Participants in the study will receive training in using the ePRIME system to report their symptoms and side effects on a weekly basis from home via the internet for 12 weeks while receiving early phase trial treatment. Patients will be sent email/text reminders to enter their symptoms on the system once a week. Patients will be reminded that the data they enter via the online system will not be reviewed promptly by their hospital team and therefore they should continue to contact their treatment team via the contact numbers they have been given.

As part of the research project, we will monitor the number of notifications for severe AE generated by the system to address concerns from the interviews conducted in the first phase of this research project that ePROs will lead to increased workload for clinicians.

ePRIME is an online system for patients to self-report symptoms and AE during cancer treatment. ePRIME allows AE reporting from home or hospital and enables patient reported data to be integrated into existing EPR to allow for the reports to be used in routine care. In addition the system is capable of generating notifications for severe AE to the relevant clinical team and providing patient advice on managing mild and moderate AE.

ePRIME symptom monitoring tool

Galina Velikova

New treatments are continually being developed to help patients living with advanced cancer, which require extensive clinical trials before authorisation for standard clinical use. Reporting of adverse events (AE) in this setting is essential to ensure treatment safety and tolerability. The current system for reporting AEs, the Common Toxicity Criteria and Adverse Events (CTCAE) relies on the clinician's interpretation of patient symptoms, but a substantial body of evidence suggests clinicians miss/underestimate AEs experienced by patients. The aim of the overall project is to explore the implementation of an electronic patient-reported outcomes (ePRO) system to gather adverse events data in early phase clinical trials (EPCT) patients. In Phase 1 of this study, through semi-structured interviews, we explored patient, healthcare, and clinical trial staffs' views about collecting electronic patient-reported outcomes in this setting. This work informed the direction of the current pilot. This proof-of-principle feasibility study will explore the feasibility and satisfaction with using an electronic system to remotely self-report AEs whilst on EPCT. The key objectives are to:

1. Evaluate the feasibility of using a secure online method (ePRIME system) to collect PRO-AEs in EPCT patients.
2. Explore patient satisfaction with the use of the ePRIME system to collect PRO AEs in EPCT patients.
3. Monitor the number of notifications for severe AEs generated by the system to address concerns from the interviews that ePROs will lead to increased workload.

To this end, a prospective longitudinal pilot will be conducted of the ePRIME system in early phase clinical trial patients in Leeds and Sheffield. A convenience sample of patients enrolled in Phase I or Phase II trials will be recruited. Patients in general oncology and haematology clinics will be included if diagnosed with metastatic or progressive disease and are presently receiving novel agents in an academic early phase clinical trial, such as chemotherapy, targeted agents, or chemo-radiotherapy. Patients will be included in this pilot whether the trial is a test of a novel drug, drug combination, or dose escalation. The study will aim to identify, approach, and consent all eligible patients over a minimum of a 12 month period. If they are over 18, able to give informed consent, have access to internet via any device, and able to read and understand English. Patients will be approached and consented within 1 month of having been entered in the clinical trial. Patients will not be eligible if they will be on the clinical trial for less than 3 months. Each patient will complete a patient-reported AE checklist at baseline (i.e. time of consent) and then weekly for 12 weeks. At the end of the 12 weeks an end-of-study interview will be conducted to explore patient satisfaction with the system. It is envisaged that this project will provide initial information on the feasibility and acceptability of a novel electronic system to facilitate the collection of patient-reported AEs in early phase trials.

ePRIME: Patient-Reported AEs in Early Phase Trials

Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences (ePRIME): Collection of Patient-reported Adverse Events in Early Phase Clinical Trials in Yorkshire

Feasibility of using a secure, online system to record, monitor, and help patients report AEs. It will be measured through:

* the number of participants consenting versus declining;
* compliance with the ePRIME trial through the number of missed completions, out of the 12 weeks (minimum) prompted by the research team;
* number and timing of participant withdrawals and reasons;
* number of completions in addition to the weekly prompts;
* number of completions that generate notifications to the early phase clinical trials ePRIME email address.

We will explore participant satisfaction with the use of the system. Through an end-of-study interview with patients and healthcare professionals we will explore the perceived burden, barriers, and opportunities and benefits of using the novel system. In addition to this, we will also explore system usability parameters such as time of log-on and log-off, time taken to complete the measures, time outs, and time spent on each page/section.

Yorkshire Cancer Research

The Leeds Teaching Hospitals NHS Trust

Sheffield Teaching Hospitals NHS Foundation Trust

University of Leeds

Professor of Psycho-social and Medical Oncology/Consultant in Medical Oncology

Blood and Lymph Conditions

All Conditions

Hematologic Diseases

Review list of 25 cancer symptoms, 20-30 minute audio-taped personal interview and 15-20 minute questionnaire.

Interview

Tito Mendoza, PhD, MS, MED

The scientific aim of this study is to evaluate patient comprehension of the 77 newly developed items as well as the extent to which the items correspond to the concepts of interest for each patient reported outcome (PRO).

A secondary aim of this study is to evaluate the usability of the technology interface for collecting the PRO data of the PRO-CTCAE system once it has been built to accommodate the learning garnered during the cognitive interviews.

Screening:

The study staff will talk to your doctor or nurse, and/or look at your medical record, to see if you are currently receiving treatment. The study staff will also look at your medical record to see if you have any future clinic visits at M. D. Anderson. This is the first step of "screening" to help the researchers decide if you are eligible to take part in this study.

If you are found to be possibly eligible to take part in this study based on the first step of screening, the second step of screening will occur:

At your clinic visit, the study staff will talk to you about this study. You will be asked questions about school, which should take about 2 minutes.

Study Visit If you are found to be eligible and you agree to take part in this study, you will look at a list of 34 cancer symptoms if you are a male or a list of 36 cancer symptoms if you are a female. You will fill out a questionnaire that asks you to mark each symptom that you may be experiencing at this time, and other information about the symptoms such as how often they occur.

After you complete the questionnaire, you will be interviewed by the study staff about how you answered some of the questions. For example, you will be asked if the words describing the symptoms were easy to understand or if other words may be more clear.

There are no right or wrong answers to any part of this study. Researchers are interested in your thoughts about the words.

Filling out the questionnaire will take about 10-15 minutes. The interview will take about 20-30 minutes.

Study Data:

The interview will be audio-recorded. Only the study staff will hear the recording. The recording will be saved on a password-protected computer that can only be accessed by the study staff.

Your responses will be coded without using your name or other personal identifying information. Only the study staff will have access to the code numbers and be able to identify you.

Your responses will not be shared with your doctor without your consent.

In some of the questions, you will be asked about your feelings (for example, whether you feel unhappy or anxious). If your responses show that you may be having emotional difficulties, you will be given a list of community agencies that provide services for emotional issues. You may also speak to your doctor about your feelings.

Length of Study:

After the study visit, your active participation will be over. In some cases, the study staff may call you to ask that you clarify some of your answers. Your medical record may also be checked to confirm the cancer diagnosis and your treatments.

This is an investigational study. Up to 100 patients will take part in this study. Up to 20 will be enrolled at M. D. Anderson.

Patient-Reported Outcomes Version of Common Terminology Criteria (CTCPRO) Cognitive Debriefing

Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing

The primary assessment tool will be the cognitive interview protocol.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Children, adolescents, and adults who are still in follow-up care (data are collected retrospectively until 2016 at the most)

Children, adolescents, and adults who left follow-up care (data are collected retrospectively until 2016 at the most)

Physical examination, diagnostic tests (e.g. lung function test, echocardiography, audiometry), and laboratory tests (e.g. kidney parameter, hormonal levels) depend on examined organ system.

Physical examination, diagnostic tests, laboratory tests

Personal history on diagnosis, treatment, and socioeconomic factors

Personal history

Katrin Scheinemann, MD

Maria Otth, MD

Daniel Drozdov, MD

Claudia Huegli, MD

The Young Survivors at Kantonsspital Aarau project assesses the prevalence and severity of late effects in survivors of childhood and adolescent cancer according to the modified CTCAE criteria prospectively. The clinical data are generated during regular follow-up care visits, the collection starts directly after completion of treatment and is longitudinally.

Background:

Around 250-300 children and adolescents below the age of 21 years are newly diagnosed with cancer in Switzerland every year. Research led to remarkable progress in survival in the last decades. The 10-year survival rate in Switzerland is currently 87%. Previous research showed that, depending on the treatment exposure, a high proportion of these survivors suffer from chronic medical conditions, so called late effects.

Many studies on late effects in former childhood cancer patients are based on retrospective data. However, this type of study design has unavoidable limitations, such as missing data, different coding and grading of severity of late effects, and the assessment at different time points. Therefore, we need prospectively collected data, including severity coding in a standardized way, to overcome these limitations.

Objectives:

The overarching aim of "Young Survivors at Kantonsspital Aarau, Switzerland" is to assess late effects in childhood cancer survivors prospectively and in a standardized way. These data will contribute to the increasing knowledge on long-term outcomes and late effects in the future. This new knowledge is important in order to be able to adapt and improve long-term follow-up care. In the longer term, survivors will benefit from this extensive and prospective data collection.

Methods:

"Young Survivors at Kantonsspital Aarau" has a registry-like design. Data produced during regular follow-up visits are collected in a comprehensive database and in a standardized way. We collect all information generated prospectively from start of the study onwards and retrospectively until January 2016. From 2016 onward, all medical records are kept electronically. We classify and grade the severity of late effects according to the modified National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.03). The outcome variables correspond to results from risk-stratified organ examinations, which are performed according to the Children's Oncology Group guidelines v5.0. The exposure variables correspond to information from the patients' medical history, including detailed information on cancer diagnosis and treatment. The data will be analyzed in an exposure- or organ system-driven approach. We start recruitment with patients diagnosed and treated at the Kantonsspital Aarau. The design of the study allows the inclusion of other clinics in the future.

Research and significance:

Research on late effects of former childhood cancer patients often relies on retrospective data collection, which is associated with unpreventable limitations. "Young Survivors at Kantonsspital Aarau" overcomes these limitations and additionally grades the severity of late effects in a standardized way. This allows us to analyze changes in severity of late effects over time, within and between survivors. This information will increase our knowledge on late effects and contribute to long-term follow-up care.

Young Survivors at Kantonsspital Aarau, Switzerland

Young Survivors at Kantonsspital Aarau, Switzerland - A Standardized Assessment of Long-Term and Late-Onset Health Events in Survivors of Childhood and Adolescent Cancer

Number of survivors with heart valve disorder, hypertension, left ventricular systolic dysfunction when at risk for cardiac late effects

Number of survivors with heart valve disorder, hypertension, left ventricular systolic dysfunction etc. when at risk for cardiac late effects

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ePRIME: Patient-Reported AEs in Early Phase Trials	NCT03461939	Cancer	ePRIME symptom ...	18 Years -	University of Leeds
Patient-Reported Outcomes Version of Common Terminology Criteria (CTCPRO) Cognitive Debriefing	NCT00909207	Advanced Cancer... Hematologic Dis... Solid Tumors	Interview	18 Years -	M.D. Anderson Cancer Center
ePRIME: Patient-Reported AEs in Early Phase Trials	NCT03461939	Cancer	ePRIME symptom ...	18 Years -	University of Leeds
Young Survivors at Kantonsspital Aarau, Switzerland	NCT04811794	Childhood Cance... Late Effects	Physical examin... Personal histor...	-	Kantonsspital Aarau

Spots Global Cancer Trial Database for ctcae

Every month we try and update this database with for ctcae cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ctcae

Every month we try and update this database with for ctcae cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ctcae cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.