Experiences of patients with peritoneal carcinomatosis-related complex care needs and their caregivers.

BACKGROUND: Patients with peritoneal carcinomatosis (PC) frequently undergo palliative procedures, yet these patients and their caregivers report being unprepared to manage ostomies, drains, and other complex care needs at home. The purpose of this study was to characterize the unique needs of these patients and their caregivers during care transitions. METHODS: Patients completed measures of health status and advance care planning, caregivers completed measures of preparedness and burden, and all participants completed measures of depression and anxiety. Participants detailed their experiences in individual, semi-structured interviews. We analyzed data using descriptive statistics and conventional content analysis. RESULTS: Sixty-one patients and 39 caregivers completed baseline measures. Twenty-four (39.3%) patients acknowledged their terminal illness and seven (11.5%) had discussed end-of-life care preferences with clinicians. Most (26/39, 66.7%) caregivers provided daily care. Among caregivers who managed symptoms, few were taught how to do so (6/20, 30%). Seven patients (11.5%) and seven caregivers (17.9%) met case criteria for anxiety, while 15 patients (24.6%) and two caregivers (5.1%) met case criteria for depression. Interview participants described a diagnosis of PC as a turning point for which there is no road map and identified the need for health systems change to minimize suffering. CONCLUSION: Patients with PC and their caregivers are highly burdened by symptoms and care needs. Patients' prognostic understanding and advance care planning are suboptimal. Interventions that train patients with PC and their caregivers to perform clinical care tasks, facilitate serious illness conversations, and provide psychosocial support are needed.

Open-Source, Step-Counting Algorithm for Smartphone Data Collected in Clinical and Nonclinical Settings: Algorithm Development and Validation Study.

BACKGROUND: Step counts are increasingly used in public health and clinical research to assess well-being, lifestyle, and health status. However, estimating step counts using commercial activity trackers has several limitations, including a lack of reproducibility, generalizability, and scalability. Smartphones are a potentially promising alternative, but their step-counting algorithms require robust validation that accounts for temporal sensor body location, individual gait characteristics, and heterogeneous health states. OBJECTIVE: Our goal was to evaluate an open-source, step-counting method for smartphones under various measurement conditions against step counts estimated from data collected simultaneously from different body locations ("cross-body" validation), manually ascertained ground truth ("visually assessed" validation), and step counts from a commercial activity tracker (Fitbit Charge 2) in patients with advanced cancer ("commercial wearable" validation). METHODS: We used 8 independent data sets collected in controlled, semicontrolled, and free-living environments with different devices (primarily Android smartphones and wearable accelerometers) carried at typical body locations. A total of 5 data sets (n=103) were used for cross-body validation, 2 data sets (n=107) for visually assessed validation, and 1 data set (n=45) was used for commercial wearable validation. In each scenario, step counts were estimated using a previously published step-counting method for smartphones that uses raw subsecond-level accelerometer data. We calculated the mean bias and limits of agreement (LoA) between step count estimates and validation criteria using Bland-Altman analysis. RESULTS: In the cross-body validation data sets, participants performed 751.7 (SD 581.2) steps, and the mean bias was -7.2 (LoA -47.6, 33.3) steps, or -0.5%. In the visually assessed validation data sets, the ground truth step count was 367.4 (SD 359.4) steps, while the mean bias was -0.4 (LoA -75.2, 74.3) steps, or 0.1%. In the commercial wearable validation data set, Fitbit devices indicated mean step counts of 1931.2 (SD 2338.4), while the calculated bias was equal to -67.1 (LoA -603.8, 469.7) steps, or a difference of 3.4%. CONCLUSIONS: This study demonstrates that our open-source, step-counting method for smartphone data provides reliable step counts across sensor locations, measurement scenarios, and populations, including healthy adults and patients with cancer.

SARS-CoV-2 vaccination, booster, and infection in pregnant population enhances passive immunity in neonates.

The effects of heterogeneous infection, vaccination and boosting histories prior to and during pregnancy have not been extensively studied and are likely important for protection of neonates. We measure levels of spike binding antibodies in 4600 patients and their neonates with different vaccination statuses, with and without history of SARS-CoV-2 infection. We investigate neutralizing antibody activity against different SARS-CoV-2 variant pseudotypes in a subset of 259 patients and determined correlation between IgG levels and variant neutralizing activity. We further study the ability of maternal antibody and neutralizing measurements to predict neutralizing antibody activity in the umbilical cord blood of neonates. In this work, we show SARS-CoV-2 vaccination and boosting, especially in the setting of previous infection, leads to significant increases in antibody levels and neutralizing activity even against the recent omicron BA.1 and BA.5 variants in both pregnant patients and their neonates.

Validation of an open-source smartphone step counting algorithm in clinical and non-clinical settings.

Background: Step counts are increasingly used in public health and clinical research to assess wellbeing, lifestyle, and health status. However, estimating step counts using commercial activity trackers has several limitations, including a lack of reproducibility, generalizability, and scalability. Smartphones are a potentially promising alternative, but their step-counting algorithms require robust validation that accounts for temporal sensor body location, individual gait characteristics, and heterogeneous health states. Objective: Our goal was to evaluate an open-source step-counting method for smartphones under various measurement conditions against step counts estimated from data collected simultaneously from different body locations ("internal" validation), manually ascertained ground truth ("manual" validation), and step counts from a commercial activity tracker (Fitbit Charge 2) in patients with advanced cancer ("wearable" validation). Methods: We used eight independent datasets collected in controlled, semi-controlled, and free-living environments with different devices (primarily Android smartphones and wearable accelerometers) carried at typical body locations. Five datasets (N=103) were used for internal validation, two datasets (N=107) for manual validation, and one dataset (N=45) used for wearable validation. In each scenario, step counts were estimated using a previously published step-counting method for smartphones that uses raw sub-second level accelerometer data. We calculated mean bias and limits of agreement (LoA) between step count estimates and validation criteria using Bland-Altman analysis. Results: In the internal validation datasets, participants performed 751.7±581.2 (mean±SD) steps, and the mean bias was -7.2 steps (LoA -47.6, 33.3) or -0.5%. In the manual validation datasets, the ground truth step count was 367.4±359.4 steps while the mean bias was -0.4 steps (LoA -75.2, 74.3) or 0.1 %. In the wearable validation dataset, Fitbit devices indicated mean step counts of 1931.2±2338.4, while the calculated bias was equal to -67.1 steps (LoA -603.8, 469.7) or a difference of 0.3 %. Conclusions: This study demonstrates that our open-source step counting method for smartphone data provides reliable step counts across sensor locations, measurement scenarios, and populations, including healthy adults and patients with cancer.

The SHARE Study: Pilot Study of a Communication Intervention Designed to Elicit Advanced-Stage Cancer Patients' Preferences and Goals.

Background: Helping seriously ill cancer patients identify and communicate their care preferences improves outcomes. Objective: The aim of this study was to pilot test the feasibility and acceptability of an intervention designed to elicit patients' preferences and goals of care and share them with their oncology teams. Design: A single-arm pilot study of a 2.5-minute video, 3-page brief questionnaire, and a wallet card with question prompts was conducted. Primary outcomes were feasibility (≥60% approach-to-consent ratio, ≥60% participants rated the intervention positively) and acceptability (≥60% recommended the intervention). Secondary outcomes, measured pre- and post-intervention, included patient anxiety and distress, hope, quality of life, and therapeutic alliance. Setting/subjects: The study subjects were advanced-stage cancer patients and their clinicians at a U.S. academic and community oncology practice. Results: Among 59 potentially eligible patients, 53 agreed to participate (90% approach-to-consent ratio); 4 were nonevaluable due to death. Overall, 45 of 49 patients (92%) rated their experience as excellent, very good, or good. Participants (mean age = 63 years, range 40-86) agreed or strongly agreed that they would recommend the video (83%), brief questionnaire (88%), and wallet card (63%). However, only 34% of participants reported reviewing the questionnaire with their oncologist. There were no increases in patient anxiety or distress associated with the intervention or reductions in hope or therapeutic alliances with oncologists (all p > 0.05); quality of life was better post-intervention (p = 0.02). Conclusions: This communication intervention that combined a video, questionnaire, and wallet card was both feasible and acceptable for helping advanced cancer patients identify their care preferences and goals and should be tested in a future randomized clinical trial. Clinical Trial Registration: ClinicalTrials.gov NCT03392090.

Developing and Field Testing BOLSTER: A Nurse-Led Care Management Intervention to Support Patients and Caregivers following Hospitalization for Gynecologic Cancer-Associated Peritoneal Carcinomatosis.

Introduction: Peritoneal carcinomatosis (PC) afflicts women with advanced gynecologic cancers. Patients with PC often require ostomies, gastric tubes, or catheters to palliate symptoms, yet patients and caregivers report feeling unprepared to manage these devices. The purpose of this study was to develop and field test the Building Out Lifelines for Safety, Trust, Empowerment, and Renewal (BOLSTER) intervention to support patients and their caregivers after hospitalization for PC. Materials and Methods: We adapted components of the Standard Nursing Intervention Protocol with stakeholders and topical experts. We developed educational content; built a smartphone application to assess patients' symptoms; and assessed preliminary feasibility and acceptability in two single-arm prepilot studies. Eligible participants were English-speaking adults hospitalized for gynecologic cancer-associated PC and their caregivers. Feasibility criteria were a ≥50% consent-to-approach ratio and ≥80% outcome measure completion. The acceptability criterion was ≥70% of participants recommending BOLSTER. Results: During the first prepilot, BOLSTER was a 10-week intervention. While 7/8 (87.5%) approached patients consented, we experienced high attrition to hospice. Less than half of patients (3/7) and caregivers (3/7) completed outcome measures. For the second prepilot, BOLSTER was a four-week intervention. All (7/7) approached patients consented. Two withdrew before participating in any study activity because they were "too overwhelmed." We excluded data from one caregiver who completed baseline measures with the patient's assistance. All remaining patients (5/5) and caregivers (4/4) completed outcome measures and recommended BOLSTER. Conclusion: BOLSTER is a technology-enhanced, nurse-led intervention that is feasible and acceptable to patients with gynecologic cancer-associated PC and their caregivers.

Stepping into survivorship pilot study: Harnessing mobile health and principles of behavioral economics to increase physical activity in ovarian cancer survivors.

OBJECTIVE: Physical activity improves physical function, quality of life, and mental health, yet fewer than 80% of ovarian cancer survivors meet activity guidelines. This pilot intervention study aimed to increase physical activity in ovarian cancer survivors by leveraging principles of behavioral economics, gamification, and social support. METHODS: This 24-week study (12-week intervention; 12-week follow-up) enrolled women with ovarian cancer after completion of first-line treatment with a self-selected "teammate." Participants used Fitbits to measure daily steps, select an increased step goal, and enroll in a collaborative game, including points and levels for achieving step goals. Primary outcomes were feasibility (defined a priori as ≥60% approach-to-consent ratio and ≥ 70% adherence to Fitbit), acceptability (≤20% of participants reporting burden or regret for participation) and preliminary efficacy (≥70% reporting increased motivation); exploratory outcomes included change in steps. RESULTS: We recruited 24 participants (mean age = 63 years, range = 37-79 years) with a 94% approach-to-consent ratio. All participants completed the intervention with 94% tracker adherence. At 24-week follow-up, 1/24 (≤5%) of participants reported burden; 0/24 (0%) reported regret for study participation; and 22/24 (>90%) agreed/strongly agreed that "the study motivated me to increase activity levels." Participants' mean daily steps were 6210.7 (±3328.1) at baseline and increased to 7643 (± 3610.9) steps (p < 0.001) during the 12-week intervention. CONCLUSIONS: This pilot study demonstrated feasibility, acceptability, and preliminary efficacy, justifying a larger randomized clinical trial to test efficacy at increasing activity levels. Future studies should examine strategies for maintaining increased activity levels in survivors over time.

Lived experiences of women reporting fatigue during PARP inhibitor maintenance treatment for advanced ovarian cancer: A qualitative study.

OBJECTIVE: Oral PARP inhibitors (PARPi) have dramatically changed the treatment landscape for patients with advanced ovarian cancer. However, a subset of patients discontinue PARPi due to treatment-related fatigue. The current study sought to explore patients' lived experiences with fatigue on PARPi. METHODS: We conducted individual semi-structured interviews with N = 23 women receiving PARPi for advanced ovarian cancer who reported moderate to severe fatigue. Audiotaped interviews were transcribed and we used thematic analysis to code transcripts for emergent themes. RESULTS: Four overarching themes emerged. First, participants described their fatigue as milder than what they experienced on intravenous chemotherapy, but noted it consistently limited their daily activities, including work, and interfered with participation in family and social events. Second, fatigue negatively impacted participants' sense of self and identity. Third, most wanted to continue treatment and believed discontinuing PARPi would lead to a cancer recurrence or death. Finally, many participants reported that their support networks were unaware of their ongoing cancer treatment or the resulting fatigue; a situation that may prove isolating and result in reduced social support. CONCLUSIONS: Our findings underscore patients' persistent experience of fatigue on PARPi, the impact of fatigue on multiple domains of functioning, and a lack of understanding of side effects resulting from oral maintenance treatments among patients' social networks. Our findings highlight the need for interventions to address treatment-related fatigue to limit the negative impacts of fatigue on ovarian cancer patients' well-being.