Lung Screening in People Cured of Hodgkin Lymphoma

Lung Cancer Clinical Trial

Official title:

Lung Screening for Hodgkin Lymphoma Survivors: a Feasibility Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04986189
• Other study ID #: CFTSp204
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lung Cancer
• Lymphoma

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