Monitoring Adolescent and Young Adult Patients With Cancer via a Smart T-Shirt: Prospective, Single-Cohort, Mixed Methods Feasibility Study (OncoSmartShirt Study).

Background: Wearables that measure vital parameters can be potential tools for monitoring patients at home during cancer treatment. One type of wearable is a smart T-shirt with embedded sensors. Initially, smart T-shirts were designed to aid athletes in their performance analyses. Recently however, researchers have been investigating the use of smart T-shirts as supportive tools in health care. In general, the knowledge on the use of wearables for symptom monitoring during cancer treatment is limited, and consensus and awareness about compliance or adherence are lacking. objectives: The aim of this study was to evaluate adherence to and experiences with using a smart T-shirt for the home monitoring of biometric sensor data among adolescent and young adult patients undergoing cancer treatment during a 2-week period. Methods: This study was a prospective, single-cohort, mixed methods feasibility study. The inclusion criteria were patients aged 18 to 39 years and those who were receiving treatment at Copenhagen University Hospital - Rigshospitalet, Denmark. Consenting patients were asked to wear the Chronolife smart T-shirt for a period of 2 weeks. The smart T-shirt had multiple sensors and electrodes, which engendered the following six measurements: electrocardiogram (ECG) measurements, thoracic respiration, abdominal respiration, thoracic impedance, physical activity (steps), and skin temperature. The primary end point was adherence, which was defined as a wear time of >8 hours per day. The patient experience was investigated via individual, semistructured telephone interviews and a paper questionnaire. Results: A total of 10 patients were included. The number of days with wear times of >8 hours during the study period (14 d) varied from 0 to 6 (mean 2 d). Further, 3 patients had a mean wear time of >8 hours during each of their days with data registration. The number of days with any data registration ranged from 0 to 10 (mean 6.4 d). The thematic analysis of interviews pointed to the following three main themes: (1) the smart T-shirt is cool but does not fit patients with cancer, (2) the technology limits the use of the smart T-shirt, and (3) the monitoring of data increases the feeling of safety. Results from the questionnaire showed that the patients generally had confidence in the device. Conclusions: Although the primary end point was not reached, the patients' experiences with using the smart T-shirt resulted in the knowledge that patients acknowledged the need for new technologies that improve supportive cancer care. The patients were positive when asked to wear the smart T-shirt. However, technical and practical challenges in using the device resulted in low adherence. Although wearables might have potential for home monitoring, the present technology is immature for clinical use.

Experiences with Wearable Sensors in Oncology during Treatment: Lessons Learned from Feasibility Research Projects in Denmark.

BACKGROUND: The fraction of elderly people in the population is growing, the incidence of some cancers is increasing, and the number of available cancer treatments is evolving, causing a challenge to healthcare systems. New healthcare tools are needed, and wearable sensors could partly be potential solutions. The aim of this case report is to describe the Danish research experience with wearable sensors in oncology reporting from three oncological wearable research projects. CASE STUDIES: Three planned case studies investigating the feasibility of different wearable sensor solutions during cancer treatment are presented, focusing on study design, population, device, aim, and planned outcomes. Further, two actual case studies performed are reported, focusing on patients included, data collected, results achieved, further activities planned, and strengths and limitations. RESULTS: Only two of the three planned studies were performed. In general, patients found the technical issues of wearable sensors too challenging to deal with during cancer treatment. However, at the same time it was demonstrated that a large amount of data could be collected if the framework worked efficiently. CONCLUSION: Wearable sensors have the potential to help solve challenges in clinical oncology, but for successful research projects and implementation, a setup with minimal effort on the part of patients is requested.

Machine learning applied in patient-reported outcome research-exploring symptoms in adjuvant treatment of breast cancer.

BACKGROUND: Patient-reported outcome (PRO) data may help us better understand the life of breast cancer patients. We have previously collected PRO data in a national Danish breast cancer study in patients undergoing adjuvant chemotherapy. The aim of the present post-hoc explorative study is to apply Machine Learning (ML) algorithms using permutation importance to explore how specific PRO symptoms influence nonadherence to six cycles of planned adjuvant chemotherapy in breast cancer patients. METHODS: We here investigate ePRO-data from the 347 patients. The ePRO presented 42 PROCTCAE questions on 25 symptoms. Patients completed the ePRO before each cycle of chemotherapy. Number of patients with completion of the scheduled six cycles of chemotherapy were registered. Two ML models were applied. One aimed at discovering the individual relative importance of the different questions in the dataset while the second aimed at discovering the relationships between the questions. Permutation importance was used. RESULTS: Out of 347 patients 238 patients remained in the final dataset, 15 patients dropped out. Two symptoms: aching joints and numbness/tingling, were the most important for dropout in the final dataset, each with an importance value of about 0.04. Model's average ROC-AUC-score being 0.706. In the second model a low performance score made the results very unreliable. CONCLUSION: In conclusion, this explorative data analysis using ML methodologies in an ePRO dataset from a population of women with breast cancer treated with adjuvant chemotherapy unravels that the symptoms aching joints and numbness/tingling could be important for drop out of planned adjuvant chemotherapy.

Patient-reported outcomes used actively in cancer patients undergoing antineoplastic treatment: A mini-review of the Danish landscape.

Introduction: Many studies using Patient-reported outcomes (PRO) data have been conducted to monitor symptoms and health-related quality of life during follow-up after cancer treatment. However new ways of using (e)PROs have emerged. We aimed to explore the Danish landscape of the use of PRO in a research setting, where PRO is used actively in cancer patients undergoing treatment, and give an overview of how it is embraced by patients and clinicians. Methods and materials: A literature search was performed in June 2023, using the keywords Denmark, cancer, and patient-reported outcomes. An expert on literature searches identified the search terms, and double screening was performed at both abstract and screening levels and full-text stage. The software tool Covidence was used. Results: 467 articles were retrieved and 19 studies were included. They described the type of ePRO instrument used and the application of active ePRO i.e. a dialogue tool in the clinical encounter, release of alerts to clinicians, and enhancement of self-management. Finally, a development in the use of active ePROs over time is elucidated and we show how it is embraced by patients and clinicians. Conclusion: This mini-review gives an overview of how ePRO solutions are tested in oncological research in Denmark and embraced by patients and clinicians. ePRO solutions in a Danish setting seem well-suited for self-management. However, if more impact is warranted, clinicians need to engage in reviewing and using ePROs. Moreover, for successful implementation, the integration of ePROs in electronic health records must be supported by IT specialists and management.

Feasibility of Using Wearables for Home Monitoring during Radiotherapy for Head and Neck Cancer-Results from the OncoWatch 1.0 Study.

Background: Consumer wearables allow objective health data monitoring, e.g., of physical activity and heart rate, which might change over a cancer treatment course. Patients with head and neck cancer (HNC) receiving radiotherapy (RT) with curative intent typically experience side effects such as pain, decreased appetite, and dehydration, which may lead to hospitalizations. Therefore, health data monitoring could be important to understand a patient's condition outside the hospital. The OncoWatch 1.0 study investigated the feasibility of using smartwatches for patients with HNC receiving RT. Methods: This study was a prospective, single-cohort feasibility study. The inclusion criteria were patients ≥ 18 years of age who planned to receive curatively intended radiotherapy for HNC. Consenting patients were asked to wear a smartwatch during RT and until two weeks after the end of RT. The primary endpoint was adherence. The secondary endpoints were data acquisition and variations in heart rate and physical activity. Results: Ten patients were included, with a median age of 62 years and eight males. The adherence rate for wearing the watch >12 h/d over the study period was 31%. The data acquisition rate was 61%. Conclusions: Although the primary endpoint was not reached, new knowledge has been established, including the secure data setup and key points that need to be addressed in future studies.

Recommendations for a Patient Concerns Inventory specific to patients with head and neck cancer receiving palliative treatment.

PURPOSE: Patient Concerns Inventory (PCI) prompt lists are designed to capture health needs and concerns that matter most to patients. A head and neck cancer (HNC)-specific PCI was initially developed for follow-up after treatment with curative intent (PCI-HNC follow-up). Patients with HNC receiving palliative treatment (PT) may have different symptoms and concerns to discuss with the healthcare professionals. The aim of this study is to establish recommendations for a PCI-HNC-PT prompt list. METHODS: The process leading to the recommendations for the PCI-HNC-PT was a four-step sequential qualitative study. First, semi-structured interviews among patients with HNC receiving treatment with palliative intent were conducted based on the original PCI-HNC follow-up prompt list. Second, a multidisciplinary reviewing panel revised the PCI-HNC follow-up based on the findings from the patient's interviews. Third, a focus group interview (FGI) with specialized oncology nurses was conducted based on the revised PCI-HNC follow-up. Fourth, the results of the patient and FGI interviews were combined and re-assessed by the multidisciplinary reviewing panel leading to a consensus on the selection and recommendation of items for the final PCI-HNC-PT. The think aloud method was used in patient and FGI interviews to establish face and content validity. RESULTS: Ten patients receiving palliative systemic treatment for HNC were included and interviewed. Face validity and content validity for the PCI list were demonstrated. Patients independently expressed that their concerns and needs fluctuate and change over time and welcomed the possibility of being supported by a PCI prompt list. The patients estimated a PCI prompt list to be relevant or very relevant. No items were found to be unacceptable or inappropriate but were revised to be more precise in their description. Additional items were suggested from the need to be actively involved in their treatment and care. The FGI led to the knowledge that the nurses did not have a systematic approach to communicate on symptoms. The nurses highlighted that the PCI prompt list is likely helpful for addressing symptoms, needs, and concerns that the nurses themselves would not immediately inquire about. The multidisciplinary reviewing panel came to a consensus on items and concerns recommended for the PCI-HNC-PT. CONCLUSION: The idea of a PCI prompt list was welcomed by patients with HNC receiving palliative treatment. The original PCI-HNC follow-up was adapted and has led to the recommendations of items and concerns for a PCI-HNC-PT prompt list. The next phase will be to feasibility test the PCI-HNC-PT in the clinical setting. The PCI prompt list has the potential to help facilitate the concerns and needs of the patients during the palliative treatment trajectory and thereby have the potential to strengthen a person-centered approach.

Feasibility of Monitoring Patients Who Have Cancer With a Smart T-shirt: Protocol for the OncoSmartShirt Study.

BACKGROUND: Studies have shown that there may be dissimilar perceptions on symptoms or side effects between patients with cancer and health care professionals. This may lead to symptomatic patients notifying the clinic irregularly or not telling the clinic at all. Wearables could help identify symptoms earlier. Patients with low socioeconomic status and less self-awareness of their health may benefit from this. A new design of wearables is a smart t-shirt that, with embedded sensors, provides measurement flows such as electrocardiogram, thoracic and abdominal respiration, and temperature. OBJECTIVE: This study evaluates the feasibility of using a smart t-shirt for home monitoring of biometric sensor data in adolescent and young adult and elderly patients during cancer treatment. METHODS: The OncoSmartShirt study is an explorative study investigating the feasibility of using the Chronolife smart t-shirt during cancer treatment. This smart t-shirt is designed with multiple fully embedded sensors and electrodes that engender 6 different measurement flows continuously. A total of 20 Danish patients with cancer ≥18 years old in antineoplastic treatment at Department of Oncology Rigshospitalet Denmark will be recruited from all cancer wards, whether patients are in curative or palliative care. Of these 20 patients, 10 (50%) will be <39 years old, defined as adolescent and young adult, and 10 (50%) will be patients >65 years old, defined as elderly. Consenting patients will be asked to wear a smart t-shirt daily for 2 weeks during their treatment course. RESULTS: The primary outcome is to determine if it is feasible to wear a smart t-shirt throughout the day (preferably 8 hours per day) for 2 weeks. Inclusion of patients started in March 2022. CONCLUSIONS: The study will assess the feasibility of using the Chronolife smart t-shirt for home monitoring of vital parameters in patients with cancer during their treatment and bring new insights into how wearables and biometric data can be used as part of symptom or side-effect recognition in patients with cancer during treatment, with the aim to increase patients' quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT05235594; https://beta.clinicaltrials.gov/study/NCT05235594. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37626.

Patient-reported outcome during radiotherapy for head and neck cancer: the use of different PRO questionnaires.

PURPOSE: Head and neck cancer (HNC) patients are typically treated with radiotherapy (RT), which might lead to side effects and deterioration of quality of life (QoL). Studies in other cancers indicate that systematic use of patient-reported outcome (PRO) can be a tool to increase awareness of patients' symptoms and improve QoL. Multiple PRO questionnaires have been developed and validated for HNC, complicating the interpretation of results from scientific studies. In this exploratory study, symptom scores from four essential symptoms present in four different HNC-specific PRO questionnaires were evaluated. METHODS: Four HNC-specific PRO questionnaires (EORTC QLQ-H&N35, FACT-H&N, MDASI-HN, and PRO-CTCAE) for patients undergoing radiotherapy were completed by eligible HNC patients up to ten times during and after RT. Four essential symptoms (pain, dysphagia, hoarseness, and dry mouth) were present in all questionnaires. The symptom scores for these symptoms were aligned and evaluated. RESULTS: Twelve patients were included and completed a total of 328 PRO questionnaires out of 420. Similarity between symptom score for the four symptoms was found, when the symptom scores were aligned. The symptom scores increased during RT and decreased afterwards for all four symptoms and in all four questionnaires. CONCLUSION: Four HNC-specific PRO questionnaires are found similar in reflecting symptom scores over time concerning four important HNC symptoms (pain, dysphagia, hoarseness, and dry mouth). PRO can contribute with targetable information about symptoms, and PRO questionnaires might be a valuable add on to clinical practice enabling a varied picture of patients' symptoms during radiotherapy.

Using Biometric Sensor Data to Monitor Cancer Patients During Radiotherapy: Protocol for the OncoWatch Feasibility Study.

BACKGROUND: Patients with head and neck cancer (HNC) experience severe side effects during radiotherapy (RT). Ongoing technological advances in wearable biometric sensors allow for the collection of objective data (eg, physical activity and heart rate), which might, in the future, help detect and counter side effects before they become severe. A smartwatch such as the Apple Watch allows for objective data monitoring outside the hospital with minimal effort from the patient. To determine whether such tools can be implemented in the oncological setting, feasibility studies are needed. OBJECTIVE: This protocol describes the design of the OncoWatch 1.0 feasibility study that assesses the adherence of patients with HNC to an Apple Watch during RT. METHODS: A prospective, single-cohort trial will be conducted at the Department of Oncology, Rigshospitalet (Copenhagen, Denmark). Patients aged ≥18 years intended for primary or postoperative curatively intended RT for HNC will be recruited. Consenting patients will be asked to wear an Apple Watch on the wrist during and until 2 weeks after RT. The study will include 10 patients. Data on adherence, data acquisition, and biometric data will be collected. Demographic data, objective toxicity scores, and hospitalizations will be documented. RESULTS: The primary outcome is to determine if it is feasible for the patients to wear a smartwatch continuously (minimum 12 hours/day) during RT. Furthermore, we will explore how the heart rate and physical activity change over the treatment course. CONCLUSIONS: The study will assess the feasibility of using the Apple Watch for home monitoring of patients with HNC. Our findings may provide novel insights into the patient's activity levels and variations in heart rate during the treatment course. The knowledge obtained from this study will be essential for further investigating how biometric data can be used as part of symptom monitoring for patients with HNC. TRIAL REGISTRATION: ClinicalTrials.gov NCT04613232; https://clinicaltrials.gov/ct2/show/NCT04613232. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/26096.

The Use of Wearables in Clinical Trials During Cancer Treatment: Systematic Review.

BACKGROUND: Interest in the use of wearables in medical care is increasing. Wearables can be used to monitor different variables, such as vital signs and physical activity. A crucial point for using wearables in oncology is if patients already under the burden of severe disease and oncological treatment can accept and adhere to the device. At present, there are no specific recommendations for the use of wearables in oncology, and little research has examined the purpose of using wearables in oncology. OBJECTIVE: The purpose of this review is to explore the use of wearables in clinical trials during cancer treatment, with a special focus on adherence. METHODS: PubMed and EMBASE databases were searched prior and up to October 3, 2019, with no limitation in the date of publication. The search strategy was aimed at studies using wearables for monitoring adult patients with cancer during active antineoplastic treatment. Studies were screened independently by 2 reviewers by title and abstract, selected for inclusion and exclusion, and the full-text was assessed for eligibility. Data on study design, type of wearable used, primary outcome, adherence, and device outcome were extracted. Results were presented descriptively. RESULTS: Our systematic search identified 1269 studies, of which 25 studies met our inclusion criteria. The types of cancer represented in the studies were breast (7/25), gastrointestinal (4/25), lung (4/25), and gynecologic (1/25); 9 studies had multiple types of cancer. Oncologic treatment was primarily chemotherapy (17/25). The study-type distribution was pilot/feasibility study (12/25), observational study (10/25), and randomized controlled trial (3/25). The median sample size was 40 patients (range 7-180). All studies used a wearable with an accelerometer. Adherence varied across studies, from 60%-100% for patients wearing the wearable/evaluable sensor data and 45%-94% for evaluable days, but was differently measured and reported. Of the 25 studies, the most frequent duration for planned monitoring with a wearable was 8-30 days (13/25). Topics for wearable outcomes were physical activity (19/25), circadian rhythm (8/25), sleep (6/25), and skin temperature (1/25). Patient-reported outcomes (PRO) were used in 17 studies; of the 17 PRO studies, only 9 studies reported correlations between the wearable outcome and the PRO. CONCLUSIONS: We found that definitions of outcome measures and adherence varied across studies, and limited consensus among studies existed on which variables to monitor during treatment. Less heterogeneity, better consensus in terms of the use of wearables, and established standards for the definitions of wearable outcomes and adherence would improve comparisons of outcomes from studies using wearables. Adherence, and the definition of such, seems crucial to conclude on data from wearable studies in oncology. Additionally, research using advanced wearable devices and active use of the data are encouraged to further explore the potential of wearables in oncology during treatment. Particularly, randomized clinical studies are warranted to create consensus on when and how to implement in oncological practice.

Comparing the patients' subjective experiences of acute side effects during radiotherapy for head and neck cancer with four different patient-reported outcomes questionnaires.

Background: The systematic use of a Patient-Reported Outcome (PRO) as symptom monitoring during cancer treatment and follow-up has the potential to increase symptom awareness, secure timely management of side effects, improve health-related quality of life and improve data quality. This study was conducted to identify the patients' experience during chemoradiotherapy for squamous cell carcinoma of the head and neck (HNSCC) and to investigate how these symptoms correspond with different PRO questionnaires. Material and methods: Semi-structured interviews on acute side effects were performed until saturation with HNSCC patients treated with high-dose radiotherapy (RT) ± concomitant chemotherapy. The symptoms were thematically grouped in organ classes in accordance with Medical Dictionary for Regulatory Activities (MedDRA). PRO questionnaires validated for patients with HNSCC during RT were identified in the literature and were compared to the patients' symptoms. Results: Thirteen patients were interviewed. The most frequently mentioned symptoms were oral pain, decreased appetite, dysphagia, dry mouth, fatigue and hoarseness, in order of frequency. A comparison between the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Head and Neck Cancer (EORTC QLQ-H&N35), the Functional Assessment of Cancer Therapy General and Head and Neck (FACT-H&N), the M.D. Anderson Symptom Inventory Head and Neck questionnaire (MDASI-HN), selected items from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the symptoms described by the patients showed that the PROs do not cover the same symptoms, and no specific questionnaire covers all patient's experiences. Conclusion: We find, that questionnaires applied in the field of PRO among patients with HNSCC undergoing RT may not fully comprise the experiences of patients and we recommend, that experiences of patients must be included in the design of trials involving PRO, in order to decrease the likelihood of missing out reports of acute side effects.