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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04986189
Other study ID # CFTSp204
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date October 1, 2022

Study information

Verified date March 2022
Source The Christie NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A single site non-commercial study in which people treated for Hodgkin lymphoma survivors will be invited to have a single low dose CT of thorax for lung cancer screening


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date October 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Aged 18-80 - 5 year or more survivor of HL - Any of: a) treated with radiotherapy for HL with radiation dose to the lung b) an alkylating agent containing chemotherapy regimen known to increase lung cancer risk - Living within approximately 40 miles of The Christie Hospital Exclusion Criteria: - Previous diagnoses of malignant neoplasm of trachea, bronchus, lung, thymus or pleura - A current diagnosis of metastatic cancer - Residents in nursing homes or housebound - Had a CT scan of the thorax within the last 12 months - Pregnant women - Unable to provide consent

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Low dose CT thorax
A low dose CT scan of the thorax to screen for lung cancer

Locations

Country Name City State
United Kingdom The Christie NHS Foundation Trust Manchester

Sponsors (2)

Lead Sponsor Collaborator
The Christie NHS Foundation Trust University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary outcome: the lung cancer screening uptake rate among eligible individuals invited to the study Feasibility outcome Measured 6 months after recruitment begins when all interested participants have undergone a full eligibility check and those eligible have undergone their baseline low dose CT scan
Secondary Decisional conflict scores in those who receive the decision aid measured using the validated Decisional Conflict Scale (score 0-100 with higher score representing higher levels of decisional conflict) 14 months
Secondary Preparedness for decision making in those who receive the decision aid using the validated Preparedness for Decision Making Scale (score 0-100 with higher score representing higher perceived levels of preparedness for decision making) 4 months
Secondary Lung cancer screening knowledge pre and post receipt of the decision aid measured using a novel scale (score 0-16 with higher score representing high levels of knowledge about lung cancer screening) 4 months
Secondary The proportion who have made an informed decision as measured by the Multidimensional Measure of Informed Choice 6 and 12 months following CT scan
Secondary Anxiety levels pre and post screening measured using the State Trait Anxiety Inventory -6 validated scale (score 6-24 with higher score representing higher levels of anxiety) 2 months post CT scan
Secondary Cancer worry severity levels pre and post screening measured using measured using 4-item Brief Worry Scale (score 4-20 with higher score representing higher cancer worry severity levels) 12 months
Secondary Cancer worry frequency measured using intrusive thoughts subscale from Revised impact of events scale (score 6-30 with higher score representing more frequent cancer worry) 12 months
Secondary Health related quality of life pre-screening then 6 and 12 months post screening measured using the validated SF-12 (short-form-12) scale (Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning) 12 months
Secondary The rates of smoking cessation 6 and 12 months following screening 12 months
Secondary The acceptability of undergoing screening measured using non-validated scale (Score 7-70 with higher score representing higher perceived acceptability of lung cancer screening) 2 months
Secondary Rates of normal, indeterminate and positive screening scans, reported according to definitions in the British Thoracic Society Pulmonary Nodule Management Guidelines 12 months
Secondary The type and prevalence of incidental findings on screening scans 12 months
Secondary The barriers and facilitators to undergoing lung cancer screening measured qualitatively and categorised according to the Theoretical Domains Framework 12 months
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