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eRAPID: Online Symptom Reporting in Lung Cancer

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ClinicalTrials.gov Identifier: NCT04324437
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : November 6, 2020
Sponsor:
Collaborators:
The Leeds Teaching Hospitals NHS Trust
Iqvia Pty Ltd
Information provided by (Responsible Party):
Galina Velikova, University of Leeds

Brief Summary:

Lung cancer is a leading cause of cancer-related ill-health and death in the United Kingdom (UK), but with advances in systemic anti-cancer therapies the prognosis for people in later stages is improving. There is growing evidence that electronic systems which enable patients to monitor and report symptoms can help improve symptom control and patient care. This study aims to investigate optimal ways of introducing an electronic symptom reporting system (eRAPID) in lung cancer care at Leeds Cancer Centre. eRAPID was developed by the University of Leeds and its integration with the electronic health records at Leeds Cancer Centre enables staff to view patient symptom reports directly. eRAPID provides advice to patients about self-management of milder symptoms, for serious symptoms patients are encouraged to contact the hospital and an alert is sent to the nurse or doctor by email.

The aim of the study is to assess the feasibility and usefulness of an electronic symptom reporting system (eRAPID) for lung cancer patients and healthcare professionals during the treatment of lung cancer and during one year follow up.

Two groups of patients will be recruited on the basis of their access to the internet at home (rather than randomisation). It is anticipated that approximately 100 patients will enrol into one of two groups:

  • Group 1: Patients with online access at home will be asked to report weekly using their own devices.
  • Group 2: Patients without online access will be asked to report on a tablet computer before their planned clinic appointments.

The eRAPID questionnaire is based on existing eRAPID items with the addition of new items specific to lung cancer. These have been developed by the clinical team and patient groups have been consulted over the suitability of the wording used.

Analysis of patient reported symptoms, quality of life and clinical information will be descriptive. Disease-related symptoms and health-related quality of life will be compared across groups of patients with a diagnosis of lung cancer. Treatment-related side effects of patients will be compared across the different types of treatment received. To determine the best means of engaging patients in systematic electronic reporting, the recruitment and compliance rate will be compared between the two patient groups. The utility of patient reported information to healthcare staff will be assessed through staff interviews.


Condition or disease Intervention/treatment Phase
Thoracic Cancer Non-small Cell Lung Cancer Small-cell Lung Cancer Pleural Mesothelioma Other: eRAPID online symptom monitoring in lung cancer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Consecutive recruitment based on patient choice into two cohorts: access to internet at home or not
Masking: None (Open Label)
Primary Purpose: Other
Official Title: eRAPID: Electronic Monitoring of Patient-reported Symptoms in Patients With a Diagnosis of Thoracic Cancer Managed at Leeds Cancer Centre
Actual Study Start Date : July 20, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022


Arm Intervention/treatment
eRAPID online symptom monitoring in lung cancer
Two groups of patients with differing internet access: access from home or access in clinic only
Other: eRAPID online symptom monitoring in lung cancer
The eRAPID in lung cancer intervention is an online symptom monitoring system which provides tailored advice depending on the severity of symptoms reported. The system is integrated into the electronic medical record and results can be viewed by the medical team.




Primary Outcome Measures :
  1. Number of participants recruited/number of patients approached (consent rate) [ Time Frame: Baseline ]
    Number of patients approached and recruited will be logged during recruitment

  2. Number of participant withdrawals [ Time Frame: 12 months ]
    Number of participant withdrawals will be logged at the time of withdrawal

  3. Reason for participant withdrawal [ Time Frame: 12 months ]
    Reasons for withdrawal will be captured in CRF at time of withdrawal

  4. Use of the intervention [ Time Frame: 6 month and 12 months ]
    Number of self-reported symptom monitoring reports and quality of life questionnaires completed

  5. Acceptability of intervention to patients [ Time Frame: 6 months and 12 months ]
    Interim and end of study interviews with patients

  6. Acceptability of intervention to clinicians [ Time Frame: 6 months and 12 months ]
    Interim and end of study interviews with clinicians

  7. Integrity of the system [ Time Frame: 6 months and 12 months ]
    Technical issues logged during the study

  8. Proportion of missing data in symptom reports and quality of life questionnaires [ Time Frame: 12 months ]
    Regular completions of symptom reports (either weekly or per scheduled clinical and quality of life questionnaires completed 12 weekly by participants

  9. Number of adverse event reports, severe adverse event alerts and patient deaths [ Time Frame: 12 months ]
    Descriptive statistics by cancer type, treatment and completion modality

  10. Use of hospital services (triage calls, acute admissions, ward stays) [ Time Frame: 12 months ]
    Descriptive statistics overall and completion modality

  11. Changes to supportive medication, treatment doses and planned therapy [ Time Frame: 12 months ]
    Descriptive statistics overall and completion modality



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of thoracic cancer: Non-small cell lung cancer (NSCLC), or Small cell lung cancer (SCLC), or Pleural mesothelioma
  • Start of a systemic anti-cancer therapy with prescribed chemotherapy, tyrosine kinase inhibitors (TKIs) or checkpoint inhibitors within the recruitment period
  • Willing and able to provide written informed consent
  • Fluency in English

Exclusion Criteria:

  • Cognitive impairment
  • Receiving best-supportive care only

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324437


Contacts
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Contact: Galina Velikova, PhD +44 113 206 7453 g.velikova@leeds.ac.uk
Contact: Rosemary Peacock, PhD +44 113 67516 r.peacock@leeds.ac.uk

Locations
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United Kingdom
St James's University Hospital, Leeds Teaching Hospital Trust Recruiting
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Contact: Rosemary Peacock, PhD    0113 206 7516    r.peacock@leeds.ac.uk   
Principal Investigator: Galina Velikova, PhD         
Sponsors and Collaborators
University of Leeds
The Leeds Teaching Hospitals NHS Trust
Iqvia Pty Ltd
Investigators
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Principal Investigator: Galina Velikova University of Leeds
Additional Information:
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Responsible Party: Galina Velikova, Professor, University of Leeds
ClinicalTrials.gov Identifier: NCT04324437    
Other Study ID Numbers: 270042
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Mesothelioma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial