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)
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.
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.
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
Number of Palliative care Referrals.
To assess the impact of use of the LCSS-QL on palliative care referrals;
Approximately 12 - 18 weeks
NATASHA LEIGHL, MD MSC
UNIVERSITY HEALTH NETWORK / PRINCESS MARGARET HOSPITAL
Canada: Ethics Review Committee