radiation fibrosis syndrome, addressing radiation-related toxicity in the heart, lungs, and thyroid gland.

Embracing Complexity-the Role of Cancer Rehabilitation in Restoring and Maintaining Function and Quality of Life in Cancer Survivors with Radiation Fibrosis Syndrome.

Purpose of Review: Despite more than 6 decades of growth and transformation, the field of cancer rehabilitation has considerable room to evolve if it is to live up to its full potential. This article will discuss the importance of this evolution in the context of radiation late effects and serve as a call for the clinical and operational expansion of the field so that it can become a key component of comprehensive cancer care. Recent Findings: The clinical and operational challenges inherent in cancer survivors with radiation late effects necessitate different thinking with respect to how rehabilitation professionals evaluate and manage patients as well as how our institutions equip these professionals to practice at the highest possible level. Summary: To achieve its promise, the field of cancer rehabilitation must evolve to embrace fully the scope, scale, and complexity of issues faced by cancer survivors with radiation late effects. Better engagement and coordination of the care team are needed to deliver this care and ensure our programs are robust, sustainable, and flexible.

The effect of a multi-component behavior change technique intervention on physical activity among individuals on primary prevention statin therapy: A dose-finding trial protocol.

BACKGROUND: Statin therapy is a mainstay of cardiovascular disease (CVD) prevention, but research shows that statin therapy alone is insufficient for preventing incident CVD and mortality. Combining statin medication with increased physical activity (PA) can lower mortality risk more than either statin or PA alone. However, PA levels often remain the same and may even decline following statin prescription. Additional information is needed to identify how to increase PA among statin users and determine the minimal length of an intervention (i.e., intervention dose) necessary to increase PA. OBJECTIVE: The study aims to identify the required dose of a behavior change technique (BCT) intervention to increase PA among individuals on primary prevention statin therapy who have an elevated risk for cardiovascular disease (CVD). METHODS: The study will utilize the modified time-to-event continual reassessment method (TiTE-CRM) in 42 participants. We expect insights relating to dose-efficacy models and BCTs (Behavior Change Techniques) to improve PA in adults at risk for CVD. This trial will also examine potential mechanisms of action (MoAs) for interventions to increase PA, identify any effect a PA intervention may have on medication adherence, and determine whether participants respond uniformly to their respective behavioral interventions. ETHICS AND DISSEMINATION: This trial was approved by the Northwell Health Institutional Review Board (IRB) and all participants will complete informed consent. The trial results will be published in a peer-reviewed journal. All publications resulting from this series of personalized trials will follow the CONSORT reporting guidelines. REGISTRATION DETAILS: This trial is registered on www. CLINICALTRIALS: gov (Number NCT05273723).

Primary care providers' comfort in caring for cancer survivors: Implications for risk-stratified care.

Personalized, risk-stratified care aims to "right size" the involvement of primary care providers (PCPs), oncology and specialized practitioners in caring for cancer survivors. Our survey found limited comfort among PCPs in cancer surveillance and management of treatment-related effects. In hypothetical case scenarios, PCPs reported least comfort in caring for a survivor of childhood cancer, followed by young adult-onset cancer, and greater comfort in caring for a survivor of adult-onset breast cancer. While education and training of PCPs is essential, risk-stratification strategies need to identify patients who may transition to primary care and those who may require ongoing survivorship-focused follow-up.

Engaging TEAM Medicine in Patient Care: Redefining Cancer Survivorship From Diagnosis.

New approaches to cancer survivorship care must address the rising number of survivors who need complex care; the need to personalize care to improve health equity; workforce shortages and clinician knowledge deficits about the long-term and late effects of cancer; the need to engage and coordinate oncology, primary care, and a large multidisciplinary team of subspecialists and programs to meet survivors' needs; and the need to control costs and deliver better value. This review proposes eight core tenets of an evolved standard of care to meet these needs by starting at diagnosis and continuing throughout oncology and into follow-up to: (1) facilitate team medicine by connecting oncology, primary care, subspecialists and programs, researchers, and patients and caregivers; (2) educate patients and support them in self-management; (3) mitigate toxicities; (4) manage comorbidities; (5) promote healthy behaviors and wellness; (6) improve health equity; (7) provide clear personalized follow-up; and (8) provide ongoing opportunities for participation in research as the standard of care. Strategies to successfully implement this care are discussed from the perspectives of oncology, primary care, and health care administration.

Depression and anxiety in colorectal cancer patients: Ties to pain, fatigue, and inflammation.

OBJECTIVE: Colorectal cancer poses a significant threat to both psychological and physical health. This study examined relationships between anxiety and depressive symptoms with pain, fatigue, and inflammation among colorectal patients. METHODS: Colorectal cancer patients (n = 88, stages 0-IV) completed a laboratory-based study visit before undergoing adjuvant cancer treatment. Patients completed questionnaires assessing depressive, anxiety, pain, and fatigue symptoms. A blood sample was also collected to measure c-reactive protein (CRP). Analyses controlled for age, sex, cancer stage, body mass index (BMI), and menopause status. RESULTS: Multiple linear regression analyses showed colorectal patients with higher depressive and anxiety symptoms had greater pain, fatigue, and CRP (ps < 0.03). Approximately one-third of patients with clinically significant depressive (CESD >16) and anxiety symptoms (BAI >16) also had clinically-elevated levels of CRP (>3 mg/L) (ps = 0.02). CONCLUSION: These results extend findings from other cancer subgroups showing heightened symptom burden among patients with depression and anxiety. They also highlight the detrimental role that elevated anxiety and depressive symptoms may play in the physical and biological side effects associated with colorectal cancer.

Exercise, Diet, and Weight Management During Cancer Treatment: ASCO Guideline.

PURPOSE: To provide guidance on exercise, diet, and weight management during active cancer treatment in adults. METHODS: A systematic review of the literature identified systematic reviews and randomized controlled trials evaluating the impact of aerobic and resistance exercise, specific diets and foods, and intentional weight loss and avoidance of weight gain in adults during cancer treatment, on quality of life, treatment toxicity, and cancer control. PubMed and the Cochrane Library were searched from January 2000 to May 2021. ASCO convened an Expert Panel to review the evidence and formulate recommendations. RESULTS: The evidence base consisted of 52 systematic reviews (42 for exercise, nine for diet, and one for weight management), and an additional 23 randomized controlled trials. The most commonly studied types of cancer were breast, prostate, lung, and colorectal. Exercise during cancer treatment led to improvements in cardiorespiratory fitness, strength, fatigue, and other patient-reported outcomes. Preoperative exercise in patients with lung cancer led to a reduction in postoperative length of hospital stay and complications. Neutropenic diets did not decrease risk of infection during cancer treatment. RECOMMENDATIONS: Oncology providers should recommend regular aerobic and resistance exercise during active treatment with curative intent and may recommend preoperative exercise for patients undergoing surgery for lung cancer. Neutropenic diets are not recommended to prevent infection in patients with cancer during active treatment. Evidence for other dietary and weight loss interventions during cancer treatment was very limited. The guideline discusses special considerations, such as exercise in individuals with advanced cancer, and highlights the critical need for more research in this area, particularly regarding diet and weight loss interventions during cancer treatment.Additional information is available at www.asco.org/supportive-care-guidelines.

Improved models of care for cancer survivors.

The number of survivors of cancer is increasing substantially. Current models of care are unsustainable and fail to address the many unmet needs of survivors of cancer. Numerous trials have investigated alternate models of care, including models led by primary-care providers, care shared between oncology specialists and primary-care providers, and care led by oncology nurses. These alternate models appear to be at least as effective as specialist-led care and are applicable to many survivors of cancer. Choosing the most appropriate care model for each patient depends on patient-level factors (such as risk of longer-term effects, late effects, individual desire, and capacity to self-manage), local services, and health-care policy. Wider implementation of alternative models requires appropriate support for non-oncologist care providers and endorsement of these models by cancer teams with their patients. The COVID-19 pandemic has driven some changes in practice that are more patient-centred and should continue. Improved models should shift from a predominant focus on detection of cancer recurrence and seek to improve the quality of life, functional outcomes, experience, and survival of survivors of cancer, reduce the risk of recurrence and new cancers, improve the management of comorbidities, and reduce costs to patients and payers. This Series paper focuses primarily on high-income countries, where most data have been derived. However, future research should consider the applicability of these models in a wider range of health-care settings and for a wider range of cancers.

Social Determinants of Health, Race, and Diabetes Population Health Improvement: Black/African Americans as a Population Exemplar.

PURPOSE OF REVIEW: To summarize evidence of impact of social determinants of health (SDOH) on diabetes risk, morbidity, and mortality and to illustrate this impact in a population context. RECENT FINDINGS: Key findings from the American Diabetes Association's scientific review of five SDOH domains (socioeconomic status, neighborhood and physical environment, food environment, health care, social context) are highlighted. Population-based data on Black/African American adults illustrate persisting diabetes disparities and inequities in the SDOH conditions in which this population is born, grows, lives, and ages, with historical contributors. SDOH recommendations from US national committees largely address a health sector response, including health professional education, SDOH measurement, and patient referral to services for social needs. Fewer recommendations address solutions for systemic racism and socioeconomic discrimination as root causes. SDOH are systemic, population-based, cyclical, and intergenerational, requiring extension beyond health care solutions to multi-sector and multi-policy approaches to achieve future population health improvement.

Systematic Review of Functional Outcomes in Cancer Rehabilitation.

OBJECTIVE: To systematically review the evidence regarding rehabilitation interventions targeting optimal physical or cognitive function in adults with a history of cancer and describe the breadth of evidence as well as strengths and limitations across a range of functional domains. DATA SOURCES: PubMed, Cumulative Index to Nursing and Allied Health Plus, Scopus, Web of Science, and Embase. The time scope was January 2008 to April 2019. STUDY SELECTION: Prospective, controlled trials including single- and multiarm cohorts investigating rehabilitative interventions for cancer survivors at any point in the continuum of care were included, if studies included a primary functional outcome measure. Secondary data analyses and pilot/feasibility studies were excluded. Full-text review identified 362 studies for inclusion. DATA EXTRACTION: Extraction was performed by coauthor teams and quality and bias assessed using the American Academy of Neurology (AAN) Classification of Evidence Scheme (class I-IV). DATA SYNTHESIS: Studies for which the functional primary endpoint achieved significance were categorized into 9 functional areas foundational to cancer rehabilitation: (1) quality of life (109 studies), (2) activities of daily living (61 studies), (3) fatigue (59 studies), (4) functional mobility (55 studies), (5) exercise behavior (37 studies), (6) cognition (20 studies), (7) communication (10 studies), (8) sexual function (6 studies), and (9) return to work (5 studies). Most studies were categorized as class III in quality/bias. Averaging results found within each of the functional domains, 71% of studies reported statistically significant results after cancer rehabilitation intervention(s) for at least 1 functional outcome. CONCLUSIONS: These findings provide evidence supporting the efficacy of rehabilitative interventions for individuals with a cancer history. The findings should be balanced with the understanding that many studies had moderate risk of bias and/or limitations in study quality by AAN criteria. These results may provide a foundation for future work to establish clinical practice guidelines for rehabilitative interventions across cancer disease types.

Cancer health self-efficacy improvement in a randomized controlled trial.

BACKGROUND: eHealth interventions can help cancer survivors self-manage their health outside the clinic. Little is known about how best to engage and assist survivors across the age and cancer treatment spectra. METHODS: The American Cancer Society conducted a randomized controlled trial that assessed efficacy of, and engagement with, Springboard Beyond Cancer, an eHealth self-management program for cancer survivors. Intent-to treat analyses assessed effects of intervention engagement for treatment (on-treatment vs completed) overall (n = 176; 88 control, 88 intervention arm) and separately by age (<60 years vs older). Multiple imputation was used to account for participants who were lost to follow-up (n = 41) or missing self-efficacy data (n = 1) at 3 months follow-up. RESULTS: Self-efficacy for managing cancer, the primary outcome of this trial, increased significantly within the intervention arm and for those who had completed treatment (Cohen's d = 0.26, 0.31, respectively). Additionally, participants with moderate-to-high engagement in the text and/or web intervention (n = 30) had a significantly greater self-efficacy for managing cancer-related issues compared to the control group (n = 68), with a medium effect size (Cohen's d = 0.44). Self-efficacy did not differ between the intervention and control arm at 3 months post-baseline. CONCLUSIONS: Study results suggest that cancer survivors benefit variably from eHealth tools. To maximize effects of such tools, it is imperative to tailor information to a priori identified survivor subgroups and increase engagement efforts.

The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention.

The Breast Cancer Weight Loss (BWEL) trial is a randomized controlled trial designed to determine whether weight loss after a breast cancer diagnosis can reduce the risk of cancer recurrence in women with overweight or obesity. The BWEL trial will compare the efficacy of a telephone-based weight-loss intervention plus health education materials versus health education materials alone on invasive disease-free survival in 3,181 women with stage II or III breast cancer and BMI > 27 kg/m2 . This report provides a detailed description of the goals and methods of the lifestyle intervention and the evidence supporting the intervention used in the BWEL trial. The intervention's primary goal for participants is to achieve and maintain a weight loss ≥ 10% of baseline weight through increased physical activity and caloric restriction. The evidence supporting the diet, physical activity, and behavioral components of this telephone-based weight-loss intervention, as well as strategies to promote participant engagement and retention, is described. The intervention is provided through 42 sessions delivered by trained health coaches over a 2-year period. If the BWEL lifestyle intervention is successful in improving cancer outcomes, then weight loss will be incorporated into the care of thousands of breast cancer patients.

The gut connection: Intestinal permeability as a pathway from breast cancer survivors' relationship satisfaction to inflammation across treatment.

BACKGROUND: Breast cancer survivors are prone to weakened gut barriers, allowing bacteria to migrate into the blood stream. Gut permeability fuels inflammation, which, among survivors, can elevate risk for comorbid disease development, cancer recurrence, and a poor quality of life; however, survivors' satisfying relationships can provide health benefits. This longitudinal study used a conceptual model addressing how intimate relationships is associated with health through changes in gut permeability and inflammation. METHOD: Breast cancer survivors (n = 139, stages 0-IIIC) completed a baseline visit before treatment and two follow-up visits 6 and 18 months after treatment ended. Women who had an abnormal breast cancer test followed by a benign diagnosis completed visits within a comparable timeframe (noncancer patient controls; n = 69). All women completed questionnaires assessing their relationship satisfaction and provided blood samples to assess two bacterial endotoxin biomarkers, lipopolysaccharide-binding protein (LBP) and soluble CD14 (sCD14), as well as C-reactive protein (CRP) and interleukin 6 (IL-6). RESULTS: Within-person multilevel mediation analyses showed that when a survivor's relationship satisfaction was higher than usual, her own LBP and LBP/sCD14 were lower, which was associated with lower than her own average CRP and IL-6 (95% CIs [-0.0104, -0.0002]). IL-6 was also higher when older survivors, but not younger survivors, experienced higher than usual intestinal permeability (p = .001). These effects of satisfying relationships held after accounting for cancer-related and behavioral factors. Post-hoc analyses showed LBP, sCD14, and LBP/sCD14 were associated with CRP for the cancer survivors, but only LBP and LBP/sCD14 were linked to CRP among the noncancer control patients. CONCLUSION: The gut environment is a new promising candidate for understanding a relationship's long-term health impact, particularly among those with elevated health risks. Survivors may reap multiple physiological benefits from satisfying relationships.