Supportive Care for Patients Newly Diagnosed With Lung Cancer

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VA Office of Research and Development

Status

Completed

Conditions

Lung Cancer

Treatments

Behavioral: Palliative Care

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01883986
NRI 12-141

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

41 participants in 2 patient groups

Intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Palliative Care
Usual Care
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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