Lung Cancer Patients' Attitudes to a Second Course of Radiotherapy

NCT04813068 | Unknown

• 1 other identifier: GN20ON632
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with lung cancer are often treated with high dose x-ray treatment (radical radiotherapy) to control the disease. After one course of radiotherapy, after a period of time, there is a risk that the cancer can come back in either the same place or nearby in the lungs. This happens to about 700 patients in the UK every year. There is no strong evidence to suggest what the best treatment is in this situation. One possible treatment is a second course of radiotherapy (re-irradiation). Early studies show that a re-irradiation may cause significant side effects like breathlessness or problems swallowing, but may control the cancer for a long period of time. We want to do a clinical trial to investigate if re-irradiation improves cancer control compared to other treatments to help guide treatment for patients with recurrent disease. Before we can go ahead with the trial, we would like to talk to patients who are have completed radiotherapy to find out what are their feelings about having a second course of radiotherapy if needed, and how the side effects from the initial course of radiotherapy or the projected side-effects from the second course would affect that decision. This information is vitally important to help develop a trial about re-irradiation in lung cancer as it will demonstrate if patients would accept a second course of radiotherapy, and, by accounting for patient concerns in the trial design, will make it more likely to recruit well. This study will perform telephone interviews with patients five weeks after completing a course of radical radiotherapy for lung cancer at the Beatson Cancer Centre. We expect to interview 16-30 patients. This study will run over the course of 1 year. This research is funded by the Beatson Cancer Charity and The University of Glasgow.

Conditions

Lung Cancer; Recurrence

Outcome Measures

Primary Outcomes (1)

• Feelings and concerns re: second radiotherapy course

  Explore patients' feelings and concerns about having a second course of radiotherapy for recurrent lung cancer. This will be assessed using thematic analysis of the transcripts of semi-structured interviews, and the outcome will be the identification of themes that participants have expressed with regard to a second course of radiotherapy e.g. "side-effects of radiotherapy", or "cost of another treatment".

  Dec 2021

Secondary Outcomes (4)

• Choice of treatment in recurrent setting

  Dec 2021

• Attitude to side effects in context of possible outcomes

  Dec 2021

• Toxicity from previous radiotherapy

  Dec 2021

• Attitude to surveillance scans

  Dec 2021

Study Arms (1)

Interview arm

Group of patients who have agreed to have a qualitative interview on the topic of recurrence of lung cancer

Other: Semi-structured interview

Interventions

Semi-structured interview OTHER

Semi-structured interview to identify attitudes to re-irradiation in lung cancer

Interview arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who are having radical radiotherapy for non-small cell lung cancer in the Beatson West of Scotland Cancer Centre, who are consent to a semi-structured interview about their experience of radiotherapy and their feelings on re-treatment if necessary

You may qualify if:

• Age 18 years old or above
• Pathological or radiological diagnosis of non-small cell lung cancer
• Undergoing radical radiotherapy to the thorax using the following fractionations (55 Gray in 20 fractions, 54 Gray in 36 fractions or any Stereotactic Ablative Body Radiotherapy (SABR) fractionation that delivers a biological effective dose of greater than 100Gy10) as part of their primary lung cancer treatment at time of study enrolment
• Patients receiving concurrent and/or adjuvant systemic therapies are permitted
• Radiotherapy is delivered in the Beatson West of Scotland Cancer Centre
• Signed, written informed consent
• Willing and able to complete study processes

You may not qualify if:

• Not fluent in English

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator
• The Beatson Cancer Charity: collaborator

Study Sites (1)

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Harrow, PhD

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Rulach, MBChB

CONTACT

0141 301 7000; robert.rulach@ggc.scot.nhs.uk

Stephen Harrow, PhD

CONTACT

0141 301 7000; stephen.harrow@ggc.scot.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 24, 2021
• Study Start: April 16, 2021
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: May 28, 2021

Record last verified: 2021-05

Locations

GB (1)