Non Small Cell Lung CancerLUNL2NCT01337102
Computer-Generated Quality of Life Assessment Program for Advanced Non-Small Cell Lung Cancer Patients (LUNL2)
A study testing Physician Receives QoL results and Physician Does not receive the results in people with Non Small Cell Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
In the treatment of advanced cancer, maximizing quality of life (QoL) is a fundamental goal for oncologists and their patients. In order to achieve this goal, some form of systematic and reliable QoL assessment is needed in routine clinical practice to evaluate the impact of advanced cancer treatments on QoL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Physician Receives QoL results and Physician Does not receive the results
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2004to Nov 2011
- 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
- Diagnosis of Primary Non Small Cell Lung Cancer
- Stage 3 or 4 Lung Cancer
- To receive 1st line Chemotherapy
- Platinum based chemotherapy or Non Platinum
- Physical ability to use the hand held device(adequate vision, manual dexterity),
- ECOG 1-2
- Written fluency in English, French, Italian, Spanish, Portuguese or Chinese
Who cannot join
- Patients will be excluded if they are unable to complete or understand the assessment process,
- If they are receiving concurrent radical radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial to Investigate the Impact of a Computer-Generated Quality of Life Assessment Program on Treatment Patterns for Advanced Non-Small Cell Lung Cancer Patients (LUNL2)
In the treatment of advanced cancer, maximizing quality of life (QoL) is a fundamental goal for oncologists and their patients. In order to achieve this goal, some form of systematic and reliable QoL assessment is needed in routine clinical practice to evaluate the impact of advanced cancer treatments on QoL. The Lung Cancer Symptom Scale (LCSS) is a validated site-specific QoL measure designed for use in patients with lung cancer undergoing treatment. Recently it has been developed into an electronic form that uses a hand-held pocket personal computer (pc) to enhance collection and presentation of QoL assessments into clinical trials and patient care. This study will evaluate the impact of this computer-generated QoL (LCSS-QL) assessment on treatment practices for advanced lung cancer patients using a randomized trial design. The investigators hypothesize that a Computer-Generated Quality of Life Assessment Program will positively impact treatment patterns for patients with lung cancer.
Specifically, the investigators hypothesize:
Read more
- Use of the LCSS-QL will increase and accelerate referral to and use of palliative care services;
- Use of the LCSS-QL will decrease the duration of palliative chemotherapy treatment with earlier identification of lack of benefit in some patients;
- Use of the LCSS-QL may decrease the use of imaging tests to assess objective tumor response as an indicator of treatment benefit.
Maximizing quality of life is one of the most important goals of palliative chemotherapy in the treatment of advanced lung cancer. If this simple practical tool can be demonstrated to improve palliative management of these patients, including optimizing duration of chemotherapy and use of palliative and supportive services based on patient QoL response, this will dramatically improve the quality of care provided to advanced lung cancer patients. This study will also provide a springboard for other ways to incorporate computer-generated QoL measurement in treatment decision-making in advanced cancer patients, including in other tumor types such as advanced breast and colorectal cancer.
Read the detailed description
Study Design The study will be conducted using an unblinded, randomized trial design. Patients starting systemic therapy for advanced NSCLC will be invited to complete the LCSS-QL upon starting first-line systemic chemotherapy and then prior to subsequent treatment visits (every 3 weeks). Patients will then be randomized at baseline to whether or not their physician will receive this information at the time of clinic visits for the duration of study participation. Randomization codes will be generated by computer program, with stratification by physician, platinum-based versus non-platinum based therapy and Eastern Cooperative Group Performance Status 0 and 1 versus 2 and 3. All patients complete the LCSS-QL at baseline, at the beginning of each cycle of chemotherapy, and at follow up visits until disease progression (initiation of subsequent therapy)or discontinue clinic visits an expected average of 12 to 18 weeks.
Patient Population All NSCLC patients with advanced disease (Stage 3B or 4) starting systemic therapy at the Princess Margaret Hospital will be eligible to participate. Inclusion criteria include the physical ability to use the hand-held instrument (adequate vision, manual dexterity), provision of written informed consent, and written fluency in English, French, Italian, Spanish, Portuguese or Chinese. Patients will be excluded if they are unable to complete or understand the assessment process, or if they are receiving concurrent radical radiotherapy.
Physician Information Physicians will be trained in interpretation of the LCSS electronic output data, in order to facilitate interpretation of the different domains of patient well-being, for example pain scores. An endorsement sheet will be printed in addition to the LCSS data, highlighting major changes in quality of life. For example, deterioration in pain control will be highlighted with suggestions to increase or change pain medication, consider radiotherapy and other pain management options, including changing systemic therapy.
Outcomes
Endpoints include palliative care referral rates, duration of systemic therapy, use of supportive interventions and QoL during treatment.
Data on the number of chemotherapy cycles administered, referral to palliative care (including timing), institution of additional supportive treatments, and number of imaging tests ordered will be collected for all patients prospectively. Data on LCSS scores, subsequent therapy, and date of death will also be recorded.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Physician Receives QoL results, Physician Does not receive the results
- Keywords
- Lung Cancer, Stage 3b, Stage 4, First Line Chemotherapy Treatment, Quality Of Life, Palliative Care, Randomized, Lung Cancer Scale
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician Receives QoL resultsProcedure or surgery
Patient completes the Lung Cancer QoL scale on the Palm held computer device and the Physician receives the print out of the results.
Physician Does not receive the resultsProcedure or surgery
Patient completes the Lung Cancer QoL scale on the Palm held computer device and the Physician does not receive the print out of the results.
| Study group | Role | What they receive |
|---|---|---|
| Physician to receive results | Other | Arm 1 Physician to receive the results of the Lung QoL scale Receives: Procedure: Physician Receives QoL results |
| Physician Does Not Receive Results | Other | Arm 2 Physician does not receive the results of the Lung QoL scale Receives: Procedure: Physician Does not receive the results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Palliative care Referrals.
To assess the impact of use of the LCSS-QL on palliative care referrals;
Measured: Approximately 12 - 18 weeks
Number of palliative first-line chemotherapy cycles administered.
To assess the impact of use of the LCSS-QL on the number of palliative first-line chemotherapy cycles administered
Measured: Approximately 12 - 18 weeks
Secondary outcomes (3)
Use of supportive treatments.
To assess the impact of use of the LCSS-QL on the use of supportive treatments including radiotherapy, home oxygen, transfusion or growth factor support, community care support;
Measured: 12 - 18 weeks
Number of imaging tests ordered.
To assess the impact of use of the LCSS-QL on the number of imaging tests ordered to evaluate patient response to therapy.
Measured: Approximately 12 - 18 weeks
Differences between study arm scores
To compare LCSS-QL scores of patients between the two study arms
Measured: Approximately 12 - 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startNov 2004
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- NATASHA LEIGHL, MD MSC, Principal investigator, UNIVERSITY HEALTH NETWORK / PRINCESS MARGARET HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337102
- Sponsor's protocol ID
- 04-0349-CE
- Acronym
- LUNL2
- Status last verified
- Mar 2017
- First submitted
- 5 Apr 2011
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Investigate the Impact of a Computer-Generated Quality of Life Assessment Program on Treatment Patterns for Advanced Non-Small Cell Lung Cancer Patients (LUNL2)
- ClinicalTrials.gov ID
- NCT01337102
- Acronym / sponsor ID
- LUNL2 / 04-0349-CE
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Lung Cancer, Stage 3b, Stage 4, First Line Chemotherapy Treatment, Quality Of Life, Palliative Care, Randomized, Lung Cancer Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada
- Study start
- Nov 2004
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 18 Apr 2011 (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.
In the treatment of advanced cancer, maximizing quality of life (QoL) is a fundamental goal for oncologists and their patients. In order to achieve this goal, some form of systematic and reliable QoL assessment is needed in routine clinical practice to evaluate the impact of advanced cancer treatments on QoL. The Lung Cancer Symptom Scale (LCSS) is a validated site-specific QoL measure designed for use in patients with lung cancer undergoing treatment. Recently it has been developed into an electronic form that uses a hand-held pocket personal computer (pc) to enhance collection and presentation of QoL assessments into clinical trials and patient care. This study will evaluate the impact of this computer-generated QoL (LCSS-QL) assessment on treatment practices for advanced lung cancer patients using a randomized trial design. The investigators hypothesize that a Computer-Generated Quality of Life Assessment Program will positively impact treatment patterns for patients with lung cancer.
Specifically, the investigators hypothesize:
- Use of the LCSS-QL will increase and accelerate referral to and use of palliative care services;
- Use of the LCSS-QL will decrease the duration of palliative chemotherapy treatment with earlier identification of lack of benefit in some patients;
- Use of the LCSS-QL may decrease the use of imaging tests to assess objective tumor response as an indicator of treatment benefit.
Maximizing quality of life is one of the most important goals of palliative chemotherapy in the treatment of advanced lung cancer. If this simple practical tool can be demonstrated to improve palliative management of these patients, including optimizing duration of chemotherapy and use of palliative and supportive services based on patient QoL response, this will dramatically improve the quality of care provided to advanced lung cancer patients. This study will also provide a springboard for other ways to incorporate computer-generated QoL measurement in treatment decision-making in advanced cancer patients, including in other tumor types such as advanced breast and colorectal cancer.
Detailed description
Study Design The study will be conducted using an unblinded, randomized trial design. Patients starting systemic therapy for advanced NSCLC will be invited to complete the LCSS-QL upon starting first-line systemic chemotherapy and then prior to subsequent treatment visits (every 3 weeks). Patients will then be randomized at baseline to whether or not their physician will receive this information at the time of clinic visits for the duration of study participation. Randomization codes will be generated by computer program, with stratification by physician, platinum-based versus non-platinum based therapy and Eastern Cooperative Group Performance Status 0 and 1 versus 2 and 3. All patients complete the LCSS-QL at baseline, at the beginning of each cycle of chemotherapy, and at follow up visits until disease progression (initiation of subsequent therapy)or discontinue clinic visits an expected average of 12 to 18 weeks.
Patient Population All NSCLC patients with advanced disease (Stage 3B or 4) starting systemic therapy at the Princess Margaret Hospital will be eligible to participate. Inclusion criteria include the physical ability to use the hand-held instrument (adequate vision, manual dexterity), provision of written informed consent, and written fluency in English, French, Italian, Spanish, Portuguese or Chinese. Patients will be excluded if they are unable to complete or understand the assessment process, or if they are receiving concurrent radical radiotherapy.
Physician Information Physicians will be trained in interpretation of the LCSS electronic output data, in order to facilitate interpretation of the different domains of patient well-being, for example pain scores. An endorsement sheet will be printed in addition to the LCSS data, highlighting major changes in quality of life. For example, deterioration in pain control will be highlighted with suggestions to increase or change pain medication, consider radiotherapy and other pain management options, including changing systemic therapy.
Outcomes
Endpoints include palliative care referral rates, duration of systemic therapy, use of supportive interventions and QoL during treatment.
Data on the number of chemotherapy cycles administered, referral to palliative care (including timing), institution of additional supportive treatments, and number of imaging tests ordered will be collected for all patients prospectively. Data on LCSS scores, subsequent therapy, and date of death will also be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician to receive results | Other | Procedure: Physician Receives QoL resultsArm 1 Physician to receive the results of the Lung QoL scale |
| Physician Does Not Receive Results | Other | Procedure: Physician Does not receive the resultsArm 2 Physician does not receive the results of the Lung QoL scale |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Primary Non Small Cell Lung Cancer
- Stage 3 or 4 Lung Cancer
- To receive 1st line Chemotherapy
- Platinum based chemotherapy or Non Platinum
- Physical ability to use the hand held device(adequate vision, manual dexterity),
Key exclusion criteria (2 listed)
- Patients will be excluded if they are unable to complete or understand the assessment process,
- If they are receiving concurrent radical radiotherapy.
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 |
|---|---|---|
| Physician Receives QoL resultsPatient completes the Lung Cancer QoL scale on the Palm held computer device and the Physician receives the print out of the results. | Procedure or surgery | Physician to receive results |
| Physician Does not receive the resultsPatient completes the Lung Cancer QoL scale on the Palm held computer device and the Physician does not receive the print out of the results. | Procedure or surgery | Physician Does Not Receive Results |
Primary outcome
Number of Palliative care Referrals.
Time frame: Approximately 12 - 18 weeks
To assess the impact of use of the LCSS-QL on palliative care referrals;
Number of palliative first-line chemotherapy cycles administered.
Time frame: Approximately 12 - 18 weeks
To assess the impact of use of the LCSS-QL on the number of palliative first-line chemotherapy cycles administered
3 secondary outcomes
Use of supportive treatments.
Time frame: 12 - 18 weeks
Number of imaging tests ordered.
Time frame: Approximately 12 - 18 weeks
Differences between study arm scores
Time frame: Approximately 12 - 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
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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.
NATASHA LEIGHL, MD MSC principal investigator
UNIVERSITY HEALTH NETWORK / PRINCESS MARGARET HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician Receives QoL results and Physician Does not receive the results in people with Non Small Cell Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 2 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: finished, as of the sponsor's last update on 14 Mar 2017. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Palliative care Referrals. (time frame: Approximately 12 - 18 weeks). The study lists 2 primary outcomes in all. 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 14 Mar 2017.