NCT04538456

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2022

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

1.5 years

First QC Date

September 1, 2020

Last Update Submit

April 23, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Physical and Social impact

    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.

    baseline

  • Psychological impact

    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.

    baseline

Secondary Outcomes (1)

  • prevalence and impact of frailty

    baseline

Study Arms (2)

used electronic Patient Reported Outcome Measures

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.

Other: questionnaire and optional interview

never used electronic Patient Reported Outcome Measures

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

Other: questionnaire and optional interview

Interventions

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.

never used electronic Patient Reported Outcome Measuresused electronic Patient Reported Outcome Measures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Additionally, participants will need to meet the criteria to be selected for one of the two cohorts of patients: 1. Lung cancer patients voluntarily using the ePROMs platform with at least 1 assessment completed in the 6 months prior to 23 March 2020 (COVID-19 lockdown date) and 1 assessment after this date or new patients who have completed their first electronic Patient Reported Outcome Measures after 23 March 2020 2. Lung cancer patients who have never complete electronic Patient Reported Outcome Measures data.

You may qualify if:

  • non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)
  • patients in active treatment or in clinical follow-up

You may not qualify if:

  • Lung cancer patients who do not speak or understand English will not be eligible to take part in the study
  • Patients under the age of 18 will be eligible for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Christie NHS Foundation

Manchester, m20 4bx, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsCOVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 4, 2020

Study Start

October 15, 2020

Primary Completion

April 16, 2022

Study Completion

April 16, 2022

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations