Clinical trial NCT04813068: Lung Cancer Patients' Attitudes to a Second Course of Radiotherapy
Official title: A Qualitative Study of Patients' Attitudes to the Risks and Potential Benefits of Potential Toxicities of Radical Re-irradiation for Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Recurrence
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: The Beatson Cancer Charity
First posted: 2021-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Not fluent in English

Primary outcomes:
measure: Feelings and concerns re: second radiotherapy course
timeFrame: Dec 2021
Secondary outcomes:
measure: Choice of treatment in recurrent setting
timeFrame: Dec 2021
measure: Attitude to side effects in context of possible outcomes
timeFrame: Dec 2021
measure: Toxicity from previous radiotherapy
timeFrame: Dec 2021
measure: Attitude to surveillance scans
timeFrame: Dec 2021
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Stephen Harrow, PhD
role: PRINCIPAL_INVESTIGATOR
References: