Back to results

Lung Screening in People Cured of Hodgkin Lymphoma

Primary Purpose

Hodgkin Lymphoma, Lung Cancer

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Low dose CT thorax

About this trial

This is an interventional screening trial for Hodgkin Lymphoma focused on measuring screening, low dose CT scan

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Invitation to have a low dose CT thorax

Arm Description

All participants are invited to undergo a low dose CT thorax

Outcomes

Primary Outcome Measures

Primary outcome: the lung cancer screening uptake rate among eligible individuals invited to the study

Feasibility outcome

Secondary Outcome Measures

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)

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)

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)

The proportion who have made an informed decision as measured by the Multidimensional Measure of Informed Choice

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)

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)

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)

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)

The rates of smoking cessation 6 and 12 months following screening

The acceptability of undergoing screening measured using non-validated scale (Score 7-70 with higher score representing higher perceived acceptability of lung cancer screening)

Rates of normal, indeterminate and positive screening scans, reported according to definitions in the British Thoracic Society Pulmonary Nodule Management Guidelines

The type and prevalence of incidental findings on screening scans

The barriers and facilitators to undergoing lung cancer screening measured qualitatively and categorised according to the Theoretical Domains Framework

Full Information

NCT ID

NCT04986189

First Posted

May 26, 2021

Last Updated

March 10, 2022

Sponsor

The Christie NHS Foundation Trust

Collaborators

University of Manchester

1. Study Identification

Unique Protocol Identification Number

NCT04986189

Brief Title

Lung Screening in People Cured of Hodgkin Lymphoma

Official Title

Lung Screening for Hodgkin Lymphoma Survivors: a Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

October 1, 2022 (Anticipated)

Study Completion Date

October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Christie NHS Foundation Trust

Collaborators

University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin Lymphoma, Lung Cancer

Keywords

screening, low dose CT scan

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Invitation to have a low dose CT thorax

Arm Type

Other

Arm Description

All participants are invited to undergo a low dose CT thorax

Intervention Type

Diagnostic Test

Intervention Name(s)

Low dose CT thorax

Intervention Description

A low dose CT scan of the thorax to screen for lung cancer

Primary Outcome Measure Information:

Title

Primary outcome: the lung cancer screening uptake rate among eligible individuals invited to the study

Description

Feasibility outcome

Time Frame

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 Measure Information:

Title

Time Frame

14 months

Title

Time Frame

4 months

Title

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)

Time Frame

4 months

Title

The proportion who have made an informed decision as measured by the Multidimensional Measure of Informed Choice

Time Frame

6 and 12 months following CT scan

Title

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)

Time Frame

2 months post CT scan

Title

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)

Time Frame

12 months

Title

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)

Time Frame

12 months

Title

Time Frame

12 months

Title

The rates of smoking cessation 6 and 12 months following screening

Time Frame

12 months

Title

The acceptability of undergoing screening measured using non-validated scale (Score 7-70 with higher score representing higher perceived acceptability of lung cancer screening)

Time Frame

2 months

Title

Rates of normal, indeterminate and positive screening scans, reported according to definitions in the British Thoracic Society Pulmonary Nodule Management Guidelines

Time Frame

12 months

Title

The type and prevalence of incidental findings on screening scans

Time Frame

12 months

Title

The barriers and facilitators to undergoing lung cancer screening measured qualitatively and categorised according to the Theoretical Domains Framework

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

The Christie NHS Foundation Trust

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Lung Screening in People Cured of Hodgkin Lymphoma

We'll reach out to this number within 24 hrs