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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
| The Beatson Cancer Charity | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interview arm | Group of patients who have agreed to have a qualitative interview on the topic of recurrence of lung cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semi-structured interview | Other | Semi-structured interview to identify attitudes to re-irradiation in lung cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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". |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Rulach, MBChB | Contact | 0141 301 7000 | 15505 | robert.rulach@ggc.scot.nhs.uk |
| Stephen Harrow, PhD | Contact | 0141 301 7000 | stephen.harrow@ggc.scot.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Harrow, PhD | NHS Greater Glasgow and Clyde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Beatson West of Scotland Cancer Centre | Recruiting | Glasgow | G12 0YN | United Kingdom |
Transcribed and anonymised interviews will be available on the University of Glasgow research repository after the trial has completed
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 18, 2021 | Mar 18, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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". | 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. | 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". | Dec 2021 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |