Supportive Care for Patients Newly Diagnosed With Lung Cancer

NCT ID: NCT01883986

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-12-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Palliative Care

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynn F. Reinke, PhD ARNP

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Locations

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

Countries

United States

Other Identifiers

NRI 12-141

Identifier Type: -

Identifier Source: org_study_id