Hodgkin Lymphoma, Lung Cancer
Conditions
Keywords
screening, low dose CT scan
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
Interventions
DIAGNOSTIC_TESTLow dose CT thorax
A low dose CT scan of the thorax to screen for lung cancer
Sponsors
University of Manchester
The Christie NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 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 |
| 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 |
Countries
United Kingdom
Outcome results
None listed