Evaluating the effect of a mobile-based symptom monitoring system for improving physical function in patients with cancer during chemotherapy: study protocol for a multicentre randomised controlled trial.

INTRODUCTION: Symptoms due to chemotherapy are common in patients with cancer. Cancer-related symptoms are closely associated with the deterioration of physical function which can be associated with decreased quality of life and increased mortality. Thus, timely symptom identification is critical for improving cancer prognosis and survival. Recently, remote symptom monitoring system using digital technology has demonstrated its effects on symptom control or survival. However, few studies examined whether remote monitoring would contribute to retaining physical function among patients with cancer. Therefore, this study aimed to evaluate the effectiveness of mobile-based symptom monitoring in improving physical function among patients with cancer under chemotherapy. METHODS AND ANALYSIS: This study is a multicentre, open-label, parallel-group, randomised controlled trial. We will recruit 372 patients at three tertiary hospitals located in Seoul, South Korea. Study participants will be randomly assigned to either an intervention group receiving the ePRO-CTCAE app and a control group receiving routine clinical practice only. The primary outcome is changes in physical function from commencement to completion of planned chemotherapy. A linear mixed model will be performed under the intention-to-treat principle. The secondary outcomes include physical activity level; changes in pain interference; changes in depressive symptom; unplanned clinical visits; additional medical expenditure for symptom management; completion rate of planned chemotherapy; changes in symptom burden and health-related quality of life; and 1-year overall mortality. ETHICS AND DISSEMINATION: The study has been approved by the institutional review board and ethics committee at the three university hospitals involved in this trial. Written informed consent will be obtained from all the participants. The results of the trial will be submitted for publication in peer-reviewed academic journals and disseminated through relevant literatures. TRIAL REGISTRATION NUMBER: KCT0007220.

Efficacy of the PRO-CTCAE mobile application for improving patient participation in symptom management during cancer treatment: a randomized controlled trial.

PURPOSE: Although mobile-based symptom monitoring is expected to improve patient participation in symptom management during anticancer therapy, previous trials have not evaluated its effectiveness. Therefore, this study aims to evaluate the impact of a symptom monitoring mobile application on improving patient participation in symptom management during anticancer therapy. METHODS: We conducted a single-center, open-label, randomized controlled trial that enrolled patients with breast, lung, head and neck, esophageal, or gynecologic cancer who were scheduled to receive anticancer therapy (oral or intravenous) between October 2020 and March 2021. We excluded patients with physical or psychological problems. The intervention group received a symptom monitoring application for 8 weeks, and the control group received the usual clinical practice. At 8 weeks, the improvement in patient participation in symptom management was assessed, and additionally quality of life and unplanned clinical visits were assessed. RESULTS: A total of 222 patients were included in the analysis, of whom 142 were randomly assigned to the intervention group and 71 to the control group. The intervention group reported better outcome in patient participation in symptom management than the control group at 8 weeks (mean scores of 8.5 vs. 8.0; P = 0.01). There were no significant differences between the groups in Quality of life (P = 0.88) and unplanned clinical visits (P = 0.39-0.76). CONCLUSIONS: This study is meaningful in figuring out that the mobile-based symptom monitoring made them more engaged in their management. Future research should continue to evaluate the effects of patient participation as mediators of clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04568278.

Surveillance of Symptom Burden Using the Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events in Patients With Various Types of Cancers During Chemoradiation Therapy: Real-World Study.

BACKGROUND: Over 90% of patients with cancer experience 1 or more symptoms caused directly by cancer or its treatment. These symptoms negatively impact on the completion of planned treatment as well as patients' health-related quality of life (HRQoL). It often results in serious complications and even life-threatening outcomes. Thus, it has been recommended that surveillance of symptom burden should be performed and managed during cancer treatment. However, differences in symptom profiles in various patients with cancer have not been fully elucidated for use in performing surveillance in the real world. OBJECTIVE: This study aims to evaluate the burden of symptoms in patients with various types of cancers during chemotherapy or radiation therapy using the PRO-CTCAE (Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events) and its impact on quality of life. METHODS: We performed a cross-sectional study of patients undergoing outpatient-based chemotherapy, radiation therapy, or both at the National Cancer Center at Goyang or at the Samsung Medical Center in Seoul, Korea between December 2017 and January 2018. To evaluate cancer-specific symptom burden, we developed 10 subsets for using the PRO-CTCAE-Korean. To measure HRQoL, we used the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Participants answered questions prior to their clinic appointments on tablets. Multivariable linear regression was used to analyze symptoms based on cancer type and to evaluate the association between the PRO-CTCAE items and the EORTC QLQ-C30 summary score. RESULTS: The mean age (SD) of the patients was 55.0 (11.9) years, and 39.94% (540/1352) were male. Overall, symptoms in the gastrointestinal category were the most dominant in all cancers. Fatigue (1034/1352, 76.48%), decreased appetite (884/1352, 65.38%), and numbness and tingling (778/1352, 57.54%) were the most frequently reported. Patients reported more local symptoms caused by a specific cancer. In terms of nonsite-specific symptoms, patients commonly reported concentration (587/1352, 43.42%), anxiety (647/1352, 47.86%), and general pain (605/1352, 44.75%). More than 50% of patients with colorectal (69/127, 54.3%), gynecologic (63/112, 56.3%), breast (252/411, 61.3%), and lung cancers (121/234, 51.7%) experienced decreased libido, whereas 67/112 (59.8%) patients with gynecologic cancer and lymphoma/myeloma reported pain during sexual intercourse. Patients with breast, gastric, and liver cancers were more likely to have the hand-foot syndrome. Worsening PRO-CTCAE scores were associated with poor HRQoL (eg, fatigue: coefficient -8.15; 95% CI -9.32 to -6.97), difficulty in achieving and maintaining erection (coefficient -8.07; 95% CI -14.52 to -1.61), poor concentration (coefficient -7.54; 95% CI -9.06 to -6.01), and dizziness (coefficient -7.24; 95% CI -8.92 to -5.55). CONCLUSIONS: The frequency and severity of symptoms differed by cancer types. Higher symptom burden was associated with poor HRQoL, which suggests the importance of appropriate surveillance of PRO symptoms during cancer treatment. Considering patients had comprehensive symptoms, it is necessary to include a holistic approach in the symptom monitoring and management strategies based on comprehensive patient-reported outcome measurements.

Graphical user interface design to improve understanding of the patient-reported outcome symptom response.

BACKGROUND: Symptom monitoring application (SMA) has clinical benefits to cancer patients but patients experience difficulties in using it. Few studies have identified which types of graphical user interface (GUI) are preferred by cancer patients for using the SMA. METHODS: This is a cross-sectional study aimed to identify preferred GUI among cancer patients to use SMA. Total of 199 patients were asked to evaluate 8 types of GUIs combining text, icon, illustration, and colors using mixed-methods. Subgroup analyses were performed according to age and gender. RESULTS: The mean age of the patients was 57 and 42.5% was male. The most preferred GUI was "Text + Icon + Color" (mean = 4.43), followed by "Text + Icon" (mean = 4.39). Older patients (≥ 60 years) preferred "Text + Icon" than younger patients (p for interaction < 0.01). Simple and intuitive text and icons were the most useful GUI for cancer patients to use the SMA. CONCLUSION: Simple and intuitive text and icons were the most useful GUI for cancer patients to use the SMA. Researchers need to be careful when applying realistic face drawings to cancer symptom monitoring applications because they can recall negative images of cancer.

Development and Validation of Digital Health Technology Literacy Assessment Questionnaire.

In clinical practice, assessing digital health literacy is important to identify patients who may encounter difficulties adapting to digital health using digital technology and service. We developed the Digital Health Technology Literacy Assessment Questionnaire (DHTL-AQ) to assess the ability to use digital health technology, services, and data. The DHTL-AQ was developed in three phases. In the first phase, the conceptual framework and domains and items were generated from a systematic literature review using relevant theory and surveys. In the second phase, a cross-sectional survey with 590 adults age ≥ 18 years was conducted at an academic hospital in Seoul, Korea in January and February 2020 to test face validity of the items. Then, psychometric validation was conducted to determine the final items and cut-off scores of the DHTL-AQ. The eHealth literacy scale, the Newest Vital Sign, and 10 mobile app task ability assessments were examined to test validity. The final DHTL-AQ includes 34 items in two domains (digital functional and digital critical literacy) and 4 categories (Information and Communications Technology terms, Information and Communications Technology icons, use of an app, evaluating reliability and relevance of health information). The DHTL-AQ had excellent internal consistency (overall Cronbach's α = 0.95; 0.87-0.94 for subtotals) and acceptable model fit (CFI = 0.821, TLI = 0.807, SRMR = 0.065, RMSEA = 0.090). The DHTL-AQ was highly correlated with task ability assessment (r = 0.7591), and moderately correlated with the eHealth literacy scale (r = 0.5265) and the Newest Vital Sign (r = 0.5929). The DHTL-AQ is a reliable and valid instrument to measure digital health technology literacy.

Who is more likely to adopt and comply with the electronic patient-reported outcome measure (ePROM) mobile application? A real-world study with cancer patients undergoing active treatment.

PURPOSE: This study aims to identify factors associated with the adoption and compliance of electronic patient-reported outcome measure (ePROM) use among cancer patients in a real-world setting. METHODS: This prospective cohort study was conducted at the Samsung Medical Center in Seoul, Korea, from September 2018 to January 2019. Cancer patients aged 18 years or older who owned smartphones and who were receiving chemotherapy or radiation therapy were eligible for this study. Patients were asked to use the app to report their symptoms every 7 days for a total of 21 days (3 weeks). Logistic regression was performed to identify the factors associated with the adoption and compliance. RESULTS: Among 580 patients, 417 (71.9%) adopted the ePROM app and 159 (27.4%) out of 417 had good compliance. Patients who had greater expectations regarding the ease of use (adjusted odds ratio [aOR] 2.67, 95% CI: 1.28-5.57) and usefulness (aOR 1.69, 95% CI: 1.05-2.72) of the ePROM app were more likely to adopt the app than those who did not. Patients who had greater satisfaction with usefulness (aOR 1.89, 95% CI 1.10-3.25) were more likely to comply with using the app, but satisfaction with ease of use was not related to the compliance. CONCLUSION: While expectation regarding the ease of use and usefulness of the ePROM app was associated with the adoption of the app, satisfaction with ease of use was not related to compliance with the ePROM app. Satisfaction with usefulness was associated with the compliance of ePROM app use.

Validation of the Korean Version of the Patient-Reported Outcomes Measurement Information System 29 Profile V2.1 among Cancer Survivors.

PURPOSE: The purpose of the study was to validate the Korean version of Patient-Reported Outcomes Measurement Information System 29 Profile v2.1 (K-PROMIS-29 V2.1) among cancer survivors. MATERIALS AND METHODS: Participants were recruited from outpatient clinics of the Comprehensive Cancer Center at the Samsung Medical Center in Seoul, South Korea, from September to October 2018. Participants completed a survey questionnaire that included the K-PROMIS-29 V2.1 and the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). Principal component analysis and confirmatory factor analysis (CFA) and Pearson's correlations were used to evaluate the reliability and validity of the K-PROMIS-29 V2.1. RESULTS: The mean age of the study participants was 54.4 years, the mean time since diagnosis was 1.2 (±2.4) years, and 349 (87.3%) completed the entire questionnaire. The Cronbach's alpha coefficients of the seven domains in the K-PROMIS-29 V2.1 ranged from 0.81 to 0.96, indicating satisfactory internal consistency. In the CFA, the goodness-of-fit indices for the K-PROMIS-29 V2.1 were high (comparative fit index, 0.91 and standardized root-mean-squared residual, 0.06). High to moderate correlations were found between comparable subscales of the K-PROMIS-29 V2.1 and subscales of the EORTC QLQ-C30 (r=0.52-0.73). CONCLUSION: The K-PROMIS-29 V2.1 is a reliable and valid measure for assessing the health-related quality of life domains in a cancer population, thus supporting their use in studies and oncology trials.

Divorce after breast cancer diagnosis and its impact on quality of life.

OBJECTIVE: This study aims to identify factors associated with divorce following breast cancer diagnosis and measures the impact of divorce on the quality of life (QoL) of patients. METHODS: We used cross-sectional survey data collected at breast cancer outpatient clinics in South Korea from November 2018 to April 2019. Adult breast cancer survivors who completed active treatment without any cancer recurrence at the time of the survey (N = 4,366) were included. The participants were classified into two groups: "maintaining marriage" and "being divorced," between at the survey and at the cancer diagnosis. We performed logistic regression and linear regression to identify the factors associated with divorce after cancer diagnosis and to compare the QoL of divorced and nondivorced survivors. RESULTS: Approximately 11.1/1,000 of married breast cancer survivors experienced divorce after cancer diagnosis. Younger age, lower education, and being employed at diagnosis were associated with divorce. Being divorced survivors had significantly lower QoL (Coefficient [Coef] = -7.50; 95% CI = -13.63, -1.36), social functioning (Coef = -9.47; 95% CI = -16.36, -2.57), and body image (Coef = -8.34; 95% CI = -6.29, -0.39) than survivors who remained married. They also experienced more symptoms including pain, insomnia, financial difficulties, and distress due to hair loss. CONCLUSION: Identifying risk factors of divorce will ultimately help ascertain the resources necessary for early intervention.

Psychometric validation of the Korean Patient-Reported Outcome Measurement Information System (PROMIS)-29 Profile V2.1 among patients with chronic pulmonary diseases.

BACKGROUND: This study aimed to validate the Korean version of the Patient-Reported Outcome Measurement Information System 29 Profile V2.1 (K-PROMIS-29 V2.1) in a sample of patients with chronic pulmonary diseases (CPDs). METHODS: Participants were recruited from the respiratory disease outpatient clinics of Samsung Medical Center in Seoul, South Korea, from September to October 2018. Participants completed a survey questionnaire, including the K-PROMIS-29 V2.1 and Short Form Health Survey version-2.0 (SF-36v2). Modified Medical Research Council (mMRC) and chronic obstructive pulmonary disease (COPD) Assessment Test (CAT) scores were obtained these scores from electronic medical records (EMRs). Exploratory and confirmatory factor analyses (CFA) and Pearson's correlations were used to evaluate the reliability and validity of the K-PROMIS-29 V2.1. RESULTS: The mean age [standard deviation (SD)] was 62.8 (12.0) years, and 19.2% had less than middle-school education. Disease types included bronchiectasis (n=46, 24.5%), COPD (n=45, 23.9%), nontuberculous mycobacterial lung disease (n=25, 13.3%), interstitial lung disease (n=22, 11.7%), and others (n=50, 26.6%). Cronbach's alpha coefficients of the 7 subdomains in the K-PROMIS-29 V2.1 ranged from 0.77 to 0.96, indicating satisfactory internal consistency. In CFA, the goodness-of-fit indices were high (comparative fit index =0.90, standardised root mean residual =0.06). Moderate correlations were observed between comparable subscales of the K-PROMIS-29 V2.1 and those of the SF-36v2 (r=0.55-0.70) and CAT (r=-0.80 to 0.70). CONCLUSIONS: The findings of this study suggest that the K-PROMIS-29 V2.1 is a reliable and valid measure for assessing a broad range of health-related quality-of-life domains in patients with CPDs.

Psychometric validation of the Korean version of PROMIS 29 Profile V2.1 among patients with lower extremity problems.

BACKGROUND: Patients with lower extremity problems (LEP) commonly experience functional loss, pain, decreased range of motion, inadequacy in daily living activities, and structural change in radiographic evaluations. However, the traditional patient-reported outcome measurement which focused on symptoms, had a limited scope of applicability. This study aimed to validate the psychometric properties of the Korean version of PROMIS-29 Profile v2.1 (K-PROMIS-29 V2.1), a multi-dimensional measure for assessing generic profile health-related quality-of-life (HRQoL) in a sample of patients with lower extremity problems (LEP). METHODS: Participants were recruited from the orthopedic outpatient clinics at the Samsung Medical Center in Seoul, South Korea from September to October 2018. Participants completed a survey questionnaire that included the K-PROMIS-29 V2.1 and the SF-36v2. Principal component analysis (PCA) and confirmatory factor analysis (CFA) and Pearson's correlations were used to evaluate the reliability and validity of the K-PROMIS-29 V2.1. RESULTS: A total of 299 participants were enrolled in the study and 258 (86%) completed the study questionnaire. The mean age (SD) of the participants was 56.6 (14.5) and 32.3%, 29.8, and 25.2% of the study participants visited outpatient clinics for foot, knee, and hip problems respectively. The Cronbach's alpha coefficients of 7 sub-domains in K-PROMIS-29 V2.1 ranged from 0.80 to 0.95, indicating satisfactory internal consistency. In CFA, the goodness-of-fit indices were high (CFI = 0.937 and SRMR = 0.061). High to moderate correlations were found between comparable subscales of the K-PROMIS-29 V2.1 and subscales of the SF-36v2 (r = 0.55-0.70). CONCLUSIONS: The K-PROMIS-29 V2.1 is a reliable and valid measure for assessing a broad range of health-related quality-of-life domains in patients with LEP. It would reflect the real-life symptoms experienced by patients with LEP.

Patient-Reported Outcomes Measurement Information System: Translation and Linguistic Validation of Six Profile Domains for Korean Adults.

BACKGROUND: The purpose of the study was to translate and linguistically validate a Korean language version of the PROMIS (K-PROMIS) for the six profile adult domains: Fatigue, Pain Intensity, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. METHODS: A total of 268 items were translated into Korean according to the Functional Assessment of Chronic Illness Therapy multilingual translation methodology. Participants first completed approximately 27 to 35 items and were then interviewed to evaluate the conceptual equivalence of the translation to the original English language source. The K-PROMIS items that met the a priori threshold of ≥ 20% of respondents with comprehension difficulties in the cognitive interview. RESULTS: 54 of the 268 items were identified as difficult items to comprehend for at least 20% of respondents in Round 1. The most frequently identified K-PROMIS domain on difficult items to comprehend was the Physical function (24.5%). Most items with linguistic difficulties were Fatigue and Physical function. Cultural difficulties were only included the Physical function and Ability to Participate in Social Roles and Activities domains. 25 of 54 items were slightly revised, and then these revised items were tested with additional six participants in Round 2, and most participants had no problems to understand modified items. CONCLUSION: The six profile adult domains of K-PROMIS have been linguistically validated. Further psychometric validation of the K-PROMIS items will provide additional information of meaningful outcomes for chronic disease and clinical setting.

The difference in knowledge and attitudes of using mobile health applications between actual user and non-user among adults aged 50 and older.

BACKGROUND: Despite the great benefits of mobile health applications (mHAs) in managing non-communicable diseases (NCDs) internationally, studies have documented general challenges to broad adoption of mHAs among older age groups. By focusing on broad adoption, these studies have been limited in their evaluation of adults aged 50 and older who have high risk of NCDs and can benefit the most from the functionalities provided by mHAs. OBJECTIVE: This study aims to evaluate the knowledge, self-confidence, perceived benefits, and barriers of using mHAs depending on experience with mHAs among adults aged 50 and older. Furthermore, we aim to identify the factors associated with the actual use of mHAs. METHODS: We conducted a cross-sectional survey at a single tertiary hospital in Seoul, Korea, between May 1 and May 31, 2018. Of the 625 participants who were contacted, 323 participants were granted full inclusion to the study. We compared demographics, knowledge, self-confidence, and perceived benefits and barriers by experience with using mHAs, then performed logistic regression to identify the factors associated with mHA use. RESULTS: Among the participants, 64.1% (N = 207) had experience using mHAs. Those in the experienced group were more likely to have more than college education (55.1% vs. 27.5%, P < 0.001) and to report a higher monthly income (≥ $7,000, 22.7% vs. 18.1%, P = 0.05) than their less-experienced counterparts. Although the experienced group was more likely to have higher self-confidence in using mHAs, about half of the study participants, including people with experience using mHAs, did not have appropriate knowledge of mobile technology. With adjusted logistic model, higher educated (adjusted PR (aPR) = 1.53, 95% CI, 1.26-1.80), higher perceived benefits of mHAs (aPR = 1.43, 95% CI, 1.04-1.83), and higher self-confidence using mHAs (aPR = 1.41, 95% CI, 1.12-1.70) were significant factors associated with mHA use. CONCLUSIONS: The use of mHAs among adults aged 50 and older is becoming more common globally; nevertheless, there are still people unable to use mHAs properly because of lack of experience and knowledge. Strategies are needed to encourage the reliable usage of mHAs among those who may need it the most by improving self-confidence and better articulating benefits.

Differences in attitudes toward genetic testing among the public, patients, and health-care professionals in Korea.

With further advances in medical genetics, genetic tests to determine predisposition to disease are becoming viable for a growing number of diseases. Accordingly, it has also become important to identify various viewpoints on genetic testing. The aims of this study were to examine awareness of and attitudes toward genetic testing among the general public (public), cancer patients (patients), and health-care professionals (clinicians and researchers) in Korea. The present survey was conducted from November 2016 to February 2017. The public and patients were surveyed via face-to-face interviews conducted by trained interviewers. Health-care professionals were surveyed via self-administered questionnaires. In total, 1500 individuals from the general public, 1500 cancer patients, 113 clinicians, and 413 researchers were surveyed. Most respondents from the public and patients had previously heard about genetic testing (public, 89.4%; patients, 92.7%, p < 0.01). Differences in attitudes toward genetic testing among the public, patients, and professionals were noted, although most respondents in the present study were aware of genetic testing. Most of the cancer patients tended to overestimate the potential benefit of genetic testing, whereas clinicians expressed concerns for genetic testing. Providing correct information to people who are scheduled to undergo or order genetic testing could help in making an informed decision thereon.