Supportive Care for Patients Newly Diagnosed With Lung Cancer

NCT01883986 | Completed Results

• 1 other identifier: NRI 12-141
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

palliative care

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at 3 Months

  Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84 with a higher score indicating a better quality of life.

  Baseline and 3 months

Secondary Outcomes (3)

• Change From Baseline in Patient Satisfaction of Care at 3 Months

  Baseline and 3 months

• Change in Baseline Quality of Clinician Communication at 3 Months

  Baseline and 3 months

• Change From Baseline in Clinician Knowledge of Patient Preferences at 3 Months

  Baseline and 3 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Palliative Care 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.

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Lynn F. Reinke, PhD, ARNP
• Organization: VA Puget Sound Health Care System

lynn.reinke1@va.gov

206-277-4186

Study Officials

• Lynn F. Reinke, PhD ARNP

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 21, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 31, 2017
• Results First Posted: January 31, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)