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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-02352 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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The goal of this study is to learn about the quality of life (QOL) in participants with advanced lung cancer.
Advanced lung cancer (ALC) will be assessed for participant outcomes in a sample which is prior initiation of palliative consultation and in a sample after the initiation of early palliative consultation.
Study goals are:
I. To determine the differences in participant outcomes including quality of life (QOL); symptom distress [Edmonton symptom assessment scale (ESAS)] and caregiver outcomes [Zarit Burden Interview {ZBI}, Hospital Anxiety and Depression scale(HADS) and FAMCARE] at week 12 in advanced lung cancer (ALC) patients receiving early palliative care consultation versus those who don't.
II. Identify the cellular, molecular, and immune basis for the development of symptoms in patients with ALC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSCLC - Current Palliative Care Referral Practices | Early palliative consultation impact assessment via questionnaires during a regularly scheduled clinic visit or during inpatient stay. |
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| Primary Caregiver | Caregiver satisfaction with quality of care and early palliative consultation impact assessed via questionnaires during a regularly scheduled clinic visit or during inpatient stay. |
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| NSCLC - After Early Palliative Care Consult System | Palliative consultation impact assessment via questionnaires during a regularly scheduled clinic visit or during inpatient stay. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QOL Questionnaire | Behavioral | Participant outcomes assessed with survey |
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| Measure | Description | Time Frame |
|---|---|---|
| Participants' QOL Assessments | Impact of early palliative consultation (defined as palliative consultation within 8 weeks of initial advanced cancer diagnosis) on participant outcomes including improvement QOL [FACT-L trial outcome index [TOI] score)]. QOL assessed with FACT-L instrument, widely used to assess QOL of advanced NSCLC. FACT-L consists of 4 general & 1 lung cancer symptom-specific subscale. General subscales include physical well-being (PWB; seven items), social/family well-being (seven items), emotional well-being (five items), and functional well-being (FWB; seven items). The seven-item lung cancer subscale (LCS) assesses symptoms commonly reported by lung cancer patients (e.g., shortness of breath, loss of weight, tightness in chest). The 21-item TOI (Trial Outcome Index) is derived by adding PWB, FWB, and LCS scores. All FACT-L items are rated on five-point scales ranging from 0 for "not at all" to 4 for "very much." Higher scores are representative of better QOL or fewer symptoms. | Baseline till participant death or end of follow-up period, assessed every 4 weeks for approximately 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Outcomes: FAMCARE Scale | Caregiver satisfaction with quality of care assessed with FAMCARE validated 12-item survey, which measures the degree of satisfaction with health care in terms of information provided, availability of care, physical individual with advanced cancer care, and psychological care. | Baseline till participant death or end of follow-up period, assessed every 4 weeks for approximately 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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MD Anderson Cancer Center Non-small cell lung cancer (NSCLC) patients
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| Name | Affiliation | Role |
|---|---|---|
| Siriam Yennu, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Official Website | View source |
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Blood specimens drawn (24 mL (8 mL x 3) at the following timepoints: baseline, every 4 weeks (+ 5 days) until end of follow-up.
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| Caregiver Satisfaction Questionnaire | Behavioral | Caregiver satisfaction with quality of care assessed with surveys |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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