Lung Cancer
Conditions
Keywords
Palliative Care, Supportive Care
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.
Interventions
BEHAVIORALPalliative 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
If consented participants became ineligible, they were not randomized into one of the two study arms.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 73 |
| 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. | 78 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 7 |
| Overall Study | Enrolled in Hospice | 3 | 2 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 2 |
Baseline characteristics
| Characteristic | Usual Care | Total | Intervention |
|---|---|---|---|
| Age, Continuous Age | 70.0 years STANDARD_DEVIATION 6.4 | 69.5 years STANDARD_DEVIATION 7.3 | 69.0 years STANDARD_DEVIATION 8.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 14 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 63 Participants | 128 Participants | 65 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 77 Participants | 148 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 73 | 7 / 78 |
| other Total, other adverse events | 22 / 73 | 13 / 78 |
| serious Total, serious adverse events | 19 / 73 | 11 / 78 |
Outcome results
Primary
Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit
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.
Time frame: Baseline and 3 Months
Population: Difference in FACT-L TOI score, Final Visit Measure, minus Baseline Visit Measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | 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 |
| Usual Care | Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit | -1.2 score on a scale | Standard Deviation 13.2 |
Secondary
Change From Baseline in Patient Satisfaction of Care at Final Visit
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.
Time frame: Baseline and 3 Months
Population: Difference in FAMCARE-13 Score, Final Visit measure minus Baseline Visit Measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change From Baseline in Patient Satisfaction of Care at Final Visit | 1.1 score on a scale | Standard Deviation 7.6 |
| Usual Care | Change From Baseline in Patient Satisfaction of Care at Final Visit | 0.5 score on a scale | Standard Deviation 8.2 |