Lung Screening in People Cured of Hodgkin Lymphoma

• Sponsor: The Christie NHS Foundation Trust (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04986189
• Collaborator: University of Manchester (Other)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 14.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma; Lung Cancer	Diagnostic Test: Low dose CT thorax	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Lung Screening for Hodgkin Lymphoma Survivors: a Feasibility Study
• Actual Study Start Date: Aug 1, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Invitation to have a low dose CT thorax All participants are invited to undergo a low dose CT thorax	Diagnostic Test: Low dose CT thorax; A low dose CT scan of the thorax to screen for lung cancer

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

2. 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]

3. 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]

4. The proportion who have made an informed decision as measured by the Multidimensional Measure of Informed Choice [6 and 12 months following CT scan]

5. 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]

6. 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]

7. 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]

8. 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]

9. The rates of smoking cessation 6 and 12 months following screening [12 months]

10. 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]

11. Rates of normal, indeterminate and positive screening scans, reported according to definitions in the British Thoracic Society Pulmonary Nodule Management Guidelines [12 months]

12. The type and prevalence of incidental findings on screening scans [12 months]

13. The barriers and facilitators to undergoing lung cancer screening measured qualitatively and categorised according to the Theoretical Domains Framework [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Christie NHS Foundation Trust	Manchester		United Kingdom	M20 4BX

Sponsors and Collaborators

• The Christie NHS Foundation Trust
• University of Manchester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Christie NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT04986189
• Other Study ID Numbers: CFTSp204
• First Posted: Aug 2, 2021
• Last Update Posted: Mar 11, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Christie NHS Foundation Trust: screening; low dose CT scan
• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease

Study Results

No Results Posted as of Mar 11, 2022