Supportive Care for Patients Newly Diagnosed With Lung Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Palliative Care Interventions for Outpatients With Newly Diagnosed Lung Cancer|
- Patient Quality of Life including symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]Patient Quality of Life including symptoms as measured by the FACT-L
- Patient Satisfaction of Care [ Time Frame: 3 months ] [ Designated as safety issue: No ]Patient satisfaction with care will be assessed by using the FAMCARE- Patient Survey.
- Quality of Clinician Communication [ Time Frame: 3 months ] [ Designated as safety issue: No ]The quality of clinician end-of-life communication will be measured from the patient's perspective by the Quality of Communication Questionnaire (QOC).
- Clinician knowledge of patient preferences [ Time Frame: 3 months ] [ Designated as safety issue: No ]Clinician knowledge of patient preferences for life sustaining treatments will be assessed at baseline and at the study end point by asking 2 validated questions to both the clinician and the patient and determining the level of agreement between the responses.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.
Behavioral: Palliative Care
Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient.
No Intervention: Usual Care
Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
Patients meeting entry criteria will be randomized to the intervention arm, palliative care plus usual care or the usual care arm. Patients randomized to the intervention arm will receive usual oncologic care and phone calls from a nurse. Outcomes measures will be collected at baseline, and 3 months.
The study will be performed at the VA Puget Sound Health Care System. The investigators will recruit individuals (n=40) with lung cancer over 1 year. The primary objective is to test the feasibility and acceptability of the intervention, and recruitment of subjects. We will estimate the effect of a nurse-led telephone based palliative care intervention to improve quality-of-life, symptom burden and patient satisfaction. In addition, using validated instruments, we will assess the potential effect size of the intervention on quality of provider communication and on clinician knowledge of patient preferences for life sustaining therapies. The results of this pilot study will inform a future randomized clinical trial to test the efficacy of the intervention on a larger scale.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01883986
|Contact: Lynn F Reinke, PhD ARNP||(206) firstname.lastname@example.org|
|Contact: Julie LaGuire, RN||(206) 764-2082||Julie.LaGuire@va.gov|
|United States, Washington|
|VA Puget Sound Health Care System Seattle Division, Seattle, WA||Recruiting|
|Seattle, Washington, United States, 98108|
|Contact: Lynn F Reinke, PhD ARNP 206-277-4186 email@example.com|
|Contact: Julie LaGuire, RN (206) 764-2082 Julie.LaGuire@va.gov|
|Sub-Investigator: David H Au, MD MS|
|Principal Investigator: Lynn F. Reinke, PhD ARNP|
|Principal Investigator:||Lynn F. Reinke, PhD ARNP||VA Puget Sound Health Care System Seattle Division, Seattle, WA|