Phase II Study: Integrated Palliative Care in Newly Diagnosed Advanced Non-Small-Cell Lung Cancer Patients

Massachusetts General Hospital, Boston, Massachusetts, United States
Journal of Clinical Oncology (Impact Factor: 18.43). 07/2007; 25(17):2377-82. DOI: 10.1200/JCO.2006.09.2627
Source: PubMed


To assess the feasibility of early palliative care in the ambulatory setting in patients with newly diagnosed advanced non-small-cell lung cancer (NSCLC).
Patients were eligible if they had a performance status of 0 to 1 and were within 8 weeks of diagnosis of advanced NSCLC. Participants received integrated care from oncology and palliative care throughout the course of their disease. Participants were scheduled to meet with the palliative care team (PCT) and complete quality-of-life (QOL) and mood questionnaires monthly for 6 months. The study was deemed feasible if 64% of patients completed at least 50% of their scheduled visits and QOL assessments.
Fifty-one patients were enrolled onto the trial. One died within 72 hours and was not assessable. Ninety percent (95% CI, 0.78 to 0.96) of study participants complied with at least 50% of the palliative care visits. Eight-six percent (95% CI, 0.73 to 0.94) of the participants met the full feasibility requirements by both meeting with the PCT and completing QOL assessments at least 50% of the time. QOL and mood analyses confirmed the high symptom burden in patients with newly diagnosed advanced NSCLC. At least 50% of participants experienced some degree of shortness of breath, cough, difficulty breathing, appetite loss, weight loss, or unclear thinking at their baseline assessment. More than one third of patients had a probable mood disorder at baseline.
Integrated palliative and oncology care is feasible in ambulatory patients with advanced NSCLC.

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Available from: Susan D Block, Sep 28, 2015
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    • "To our knowledge it is the first trial to investigate ‘early SPC’ for patients with a broad spectrum of cancer diagnosis, and the first trial to investigate screening-based referral to SPC. In addition it is the first to provide detailed information about the specific interventions given by the SPC centres; a knowledge that has been requested [30]. "
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    ABSTRACT: Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialised palliative care (SPC) could improve their symptoms and problems.The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer, who report palliative needs in a screening, will benefit from being referred to 'early SPC'. DanPaCT is a clinical, multicentre, parallel-group superiority trial with balanced randomisation (1:1).The planned sample size is 300 patients. Patients are randomised to specialised palliative care (SPC) plus standard treatment versus standard treatment. Consecutive patients from oncology departments are screened for palliative needs with a questionnaire if they: a) have metastatic cancer; b) are 18 years or above; and c) have no prior contact with SPC. Patients with palliative needs (i.e. symptoms/problems exceeding a certain threshold) according to the questionnaire are eligible. The primary outcome is the change in the patients' primary need (the most severe symptom/problem measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)). Secondary outcomes are other symptoms/problems (EORTC QLQ-C30), satisfaction with health care (FAMCARE P-16), anxiety and depression (the Hospital Anxiety and Depression scale), survival, and health care costs. Only few trials have investigated the effects of SPC. To our knowledge DanPaCT is the first trial to investigate screening based 'early SPC' for patients with a broad spectrum of cancer diagnosis.Trial registration: Current controlled Trials NCT 01348048.
    Full-text · Article · Oct 2013 · BMC Palliative Care
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    • "Although more recent reports suggested that patients are being seen earlier by specialist palliative care services, there is still uncertainty about the most appropriate time to involve a palliative care service. There is growing emphasis on an integrated approach with palliative care being delivered together with standard or even investigational treatments [27]. Rather than trying to determine timing of referral for palliative care in relation to prognosis, a focus on the needs of the patient and their family is advocated [10] "

    Full-text · Article · Jul 2009 · Pain
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    • "The approach was essentially a " both –and " (as opposed to " either–or " ) model in which there would be a smooth transition from mostly anticancer treatment to mostly palliative care (Byock, 2000). Models with some similar features have been called integrated (Temel et al., 2007), concurrent, or simultaneous care (Meyers & Linder, 2003; Pitorak et al., 2003; Byock et al., 2006). "
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    ABSTRACT: There is a paucity of randomized controlled trials (RCTs) to evaluate models of palliative care. Although interventions vary, all have faced a variety of methodological challenges including adequate recruitment, missing data, and contamination of the control group. We describe the ENABLE II intervention, methods, and sample baseline characteristics to increase intervention and methodological transparency, and to describe our solutions to selected methodological issues. Half of the participants recruited from our rural U.S. comprehensive cancer center and affiliated clinics were randomly assigned to a phone-based, nurse-led educational, care coordination palliative care intervention model. Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, quality of life, mood, and functional status were assessed every 3 months until death. Baseline data of 279 participants were similar to normative samples. Solutions to methodological challenges of recruitment, missing data, and "usual care" control group contamination are described. It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT.
    Full-text · Article · Apr 2009 · Palliative and Supportive Care
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