Non Small Cell Lung Cancer Clinical Trial
— LUNL2Official 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)
Verified date | March 2017 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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:
1. Use of the LCSS-QL will increase and accelerate referral to and use of palliative care
services;
2. Use of the LCSS-QL will decrease the duration of palliative chemotherapy treatment with
earlier identification of lack of benefit in some patients;
3. 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.
Status | Completed |
Enrollment | 103 |
Est. completion date | November 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria - 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 Exclusion Criteria: - Patients will be excluded if they are unable to complete or understand the assessment process, - If they are receiving concurrent radical radiotherapy. |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Mount Sinai Hospital, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Palliative care Referrals. | To assess the impact of use of the LCSS-QL on palliative care referrals; | Approximately 12 - 18 weeks | |
Primary | 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 | Approximately 12 - 18 weeks | |
Secondary | 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; | 12 - 18 weeks | |
Secondary | 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. | Approximately 12 - 18 weeks | |
Secondary | Differences between study arm scores | To compare LCSS-QL scores of patients between the two study arms | Approximately 12 - 18 weeks |
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