Trial Outcomes & Findings for Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II (NCT NCT03007953)

Last Updated: 2023-07-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

151 participants

Primary outcome timeframe

Baseline and 3 Months

Results posted on

2023-07-27

Participant Flow

We identified lung cancer patients at the Puget Sound Health Care System, the Birmingham VA, and the Portland VA. Virtually all patients undergoing evaluation for lung cancer were presented at the Tumor Board and/or were evaluated in the chest (thoracic surgery and pulmonary), oncology, radiation oncology, or lung cancer clinics. All patients were screened weekly to determine study eligibility. Recruitment began when the first patient enrolled on December 2016 and lasted to June 2019.

If consented participants became ineligible, they were not randomized into one of the two study arms.

Participant milestones

Participant milestones
Measure	Intervention 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). 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), 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.	Usual Care Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.
Overall Study STARTED	73	78
Overall Study COMPLETED	57	65
Overall Study NOT COMPLETED	16	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention 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). 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), 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.	Usual Care Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.
Overall Study Withdrawal by Subject	5	2
Overall Study Death	5	7
Overall Study Lost to Follow-up	3	2
Overall Study Enrolled in Hospice	3	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=73 Participants 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). 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), 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.	Usual Care n=78 Participants Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.	Total n=151 Participants Total of all reporting groups
Age, Continuous Age	69.0 years STANDARD_DEVIATION 8.6 • n=39 Participants	70.0 years STANDARD_DEVIATION 6.4 • n=41 Participants	69.5 years STANDARD_DEVIATION 7.3 • n=35 Participants
Sex: Female, Male Female	2 Participants n=39 Participants	1 Participants n=41 Participants	3 Participants n=35 Participants
Sex: Female, Male Male	71 Participants n=39 Participants	77 Participants n=41 Participants	148 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=39 Participants	2 Participants n=41 Participants	5 Participants n=35 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	2 Participants n=41 Participants	2 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	5 Participants n=39 Participants	9 Participants n=41 Participants	14 Participants n=35 Participants
Race (NIH/OMB) White	65 Participants n=39 Participants	63 Participants n=41 Participants	128 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	2 Participants n=41 Participants	2 Participants n=35 Participants

PRIMARY outcome

Timeframe: Baseline and 3 Months

Population: Difference in FACT-L TOI score, Final Visit Measure, minus Baseline Visit Measure

Outcome measures

Outcome measures
Measure	Intervention n=73 Participants 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). 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), 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.	Usual Care n=78 Participants Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.
Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit	1.8 score on a scale Standard Deviation 16.8	-1.2 score on a scale Standard Deviation 13.2

SECONDARY outcome

Timeframe: Baseline and 3 Months

Population: Difference in FAMCARE-13 Score, Final Visit measure minus Baseline Visit Measure

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.

Outcome measures

Outcome measures
Measure	Intervention n=73 Participants 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). 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), 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.	Usual Care n=78 Participants Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.
Change From Baseline in Patient Satisfaction of Care at Final Visit	1.1 score on a scale Standard Deviation 7.6	0.5 score on a scale Standard Deviation 8.2

Adverse Events

Intervention

Serious events: 19 serious events

Other events: 22 other events

Deaths: 5 deaths

Usual Care

Serious events: 11 serious events

Other events: 13 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Intervention n=73 participants at risk 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). 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), 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.	Usual Care n=78 participants at risk Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.
Respiratory, thoracic and mediastinal disorders Serious adverse events	26.0% 19/73 • Number of events 29 • Each participant was assessed for adverse events through the study completion, e.g. 3 months or at the end of cancer treatment. ER visits, hospitalizations, and death are expected for patients with advanced cancers. All ER/Hospitalizations/Deaths were collected during medical record review and patients self-report (intervention arm only). They were reviewed at weekly study meetings and annually by the IRBs for each study site. Organ systems were not collected. N/A	14.1% 11/78 • Number of events 14 • Each participant was assessed for adverse events through the study completion, e.g. 3 months or at the end of cancer treatment. ER visits, hospitalizations, and death are expected for patients with advanced cancers. All ER/Hospitalizations/Deaths were collected during medical record review and patients self-report (intervention arm only). They were reviewed at weekly study meetings and annually by the IRBs for each study site. Organ systems were not collected. N/A

Other adverse events

Other adverse events
Measure	Intervention n=73 participants at risk 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). 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), 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.	Usual Care n=78 participants at risk Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.
General disorders Emergency Department Visits	30.1% 22/73 • Number of events 35 • Each participant was assessed for adverse events through the study completion, e.g. 3 months or at the end of cancer treatment. ER visits, hospitalizations, and death are expected for patients with advanced cancers. All ER/Hospitalizations/Deaths were collected during medical record review and patients self-report (intervention arm only). They were reviewed at weekly study meetings and annually by the IRBs for each study site. Organ systems were not collected. N/A	16.7% 13/78 • Number of events 17 • Each participant was assessed for adverse events through the study completion, e.g. 3 months or at the end of cancer treatment. ER visits, hospitalizations, and death are expected for patients with advanced cancers. All ER/Hospitalizations/Deaths were collected during medical record review and patients self-report (intervention arm only). They were reviewed at weekly study meetings and annually by the IRBs for each study site. Organ systems were not collected. N/A

Additional Information

Dr. Lynn F. Reinke

Department of Veterans Affairs

Phone: 206-277-4186

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place