Supportive Care for Patients Newly Diagnosed With Lung Cancer

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01883986
First received: June 18, 2013
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Lung Cancer
Behavioral: Palliative Care

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: February 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

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. 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883986

Locations
United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Investigators
Principal Investigator: Lynn F. Reinke, PhD ARNP VA Puget Sound Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01883986     History of Changes
Other Study ID Numbers: NRI 12-141, NRI12-241
Study First Received: June 18, 2013
Last Updated: May 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
palliative care

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 01, 2014