Lung CancerNCT01213745
The Use of a Quality of Life Questionnaire in Patients With Lung Cancer
A study testing Intervention and Attention in people with Lung Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will investigate the effectiveness of using the European Organisation for Research and Treatment of cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13) to identify and target therapies in patients with lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Intervention and Attention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Jul 2012
- Phase
- Interventional
- 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
Who may be able to join
- male or female age > 18 years
- patients who are able to adequately understand written and spoken english
- diagnosis of lung cancer (non small cell, small cell, mesothelioma)
- no plan to commence treatment (chemotheraphy, targeted therapies, radioterhapy, surgery) with 6 weeks
- both radically or palliatively treated patients remain eligible
- patients whose toxicities from their primary treatment has resolved or have stabilised for a period of 7 days
Who cannot join
- patients are taking part on any other QoL studies
- taking part in any other studies that requires QoL questionnaires, extra visits or investigations
- currently on treatment (chemotherapy, radiotherapy, surgery or targeted therapies)
- they have on going toxicities from their treatment which have not been stablised (required intervention within last 7 days)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
Dr M O'Brien, 02086613278, mary.o'brien@rmh.nhs.uk
Mr M Laybourne, 02086613835, matthew.laybourne@rmh.nhs.uk
About this study
Official title: A Prospective Randomised Controlled Study to Investigate the Effectiveness of Using a Quality of Life Questionnaire to Target Interventions to Improve Quality of Life in Patients With Lung Cancer
This study will investigate the effectiveness of using the European Organisation for Research and Treatment of cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13) to identify and target therapies in patients with lung cancer. The study will assess whether using the questionnaire will result in an improvement in QoL.
Read the detailed description
Patients with lung cancer who have completed a course of treatment (or who are in-between treatment) at the Royal Marsden Hospital would be eligible for inclusion in the study. Participants will be randomised into 3 groups. Group 1 - this group will complete the QoL questionnaire and will receive targeted therapies by a doctor (and other members of the oncology team) during a clinic consultation. Group 2 - will complete the QoL questionnaire however the questionnaire will not be seen by the doctor during a clinic consultation. Group 3 - the control group will not complete the QoL questionnaire before a clinic consultation. All patients will complete a diary of all contact they have with health care professionals during the study. The study will last for 6 weeks and at the end of the study all patients will complete the QoL questionnaire.
- Conditions
- Lung Cancer
- Being tested
- Intervention, Attention, Control
- Keywords
- lung, cancer, quality of life
- Medical subject headings
- Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
AttentionOther
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Intervention |
| Attention | Experimental | Not described Receives: Other: Attention |
| Control | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life
Secondary outcomes (1)
To investigate whether the use of EORTC QLQ-C30 + lung cancer module results in less patient contact with health care professionals during the 6 week study period for the 3 groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Dr M O'Brien, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213745
- Sponsor's protocol ID
- CCR3454
- Status last verified
- Oct 2010
- First submitted
- 1 Oct 2010
- Last updated
- 21 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Nimako K, Ayite B, Priest K, Severn J, Fries HM, Gunapala R, Bhosle J, Popat S, O'Brien M. A randomised assessment of the use of a quality of life questionnaire with or without intervention in patients attending a thoracic cancer clinic. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12402. Epub 2015 Nov 10.
PubMed 26556778
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Controlled Study to Investigate the Effectiveness of Using a Quality of Life Questionnaire to Target Interventions to Improve Quality of Life in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT01213745
- Acronym / sponsor ID
- CCR3454
- Conditions
- Lung Cancer
- Keywords
- lung, cancer, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 4 Oct 2010 (estimated)
- 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.
This study will investigate the effectiveness of using the European Organisation for Research and Treatment of cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13) to identify and target therapies in patients with lung cancer. The study will assess whether using the questionnaire will result in an improvement in QoL.
Detailed description
Patients with lung cancer who have completed a course of treatment (or who are in-between treatment) at the Royal Marsden Hospital would be eligible for inclusion in the study. Participants will be randomised into 3 groups. Group 1 - this group will complete the QoL questionnaire and will receive targeted therapies by a doctor (and other members of the oncology team) during a clinic consultation. Group 2 - will complete the QoL questionnaire however the questionnaire will not be seen by the doctor during a clinic consultation. Group 3 - the control group will not complete the QoL questionnaire before a clinic consultation. All patients will complete a diary of all contact they have with health care professionals during the study. The study will last for 6 weeks and at the end of the study all patients will complete the QoL questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Intervention |
| Attention | Experimental | Other: Attention |
| Control | Active comparator | Other: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male or female age > 18 years
- patients who are able to adequately understand written and spoken english
- diagnosis of lung cancer (non small cell, small cell, mesothelioma)
- no plan to commence treatment (chemotheraphy, targeted therapies, radioterhapy, surgery) with 6 weeks
- both radically or palliatively treated patients remain eligible
Key exclusion criteria (4 listed)
- patients are taking part on any other QoL studies
- taking part in any other studies that requires QoL questionnaires, extra visits or investigations
- currently on treatment (chemotherapy, radiotherapy, surgery or targeted therapies)
- they have on going toxicities from their treatment which have not been stablised (required intervention within last 7 days)
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 |
|---|---|---|
| Intervention | Other | Intervention |
| Attention | Other | Attention |
| Control | Other | Control |
Primary outcome
To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life
1 secondary outcome
To investigate whether the use of EORTC QLQ-C30 + lung cancer module results in less patient contact with health care professionals during the 6 week study period for the 3 groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2010.
- Derived from this study: PubMed 26556778Nimako K, Ayite B, Priest K, Severn J, Fries HM, Gunapala R, Bhosle J, Popat S, O'Brien M. A randomised assessment of the use of a quality of life questionnaire with or without intervention in patients attending a thoracic cancer clinic. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12402. Epub 2015 Nov 10.
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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.
Dr M O'Brien principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention and Attention in people with Lung Cancer, run by Royal Marsden NHS Foundation Trust 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 6 inclusion and 4 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 21 Oct 2010. 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 Dr M O'Brien (02086613278, mary.o'brien@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01213745, which also lists 1 linked publication.
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 21 Oct 2010.