Supportive Care for Patients Newly Diagnosed With Lung Cancer

Lung Cancer Clinical Trial

Official title:

Palliative Care Interventions for Outpatients With Newly Diagnosed Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883986
• Other study ID #: NRI 12-141
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: February 10, 2016
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Quality of Life including symptoms	Patient Quality of Life including symptoms as measured by the FACT-L	3 months	No
Secondary	Patient Satisfaction of Care	Patient satisfaction with care will be assessed by using the FAMCARE- Patient Survey.	3 months	No
Secondary	Quality of Clinician Communication	The quality of clinician end-of-life communication will be measured from the patient's perspective by the Quality of Communication Questionnaire (QOC).	3 months	No
Secondary	Clinician knowledge of patient preferences	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.	3 months	No