Clinical trial NCT01883986: Supportive Care for Patients Newly Diagnosed With Lung Cancer
Official title: Palliative Care Interventions for Outpatients With Newly Diagnosed Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: palliative care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-06-21
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of this project are to assess the feasibility of recruiting patients and delivering a nurse-led telephone based palliative care intervention for patients with newly diagnosed lung cancer and to assess if among patients with newly diagnosed lung cancer, the investigators can estimate the effect of a nurse-led telephone based palliative care intervention on quality-of-life, symptom burden and patient satisfaction.

Detailed description: 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. The investigators 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, the investigators 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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed at the Puget Sound Health Care System with a primary diagnosis of lung cancer,
* any cell type or stage,
* diagnosed within 8 weeks of study enrollment.
* Must have telephone access,
* ability of understand English and
* provide informed consent.

Exclusion Criteria:

* Patients not eligible to participate in the study include those who are inpatients prior to randomization,
* those who are under the care of palliative care or hospice at the time of randomization,
* those who have severe mental health disorders,
* those who are unable to speak directly with the nurse over the telephone,
* or those that have the inability to provide informed consent. Investigators will recruit individuals (n=40) with lung cancer over a 12 month period.

Primary outcomes:
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at 3 Months
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change From Baseline in Patient Satisfaction of Care at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Baseline Quality of Clinician Communication at 3 Months
timeFrame: Baseline and 3 months
measure: Change From Baseline in Clinician Knowledge of Patient Preferences at 3 Months
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Lynn F. Reinke, PhD ARNP
role: PRINCIPAL_INVESTIGATOR
References: