Lung CancerNCT04813068
Lung Cancer Patients' Attitudes to a Second Course of Radiotherapy
An observational study of Lung Cancer and Recurrence, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Recurrence
- What is being tested?
- Semi-structured interview
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Apr 2021to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Not fluent in English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Robert J Rulach, MBChB, 0141 301 7000, robert.rulach@ggc.scot.nhs.uk
About this study
Official title: A Qualitative Study of Patients' Attitudes to the Risks and Potential Benefits of Potential Toxicities of Radical Re-irradiation for Lung Cancer
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.
Read more
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
- Being tested
- Semi-structured interview
- Medical subject headings
- Lung Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewOther
Semi-structured interview to identify attitudes to re-irradiation in lung cancer
| Study group | Role | What they receive |
|---|---|---|
| Interview arm | Group of patients who have agreed to have a qualitative interview on the topic of recurrence of lung cancer Receives: Other: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Dec 2021
Secondary outcomes (4)
Choice of treatment in recurrent setting
Identify factors that patients consider when deciding on potential treatments in the setting of locally recurrent lung cancer (including effect of COVID-19 on treatment choice). 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 choosing a treatment in the event of relapse e.g. "worry about chemotherapy side-effects", or "risk of infection".
Measured: Dec 2021
Attitude to side effects in context of possible outcomes
Investigate how patients' acceptance of side effects changes with the different projected outcomes of re-irradiation. This will be assessed using thematic analysis of the transcripts of semi-structured interviews, and the outcome will be the identification of any hierarchy of side-effects that patients would rather not experience e.g. "I can cope with fatigue but I don't want to be breathless".
Measured: Dec 2021
Toxicity from previous radiotherapy
Explore the relationship between the toxicities patients experienced during radiotherapy and their attitudes to a second course of radiotherapy. As part of the semi-structured interview, participants will be asked to grade the severity of symptoms on a three point scale (mild/moderate/severe) and then state if they would consider a second course of radiotherapy if needed (yes/no). There will be scope in the semi-structured interview to expand on any topic, and this will undergo thematic analysis.
Measured: Dec 2021
Attitude to surveillance scans
Investigate patients' awareness of surveillance imaging after radical treatment and willingness for scans. 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 surveillance e.g. "I'd prefer to have frequent scans to see if there is any change in the tumour", or "frequent scans make me anxious".
Measured: Dec 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start16 Apr 2021
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, The Beatson Cancer Charity
- Responsible party
- Sponsor
- Investigators
- Stephen Harrow, PhD, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813068
- Sponsor's protocol ID
- GN20ON632
- Status last verified
- May 2021
- First submitted
- 12 Mar 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Transcribed and anonymised interviews will be available on the University of Glasgow research repository after the trial has completed
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Study of Patients' Attitudes to the Risks and Potential Benefits of Potential Toxicities of Radical Re-irradiation for Lung Cancer
- ClinicalTrials.gov ID
- NCT04813068
- Acronym / sponsor ID
- GN20ON632
- Conditions
- Lung Cancer, Recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow, The Beatson Cancer Charity
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interview arm | – | Other: Semi-structured interviewGroup of patients who have agreed to have a qualitative interview on the topic of recurrence of lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Not fluent in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured interviewSemi-structured interview to identify attitudes to re-irradiation in lung cancer | Other | Interview arm |
Primary outcome
Feelings and concerns re: second radiotherapy course
Time frame: Dec 2021
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".
4 secondary outcomes
Choice of treatment in recurrent setting
Time frame: Dec 2021
Attitude to side effects in context of possible outcomes
Time frame: Dec 2021
Toxicity from previous radiotherapy
Time frame: Dec 2021
Attitude to surveillance scans
Time frame: Dec 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Individual participant dataSharing planned: Undecided. Transcribed and anonymised interviews will be available on the University of Glasgow research repository after the trial has completed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Harrow, PhD principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Recurrence, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Rulach, MBChB (0141 301 7000 ext. 15505, robert.rulach@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feelings and concerns re: second radiotherapy course (time frame: Dec 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.