Clinical trial NCT04986189: Lung Screening in People Cured of Hodgkin Lymphoma
Official title: Lung Screening for Hodgkin Lymphoma Survivors: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hodgkin Lymphoma
Lung Cancer
Keywords: screening
low dose CT scan
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2021-08-02
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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


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

Primary outcomes:
measure: Primary outcome: the lung cancer screening uptake rate among eligible individuals invited to the study
timeFrame: 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 outcomes:
measure: 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)
timeFrame: 14 months
measure: 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)
timeFrame: 4 months
measure: 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)
timeFrame: 4 months
measure: The proportion who have made an informed decision as measured by the Multidimensional Measure of Informed Choice
timeFrame: 6 and 12 months following CT scan
measure: 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)
timeFrame: 2 months post CT scan
measure: 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)
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
measure: The rates of smoking cessation 6 and 12 months following screening
timeFrame: 12 months
measure: The acceptability of undergoing screening measured using non-validated scale (Score 7-70 with higher score representing higher perceived acceptability of lung cancer screening)
timeFrame: 2 months
measure: Rates of normal, indeterminate and positive screening scans, reported according to definitions in the British Thoracic Society Pulmonary Nodule Management Guidelines
timeFrame: 12 months
measure: The type and prevalence of incidental findings on screening scans
timeFrame: 12 months
measure: The barriers and facilitators to undergoing lung cancer screening measured qualitatively and categorised according to the Theoretical Domains Framework
timeFrame: 12 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
References: