Non Small Cell Lung Cancer Clinical Trial
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:
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.
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.
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