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NCT Number: NCT04986189

Lung Screening in People Cured of Hodgkin Lymphoma

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

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low dose CT thorax

Diagnostic Test

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

Primary outcomes

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

    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

    Feasibility outcome

Secondary outcomes

  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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 4 months

  4. 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

  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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 12 months

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

    Time frame: 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)

    Time frame: 2 months

  11. 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

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

    Time frame: 12 months

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

The Christie NHS Foundation Trust

Other

Collaborators

  • University of Manchester

Registry information

Official study title

Lung Screening for Hodgkin Lymphoma Survivors: a Feasibility Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2021
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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