Anxiety Disorder, Depression, Esophageal Cancer, Extrahepatic Bile Duct Cancer, Gastric Cancer, Liver Cancer, Malignant Mesothelioma, Non-small Cell Lung Cancer, Pancreatic Cancer, Small Cell Lung Cancer
Conditions
Brief summary
The study intervention consists of the early integration of palliative care services into standard oncology care in an outpatient setting for patients with advanced lung and non-colorectal gastrointestinal malignancies who are not being treated with curative intent. The palliative care services provided to patients randomized to the intervention will be provided by board-certified physicians and/or advanced practice nurses and will focus on the following areas: (1) developing and maintaining the therapeutic relationship with the patients and family caregivers; (2) assessing and treating patient symptoms; (3) providing support and reinforcement of coping with advanced cancer in patients and family caregivers; (4) assessing and enhancing prognostic awareness and illness understanding in patients and family caregivers; (5) assisting with treatment decision-making; and (6) end-of-life care planning.
Detailed description
There will be about 400 patients enrolled in this intervention study and there will be about 300 family caregivers enrolled as well. This study will consist of two study groups as previously described. The effects of the early involvement of the palliative care team will be compared to the usual approach of receiving care mostly from the cancer treatment team. The stratification factors include tumor type (lung vs. esophageal/gastric vs. hepatic/biliary/pancreatic) and family care giver participation (yes vs. no). Patients will be on this study for as long as they receive care. Institutions must have an outpatient palliative care clinic that meets the study site requirements as defined in the protocol. The outpatient clinic leadership must include a physician and/or advanced practice nurses board certified in palliative care. The primary and secondary endpoints are described below. Primary Endpoint: To determine the efficacy of early integrated palliative care on patient reported quality of life at 12 weeks using the FACT in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer Secondary Endpoints: * To determine the efficacy of early integrated palliative care on other patient reported outcomes in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer, by assessing the endpoints defined in the protocol * To determine the efficacy of early integrated palliative care on family caregiver reported outcomes in those newly diagnosed incurable lung or non-colorectal gastrointestinal cancer, by assessing the endpoints defined in the protocol * To assess the impact of early integrated palliative care on the quality of end-of-life care and resource utilization in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer by assessing the endpoints defined in the protocol * To determine concordance between patient and family caregiver report of prognosis/ curability
Interventions
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Study Patient Participant Eligibility Requirements: 1. Documentation of Disease: Confirmed advanced lung cancer (NSCLC, small cell lung cancer, or mesothelioma) or non-colorectal GI cancer (esophageal, gastric, hepatic, biliary, or pancreatic) not being treated with curative intent. 2. Informed of diagnosis of incurable disease within the previous 8 weeks. 3. Age ≥ 18 years 4. ECOG Performance Status 0-2 5. Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member. 6. Planning to receive all medical care for cancer at the enrolling institution. 7. Participants must be under the care of an oncologist, but their current plan may or may not include chemotherapy or other forms of tumor-directed therapies. Study Family Caregiver Participant Eligibility Requirements: 1. Relative or friend who is identified by the patient participant who plans to regularly accompany the patient to the majority of their clinic visits. 2. Family caregiver must live with the patient or have in-person contact with him or her at least twice per week. 3. Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member. 4. Age ≥ 18 years Note: An eligible patient may participate in this trial without an eligible family caregiver being registered.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G) | Up to 12 weeks | Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Higher scores on FACT-G indicate better QOL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Depression | Up to 12 weeks | Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Depression on a 0-21 scale, with lower scores corresponding to lower depression and higher scores corresponding to higher depression. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Depression indicate less depression symptoms. |
| Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Anxiety | Up to 12 weeks | Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Anxiety on a 0-21 scale, with lower scores corresponding to lower anxiety and higher scores corresponding to higher anxiety. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Anxiety indicate less anxiety symptoms. |
| Prognostic Understanding at Week-12 as Measured by Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying? Question on the Prognosis and Treatment Perceptions Questionnaire | Up to 12 weeks | Prognostic Understanding at Week-12 as measured by Prognosis and Treatment Perceptions Questionnaire: Have you and your oncologist discussed any particular wishes about the care you would want to receive if you were dying? responses at Week-12 are reported below. |
| Change in QOL on the SF-36 Over Time | Up to 3 years | — |
| Rate of Referral, Enrollment and Length of Stay on Hospice | Up to 3 years | — |
| Change in Quality of Life (QOL) From Baseline to Week 24 Per the Functional Assessment of Cancer Therapy-General (FACT-G) | Up to 24 weeks | Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-24 was calculated by subtracting the baseline scores from the scores at week-24. Higher scores on FACT-G indicate better QOL. |
| Number of Hospital and Intensive Care Unit (ICU) Admissions and Days | Up to 3 years | — |
| Chemotherapy and Radiation Administration | Up to 3 years | — |
| Overall Survival | Up to 3 years | — |
| Concordance Between Patient and Family Caregiver Report of Prognosis/Curability | Up to 3 years | — |
| Location of Death | Up to 3 years | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 (Early Palliative Care) Patients receive early palliative care and standard oncology care. Patients and family caregivers will be asked to complete quality-of-life questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. | 195 |
| Arm 2 (Usual Care) Patients receive standard oncology care. Patient and family caregiver will be asked to complete self-report questionnaires at weeks 6, 12, and 24. Survival follow-up will be every 4 months from week 24 until death or up to 3 years. Palliative care visit only upon request from attending oncologist(s) or patient/family. | 196 |
| Total | 391 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 7 | 7 |
Baseline characteristics
| Characteristic | Total | Arm 1 (Early Palliative Care) | Arm 2 (Usual Care) |
|---|---|---|---|
| Age, Continuous | 65.2 years | 65.5 years | 65.0 years |
| ECOG Performance Status 0 | 88 Participants | 47 Participants | 41 Participants |
| ECOG Performance Status 1 | 235 Participants | 108 Participants | 127 Participants |
| ECOG Performance Status 2 | 68 Participants | 40 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants | 24 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants | 12 Participants | 9 Participants |
| Race (NIH/OMB) White | 303 Participants | 148 Participants | 155 Participants |
| Region of Enrollment United States | 391 Participants | 195 Participants | 196 Participants |
| Sex: Female, Male Female | 170 Participants | 81 Participants | 89 Participants |
| Sex: Female, Male Male | 221 Participants | 114 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G)
Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Higher scores on FACT-G indicate better QOL.
Time frame: Up to 12 weeks
Population: Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (Early Palliative Care) | Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G) | 3.35 units on a scale | Standard Deviation 14.7 |
| Arm 2 (Usual Care) | Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G) | 0.12 units on a scale | Standard Deviation 12.7 |
p-value: 0.10495% CI: [-0.67, 7.13]ANCOVA
Secondary
Change in QOL on the SF-36 Over Time
Time frame: Up to 3 years
Secondary
Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Anxiety
Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Anxiety on a 0-21 scale, with lower scores corresponding to lower anxiety and higher scores corresponding to higher anxiety. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Anxiety indicate less anxiety symptoms.
Time frame: Up to 12 weeks
Population: Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (Early Palliative Care) | Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Anxiety | -1.13 units on a scale | Standard Deviation 2.7 |
| Arm 2 (Usual Care) | Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Anxiety | -0.32 units on a scale | Standard Deviation 2.8 |
p-value: 0.03395% CI: [-1.54, -0.07]ANCOVA
Secondary
Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Depression
Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Depression on a 0-21 scale, with lower scores corresponding to lower depression and higher scores corresponding to higher depression. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Depression indicate less depression symptoms.
Time frame: Up to 12 weeks
Population: Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (Early Palliative Care) | Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Depression | 0.54 units on a scale | Standard Deviation 4 |
| Arm 2 (Usual Care) | Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Depression | 0.46 units on a scale | Standard Deviation 3.6 |
p-value: 0.88495% CI: [-0.94, 2.09]ANCOVA
Secondary
Change in Quality of Life (QOL) From Baseline to Week 24 Per the Functional Assessment of Cancer Therapy-General (FACT-G)
Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-24 was calculated by subtracting the baseline scores from the scores at week-24. Higher scores on FACT-G indicate better QOL.
Time frame: Up to 24 weeks
Population: Only participants with available data on the individual study measure at baseline and 24 weeks were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (Early Palliative Care) | Change in Quality of Life (QOL) From Baseline to Week 24 Per the Functional Assessment of Cancer Therapy-General (FACT-G) | 3.80 units on a scale | Standard Deviation 15.3 |
| Arm 2 (Usual Care) | Change in Quality of Life (QOL) From Baseline to Week 24 Per the Functional Assessment of Cancer Therapy-General (FACT-G) | 0.69 units on a scale | Standard Deviation 13.3 |
p-value: 0.18895% CI: [-1.54, 7.77]ANCOVA
Secondary
Chemotherapy and Radiation Administration
Time frame: Up to 3 years
Secondary
Concordance Between Patient and Family Caregiver Report of Prognosis/Curability
Time frame: Up to 3 years
Secondary
Location of Death
Time frame: Up to 3 years
Secondary
Number of Hospital and Intensive Care Unit (ICU) Admissions and Days
Time frame: Up to 3 years
Secondary
Overall Survival
Time frame: Up to 3 years
Secondary
Prognostic Understanding at Week-12 as Measured by Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying? Question on the Prognosis and Treatment Perceptions Questionnaire
Prognostic Understanding at Week-12 as measured by Prognosis and Treatment Perceptions Questionnaire: Have you and your oncologist discussed any particular wishes about the care you would want to receive if you were dying? responses at Week-12 are reported below.
Time frame: Up to 12 weeks
Population: Only participants with available data on the individual study measure at week 12 were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1 (Early Palliative Care) | Prognostic Understanding at Week-12 as Measured by Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying? Question on the Prognosis and Treatment Perceptions Questionnaire | Yes | 30 Participants |
| Arm 1 (Early Palliative Care) | Prognostic Understanding at Week-12 as Measured by Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying? Question on the Prognosis and Treatment Perceptions Questionnaire | No | 69 Participants |
| Arm 2 (Usual Care) | Prognostic Understanding at Week-12 as Measured by Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying? Question on the Prognosis and Treatment Perceptions Questionnaire | Yes | 16 Participants |
| Arm 2 (Usual Care) | Prognostic Understanding at Week-12 as Measured by Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying? Question on the Prognosis and Treatment Perceptions Questionnaire | No | 94 Participants |
p-value: 0.006Chi-squared
Secondary
Rate of Referral, Enrollment and Length of Stay on Hospice
Time frame: Up to 3 years