eRAPID: Online Symptom Reporting in Lung Cancer

NCT04324437 | Completed

• 1 other identifier: 270042
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Cancer; Non-small Cell Lung Cancer; Small-cell Lung Cancer; Pleural Mesothelioma

Outcome Measures

Primary Outcomes (11)

• Number of participants recruited/number of patients approached (consent rate)

  Number of patients approached and recruited will be logged during recruitment

  Baseline

• Number of participant withdrawals

  Number of participant withdrawals will be logged at the time of withdrawal

  12 months

• Reason for participant withdrawal

  Reasons for withdrawal will be captured in CRF at time of withdrawal

  12 months

• Use of the intervention

  Number of self-reported symptom monitoring reports and quality of life questionnaires completed

  6 month and 12 months

• Acceptability of intervention to patients

  Interim and end of study interviews with patients

  6 months and 12 months

• Acceptability of intervention to clinicians

  Interim and end of study interviews with clinicians

  6 months and 12 months

• Integrity of the system

  Technical issues logged during the study

  6 months and 12 months

• Proportion of missing data in symptom reports and quality of life questionnaires

  Regular completions of symptom reports (either weekly or per scheduled clinical and quality of life questionnaires completed 12 weekly by participants

  12 months

• Number of adverse event reports, severe adverse event alerts and patient deaths

  Descriptive statistics by cancer type, treatment and completion modality

  12 months

• Use of hospital services (triage calls, acute admissions, ward stays)

  Descriptive statistics overall and completion modality

  12 months

• Changes to supportive medication, treatment doses and planned therapy

  Descriptive statistics overall and completion modality

  12 months

Study Arms (1)

eRAPID online symptom monitoring in lung cancer

OTHER

Two groups of patients with differing internet access: access from home or access in clinic only

Other: eRAPID online symptom monitoring in lung cancer

Interventions

eRAPID online symptom monitoring in lung cancer OTHER

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.

eRAPID online symptom monitoring in lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment
• Receiving best-supportive care only

Sponsors & Collaborators

• University of Leeds: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator
• Iqvia Pty Ltd: collaborator

Study Sites (1)

St James's University Hospital, Leeds Teaching Hospital Trust

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

Related Links

• Research group website and webpage relating to the study

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Pleural Neoplasms

Study Officials

• Galina Velikova

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Consecutive recruitment based on patient choice into two cohorts: access to internet at home or not

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 27, 2020
• Study Start: July 20, 2020
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)