Lung Screening in People Cured of Hodgkin Lymphoma

Study Overview
=================
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

Official Title
-----------------
Lung Screening for Hodgkin Lymphoma Survivors: a Feasibility Study

Conditions
-----------------
Hodgkin Lymphoma, Lung Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Low dose CT thorax


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Invitation to have a low dose CT thorax<br>All participants are invited to undergo a low dose CT thorax | Diagnostic Test: Low dose CT thorax<br>* A low dose CT scan of the thorax to screen for lung cancer<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| The proportion who have made an informed decision as measured by the Multidimensional Measure of Informed Choice |  | 6 and 12 months following CT scan | 
| 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 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 | 
| 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 | 
| 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 rates of smoking cessation 6 and 12 months following screening |  | 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 | 
| Rates of normal, indeterminate and positive screening scans, reported according to definitions in the British Thoracic Society Pulmonary Nodule Management Guidelines |  | 12 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screening, low dose CT scan