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

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham VA Medical Center, Birmingham, AL, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols.

Other names: Supportive Care

Primary outcomes

Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit

Time frame: 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 outcomes

Change From Baseline in Patient Satisfaction of Care at Final Visit

Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: PCI2

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Jan 2, 2017
Registry last updated: Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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