scholarly journals A Novel Digital Patient-Reported Outcome Platform for Head and Neck Oncology Patients–-A Pilot Study

2016 ◽  
Vol 9 ◽  
pp. CMENT.S40219 ◽  
Author(s):  
Maria K. Peltola ◽  
Joel S. Lehikoinen ◽  
Lauri T. Sippola ◽  
Kauko Saarilahti ◽  
Antti A. Mäkitie

Introduction The patient's role in toxicity reporting is increasingly acknowledged. There is also a need for developing modern communication methods between the patient and the medical personnel. Furthermore, the increasing number of head and neck cancer (HNC) patients is reflected in the volume of treatment follow-up visits, which remains a challenge for the health care. Electronic patient-reported outcome (ePRO) measures may provide a cost-efficient way to organize follow-up for cancer patients. Materials and Methods We tested a novel ePRO application called Kaiku®, which enables real-time, online collection of patient-reported outcomes, such as side effects caused by treatment and quality of life. We conducted a pilot study to assess the suitability of Kaiku® for HNC patients at the Department of Oncology, Helsinki University Hospital, Helsinki, Finland. Patients used Kaiku® during and one month after radiotherapy to report treatment-related side effects and quality of life. Two physicians and a nurse performed the practical electronic communication part of the study. Results Five of the nine patients agreed to participate in the study: three of them had local early-stage larynx cancer (T2N0, T1aN0, and T2N0) and the remaining two patients had early-stage base of tongue cancer (T2N0 and T1N2b). The degree of side effects reported by the patients via Kaiku® ranged from mild to life threatening. The number of outcome data points on patients' progress was significantly increased, which resulted in a better follow-up and improved communication between the patient and the care team. Conclusions Kaiku® seems to be a suitable tool to monitor side effects and quality of life during and after radiotherapy among HNC patients. Kaiku® and similar tools could be useful in organizing a cost-effective follow-up process for HNC patients. We recommend conducting a larger study to further assess the impact of an ePRO solution in routine clinical practice. • ePRO solutions may aid in the follow-up for cancer patients. • They seem suitable to monitor, for example, side effects and quality of life. • These systems ensure fast patient-driven reporting.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Salzwedel ◽  
I Koran ◽  
E Langheim ◽  
A Schlitt ◽  
J Nothroff ◽  
...  

Abstract Introduction Comprehensive cardiac rehabilitation (CR) programs based on the bio-psycho-social approach of the international classification of functioning and disease are carried out to achieve improved prognosis, superior health-related quality of life (HRQL) and social integration. We aimed to identify predictors of returning to work (RTW) and HRQL among cardiovascular risk factors and physical performance as well as patient-reported outcome measures (PROMs) modifiable during CR. Methods We designed a prospective observational multi-center study and enrolled 1,586 patients (2017/18) in 12 German rehabilitation centers regardless of their primary allocation diagnoses (e.g. acute myocardial infarction (AMI), coronary artery bypass grafting (CABG), coronary artery disease (CAD), valvular disease). Besides general data (e.g. age, gender, diagnoses), parameters of risk factor management (e.g. smoking, lipid profile, hypertension, lifestyle change motivation), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance), and PROMs (e.g. depression, heart-focused anxiety, HRQL, subjective well-being, somatic and mental health, pain, general self-efficacy, pension desire as well as self-assessment of occupational prognosis using several questionnaires) were documented at CR admission and discharge. 6 months after discharge, status of RTW and HRQL (SF-12) were captured by a follow-up (FU) survey and analyzed in multivariable regression models with multiple imputation of missing values. Results Out of the study participants, 1,262 patients (54±7 years, 77% men) responded to the follow-up survey and could be analyzed regarding the outcome parameters. Most of them were assigned to CR primarily due to AMI (40%) or CAD without myocardial infarction (18%), followed by heart valve diseases in 12% of patients and CABG (8%). 864 patients (69%) returned to work within the follow-up period. Pension desire, negative self-assessed occupational prognosis, heart-focussed anxiety, major life events, smoking and heart failure were negatively associated with RTW, while higher endurance training load, HRQL and work stress were positively associated (Figure 1). HRQL after 6 months was determined more by PROMs (e.g. pension desire, heart-focused anxiety, physical/mental HRQL in SF-12, physical/mental health in indicators of rehab-status questionnaire (IRES-24), stress, well-being in the World Health Organization well-being index and self-efficacy expectations) than by clinical parameters or physical performance. Conclusions Patient-reported outcome measures predominantly influenced RTW and HRQL in heart-disease patients, whereas patients' pension desire and heart-focussed anxiety had a dominant impact on all investigated endpoints. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. Figure 1. Predictors of returning to work Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German pension insurance


Author(s):  
Marilot C. T. Batenburg ◽  
Wies Maarse ◽  
Femke van der Leij ◽  
Inge O. Baas ◽  
Onno Boonstra ◽  
...  

Abstract Purpose To evaluate symptoms of late radiation toxicity, side effects, and quality of life in breast cancer patients treated with hyperbaric oxygen therapy (HBOT). Methods For this cohort study breast cancer patients treated with HBOT in 5 Dutch facilities were eligible for inclusion. Breast cancer patients with late radiation toxicity treated with ≥ 20 HBOT sessions from 2015 to 2019 were included. Breast and arm symptoms, pain, and quality of life were assessed by means of the EORTC QLQ-C30 and -BR23 before, immediately after, and 3 months after HBOT on a scale of 0–100. Determinants associated with persistent breast pain after HBOT were assessed. Results 1005/1280 patients were included for analysis. Pain scores decreased significantly from 43.4 before HBOT to 29.7 after 3 months (p < 0.001). Breast symptoms decreased significantly from 44.6 at baseline to 28.9 at 3 months follow-up (p < 0.001) and arm symptoms decreased significantly from 38.2 at baseline to 27.4 at 3 months follow-up (p < 0.001). All quality of life domains improved at the end of HBOT and after 3 months follow-up in comparison to baseline scores. Most prevalent side effects of HBOT were myopia (any grade, n = 576, 57.3%) and mild barotrauma (n = 179, 17.8%). Moderate/severe side effects were reported in 3.2% (n = 32) of the patients. Active smoking during HBOT and shorter time (i.e., median 17.5 vs. 22.0 months) since radiotherapy were associated with persistent breast pain after HBOT. Conclusion Breast cancer patients with late radiation toxicity reported reduced pain, breast and arm symptoms, and improved quality of life following treatment with HBOT.


1997 ◽  
Vol 116 (6) ◽  
pp. 666-673 ◽  
Author(s):  
Eva Hammerlid ◽  
Kristin Bjordal ◽  
Marianne Ahlner-ELMQVIST ◽  
Magnus Jannert ◽  
Stein Kaasa ◽  
...  

Despite modern advances in the treatment of head and neck cancer, the survival rate fails to improve. Considering the different treatment modalities involved, quality of life has been thought of as an additional end point criterion for use in clinical trials. A Nordic protocol to measure the quality of life of head and neck cancer patients before, during, and after treatment was established. Before the study, a pilot study was done with this protocol. The main purpose of this pilot study was to find out whether this cancer population would answer quality-pf-life questionnaires repeatedly (six times) over a 1-year period and whether the chosen questionnaires—a core questionnaire (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)), a tumor-specific questionnaire, and a psychological distress measure (Hospital Anxiety and Depression scale (HAD))—were sensitive for changes to functions and symptoms during the study year. The results presented in this article all refer to the pilot study. Forty-eight consecutive patients agreed to participate in the study. The most common tumor locations were the oral cavity (17) and the larynx (12). Almost all patients received combined treatment: 45 of 48 radiation therapy, 18 of 48 chemotherapy, and 17 of 48 surgery. After the primary treatment, 40 patients had complete tumor remission. Four of the 48 patients did not answer any questionnaires and were therefore excluded from the study. Of the remaining 44 patients, 3 died during the study year, and another 6 withdrew for various reasons. Thirty-five (85%) of the 41 patients alive at the 1-year follow-up answered all six questionnaires and thus completed the study. Mailed questionnaires were used throughout the study. All questionnaires were well accepted and found to be sensitive to changes during the study year. The greatest variability was found for symptoms and functions related specifically to head and neck cancer. The symptoms were swallowing difficulties, hoarse voice, sore mouth, dry mouth, and problems with taste. They all showed the same pattern, with an increase of symptoms during and just after finishing the treatment. The HAD scale revealed a high level of psychological distress, with 21% probable cases of psychiatric morbidity at diagnosis. In conclusion, it was shown that the study design and questionnaires were feasible for the forthcoming prospective quality-of-life assessment of Swedish and Norwegian head and neck cancer patients.


2019 ◽  
Vol 3 (4) ◽  
Author(s):  
Paolo Tordiglione ◽  
Fabio Silvio Mario Araimo ◽  
Carmela Imperiale ◽  
S. Zancla

BACKGROUND: Our group in Policlinic Umberto I - University Hospital of Sapienza Rome - has decided to further investigate if Ozone therapy can be of support in oncology. In literature it has been reported that ozone applications in oncology or in cancer cells is associated with: high efficiency in preventing chemotherapy complications (nausea, vomiting, opportunistic infections, asthenia) as well as confining or restricting the expansion of tumours.(1-5) PURPOSE: The aim of our study in to evaluate and eventually confirm the validity of ozone treatments in order to consider such procedures as a possible and concrete support therapy for oncology patients undertaking chemotherapy. A statistical significance and clinical evaluation of our work would finally give a scientifically validation, still missing, to officially consider ozone therapy as one of the many possible integrative therapy in oncology. DESIGN: It is a pilot study designed and approved by the Ethical Committee of the University of Rome, La Sapienza (March 2017) to evaluate quality of life and reduction of side effects of adjuvant chemotherapy in 20 breast cancer patients. METHODS: The selected patients will be treated with systemic ozone treatment: Ozonated autohemotherapy will be performed according to the following method: 200 ml venous blood will be exposed an equal amount of O2 /O3 (200 ml) The ozone concentration will be gradually increased as follows: 20-30-40 mcrg/mL with a specific schedule until each patient will receive 15 applications overall. The sessions will be scheduled according to a specific timetable during the administration of adjuvant chemotherapy by means of Epirubicin and Cyclophsphamide (EC) every 3 weeks for 4 cycles followed by Paclitaxel for 12 consecutive weeks. Ozone therapy will not be applied on days of chemotherapy in order to avoid interaction between chemotherapeutics and ozonides. Biochemical blood analysis and stress oxidative blood test will be used as parameters for activity of antioxidant defence system. Quality of life will be evaluated with Fact G Test. It is the first study to have been evaluated and approved by an official university ethical committee and we will be glad to publish our result as soon as possible. On this behalf it would be great if any other centre could be interested in cooperating with us so to transform this pilot study into a multicentre study with larger numbers and therefore, with a greater impact on the international community. Our aim is to give cancer patients a better life quality in general and especially help them overcome all the side effects during the chemotherapy. This could open a new scenario in the alternative complementary treatments in oncology.


2020 ◽  
Author(s):  
Sanna Iivanainen ◽  
Tuomo Alanko ◽  
Pia Vihinen ◽  
Teemu Konkola ◽  
Jussi Ekstrom ◽  
...  

BACKGROUND Immune checkpoint inhibitors (ICIs) have become a standard of care for various tumor types. Their unique spectrum of side effects demands continuous and long-lasting assessment of symptoms. Electronic patient-reported outcome (ePRO) follow-up has been shown to improve survival and quality of life of cancer patients treated with chemotherapy. OBJECTIVE This study aimed to investigate whether ePRO follow-up of cancer patients treated with ICIs is feasible. The study analyzed (1) the variety of patient reported symptoms, (2) etiology of alerts, (3) symptom correlations, and (4) patient compliance. METHODS In this prospective, one-arm, multi-institutional study, we recruited adult cancer patients whose advanced cancer was treated with anti-programmed cell death protein 1 (PD)- ligand (L)1 agents in outpatient settings. The ePRO tool consisted of a weekly questionnaire evaluating the presence of typical side effects, with an algorithm assessing the severity of the symptom according to National Cancer Institute Common Terminology Criteria for Adverse Events and an urgency algorithm sending alerts to the care team. A patient experience survey was conducted monthly. The patients were followed up to 6 months or until disease progression. RESULTS A total of 889 symptom questionnaires was completed by 37 patients (lung cancer, n=15; melanoma, n=9; genitourinary cancer, n=9; head and neck cancer, n=4). Patients showed good adherence to ePRO follow-up. The most common grade 1 symptoms were fatigue (28%) and itching (13%), grade 2 symptoms were loss of appetite (12%) and nausea (12%), and grade 3-4 symptoms were cough (6%) and loss of appetite (4%). The most common reasons for alerts were loss of appetite and shortness of breath. In the treatment benefit analysis, positive correlations were seen between clinical benefit and itching as well as progressive disease and chest pain. CONCLUSIONS According to the results, ePRO follow-up of cancer patients receiving ICIs is feasible. ePROs capture a wide range of symptoms. Some symptoms correlate to treatment benefit, suggesting that individual prediction models could be generated. CLINICALTRIAL Clinical Trials Register, NCT3928938; https://clinicaltrials.gov/ct2/show/NCT03928938


2021 ◽  
Author(s):  
Pimrapat Gebert ◽  
Daniel Schindel ◽  
Johann Frick ◽  
Liane Schenk ◽  
Ulrike Grittner

Abstract BackgroundPatient-reported outcome measures (PROMs) are commonly used and are surrogates for clinical outcomes in cancer research. In the research setting of very severe diseases such as cancer, it is difficult to avoid the problem of incomplete questionnaires from drop-out or missing data due to patients who deceased during observation period. We aimed to explore patient characteristics and patient-reported outcomes associated with the time-to-dropout. MethodsIn the Oncological Social Care Project (OSCAR) study the condition of participants was assessed four times within 12 months (t0: baseline, t1: 3 months, t2: 6 months, and t3: 12 months) by validated PROMs. We performed competing-risks regression based on Fine and Gray’s proportional sub-distribution hazards model for exploring factors associated with time-to-dropout. Death was considered as competing risk. ResultsThree hundred sixty-two participants were analyzed in the study. 193 (53.3%) completed follow-up at 12 months, 67 (18.5%) patients dropped out, and 102 patients (28.2%) died during the study period. Poor subjective social support was related to higher risk for drop-out (SHR=2.10; 95%CI: 1.01 – 4.35). Lower values in health-related quality of life were related to drop-out and death. The subscales global health status/QoL, role functioning, physical functioning, and fatigue symptom in the EORTC QLQ-C30 were key characteristics associated with early drop-out.ConclusionSeverely affected cancer patients with poor social support and poor quality of life seem more likely to drop out of studies compared to patients with higher levels of social support and quality of life. This should be considered when planning studies assessing cancer patients. Methods to monitor drop-outs timely and handle missing outcomes might be used. Results of such studies have to be interpreted with caution in light of the particular drop-out mechanisms.


2019 ◽  
Vol 5 (suppl) ◽  
pp. 9-9
Author(s):  
Naiyarat Prasongsook ◽  
Kasan Seetalarom ◽  
Siriwimon Saichaemchan ◽  
Kitipong Udomdamrongkul

9 Background: Web-based patient reported outcome (PRO) improved quality of life (QoL), and overall survival (OS) in patients with advanced NSCLC who were treating with specific therapy. Lung Cancer Care application is a mobile application program that provides patients with individually tailored information on patient reported outcome. This study aims to invent a novel mobile application evaluating PRO for Thai NSCLC patients, and to evaluate the validity of mobile application. Methods: Our mobile application-based PRO was designed for monitoring quality of life. The validity of the application was tested following guidelines for translating, and validating a questionnaire. The quality of life score (FACT-L score). After the validated mobile application-based PRO, patients with advanced NSCLC were randomized to use mobile application-based PRO versus routine follow-up. The primary endpoint was quality of life (QoL). Secondary endpoint was OS. Results: Thirty-three patients with advanced NSCLC were enrolled. The mean of FACT-L score at baseline in mobile application-based PRO arm and routine follow up arm was similar (90.08 ± 5.66 vs 91.78 ± 5.26, p-value= 0.82). Patients with mobile application group had more FACT-L score at 3 months than patients with routine follow up arm (106 ± 5.97 vs 99.96 ± 5.74, p-value = 0.07). There was a trend towards increased in different mean of FACT-L score at baseline and 3 months in patients with mobile application compared to patients with routine follow up ( p-value = 0.05). The median follow-up time was 5.43 months, patients with mobile application had longer median OS than patients with routine follow up (4 months vs 2.9 months, p-value = 0.5). Conclusions: Lung Cancer Care application based on self-reported symptoms is a novel electronic device for real-time patient care monitoring. Our study results showed trend towards improved quality of life from using this novel mobile application. However, there was small samples for pilot testing, the relatively large sampling errors may reduce the statistical power needed to validate this tool.


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