Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

All men will receive EPIC-26 in paper and also an electronic version.

Patients are asked to complete EPIC-26 questionnaire in paper and electronically

electronic PROMs questionnaire

Antti S Rannikko, MD, PhD

This is an observational study where prostate cancer related PROMs (EPIC-26) is collected using two different methods (by paper questionnaires and electronically) and patient experience and preference is asked.

Prostate cancer patients that are treated with radiation therapy for local prostate cancer receive EPIC-26 before treatment and during follow-up. EPIC-26 is collected both traditionally using paper questionnaires and electronically. Patients experience and preference for these are asked.

Electrical Patient Reported Outcome of Prostate Cancer RadioTherapy

Protocol will be shared on the study group website once registered in ClinicalTrials.Gov.

patient preference for type of questionnaire (paper versus electronic)

Patient QoL after RT (EPIC-26, scale 0-100)

Helsinki University Central Hospital

assistant professor

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Anette S. Kargo, MD

Karina D. Steffensen, MD, PhD

In 2015 the Danish healthcare authorities initiated major changes in the follow-up (FU) program for patients with ovarian cancer. The new FU program argues that there is no effect of routine monitoring, and every patient's FU is now individualized. These changes have caused major concern, especially regarding the omission of routine examinations aimed at detection of recurrence, since clinical symptoms of relapse can be diffuse. Clearly, tools and FU plans to support the patients in feeling safe during FU are of vital importance.

Patient-reported outcome measures (PROM) is a tool to improve the focus on patients' needs, symptoms and preferences. It is also a tool to monitor quality of life (QoL), and side effects.

300 patients with ovarian cancer are planned to be enrolled after primary treatment when they enter follow-up program. This is a multi-center study.

All participants fill in a questionnaire at baseline and then every 3 months for two years, and every 6 months the third year. The questionnaire consists of EORTC-QLQ-C30, EORTC-OV28, and questions on symptoms of relapse. At baseline the questionnaire is extended with demographic issues.

The patients will also fill in a brief questionnaire (CollaboRATE) dealing with patient satisfaction and the level of shared decision making experienced.

All participants are followed for 3 years.

Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making

Danish Cancer Society

AmbuFlex

Vejle Hospital

Patients in the intervention group will receive weekly teleconsultation of 30 minutes during 8 weeks through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be performed by a remote physiotherapist and will consist of a series of rehabilitation exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist and will consist of techniques for managing emotions and stress. In the intervention group, patients will also have the possibility to wear a smartwatch to automatically collect physical parameters.

Patients in the control group will receive usual care.

Pilot 1a/b : the tele-rehabilitation intervention in BC or H\&N operated patients will consist of a series of exercises. The physiotherapist during teleconsultation rehabilitation program will explain to the patient how to perform the movements and regulate breathing. Practical advice on correct and incorrect habits will also be dispensed by the physiotherapist during the teleconsultation.

Pilot 2: the tele-rehabilitation intervention will consist of tele psychological support performed by a trained psychologist in each participating center It will consist of the learning of techniques for managing negative emotions, for relaxation and for implementing effective behavioural and coping strategies.

For each group, the TC will be scheduled every week for 8 weeks. The session will be available on a secure platform (Edumeet). Moreover, if they agree to, patients will also wear a smart watch to monitor physical parameters such as physical activity, sleeping and heart rate.

Telemedicine

Andrea Pace, Dr

Victoria Leclercq, PhD

Timon Vandamme, Dr

Contantinos Zambogou

Angelos Kassianos, Dr

Anastasia Constantinidou

Eleni Timotheadou

József Lövey, Dr

Des OToole

Maria C Piccirillo

Viktoras Rudzianskas

Jolanta Paskeviciene

Marija Turlinksienė

Rui Soares

Joana Dias

Maria Moura

Otilia Romano

Eunice Silva

Cvetka Grašič Kuhar

Ignacio Durán

David Vicente

The integration of teleconsultation (TC) and telemonitoring (TM) in cancer patients care may allow to improve person-centered care and patients' empowerment.

The eCAN JA explores the role of telemedicine tools (i.e. TC \& TM) in clinical trials focusing on tele-rehabilitation and tele-psychological support in different populations of cancer patients in 10 European countries. The pilots will be conducted among 354 patients affected by breast (BC, pilot 1a), head \& neck (H\&N, pilot 1b) and advanced (pilot 2) cancers.

The main aim is to assess the effect of TC and TM program focused on rehabilitation and psychological support for cancer patients on patient reported outcomes measures (PROMs) in three pilots compare to usual care.

Patients will be randomly assigned either to the intervention or control groups using a 1:1 ratio. Patients in the intervention group will receive weekly TC of 30 minutes during 8 weeks through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be performed by a remote physiotherapist and will consist of a series of rehabilitation exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist and will consist of techniques for managing emotions and stress. In the intervention group, patients will also have the possibility to wear a smartwatch to automatically collect physical parameters. Patients in the control group will receive usual care.

PROMs (i.e. quality of life, distress and pain) and physical parameters (i.e. physical activity, sleep quality and heart rate) will be monitored by a dedicated telemonitoring systems. A secure web platform will provide dashboard to clinicians for decision support. Patients' experience and costs data will be also collected. The results of the eCAN project will improve our knowledge on benefits and risks for TC and TM in cancer patients care.

Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA

Telerehabilitation and Tele-psychological Support in Cancer Patients: the Pilots Projects of eCAN JA

physical activity, number of steps, will be collected via wearable devices

The average sleep quality (light sleep, deep sleep, REM sleep) will be collected via wearable device (Garmin watche)

Daily heart rate (beats per minute) trend will be collected via wearable device (Garmin watche)

Costs that arose for patients will be collected using a patient-reported cost questionnaire.

usability of the teleconsultation program and telemonitoring with mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients

usability of the teleconsultation program and telemonitoring with TELEHEALTH USABILITY QUESTIONNAIRE (TUQ)

Visual Analogical Scale (VAS). The ends are defined as the extreme limits of the parameter to be measured (orientated from the left (0 the worst) to the right (100 the best).

NCCN Distress thermometer.Distress is an unpleasant experience of a mental, physical, social, or spiritual nature. It can affect the way you think, feel, or act. Distress may make it harder to cope with having cancer, its symptoms, or its treatment. Please circle the number (0-10) that best describes how much distress you have been experiencing in the past week, including today.

European Commission

Sciensano

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Immunomodulating Agents

Patients will receive standard of care curative-intent radiotherapy treatment as decided by their primary oncologist. This includes radical radiotherapy, sequential chemoradiotherapy and concurrent chemoradiotherapy +/- consolidation immunotherapy.

No changes in treatment. Patients will have data collected at baseline, during radiotherapy and for one year following radiotherapy. This longitudinal collection will include blood for circulating-tumour DNA analysis, electronic PROMS and radiomic analysis of standard of care imaging.

Ashley Horne

Clare Dempsey

Corinne Faivre-Finn

In stage 3 NSCLC, treatment and follow-up are generally performed in a 'one-size-fits-all' manner. In the setting of metastatic lung cancer there has been considerable success identifying biomarkers, which allow treatments to be tailored and lead to more personalised medicine. In patients with stage 3 disease there exists a significant unmet clinical need for equivalent biomarkers to guide treatment decisions such as to identify poor responders, predict benefit from treatment and diagnose relapse before standard of care imaging. Recent advances have made it possible to detect and quantify circulating-tumour DNA in peripheral blood of patients with stage 3 NSCLC, a promising prognostic biomarker and a measure of minimal residual disease. In addition, the information contained in routine medical images and electronic patient reported outcome measure (ePROM) questionnaires can add further predictive power to circulating tumour DNA and other clinical factors to determine patient's outcome. There is scope to integrate biomarkers in treatment decision algorithms aiming to make personalised treatment modifications (e.g. decision to treat with immunotherapy or not). VIGILANCE is a highly exploratory observational study to understand how these biomarkers might inform a future hypothesis driven interventional study.

Circulating-tumour DNA is collected for analysis

Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer

Cancer Research UK

University of Manchester

Professor Corinne Faivre-Finn

In the audit-phase, a group of 59 patients will be recruited and followed over a 12 month period. Data will be collected on clinical and patient outcomes in an audit in order to be able to compare to the intervention (after-phase) group.

In the pilot-phase, a group of 59 patients will be recruited and followed over a 6-12 month period. Patients in this group will be assigned to the new remote monitoring follow-up pathway (ePRIME), whereby instead of attending routine outpatient appointments they are monitored remoted via a online symptom monitoring questionnaire and related clinical tests undertaken remotely. All information is collated in the patient's electronic patient record, and clinicians will review/respond to the data as necessary.

ePRIME is an remote monitoring pathway that includes an online system for patients to self-report symptoms and AE following cancer treatments. ePRIME allows AE reporting from home 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 alerts for serious symptoms to the relevant clinical team and providing patient advice on managing mild and moderate symptoms.

ePRIME

Galina Velikova

Improvements in cancer treatment have led to an increasing number of patients being cured or in remission, but they are followed up to detect recurrence, manage persistent symptoms and late treatment effects. With growing survivors, traditional hospital follow-up is not sustainable. New models of follow-up care are needed. This research project aims to develop and establish the feasibility of introducing a new electronic care pathway/system for remote monitoring ovarian cancer patients in remission. The project includes a development phase, followed by an audit \& pilot intervention phase to explore the feasibility of a new pathway/system for remote monitoring.

Background Improvements in cancer treatment have led to an increasing number of patients being cured or in remission, but they are followed up to detect recurrence, manage persistent symptoms and late treatment effects. With growing survivors, traditional hospital follow-up is not sustainable. New models of follow-up care are needed.

Aim To develop and establish the feasibility of introducing a new electronic care pathway/system for remote monitoring ovarian cancer patients in remission.

Methods An existing online patient symptom reporting system will be extended for use in remote follow-up. A tracking program will be developed and IT systems integrated in the local hospitals.

Development Phase:

a) Scoping literature review of existing validated symptom measures. b) Consultation with expert groups to establish choice of questions, relevant symptoms, timing/frequency for monitoring. c) Interviews with patients and clinicians to explore current pathway and redesign.

Audit of usual care phase In this phase consecutive eligible ovarian, fallopian tube, primary peritoneal, endometrial or female genital (not otherwise specified) cancer patients (on completion of their first/second line of treatment) will be approached and data on clinical outcomes collected at the routine 3 monthly outpatient appointments for 12 months and PROMs collected 6 monthly. We aim to recruit around 60 patients.

Pilot Intervention phase In the intervention group the feasibility of the re-designed care pathway (intervention) will be piloted in a separate group of eligible ovarian, fallopian tube, primary peritoneal, endometrial or female genital (not otherwise specified) cancer patients. The patients approached will be a mixture of those who are entering follow-up after recently completing their first/second line treatment, and those who have already been attending for some time (months/years) for routine follow-up after their first/second line treatment. We aim to recruit around 60 patients. Consenting patients will be reminded to use the online system every 3 months and have a mandatory blood test by their GP/local hospital. Information will be available for the clinical teams to access electronically. Patients will always have the option to choose to speak or see their 'key clinician'. Virtual clinics will be held for key clinicians to review and respond to remote monitoring data. Clinical and patient outcomes will be collected for a 6-12 month period (this timeframe is dependent on the date of study entry and the funding period remaining). Following the pilot intervention period, 10 patients (or more if deemed necessary) and 6 clinicians will also be interviewed.

Outcomes

* Develop a new electronic care pathway/system for remote monitoring patients in remission
* Obtain initial data on clinical and patient feasibility.

Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences

Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences: Implement the System for Remote Monitoring of Cancer Patients in Remission

Number of patients recruited and number of patients approached will be logged by research team during recruitment (including reasons for non-recruitment)

Number of participant withdrawals will be logged by research team at the time of any withdrawals

Reasons for withdrawal will be assessed via case record form completed by researcher with the participant at time of withdrawal and collated at the end of the study

Patients will be reminded to complete an electronic questionnaire about their symptoms at 3 months

Patients will be reminded to complete an electronic questionnaire about their symptoms at 6 months

Patients will be reminded to complete an electronic questionnaire about their symptoms at 9 months

Patients will be reminded to complete an electronic questionnaire about their symptoms at 12 months

Patient acceptability explored through end-of-study questionnaires and interviews

Clinician acceptability explored through end-of-study questionnaires and interviews

Yorkshire Cancer Research

The Leeds Teaching Hospitals NHS Trust

Bradford Teaching Hospitals NHS Foundation Trust

Calderdale and Huddersfield NHS Foundation Trust

Airedale NHS Foundation Trust

University of Leeds

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

Infections

Symptoms and General Pathology

COVID-19

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung cancer patients who have used the electronic Patient Reported Outcome Measures system before and after COVID-19 lock down or new patients who have completed their first electronic Patient Reported Outcome Measures after COVID-19 lock down.

Lung cancer patients who have never completed electronic Patient Reported Outcome Measures.

Participants will be sent an online or paper questionnaire. If participants have expressed an interest in taking part in an interview, they may be contacted by a member of the research team. The interviews will be conducted over the phone at time suitable for the participant. There will be no study specific hospital visits.

questionnaire and optional interview

During the COVID-19 pandemic, people's lives have changed dramatically. People with lung cancer who are shielding may have been particularly affected as they may be unable to carry out many of their normal daily activities, such as grocery shopping and exercise, and are unable to interact with friends and family. People with lung cancer will also have experienced some changes to the clinical services available to them at The Christie. Using a questionnaire and interviews, the investigators want to understand patient experiences of the changes in their daily lives and the changes to their clinical care. This will help us to see if people with lung cancer need any additional support services or if there are any changes the investigators can make to clinical services to improve patient experiences. Eligible patients will be any lung cancer patients receiving current treatment or in active follow up.

The COVID-19 pandemic, declared by the World Health Organisation (WHO) on 11 March 2020, has managed to dramatically change all of our lives in just a few short months. Due to the unprecedented demand to protect the National Health service (NHS), on 23 March 2020 the United Kingdom (UK) government initiated a lock down, imposing wide-ranging restrictions on freedom of movement. Cancer services have been being particularly impacted across the country.

Around 48,000 patients are newly diagnosed with lung cancer in the UK each year. Those who require active treatment may be offered radiotherapy, systemic anticancer therapy including chemotherapy, targeted therapy or immunotherapy, or a combination of both. A recent document published by Public Health England(PHE) has classified lung cancer patients receiving any of these treatments as 'extremely vulnerable.' Common co-existing comorbidities such as Chronic Obstructive Pulmonary Disease (COPD) also place patients into this category. Their vulnerability may be further amplified when considering that 44% of all new lung cancer diagnoses are in people aged \>75 years and a significant proportion is particularly frail. The advice from PHE for these 'extremely vulnerable' patients was to shield, meaning they should not leave their homes or attend any social gatherings, even with family or friends. Shielding unfortunately is not without its own challenges. It may prevent many patients from carrying out their daily life activities independently, limit their ability to exercise and impact their mental further. This is particularly relevant for those patients more vulnerable or frail. It would therefore be expected that these patients are likely to develop some degree of psychological distress. The act of shielding itself may be implicated in this owing to increased social isolation, upset to normal routines and general anxiety regarding COVID-19 related or other issues. In addition any change to routine lung cancer management in these patients may exacerbate this distress further. Those with underlying mental health issues are at particular risk.

During the COVID-19 pandemic both the lung cancer diagnosis and its subsequent management have been affected. These rapid changes reflected the shifting risk-benefit ratio for patients and diminished resources. Beyond modifications in treatment pathways, telephone consultations have replaced many face to face appointments in an attempt to reduce visits to hospital. The use of electronic Health tools and telemedicine has therefore suddenly come to the fore front of clinical practice.

At the Christie NHS Foundation Trust, all lung cancer patients have been given the opportunity to regularly complete electronic patient reported outcome measures routinely as part of their clinical care since December 2018. Patients are sent a text message either on the day of a new patient appointment or three days before a follow-up appointment. They are asked to complete the electronic Patient Reported Outcome Measures specifically selected for each patient's diagnosis and treatment pathway including a list of symptoms based on the Common Terminology Criteria for Adverse Events. The EuroQual-5D quality of life questionnaire is also included. This allows clinicians to review patients' symptoms before the consultation, allowing him/her to focus on the concerning symptoms and quality of life issues. Moreover, all new lung cancer patients are also screened for frailty within the Frailty Project through the electronic use of Rockwood Clinical Frailty Scale which is performed by clinicians.

Impact of COVID-19 on Lung Cancer Patients

Understanding the Physical, Social and Psychological Impact of COVID-19 on Frail and Shielded Lung Cancer Patients

Physical and social impact will be captured by the EuroQual-5D quality of life and questions regarding patient's diagnosis and treatment pathway including a list of symptoms based on the Common Terminology Criteria for Adverse Events.

Emotional impact will be assessed using the Hospital Anxiety Depression Scale. Scores range from 0-21 for each of the two subscales (anxiety and depression), with higher scores indicating greater anxiety and depression.

Frailty will be assessed using the Rockwood Clinical Frailty Scale. With scores ranging from 1-9, with higher scores indicating higher frailty.

The Christie NHS Foundation Trust

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Group 1 consists of breast cancer patients with local or locally advanced disease. All participants will complete the EORTC QLQ-C30 and BR-45 questionnaires. A subgroup of participants within this group (those who have changed disease or treatment status) will be asked to complete the above questionnaires again, three months later (+-1 week). They will also complete an anchor question. Completing twice is for the responsiveness to change analysis.

Group 2 consists of metastatic breast cancer patients. All participants will complete the EORTC QLQ-C30 and BR-45 questionnaires at one time point only.

Group 3 consists of follow up breast cancer patients. All participants will complete the EORTC QLQ-C30 and BR-45 questionnaires. One-to two weeks later, a subgroup of participants in this group (with no evidence of disease and /or change in health status) will complete the above questionnaires, as well as an anchor question. Completing twice is for the test-retest analysis.

The EORTC QLQ-BR23 questionnaire has been updated with a further twenty-two items to create the EORTC QLQ-BR45. This updated questionnaire contains items to encapsulate advancements in knowledge about the epidemiology of breast cancer and side effects experienced with new treatments. This study will test the psychometric properties of the EORTC QLQ-BR45 as a measure of quality of life in patients with breast cancer.

EORTC QLQ-BR45 questionnaire

Female breast cancer is still the most frequent type of cancer in Europe with 21 per 100,000 women .The EORTC QLQ-BR23 was one of the first modules developed to be used in conjunction with the core questionnaire EORTC QLQ-C30 and was published in 1996. Since the beginning of the work on the EORTC QLQ-BR23 some 20 years ago, much knowledge has been gathered about the epidemiology of breast cancer, and major advances have been made with regard to diagnostic and therapeutic options. Therefore, the EORTC Quality of life group decided to update the BC23. A phase 1 to 3 module development project has been completed. This resulted in a 45 item module, retaining 23 of the original items and adding 22 new items, particularly tapping into the side effects of new systemic and local therapies.

The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ-C30 in patients diagnosed with breast cancer. Participants will be enrolled in four groups according to their disease stage (1. local/locally advanced disease, 2. metastatic disease, 3. follow up. Various combinations of therapies are permissible.

According to sample size calculations, we will include a total of N =490 patients from 12 countries.

Participants will be invited to complete the QLQ-C30 and the QLQ-BC45, followed by the Debriefing Questionnaire. Data of all patients will be used to evaluate the scale structure, internal consistency, convergent and discriminant validity. A subgroup of follow up patients with no evidence of disease (no change in health status) will be invited to complete the QLQ-C30 and the QLQ-BC45 for a second time one to two weeks later for the test-retest analysis. A subgroup of patients from the local/ locally advanced breast cancer group (who have had change in disease or treatment status after the first assessment) will be invited to complete a second set of questionnaires for the response to change analysis. Sociodemographic and clinical data will be recorded using standardized case report forms (CRF).

An EORTC Study Updating the QLQ-BR23 to BR45

An International Phase 4 Field Study to Analyse the Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Breast Cancer (EORTC QLQ-BR23, Update EORTC QLQ-BR45)

This is a questionnaire validation study. No reporting score on scale.

European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Electrical Patient Reported Outcome of Prostate Cancer RadioTherapy	NCT05187026	Prostate Cancer	electronic PROM...	18 Years - 100 Years	Helsinki University Central Hospital
Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making	NCT02916875	Ovarian Cancer PROM Quality of Life		18 Years -	Vejle Hospital
Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA	NCT06007001	Cancer	Telemedicine	18 Years - 75 Years	Sciensano
Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer	NCT06086574	Lung Cancer Sta...		18 Years -	University of Manchester
Individual Survivorship Program for Ovarian Cancer Patients Based on PROM's and Shared Decision Making	NCT02916875	Ovarian Cancer PROM Quality of Life		18 Years -	Vejle Hospital
Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA	NCT06007001	Cancer	Telemedicine	18 Years - 75 Years	Sciensano
Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA	NCT06007001	Cancer	Telemedicine	18 Years - 75 Years	Sciensano
Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences	NCT02847715	Cancer	ePRIME	18 Years -	University of Leeds
Impact of COVID-19 on Lung Cancer Patients	NCT04538456	Lung Cancer PROM Covid19 Psychological	questionnaire a...	18 Years -	The Christie NHS Foundation Trust
Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA	NCT06007001	Cancer	Telemedicine	18 Years - 75 Years	Sciensano
An EORTC Study Updating the QLQ-BR23 to BR45	NCT04270123	Cancer Breast Cancer	EORTC QLQ-BR45 ...	18 Years -	University of Leeds
ePRIME: Patient-Reported AEs in Early Phase Trials	NCT03461939	Cancer	ePRIME symptom ...	18 Years -	University of Leeds
Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences	NCT02847715	Cancer	ePRIME	18 Years -	University of Leeds
ePRIME: Patient-Reported AEs in Early Phase Trials	NCT03461939	Cancer	ePRIME symptom ...	18 Years -	University of Leeds
An EORTC Study Updating the QLQ-BR23 to BR45	NCT04270123	Cancer Breast Cancer	EORTC QLQ-BR45 ...	18 Years -	University of Leeds

Spots Global Cancer Trial Database for prom

Every month we try and update this database with for prom 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 prom

Every month we try and update this database with for prom 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 prom 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.