Biobehavioral predictors of mood, pain, fatigue, and insomnia in endometrial cancer survivors.

OBJECTIVE: Endometrial cancer survivors experience persistent health-related quality of life concerns, including pain, fatigue, and disrupted emotional and social functioning. The purpose of this longitudinal study was to evaluate associations between biobehavioral factors, including daytime physical activity, nighttime sleep, and 24-h circadian rest-activity rhythms, with psychological and physical symptoms following endometrial cancer surgery. METHODS: This study included 69 adult female patients undergoing surgery for endometrial cancer. At each of three assessment points (1, 4, and 16 weeks post-surgery), participants wore a wrist actigraph for 3 days and completed a sleep log and self-report measures of depression and anxiety (Inventory of Depression and Anxiety Symptoms), pain (Brief Pain Inventory), fatigue (Fatigue Symptom Inventory), and insomnia (Insomnia Severity Index). Physical activity, sleep, and 24-h rest-activity indices were derived from actigraphy. Mixed- and fixed-effects linear regression models were utilized to evaluate relationships between actigraphy indices and patient-reported outcomes. RESULTS: Clinically elevated fatigue persisted for a majority of participants (64 %), while a sizeable minority continued to report clinically elevated insomnia (41 %) and pain (19 %) at 16-weeks post-surgery. Participants who recorded less daytime activity, more disrupted sleep, and less consistent 24-h rest-activity rhythms by actigraphy reported more depression and anxiety symptoms and greater pain and fatigue. Within individual participants, at time points when activity was lowest, sleep most disrupted, and 24-h rest-activity rhythms least consistent, participants experienced more psychological and physical symptoms. CONCLUSIONS: Findings suggest that disruptions in daytime physical activity, nighttime sleep, and 24-h rest-activity patterns contribute to patient-reported outcomes in the weeks and months after endometrial cancer treatment. Findings support modifiable intervention targets to address co-occurring physical and psychological symptoms and optimize health and recovery after endometrial cancer surgery.

Evaluating implementation of a community-focused patient navigation intervention at an NCI-designated cancer center using RE-AIM.

BACKGROUND: Patient navigation is an evidence-based intervention that reduces cancer health disparities by directly addressing the barriers to care for underserved patients with cancer. Variability in design and integration of patient navigation programs within cancer care settings has limited this intervention's utility. The implementation science evaluation framework, RE-AIM, allows quantitative and qualitative examination of effective implementation of patient navigation programs into cancer care settings. METHODS: The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework was used to evaluate implementation of a community-focused patient navigation intervention at an NCI-designated cancer center between June 2018 and October 2021. Using a 3-month longitudinal, non-comparative measurement period, univariate and bivariate analyses were conducted to examine associations between participant-level demographics and primary (i.e., barrier reduction) and secondary (i.e., patient-reported outcomes) effectiveness outcomes. Mixed methods analyses were used to examine adoption and delivery of the intervention into the cancer center setting. Process-level analyses were used to evaluate maintenance of the intervention. RESULTS: Participants (n = 311) represented a largely underserved population, as defined by the National Cancer Institute, with the majority identifying as Hispanic/Latino, having a household income of $35,000 or less, and being enrolled in Medicaid. Participants were diagnosed with a variety of cancer types and most had advanced staged cancers. Pre-post-intervention analyses indicated significant reduction from pre-intervention assessments in the average number of reported barriers, F(1, 207) = 117.62, p < .001, as well as significant increases in patient-reported physical health, t(205) = - 6.004, p < .001, mental health, t(205) = - 3.810, p < .001, self-efficacy, t(205) = - 5.321, p < .001, and satisfaction with medical team communication, t(206) = - 2.03, p = .029. Referral patterns and qualitative data supported increased adoption and integration of the intervention into the target setting, and consistent intervention delivery metrics suggested high fidelity to intervention delivery over time. Process-level data outlined a successful transition from a grant-funded community-focused patient navigation intervention to an institution-funded program. CONCLUSIONS: This study utilized the implementation science evaluation framework, RE-AIM, to evaluate implementation of a community-focused patient navigation program. Our analyses indicate successful implementation within a cancer care setting and provide a potential guide for other oncology settings who may be interested in implementing community-focused patient navigation programs.

Developing an ACT-based intervention to address lung cancer stigma: Stakeholder recommendations and feasibility testing in two NCI-designated cancer centers.

Objective: Few psychosocial interventions have been tailored to meet the unique needs of patients diagnosed with lung cancer. This pilot study developed and tested a six-week intervention for reducing lung cancer stigma.Design and Subjects: Guided by qualitative interviews conducted with 9 lung cancer patients and 5 thoracic oncology care providers, Acceptance and Commitment Therapy was adapted for treatment of lung cancer stigma (ACT-LCS). In a subsequent single arm pilot study, 22 lung cancer patients reporting high levels of stigma completed the intervention.Setting: NCI-designated cancer centers in the Southwestern and Eastern United States.Results: Of 46 eligible patients, 22 provided consent, with 20 completing the intervention (10 in-person, 10 telehealth). Overall stigma decreased across timepoints, largely driven by reductions in internalized stigma. There were also significant reductions in social isolation, sleep disturbance, and fatigue.Conclusions: The ACT-LCS protocol demonstrates preliminary feasibility and acceptability. This intervention may be particularly suited for helping patients navigate feelings associated with internalized stigma.

Implementing patient navigation programs: Considerations and lessons learned from the Alliance to Advance Patient-Centered Cancer Care.

BACKGROUND: Six multidisciplinary cancer centers were selected and funded by the Merck Foundation (2017-2021) to collaborate in the Alliance to Advance Patient-Centered Cancer Care ("Alliance"), an initiative to improve patient access, minimize health disparities, and enhance the quality of patient-centered cancer care. These sites share their insights on implementation and expansion of their patient navigation efforts. METHODS: Patient navigation represents an evidence-based health care intervention designed to enhance patient-centered care and care coordination. Investigators at 6 National Cancer Institute-designated cancer centers outline their approaches to reducing health care disparities and synthesize their efforts to ensure sustainability and successful transferability in the management of patients with cancer and their families in real-world health care settings. RESULTS: Insights are outlined within the context of patient navigation program effectiveness and supported by examples from Alliance cancer center sites: 1) understand the patient populations, particularly underserved and high-risk patients; 2) capitalize on the existing infrastructure and institutional commitment to support and sustain patient navigation; and 3) build capacity by mobilizing community support outside of the cancer center. CONCLUSIONS: This process-level article reflects the importance of collaboration and the usefulness of partnering with other cancer centers to share interdisciplinary insights while undergoing intervention development, implementation, and expansion. These collective insights may be useful to staff at other cancer centers that look to implement, enhance, or evaluate the effectiveness of their patient navigation interventions.

Knowledge of Required Medical Surveillance Among Adolescent and Young Adult Survivors of Childhood Cancer.

PURPOSE: Adolescent and young adult (AYA) cancer survivors experience treatment-related late effects so guidelines recommend providing a treatment summary, yearly follow-up, and risk-adapted testing. AYA survivors' knowledge of surveillance follow-up was studied. RESULTS: Survey responses for 73 AYAs were stratified: low (0 to 1 correct; n=18; 24.7%) versus high knowledge (2 to 4 correct; n=55; 75.3%) of their required testing. Patient-reported Outcomes Measurement Information System (PROMIS) scores fell within average ranges for participant age ( T -scores: 52.4 for physical function, 49.3 for anxiety, 46.3 for depression, and 44.7 for fatigue). Younger age at survivorship visit was a significant predictors of improved knowledge scores. CONCLUSION: Despite attendance at a survivorship clinic, minority of participants (9.5%) demonstrated complete knowledge of surveillance testing needs. Most survivors are aware of some of their surveillance needs. PROMIS scores were not associated with surveillance knowledge.

Patient-reported financial toxicity, quality of life, and health behaviors in insured US cancer survivors.

PURPOSE: Fighting cancer is a costly battle, and understanding the relationship between patient-reported financial toxicity (FT) and health outcomes can help inform interventions for post-treatment cancer survivors. METHODS: Stages I-III solid tumor, insured US cancer survivors (N = 103) completed a survey addressing FT (as measured by the standardized COST measure) and clinically relevant health outcomes (including health-related quality of life [HRQOL] and adherence to recommended survivorship health behaviors). Univariate and multivariate analyses were used to assess demographic and disease-specific correlates of FT, and to assess the predictive value of FT on HRQOL and adherence to survivorship health behaviors. RESULTS: Approximately 18% of respondents noted FT levels associated with significant financial burden. In univariate analyses, after correcting for multiple comparisons, greater FT was associated with unpartnered status, non-retirement, and lower level of educational attainment. Greater FT was also significantly associated with HRQOL components of anxiety, fatigue, pain, physical functioning, and social functioning. FT was not significantly associated with any measured survivorship health behaviors. In multivariate analyses, FT was found to be a meaningful predictor of patient-reported anxiety, fatigue, physical functioning, and social functioning above and beyond theoretically and statistically relevant demographic characteristics. CONCLUSIONS: Although overall levels of FT were lower among cancer survivors in this sample, as compared with active treatment patients assessed in previous studies, financial burden continued to be a concern for a significant minority of cancer survivors and was associated with components of reduced HRQOL. Further research is needed to understand FT among underinsured survivors and those treated in community oncology settings. IMPLICATIONS FOR CANCER SURVIVORS: Incorporation of FT assessment into survivorship care planning could enhance clinical assessment of survivors' FT vulnerability, help address the dynamic and persistent challenges of survivorship, and help identify those most in need of intervention across the cancer care continuum.

Feasibility and acceptability of a pilot tailored text messaging intervention for adolescents and young adults completing cancer treatment.

PURPOSE: Despite cure, adolescents and young adults (AYA) who complete cancer treatment remain at risk for numerous physical and psychological late effects. However, engagement in recommended follow-up care, knowledge of cancer treatment history and risks, and adoption of health promoting behaviors are often suboptimal. The pilot randomized controlled trial assessed the feasibility and acceptability of a text messaging intervention (THRIVE; Texting Health Resources to Inform, motiVate, and Engage) designed to promote well-being, and health knowledge and behaviors. METHODS: Sixty-one AYA who recently completed cancer therapy enrolled and were randomized to receive THRIVE (n = 31) or an AYA survivor handbook (n = 30). Participants from both groups completed baseline measures and follow-up surveys 16 weeks later. AYA randomized to THRIVE received one to two health-related text messages per day over 16 weeks. RESULTS: THRIVE demonstrated a high level of acceptability and feasibility. Exploratory analyses highlighted promising improvements in knowledge, fruit/vegetable intake, and perceptions of health vulnerability. CONCLUSIONS: Text messaging is an acceptable and feasible intervention approach for improving well-being and health of AYA survivors. Future research is needed to test the impact of text messaging in a larger trial, including whether or not such an intervention can improve clinical outcomes, such as survivors' engagement in follow-up care.

Registry study to assess hair loss prevention with the Penguin Cold Cap in breast cancer patients receiving chemotherapy.

PURPOSE: Chemotherapy-induced alopecia is a distressing side effect of cancer treatment. The aim of this registry study was to assess efficacy and tolerability of scalp hypothermia using Penguin Cold Caps (Penguin) in breast cancer patients. METHODS: Hair loss was assessed by patients using a 100-point Visual Analog Scale (VAS) and by physicians using the 5-point Dean Scale at baseline, every 3-4 weeks during chemotherapy, and at least 1 month after completion of chemotherapy. The primary efficacy endpoint for success was defined as ≤50% hair loss by patient report (VAS) at follow-up (FUP). Tolerability and satisfaction were assessed by patient report. RESULTS: 103 patients enrolled between 7/2010 and 6/2015; 97 are evaluable for the primary endpoint. Chemotherapy included docetaxel/cyclophosphamide (TC; n = 50) for 4-6 cycles every 3 weeks, weekly paclitaxel for 12 weeks then doxorubicin/cyclophosphamide (P/AC; n = 23) for 4 cycles every 2-3 weeks, AC then paclitaxel (AC/P; n = 10), docetaxel/carboplatin ± trastuzumab (TCH; n = 4) for 4-6 cycles every 3 weeks. Overall, 61% of patients successfully prevented CIA; impact was regimen specific: TCH 100%, TC × 4 84%, TC × 5-6 50%, P/AC 43%, AC/P 20%. The most common toxicity was headache, reported by 78.5% of patients with mean pain level 37/100. Satisfaction among those who completed scalp cooling (SC) and FUP ranged from 74 to 100%. All patients who completed SC/FUP recommended Penguin. CONCLUSIONS: Scalp hypothermia with Penguin is effective in reducing alopecia, particularly for non-anthracycline-based shorter regimens. Penguin was well tolerated and viewed favorably by most patients.

Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer.

Importance: Chemotherapy-induced alopecia is a common and distressing adverse effect. In previous studies of scalp cooling to prevent chemotherapy-induced alopecia, conclusions have been limited. Objectives: To evaluate whether use of a scalp cooling system is associated with a lower amount of hair loss among women receiving specific chemotherapy regimens for early-stage breast cancer and to assess related changes in quality of life. Design, Setting, and Participants: A prospective cohort study conducted at 5 US medical centers of women with stage I or II breast cancer receiving adjuvant or neoadjuvant chemotherapy regimens excluding sequential or combination anthracycline and taxane (106 patients in the scalp cooling group and 16 in the control group; 14 matched by both age and chemotherapy regimen). The study was conducted between August 2013 and October 2014 with ongoing annual follow-up for 5 years. Exposures: Use of a scalp cooling system. Scalp cooling was initiated 30 minutes prior to each chemotherapy cycle, with scalp temperature maintained at 3°C (37°F) throughout chemotherapy and for 90 minutes to 120 minutes afterward. Main Outcomes and Measures: Self-estimated hair loss using the Dean scale was assessed 4 weeks after the last dose of chemotherapy by unblinded patient review of 5 photographs. A Dean scale score of 0 to 2 (≤50% hair loss) was defined as treatment success. A positive association between scalp cooling and reduced risk of hair loss would be demonstrated if 50% or more of patients in the scalp cooling group achieved treatment success, with the lower bound of the 95% CI greater than 40% of the success proportion. Quality of life was assessed at baseline, at the start of the last chemotherapy cycle, and 1 month later. Median follow-up was 29.5 months. Results: Among the 122 patients in the study, the mean age was 53 years (range, 28-77 years); 77.0% were white, 9.0% were black, and 10.7% were Asian; and the mean duration of chemotherapy was 2.3 months (median, 2.1 months). No participants in the scalp cooling group received anthracyclines. Hair loss of 50% or less (Dean score of 0-2) was seen in 67 of 101 patients (66.3%; 95% CI, 56.2%-75.4%) evaluable for alopecia in the scalp cooling group vs 0 of 16 patients (0%) in the control group (P < .001). Three of 5 quality-of-life measures were significantly better 1 month after the end of chemotherapy in the scalp cooling group. Of patients who underwent scalp cooling, 27.3% (95% CI, 18.0%-36.6%) reported feeling less physically attractive compared with 56.3% (95% CI, 31.9%-80.6%) of patients in the control group (P = .02). Of the 106 patients in the scalp cooling group, 4 (3.8%) experienced the adverse event of mild headache and 3 (2.8%) discontinued scalp cooling due to feeling cold. Conclusions and Relevance: Among women undergoing non-anthracycline-based adjuvant chemotherapy for early-stage breast cancer, the use of scalp cooling vs no scalp cooling was associated with less hair loss at 4 weeks after the last dose of chemotherapy. Further research is needed to assess outcomes after patients receive anthracycline regimens, longer-term measures of alopecia, and adverse effects. Trial Registration: clinicaltrials.gov Identifier: NCT01831024.

Supporting a Young Adult with Social Anxiety Disorder and Improving Engagement in Cancer Care: A Case Report.

Adolescent and young adult (AYA) patients with cancer often demonstrate suboptimal engagement in cancer care due to a host of logistical, developmental, and psychological factors. This clinical case study of a young adult (YA) with cancer highlights the multiple ways in which social anxiety disorder (SAD) impacted a YA's engagement in cancer care. The case study also details the use of an evidence-based treatment for SAD to support behavioral change. Identification and receipt of timely evidence-based psychological intervention for SAD have the potential to improve AYA well-being and enhance cancer care engagement.

Development of Training in Problem Solving for Caregivers of Childhood Brain Tumor Survivors.

BACKGROUND: Family management (FM) challenges of maternal caregivers of young adult survivors of childhood brain tumors are well documented, but there are no evidence-based caregiver interventions to improve FM. OBJECTIVES: The aims of this study were to (1) generate the knowledge necessary for developing a caregiver intervention (stage 0) and (2) modify an existing, efficacious intervention by engaging stakeholders (stage 1). METHODS: Stages 0 and 1 of the National Institutes of Health Stage Model for Behavioral Intervention Development and the FM Styles Framework were used in this study. RESULTS: In stage 0, families with condition-focused FM patterns were identified as at risk for poor problem solving. The 12-item Condition Management Ability scale of the FM Measures was selected as the screener to identify condition-focused maternal caregivers. Problem solving was identified as a potential mechanism for promoting behavior change. In stage 1, Bright IDEAS for Everyday Living was modified by integrating the FM Styles Framework creating Training in Problem Solving for Caregivers of Young Adult Survivors of Childhood Brain Tumors. Qualitative and quantitative assessments of feasibility and acceptability by maternal caregivers were excellent and used to improve selected areas of concern. CONCLUSION: Feedback from stakeholders indicates that Training in Problem Solving is a promising approach to shifting FM patterns and improving the functioning of caregivers, young adult survivors, and families. IMPLICATIONS FOR NURSING PRACTICE: When developing interventions, the use of systemic methods can provide both clinically based and scientifically acceptable solutions. Those interventions based on both problem solving and FM are potentially promising but need further testing.

Preferences for cancer survivorship care among adolescents and young adults who experienced healthcare transitions and their parents.

PURPOSE: This study aimed to elucidate experiences and preferences for survivorship care delivery among adolescent and young adult (AYA) childhood cancer survivors who experienced healthcare transitions. METHODS: Eight focus groups were conducted with two groups of AYA survivors and their parents: (1) those who recently completed cancer treatment and are beginning follow-up care and (2) those who disengaged in follow-up care after the transition from pediatric to adult survivorship clinics. Interviewers used a structured interview guide that contained questions about perceptions and preferences for survivorship care models, resources, and tools (e.g., a survivorship care plan). We employed directed content analysis techniques to identify and organize relevant themes. RESULTS: Results of this study support six primary themes for optimizing survivorship care models for AYA: (1) improve knowledge of late effects and need for LTFU; (2) provide supportive services that help to address fear and uncertainty about health; (3) adapt survivorship care to be consistent with AYA developmental factors; (4) increase support surrounding healthcare transitions; (5) improve survivorship care communication and coordination between patients and families, and between providers; and (6) incorporate digital health tools. CONCLUSIONS: These groups represent vulnerable patient populations in AYA survivorship care and their perspectives highlight potential clinical and research priorities for enhancing long-term care models. IMPLICATIONS FOR CANCER SURVIVORS: Elucidating AYA and parent recommendations for survivorship care delivery can help to promote continuous engagement in care, target unmet needs, and promote health through survivorship models that are deemed acceptable to both patients and families.

Iterative Development of a Tailored mHealth Intervention for Adolescent and Young Adult Survivors of Childhood Cancer.

Objectives: Methods for developing mobile health (mHealth) interventions are not well described. To guide the development of future mHealth interventions, we describe the application of the agile science framework to iteratively develop a mHealth intervention for adolescent and young adult (AYA) survivors of childhood cancer. Methods: We created the AYA STEPS mobile app (AYA Self-management via Texting, Education, and Plans for Survivorship) by modifying and integrating two existing programs: an online survivorship care plan (SCP) generator and a text messaging self-management intervention for AYA off treatment. The iterative development process involved three stages of agile science: 1) Formative work, 2) Obtaining feedback about the first AYA STEPS prototype, and 3) Pilot testing and finalization of a prototype. We determined preferences of AYA stakeholders as well as discovered and addressed technology problems prior to beginning a subsequent randomized controlled trial. Results: AYA survivors reported that the app and the embedded tailored messages related to their health and SCP, were easy to use and generally satisfying and beneficial. Usage data supported that AYA were engaged in the app. Technology glitches were discovered in the pilot and addressed. Conclusions: The iterative development of AYA STEPS was essential for creating a consistent and acceptable end user experience. This study serves as one example of how behavioral scientists may apply agile science to their own mHealth research.

Multilevel Opportunities to Address Lung Cancer Stigma across the Cancer Control Continuum.

The public health imperative to reduce the burden of lung cancer has seen unprecedented progress in recent years. Fully realizing the advances in lung cancer treatment and control requires attention to potential barriers in their momentum and implementation. In this analysis, we present and evaluate the argument that stigma is a highly significant barrier to fulfilling the clinical promise of advanced care and reduced lung cancer burden. This evaluation of the stigma of lung cancer is based on a multilevel perspective that incorporates the individual, persons in the individual's immediate environment, the health care system, and the larger societal structure that shapes perceptions and decisions. We also consider current interventions and interventional needs within and across aspects of the lung cancer continuum, including prevention, screening, diagnosis, treatment, and survivorship. Current evidence suggests that stigma detrimentally affects psychosocial, communication, and behavioral outcomes over the entire lung cancer control continuum and across multiple levels. Interventional efforts to alleviate stigma in the context of lung cancer show promise, yet more work is needed to evaluate their impact. Understanding and addressing the multilevel role of stigma is a crucial area for future study to realize the full benefits offered by lung cancer prevention, control, and treatment. Coordinated, interdisciplinary, and well-conceptualized efforts have the potential to reduce the barrier of stigma in the context of lung cancer and facilitate demonstrable improvements in clinical care and quality of life.