Lung Screening in People Cured of Hodgkin Lymphoma

Not Applicable

Completed

• Conditions: Hodgkin Lymphoma; Lung Cancer
• Interventions: Diagnostic Test: Low dose CT thorax

• Registration Number: NCT04986189
• Lead Sponsor: The Christie NHS Foundation Trust

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-07-29
• Study Start: 2021-08-01
• Study First Posted: 2021-08-02
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Invitation to have a low dose CT thorax	Low dose CT thorax	All participants are invited to undergo a low dose CT thorax

Primary Outcome Measures

Name	Time	Method
Primary outcome: the lung cancer screening uptake rate among eligible individuals invited to the study	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	Feasibility outcome

Secondary Outcome Measures

Name	Time	Method
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
Rates of normal, indeterminate and positive screening scans, reported according to definitions in the British Thoracic Society Pulmonary Nodule Management Guidelines	12 months
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
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
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
The type and prevalence of incidental findings on screening scans	12 months
The barriers and facilitators to undergoing lung cancer screening measured qualitatively and categorised according to the Theoretical Domains Framework	12 months
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
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
The proportion who have made an informed decision as measured by the Multidimensional Measure of Informed Choice	6 and 12 months following CT scan
The rates of smoking cessation 6 and 12 months following screening	12 months
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
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

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom