| Primary | Patient Quality of Life Patient Quality of Life 12 Weeks After Surgery | Patient quality of life will be measured by the Functional Assessment of Chronic Illness Therapy Palliative care subscale (FACIT-PAL). FACIT-PAL is a compilation of general questions divided into four primary QOL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. FACIT-PAL has 46 item self report measure. The range is from 0-184 for the FACIT-PAL. A higher score is a better outcome. | | Posted | | Mean | Standard Deviation | score on a scale | | Up to 12 weeks after surgery | | | | ID | Title | Description |
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| OG000 | Surgeon-palliative Care Team Co-management | In the Surgeon-palliative care team co-management arm, all patients receive the surgical care of surgeon alone management, which includes surgeon and the surgical team. In addition to this surgeon alone care, palliative care will also be provided by a specialist team. For patients in this arm, patients and/or family members will be seen by the palliative care team: (1) in an outpatient setting prior to surgery, (2) in the hospital within 72 hours of their initial surgery and as needed afterwards, and (3) via phone on in-clinic (per patient preference) on an at least monthly basis and/or as needed for 12 weeks following surgery. Surgeon-palliative care team co management: Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team | | OG001 | Surgeon Alone Management | The surgeon and surgical team will manage symptoms, psychosocial support, and prognostic related communication. The surgeon and surgical team care for the patient and their family both prior to and following surgery. The surgeon team is given guidelines published by the National Cancer Coalition Network as to when palliative care specialist consultation is recommended Surgeon team alone management: The surgeon and surgical team will manage |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000138.54± 28.28
- OG001136.90± 28.96
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Regression, Linear | | .623 | The a priori threshold for statistical significance was < 0.05. | Mean Difference (Final Values) | -1.63 | | | 2-Sided | 95 | -8.15 | 4.89 | | | | | Superiority | | |
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| Secondary | Patient Mood Symptoms Assessment 12 Weeks After Surgery | Patient symptoms were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29) version 2.1. PROMIS-29 survey questions were each rated on a 5-point Likert scale (range: 1 to 5, higher scores represent a better outcome). Item responses were converted to PROMIS T-scores per the PROMIS scoring manual (population mean = 50, SD = 10). T-scores were then converted to standardized z-scores using the formula (T-score - 50) / 10. Composite physical and mental health z-scores were calculated using weighted domain z-scores. Higher z-scores indicate better outcomes, and negative z-scores indicate scores below the population reference mean. | Participants with available survey data | Posted | | Mean | Standard Deviation | z-score | | Up to 12 weeks after surgery | | | | ID | Title | Description |
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| OG000 | Surgeon-palliative Care Team Co-management | In the Surgeon-palliative care team co-management arm, all patients receive the surgical care of surgeon alone management, which includes surgeon and the surgical team. In addition to this surgeon alone care, palliative care will also be provided by a specialist team. For patients in this arm, patients and/or family members will be seen by the palliative care team: (1) in an outpatient setting prior to surgery, (2) in the hospital within 72 hours of their initial surgery and as needed afterwards, and (3) via phone on in-clinic (per patient preference) on an at least monthly basis and/or as needed for 12 weeks following surgery. Surgeon-palliative care team co management: Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team |
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| Secondary | Patient Palliative Symptoms Assessment | Patient will be assessed for twelve symptoms (pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, constipation, financial distress, and spiritual pain) using a modified Edmonton Symptom Assessment System (ESAS). Each symptom is rated from 0 to 10 on a numerical scale, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity. | data were not collected for this outcome measure | Posted | | | | | | Up to 12 weeks after surgery | | | | ID | Title | Description |
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| OG000 | Surgeon-palliative Care Team Co-management (Intervention) | In the Surgeon-palliative care team co-management arm, all patients receive the surgical care of surgeon alone management, which includes surgeon and the surgical team. In addition to this surgeon alone care, palliative care will also be provided by a specialist team. For patients in this arm, patients and/or family members will be seen by the palliative care team: (1) in an outpatient setting prior to surgery, (2) in the hospital within 72 hours of their initial surgery and as needed afterwards, and (3) via phone on in-clinic (per patient preference) on an at least monthly basis and/or as needed for 12 weeks following surgery. Surgeon-palliative care team co management: Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team | | OG001 | Surgeon Alone Management (Control) | The surgeon and surgical team will manage symptoms, psychosocial support, and prognostic related communication. The surgeon and surgical team care for the patient and their family both prior to and following surgery. The surgeon team is given guidelines published by the National Cancer Coalition Network as to when palliative care specialist consultation is recommended Surgeon team alone management: The surgeon and surgical team will manage |
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| Secondary | Patient Spiritual Assessment 12 Weeks After Surgery | Patient spiritual symptoms assessment will be assessed using Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp-12); 12 item Spiritual Well-being Scale. Score range: 0 to 48; higher scores correspond to better spiritual well-being. | Participants with available survey data | Posted | | Mean | Standard Deviation | score on a scale | | Up to 12 weeks after surgery | | | | ID | Title | Description |
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| OG000 | Surgeon-palliative Care Team Co-management (Intervention) | In the Surgeon-palliative care team co-management arm, all patients receive the surgical care of surgeon alone management, which includes surgeon and the surgical team. In addition to this surgeon alone care, palliative care will also be provided by a specialist team. For patients in this arm, patients and/or family members will be seen by the palliative care team: (1) in an outpatient setting prior to surgery, (2) in the hospital within 72 hours of their initial surgery and as needed afterwards, and (3) via phone on in-clinic (per patient preference) on an at least monthly basis and/or as needed for 12 weeks following surgery. Surgeon-palliative care team co management: Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team | | OG001 | Surgeon Alone Management (Control) | The surgeon and surgical team will manage symptoms, psychosocial support, and prognostic related communication. The surgeon and surgical team care for the patient and their family both prior to and following surgery. The surgeon team is given guidelines published by the National Cancer Coalition Network as to when palliative care specialist consultation is recommended Surgeon team alone management: The surgeon and surgical team will manage |
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| Secondary | Patient Prognostic Awareness Assessment Assessment 12 Weeks After Surgery | Patient prognostic awareness is determined based on the Cancer Care Outcomes Research & Surveillance Consortium (CANCORS) study prognostic awareness questions before and after surgery. To each question, the respondent replied Very likely, Somewhat likely, A little likely, Not at all likely, or Don't know. | Participants who completed the respective survey questions are included in the analysis. | Posted | | Count of Participants | | Participants | | Up to 12 weeks after surgery | | | | ID | Title | Description |
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| OG000 | Surgeon-palliative Care Team Co-management (Intervention) | In the Surgeon-palliative care team co-management arm, all patients receive the surgical care of surgeon alone management, which includes surgeon and the surgical team. In addition to this surgeon alone care, palliative care will also be provided by a specialist team. For patients in this arm, patients and/or family members will be seen by the palliative care team: (1) in an outpatient setting prior to surgery, (2) in the hospital within 72 hours of their initial surgery and as needed afterwards, and (3) via phone on in-clinic (per patient preference) on an at least monthly basis and/or as needed for 12 weeks following surgery. Surgeon-palliative care team co management: Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team | | OG001 | Surgeon Alone Management (Control) | |
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| Secondary | Patient Mortality up to 6 Months | Number of surviving patients in both arms will be reported at end of 6 months. | | Posted | | Count of Participants | | Participants | | Up to 6 months after surgery | | | | ID | Title | Description |
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| OG000 | Surgeon-palliative Care Team Co-management (Intervention) | In the Surgeon-palliative care team co-management arm, all patients receive the surgical care of surgeon alone management, which includes surgeon and the surgical team. In addition to this surgeon alone care, palliative care will also be provided by a specialist team. For patients in this arm, patients and/or family members will be seen by the palliative care team: (1) in an outpatient setting prior to surgery, (2) in the hospital within 72 hours of their initial surgery and as needed afterwards, and (3) via phone on in-clinic (per patient preference) on an at least monthly basis and/or as needed for 12 weeks following surgery. Surgeon-palliative care team co management: Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team | | OG001 | Surgeon Alone Management (Control) | The surgeon and surgical team will manage symptoms, psychosocial support, and prognostic related communication. The surgeon and surgical team care for the patient and their family both prior to and following surgery. The surgeon team is given guidelines published by the National Cancer Coalition Network as to when palliative care specialist consultation is recommended Surgeon team alone management: The surgeon and surgical team will manage |
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| Secondary | Caregiver Mood Symptom Assessment at 12 Weeks After Surgery | Caregiver symptoms were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29) version 2.1. PROMIS-29 survey questions were each rated on a 5-point Likert scale (range: 1 to 5, higher scores represent a better outcome). Item responses were converted to PROMIS T-scores per the PROMIS scoring manual (population mean = 50, SD = 10). T-scores were then converted to standardized z-scores using the formula (T-score - 50) / 10. Composite physical and mental health z-scores were calculated using weighted domain z-scores. Higher z-scores indicate better outcomes, and negative z-scores indicate scores below the population reference mean. | Participants who completed the survey are included in the analysis | Posted | | Mean | Standard Deviation | z-score | | Up to 12 weeks after surgery | | | | ID | Title | Description |
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| OG000 | Surgeon-palliative Care Team Co-management (Intervention) | In the Surgeon-palliative care team co-management arm, all patients receive the surgical care of surgeon alone management, which includes surgeon and the surgical team. In addition to this surgeon alone care, palliative care will also be provided by a specialist team. For patients in this arm, patients and/or family members will be seen by the palliative care team: (1) in an outpatient setting prior to surgery, (2) in the hospital within 72 hours of their initial surgery and as needed afterwards, and (3) via phone on in-clinic (per patient preference) on an at least monthly basis and/or as needed for 12 weeks following surgery. Surgeon-palliative care team co management: Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team |
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| Secondary | Caregiver Burden Measurement 12 Weeks After Surgery | The Zarit Caregiver Burden Scale (ZBI-12) is a 12-item measure of caregiver burden caring for a patient with chronic illness, focusing on the emotional, physical, and social aspects of caregiving. The questions are ranked on a 5-point Likert scale. The total score is 0-48 a higher score indicates a worse outcome (more caregiver burden). | | Posted | | Median | Inter-Quartile Range | score on a scale | | Up to 12 weeks after surgery | | | | ID | Title | Description |
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| OG000 | Surgeon-palliative Care Team Co-management (Intervention) | In the Surgeon-palliative care team co-management arm, all patients receive the surgical care of surgeon alone management, which includes surgeon and the surgical team. In addition to this surgeon alone care, palliative care will also be provided by a specialist team. For patients in this arm, patients and/or family members will be seen by the palliative care team: (1) in an outpatient setting prior to surgery, (2) in the hospital within 72 hours of their initial surgery and as needed afterwards, and (3) via phone on in-clinic (per patient preference) on an at least monthly basis and/or as needed for 12 weeks following surgery. Surgeon-palliative care team co management: Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team | | OG001 | Surgeon Alone Management (Control) | The surgeon and surgical team will manage symptoms, psychosocial support, and prognostic related communication. The surgeon and surgical team care for the patient and their family both prior to and following surgery. The surgeon team is given guidelines published by the National Cancer Coalition Network as to when palliative care specialist consultation is recommended Surgeon team alone management: The surgeon and surgical team will manage |
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| Secondary | Caregiver Spiritual Measure at 12 Weeks | Caregiver spiritual symptoms assessment will be assessed using Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp-12); 12 item Spiritual Well-being Scale (score range: 0 to 48; higher scores correspond to better spiritual well-being). | Participants with available survey data | Posted | | Mean | Standard Deviation | score on a scale | | Up to 12 weeks after surgery | | | | ID | Title | Description |
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| OG000 | Surgeon-palliative Care Team Co-management (Intervention) | In the Surgeon-palliative care team co-management arm, all patients receive the surgical care of surgeon alone management, which includes surgeon and the surgical team. In addition to this surgeon alone care, palliative care will also be provided by a specialist team. For patients in this arm, patients and/or family members will be seen by the palliative care team: (1) in an outpatient setting prior to surgery, (2) in the hospital within 72 hours of their initial surgery and as needed afterwards, and (3) via phone on in-clinic (per patient preference) on an at least monthly basis and/or as needed for 12 weeks following surgery. Surgeon-palliative care team co management: Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team | | OG001 | Surgeon Alone Management (Control) | The surgeon and surgical team will manage symptoms, psychosocial support, and prognostic related communication. The surgeon and surgical team care for the patient and their family both prior to and following surgery. The surgeon team is given guidelines published by the National Cancer Coalition Network as to when palliative care specialist consultation is recommended Surgeon team alone management: The surgeon and surgical team will manage |
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| Secondary | Caregiver Prognostic Awareness Assessment at 12 Weeks | Caregiver prognostic awareness was determined based on the Cancer Care Outcomes Research & Surveillance Consortium (CANCORS) study prognostic awareness questions before and after surgery. To each question, the respondent replied Very likely, Somewhat likely, A little likely, Not at all likely, or Don't know. | Participants who completed the respective survey questions are included in the analysis. | Posted | | Count of Participants | | Participants | | Up to 12 weeks after surgery | | | | ID | Title | Description |
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| OG000 | Surgeon-palliative Care Team Co-management (Intervention) | In the Surgeon-palliative care team co-management arm, all patients receive the surgical care of surgeon alone management, which includes surgeon and the surgical team. In addition to this surgeon alone care, palliative care will also be provided by a specialist team. For patients in this arm, patients and/or family members will be seen by the palliative care team: (1) in an outpatient setting prior to surgery, (2) in the hospital within 72 hours of their initial surgery and as needed afterwards, and (3) via phone on in-clinic (per patient preference) on an at least monthly basis and/or as needed for 12 weeks following surgery. Surgeon-palliative care team co management: Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team | | OG001 | Surgeon Alone Management (Control) | The surgeon and surgical team will manage symptoms, psychosocial support, and prognostic related communication. The surgeon and surgical team care for the patient and their family both prior to and following surgery. The surgeon team is given guidelines published by the National Cancer Coalition Network as to when palliative care specialist consultation is recommended Surgeon team alone management: The surgeon and surgical team will manage |
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