Recruitment

Recruitment Status
Completed
Estimated Enrollment
40

Inclusion Criterias

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

Exclusion Criterias

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

Summary

Conditions
Lung Cancer
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 40 years and 125 years
Gender
Both males and females

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...

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.

Inclusion Criterias

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

Exclusion Criterias

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

Locations

Seattle, Washington, 98108
Seattle, Washington, 98108

Tracking Information

NCT #
NCT01883986
Collaborators
Not Provided
Investigators
  • Principal Investigator: Lynn F. Reinke, PhD ARNP VA Puget Sound Health Care System Seattle Division, Seattle, WA
  • Lynn F. Reinke, PhD ARNP VA Puget Sound Health Care System Seattle Division, Seattle, WA