None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate whether early referral for palliative care can improve quality of life, cost effectiveness and quality of end of life care for adults who are newly diagnosed with advanced lung cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with advanced non-small cell lung cancer, extensive small cell lung cancer or advanced malignant pleural mesothelioma within the last 60 days. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either standard care referral to palliative care at the discretion of the treating oncologist, or to receive early referral to palliative care within 7 days of enrolling in this trial. With the exception of the timing of the referral, the palliative care received by each group will be as per standard care, with information and care provided by the palliative care team as required for each participant. Participants will be asked to complete a number of questionnaires relating to quality of life and cancer symptoms at regular time points until their death. Carers will be asked to complete quality of life and death questionnaires and an interview at regular intervals up to six months following participant death. It is anticipated that the findings from this trial will provide information on whether early referral to palliative care following diagnosis of advanced lung cancer is beneficial for patient quality of life and end of life, and cost-effectiveness of care.
Interventions
Standard oncological care plus early referral (within 7 days of randomisation) to a
hospital-based palliative care service for the specified palliative care intervention (first consultation within 90 days of the diagnosis of advanced lung cancer or mesothelioma). The intervention is the early referral to palliative care - there is no change to the palliative care received, which is at the discretion of the treating physician until patient death.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults, aged 18 years and older, with a histological or cytological diagnosis within the last 60 days of either: (a) Advanced NSCLC (this includes de novo stage IV disease, recurrent NSCLC after definitive treatment, and locally advanced disease which is not planned for curative resection). Patients planned to receive curative intent chemoradiation for locally advanced disease are eligible or (b) Advanced SCLC (this includes extensive stage SCLC, recurrent SCLC after definitive treatment and locally advanced disease), or (c) Advanced MPM which is not planned for extrapleural pneumonectomy or pleurectomy-decortication. 2. Australia-modified Karnofsky performance status of 50 to 100 at the time of randomisation (see Appendix 1). 3. Willing and able to comply with all study requirements, including ability at the time of screening to complete the QOL questionnaires without assistance, in accordance with protocol requirements. 4. Signed, written informed consent.
Exclusion criteria
1. Immediate referral to palliative care required, or already referred to palliative care (this includes referral to a community or hospital based palliative care service, or palliative care physician). 2. Life expectancy of less than 3 months. 3. Serious medical or psychiatric onditions that might limit the ability of the patient to comply with the protocol.
Outcome results
None listed