Paula Y. Rosenblatt

Background Survivorship Care Plans (SCPs) support the transition from active cancer treatment to long-term survivorship. The POSTHOC mobile application (app) was developed to digitize the SCP, improving accessibility, modifiability, longevity, and usefulness, while promoting adherence to diet and physical activity recommendations. This study tested the feasibility, acceptability, and usability of the POSTHOC app and its effect on global symptom burden compared to a traditional SCP among recent cancer survivors. Methods In a phase I/II randomized controlled trial, cancer survivors within 12 weeks of curative treatment were recruited. Participants were randomized 2:1 POSTHOC:usual care. The POSTHOC arm had full use of the app for 12 weeks, while the usual care arm received a static SCP. Outcomes were assessed at baseline, 6 weeks, and 12 weeks, which included symptom burden (MD Anderson Symptom Inventory), diet (ASA24, 24-h recall), and physical activity (Fitbit). Acceptability (custom usefulness scale) and usability (System Usability Scale, range 0–100) were assessed within the POSTHOC arm at weeks 6 and 12. Mixed models tested SCP effects on outcomes. At week 12, participants also reflected on patient-provider communication regarding healthy lifestyle behaviors. Results Fifty-one participants consented, 41 participants (80%) successfully downloaded the app, and 34 were randomized. In the POSTHOC group, 48% (95% CI: 28–68%) and 52% (95% CI: 32–72%) recorded symptoms and/or diet in the app at weeks 6 and 12, respectively, which was below the a priori 75% usage hypothesis. POSTHOC participants reported moderate usefulness of the app at week 6 (mean ± SD = 3.5 ± 2.2) and week 12 (4.3 ± 2.4). In regard to usability, POSTHOC participants rated the app 62.7 ± 21.1 at week 6 and 65.7 ± 18.1 at week 12, which is slightly below “average” in industry standards. In regard to exploratory symptom outcomes, the POSTHOC group showed a greater reduction in symptom burden than controls at week 12 [b = 3.40 (95% CI: 0.51‒6.28), p = 0.022, ES = 0.36]. Improvements were also observed at week 12 for memory problems [b = 0.42 (95% CI: 0.03‒0.82), p = 0.034; ES = 0.30] and symptom interference with walking [b = 0.47 (95% CI: 0.05‒0.90), p = 0.030; ES = 0.45]. On average, participants desired more communication about healthy behaviors, reporting dissatisfaction with these conversations on average [2.6 (95% CI 1.5‒3.8), range 1–5]. Conclusions POSTHOC is a partially feasible digital SCP with moderate usability and potential to reduce symptom burden in cancer survivors, supporting mobile health approaches to survivorship care. Future studies should explore the effects of a mobile SCP on symptom outcomes as a primary outcome. Trial Registration ClinicalTrials.gov: NCT05499663. Graphical Abstract

Background and Objectives: Cancer‐related fatigue is a multifactorial condition that affects most people undergoing chemotherapy. To elucidate potential biological underpinnings of fatigue, this study tested correlations between patient‐reported fatigue and (1) functional measures and (2) transcriptomics of whole blood. Methods: Women undergoing chemotherapy were recruited to a cross‐sectional study. Participants reported subjective fatigue on the Functional Assessment for Chronic Illness Therapy‐Fatigue (FACIT‐F) and Brief Fatigue Inventory (BFI) questionnaires. Participants completed upper‐ and lower‐body functional assessments as an objective fatigability measure. Fasted blood samples were analyzed for complete blood counts (CBCs) to quantify cell type, and RNA‐Seq on whole blood was investigated for a distinct transcriptional signature in patients with high vs. low fatigue. Principal component analysis revealed that transcriptomic profiles clustered based on the neutrophil level, lymphocyte level, and several other clinical factors, which were accounted for when assessing differentially expressed genes. Results: Participants had breast ( n = 29) or uterine ( n = 1) cancer, were 53.4 ± 13.5 years old, and identified as Black/African American (56%) or White (44%). Hand grip strength, static fatigue index, and sit‐to‐stand assessments were not associated with FACIT‐F fatigue subscale responses. From RNA‐Seq data, higher fatigue was associated with fewer SH3RF1 transcripts ( p = 4.1 e ‐3) and more CAPRIN2 transcripts ( p = 8.2 e ‐3). Unbiased gene ontology/pathway analyses revealed perturbed biological processes in mitochondrial function, chiefly aerobic respiration (normalized effect size [ES] = −2.1), electron transport chain (ES = −1.9), generation of precursor metabolites and energy (ES = −1.8), and fatty acid oxidation (ES = −2.0), which tended to be downregulated among participants with more fatigue. Cellular components analyses consistently showed downregulation of mitochondrial proteins among those with higher fatigue (ESs = −1.7–−2.2). Future studies should investigate dietary, physical activity, and/or pharmaceutical interventions to optimize the efficiency of mitochondrial energy production during treatment to mitigate fatigue.

Background: Survivorship care plans (SCPs) are provided at the completion of cancer treatment to aid in the transition from active treatment to long-term survivorship. They describe the details of a patient’s diagnosis and treatment and offer recommendations for follow-up appointments, referrals, and healthy behaviors. The plans are currently paper-based and become outdated as soon as a patient’s health status changes. There is a need to digitize these plans to improve their accessibility, modifiability, and longevity. With current technology, SCPs can be linked to mobile devices and activity trackers so that patients can track health behaviors and compare them to their clinical goals, taking charge of their own health. Objective: A mobile app, POSTHOC (POST-Treatment Health Outcomes of Cancer Survivors), that digitizes the SCP was developed, with goals of integrating it with wearable technologies and electronic medical records. Herein, we are conducting a randomized controlled trial that evaluates the POSTHOC app versus the traditional SCP on total symptom burden in the early posttreatment period. Methods: We will recruit 54 patients who have recently completed curative therapy for cancer (any type) in person and remotely. They will be randomized 2:1, POSTHOC:usual care (unblinded). Those randomized to the POSTHOC group will receive their SCP via the app and will choose to focus on nutrition or exercise for the duration of the study based on their individual plan and personal preferences. Those randomized to the control group will get a paper-based plan. At baseline, 6 weeks, and 12 weeks, we will evaluate patient-reported outcomes, including total symptom burden (web-based questionnaire), diet (24-hour Automated Self-Administered [ASA24]), and physical activity (Fitbit Charge 6 [Google LLC]). We will also collect quantitative and qualitative feedback on the usability of the app from those in the POSTHOC arm to improve the app for future implementation studies, with a specific focus on patient-provider communication. For feasibility, we will calculate the percentage of patients who used the POSTHOC app at least 3 times per week. We will use linear mixed models to evaluate the effects of the POSTHOC app versus those of usual care on other outcomes at weeks 6 and 12. Results: This trial is open to accrual in the University of Maryland Medical System as of March 2024, and as of July 3, 2024, a total of 20 participants have consented. Conclusions: This study is among the first to digitize the SCP in a mobile app and test the effects of a mobile health–delivered behavioral health intervention on symptom burden in cancer survivors. Our results will provide evidence about the effects of health self-management on symptoms. This knowledge will be integral to larger randomized controlled studies, integration with the electronic medical record, and nationwide implementation. Trial Registration: ClinicalTrials.gov NCT05499663; https://clinicaltrials.gov/ct2/show/NCT05499663 International Registered Report Identifier (IRRID): DERR1-10.2196/59222

BACKGROUND Survivorship care plans (SCPs) are provided at the completion of cancer treatment to aid in the transition from active treatment to long-term survivorship. They describe the details of a patient’s diagnosis and treatment and offer recommendations for follow-up appointments, referrals, and healthy behaviors. The plans are currently paper-based and become outdated as soon as a patient’s health status changes. There is a need to digitize these plans to improve their accessibility, modifiability, and longevity. With current technology, SCPs can be linked to mobile devices and activity trackers so that patients can track health behaviors and compare them to their clinical goals, taking charge of their own health. OBJECTIVE A mobile app, POSTHOC (POST-Treatment Health Outcomes of Cancer Survivors), that digitizes the SCP was developed, with goals of integrating it with wearable technologies and electronic medical records. Herein, we are conducting a randomized controlled trial that evaluates the POSTHOC app versus the traditional SCP on total symptom burden in the early posttreatment period. METHODS We will recruit 54 patients who have recently completed curative therapy for cancer (any type) in person and remotely. They will be randomized 2:1, POSTHOC:usual care (unblinded). Those randomized to the POSTHOC group will receive their SCP via the app and will choose to focus on nutrition or exercise for the duration of the study based on their individual plan and personal preferences. Those randomized to the control group will get a paper-based plan. At baseline, 6 weeks, and 12 weeks, we will evaluate patient-reported outcomes, including total symptom burden (web-based questionnaire), diet (24-hour Automated Self-Administered [ASA24]), and physical activity (Fitbit Charge 6 [Google LLC]). We will also collect quantitative and qualitative feedback on the usability of the app from those in the POSTHOC arm to improve the app for future implementation studies, with a specific focus on patient-provider communication. For feasibility, we will calculate the percentage of patients who used the POSTHOC app at least 3 times per week. We will use linear mixed models to evaluate the effects of the POSTHOC app versus those of usual care on other outcomes at weeks 6 and 12. RESULTS This trial is open to accrual in the University of Maryland Medical System as of March 2024, and as of July 3, 2024, a total of 20 participants have consented. CONCLUSIONS This study is among the first to digitize the SCP in a mobile app and test the effects of a mobile health–delivered behavioral health intervention on symptom burden in cancer survivors. Our results will provide evidence about the effects of health self-management on symptoms. This knowledge will be integral to larger randomized controlled studies, integration with the electronic medical record, and nationwide implementation. CLINICALTRIAL ClinicalTrials.gov NCT05499663; https://clinicaltrials.gov/ct2/show/NCT05499663 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/59222

This chapter reviews the initial assessment and management of metastatic breast cancer (MBC). It reviews hormonal therapy (HT), combination hormonal and targeted therapy, single agent chemotherapy, and combination chemotherapy. Selective estrogen receptor modulators (SERMs) such as tamoxifen have been used for many years for the treatment of MBC, although with limited data for the premenopausal population. There are no prospective data that demonstrate conclusively that combination chemotherapy improves survival when compared to single agent cytotoxic chemotherapy for treatment of MBC. Anthracyclines are active agents in the treatment of MBC. A patient with MBC who does not want intravenous (IV) chemotherapy may choose to start with the oral capecitabine. Coupled with the fact that patients with bone only metastases tend to have longer survival and bone metastases may be associated with significant morbidity, bone metastases present a diverse challenge in the treatment of MBC.