Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Behavioral: Palliative Care

• Registration Number: NCT03007953
• Lead Sponsor: VA Office of Research and Development

Brief Summary

The focus of the study is to test a nurse-led telephone-based palliative care intervention on improving the delivery of care for patients with newly diagnosed lung cancer. The study is a three site randomized control trial to determine the efficacy of the intervention on improving patients' quality of life, symptom burden, and satisfaction of care. Additionally, the study will test an innovative care delivery model to improve patients' access to palliative care. The investigators will also determine the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients' goals of care.

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. Outcome measures will be collected at baseline and at the end of the patients' primary cancer treatment. The study will be performed at the Puget Sound Health Care System, Birmingham VA and Portland VA. The investigators will recruit individuals (n=138) with lung cancer over 2.5 years. The primary objective is to determine the efficacy of the nurse-led telephone-based palliative intervention on improving patients' quality of life, symptom burden, and satisfaction of care. In addition, using validated instruments, the investigators will assess the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients' goals of care. The results of this study will inform a future effectiveness/implementation study.

Study Timeline

• Study Start: 2016-12-05
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2017-01-02
• Primary Completion: 2019-12-11
• Study Completion: 2019-12-11
• Results First Submitted: 2021-06-07
• Results First Submitted QC: 2021-09-09
• Results First Posted: 2021-10-07
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

Patients diagnosed at the Puget Sound Health Care System, Birmingham VA, or Portland VA with a primary diagnosis of lung cancer that requires more than surgical resection:

• diagnosed within 8 weeks of recruitment
• must have telephone access
• ability to understand English
• able to participate in informed consent process

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Palliative Care	This is a 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, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months).

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit	Baseline and 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. Among patients with newly diagnosed lung cancer, provision of a telephone-based palliative care intervention will be associated with a change in FACT-L TOI score. The investigators will assess the difference in FACT-L TOI scores between the intervention and control subjects.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Patient Satisfaction of Care at Final Visit	Baseline and 3 Months	Patient satisfaction with care will be assessed by using the FAMCARE-Patient Survey 13 (full unabbreviated scale name). The FAMCARE is a 13 item, 5 point likert-scale validated questionnaire measuring patient satisfaction with cancer care and assessing interactions with health care providers, performance status and symptom burden. Only total score are reported (no subscales). Scores range from 13-65 with scores of 52 \> being satisfied with care. In full randomized clinical trials the estimated MID is 5 points from baseline to 12 weeks. Among patients with newly diagnosed lung cancer, provision of a telephone-based palliative care intervention will be associated with a change in FAMCARE-P13 score. The investigators will assess the difference in FAMCARE-P13 scores between the intervention and control subjects.

Trial Locations

Locations (3)

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States

Birmingham VA Medical Center, Birmingham, AL; 🇺🇸 Birmingham, Alabama, United States

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States