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Frequently people diagnosed with cancer experience physical and emotional symptoms during the course of their disease. These symptoms can be very distressing to both the patient and the family members. The study doctor wants to know if the introduction of a team of clinicians that specialize in the lessening of many of these distressing symptoms may improve your overall care. This team of clinicians is called the palliative care team and they focus on ways to improve your pain and other symptom management (i.e. shortness of breath, fatigue, anxiety, etc.) and to assist you and your family in coping with the emotional, social, and spiritual issues associated with your diagnosis. The team consists of physicians, advanced practice nurses, case managers, and nurses who have been specially trained in the care of patients facing serious illness.
This research study is being done because although many people with cancer receive palliative care late in the course of their illness, the study team thinks palliative care may be more useful when it is started earlier and in this case before surgery. The main purpose of this study is to compare two types of care -usual surgery and cancer care and usual surgery and cancer care with comprehensive palliative care services to see which is better for improving the experience of patients and families with cancer.
The Surgery for Cancer with Option of Palliative Care Expert (SCOPE) Trial is an investigation that will study the effect of a palliative care implementation during the preoperative, perioperative, and postoperative phase for adults undergoing cancer surgery for selected gastrointestinal and genitourinary malignancies. SCOPE will be a single-blind, single-institution randomized controlled trial of 236 patients. Intervention arm patients will receive a preoperative outpatient specialty palliative care consultation from a palliative care provider (physician or nurse practitioner) in addition to inpatient and outpatient palliative care follow-up postoperatively. Control arm patients will receive usual care with palliative care available at the discretion of the primary treatment team (currently these patients rarely get palliative care and usually only in the last weeks of life). The central hypothesis of the SCOPE Trial is that preoperative, perioperative, and postoperative specialty palliative care will improve patient functioning and quality of life in patients undergoing resection of selected GI and GU malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palliative Care Intervention | Experimental |
| |
| Standard of Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Care Intervention | Behavioral | These patients will receive the palliative care intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical and Functional Quality of Life as Measured by the FACT-G TOI | FACT-Gastric Trial Outcome Index (TOI) is an efficient summary index of physical/functional outcomes and is comprised of two subscales from the FACT-Gastric Score: the physical wellbeing subscale (7 questions) and the functional wellbeing scale (7 questions). Each question uses a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Total scores on the FACT-TOI range from 0-56. The higher the score, the better the quality of life. | 90 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as Measured by the FACT-G | The FACT-G is a patient self-administered 27-item questionnaire that measures health state in cancer patients in prior 7 days, including physical, social, emotional, and functional well-being. Scoring: Five-point scale: 0 (not at all) to 4 (very much). Total score is from 0-108. The higher the score, the better quality of life (QOL). | 90 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Physical and Functional Quality of Life | FACT-G TOI Score | 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation |
| Functional Status | Karnofsky Performance Status--a score that ranges from 0 to 100, with 100 indicating full functional status and 0 indicating death |
Inclusion Criteria:
adult patients (≥18 years old) scheduled for one of the following abdominal operations with intent to provide cure or durable oncologic control of malignancy:
Total or partial gastrectomy requiring anastomosis
Total or partial pancreatectomy
Partial hepatectomy
Colectomy or proctactomy if one of the following 3 conditions is also met:
i) patient age is 65 years or older ii) disease is metastatic iii) disease is locally invasive requiring extensive resection
Radical cystectomy
Pelvic exenteration
Abdominal debulking for ovarian or endometrial carcinoma
Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
Exclusion Criteria:
Non-English speaking patient
Residence >150 miles away from Vanderbilt and do not visit the Nashville area regularly
No telephone or otherwise unwilling/unable to complete follow-ups
Prisoner
Current enrollment in a study that does not allow co-enrollment or that uses a non-pharmacologic, non-procedural intervention directed at surgical or cancer care.
Deaf
Severe prior cognitive or neurodegenerative disorder that prevents a patient from living independently at baseline
Inability to obtain informed consent from patient meeting all inclusion criteria for the following reasons:
Currently participating in palliative care or seeing a palliative care provider.
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| Name | Affiliation | Role |
|---|---|---|
| Myrick C Shinall, MD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37163249 | Derived | Shinall MC Jr, Martin SF, Karlekar M, Hoskins A, Morgan E, Kiehl A, Bryant P, Orun OM, Raman R, Tillman BF, Hawkins AT, Brown AJ, Bailey CE, Idrees K, Chang SS, Smith JA Jr, Tan MCB, Magge D, Penson D, Ely EW. Effects of Specialist Palliative Care for Patients Undergoing Major Abdominal Surgery for Cancer: A Randomized Clinical Trial. JAMA Surg. 2023 Jul 1;158(7):747-755. doi: 10.1001/jamasurg.2023.1396. | |
| 33926535 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Palliative Care Intervention | Palliative Care Intervention: These patients will receive the palliative care intervention. |
| FG001 | Standard of Care | Patients received standard perioperative care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Excludes one patient who was excluded after randomization
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| ID | Title | Description |
|---|---|---|
| BG000 | Palliative Care Intervention | Palliative Care Intervention: These patients will receive the palliative care intervention. |
| BG001 | Standard of Care | These patients received standard perioperative care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physical and Functional Quality of Life as Measured by the FACT-G TOI | FACT-Gastric Trial Outcome Index (TOI) is an efficient summary index of physical/functional outcomes and is comprised of two subscales from the FACT-Gastric Score: the physical wellbeing subscale (7 questions) and the functional wellbeing scale (7 questions). Each question uses a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Total scores on the FACT-TOI range from 0-56. The higher the score, the better the quality of life. | Includes all patients who completed the FACT-G instrument at 90 days | Posted | Median | Inter-Quartile Range | units on a scale | 90 days after operation |
|
12 months
As described in the clinical trials.gov definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Palliative Care Intervention | Palliative Care Intervention: These patients will receive the palliative care intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myrick Shinall, principal investigator | Vanderbilt University Medical Center | 615-343-5613 | ricky.shinall@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2021 | Dec 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Days Alive at Home Without an Emergency Room Visit | A count of all the days that the patient 1) has no emergency room visits, and 2) is not an inpatient of a hospital or other health-care facility | 90 days after operation |
| Post-Traumatic Stress Disorder (PTSD) Symptoms | Score on the PTSD Checklist-Civilian Version--a 17-item scale scored from 17-85 with higher scores indicating more PTSD symptoms | 180 days after operation |
| Overall Survival | 1 year |
| 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation |
| Quality of Life | FACT-G Score | 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation |
| Depression | PROMIS Depression-6 Score--A six item scale with scores from 5-30 with higher scores indicating more symptoms of depression | 90 days, 180 days after operation |
| Anxiety | PROMIS Anxiety-6 Score--A six item scale with scores from 5-30 with higher scores indicating more anxiety | 90 days, 180 days after operation |
| Time to Adjuvant Therapy | Number of days from operation until adjuvant chemotherapy or radiation is initiated | 90 days |
| Satisfaction With Hospital Stay | The answer to the following question: Using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible, what number would you use to rate this hospital during your stay? | 30 days |
| Post-Traumatic Growth | Post-Traumatic Growth Inventory score--a 21-item scale scored from 0-105 with higher scores indicating more growth after trauma | 180 days |
| Care-Giver Burden | Zarit Burden Interview score--a 12 item scale with score 0-48 with higher scores indicating more care-giver burden | 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation |
| Hospital Admissions | Number of hospital admissions | 3 years |
| ER Visits | Number of visits to the emergency room | 3 years |
| Employment | Patient report of whether or not he or she is currently employed (yes/no question) and if yes, whether the employment is full-time or part-time | 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation |
| Community vs. Facility Residence | Patient report of whether he or she lives in a private residence or in a healthcare facility (i.e. assisted living, long-term care facility, nursing home, etc.) | 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation |
| Size of Life Space | Life Space Assessment Questionnaire score--a five item scale with scores from 0-120 with higher scores indicating larger life space i.e. larger area traversed during daily activities | 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation |
| Length of Hospice Enrollment | last 30 days of life |
| Receipt of Chemotherapy in Last 14 Days of Life | last 14 days of life |
| Days at Home Without an ER Visit in Last 30 Days of Life | last 30 days of life |
| Quality of End-of-life Care | FATE-S score | last 30 days of life |
| Location of Death | Care-giver report of whether patient died in a private residence or in a healthcare facility such as a nursing home, hospital, or inpatient hospice facility | last 30 days of life |
| Survival | 3 years |
| Derived |
| Orun OM, Shinall MC Jr, Hoskins A, Morgan E, Karlekar M, Martin SF, Ely EW, Raman R. Statistical analysis plan for the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) trial: a randomized controlled trial of a specialist palliative care intervention for patients undergoing surgery for cancer. Trials. 2021 Apr 29;22(1):314. doi: 10.1186/s13063-021-05256-y. |
| 31829237 | Derived | Shinall MC Jr, Hoskins A, Hawkins AT, Bailey C, Brown A, Agarwal R, Duggan MC, Beskow LM, Periyakoil VS, Penson DF, Jarrett RT, Chandrasekhar R, Ely EW. A randomized trial of a specialist palliative care intervention for patients undergoing surgery for cancer: rationale and design of the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) Trial. Trials. 2019 Dec 11;20(1):713. doi: 10.1186/s13063-019-3754-0. |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| FACT-TOI | FACT-Gastric Trial Outcome Index (TOI) is an efficient summary index of physical/functional outcomes and is comprised of two subscales from the FACT-Gastric Score: the physical wellbeing subscale (7 questions) and the functional wellbeing scale (7 questions). Each question uses a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Total scores on the FACT-TOI range from 0-56. The higher the score, the better the quality of life. | Median | Inter-Quartile Range | units on a scale |
|
| FACT-G | The FACT-G is a patient self-administered 27-item questionnaire that measures health state in cancer patients in prior 7 days, including physical, social, emotional, and functional well-being. Scoring: Five-point scale: 0 (not at all) to 4 (very much). Total score is from 0-108. The higher the score, the better quality of life (QOL). | Median | Inter-Quartile Range | units on a scale |
|
| OG001 |
| Standard of Care |
These patients received standard perioperative care |
|
|
| Secondary | Quality of Life as Measured by the FACT-G | The FACT-G is a patient self-administered 27-item questionnaire that measures health state in cancer patients in prior 7 days, including physical, social, emotional, and functional well-being. Scoring: Five-point scale: 0 (not at all) to 4 (very much). Total score is from 0-108. The higher the score, the better quality of life (QOL). | All patients who completed the FACT-G instrument at 90 days | Posted | Median | Inter-Quartile Range | units on a scale | 90 days after operation |
|
|
|
| Secondary | Days Alive at Home Without an Emergency Room Visit | A count of all the days that the patient 1) has no emergency room visits, and 2) is not an inpatient of a hospital or other health-care facility | All included patients | Posted | Median | Inter-Quartile Range | days | 90 days after operation |
|
|
|
| Secondary | Post-Traumatic Stress Disorder (PTSD) Symptoms | Score on the PTSD Checklist-Civilian Version--a 17-item scale scored from 17-85 with higher scores indicating more PTSD symptoms | Not Posted | 180 days after operation | Participants |
| Secondary | Overall Survival | All included patients | Posted | Number | 95% Confidence Interval | proportion of patients surviving 1 year | 1 year |
|
|
|
| Other Pre-specified | Physical and Functional Quality of Life | FACT-G TOI Score | Not Posted | 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation | Participants |
| Other Pre-specified | Functional Status | Karnofsky Performance Status--a score that ranges from 0 to 100, with 100 indicating full functional status and 0 indicating death | Not Posted | 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation | Participants |
| Other Pre-specified | Quality of Life | FACT-G Score | Not Posted | 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation | Participants |
| Other Pre-specified | Depression | PROMIS Depression-6 Score--A six item scale with scores from 5-30 with higher scores indicating more symptoms of depression | Not Posted | 90 days, 180 days after operation | Participants |
| Other Pre-specified | Anxiety | PROMIS Anxiety-6 Score--A six item scale with scores from 5-30 with higher scores indicating more anxiety | Not Posted | 90 days, 180 days after operation | Participants |
| Other Pre-specified | Time to Adjuvant Therapy | Number of days from operation until adjuvant chemotherapy or radiation is initiated | Not Posted | 90 days | Participants |
| Other Pre-specified | Satisfaction With Hospital Stay | The answer to the following question: Using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible, what number would you use to rate this hospital during your stay? | Not Posted | 30 days | Participants |
| Other Pre-specified | Post-Traumatic Growth | Post-Traumatic Growth Inventory score--a 21-item scale scored from 0-105 with higher scores indicating more growth after trauma | Not Posted | 180 days | Participants |
| Other Pre-specified | Care-Giver Burden | Zarit Burden Interview score--a 12 item scale with score 0-48 with higher scores indicating more care-giver burden | Not Posted | 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation | Participants |
| Other Pre-specified | Hospital Admissions | Number of hospital admissions | Not Posted | 3 years | Participants |
| Other Pre-specified | ER Visits | Number of visits to the emergency room | Not Posted | 3 years | Participants |
| Other Pre-specified | Employment | Patient report of whether or not he or she is currently employed (yes/no question) and if yes, whether the employment is full-time or part-time | Not Posted | 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation | Participants |
| Other Pre-specified | Community vs. Facility Residence | Patient report of whether he or she lives in a private residence or in a healthcare facility (i.e. assisted living, long-term care facility, nursing home, etc.) | Not Posted | 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation | Participants |
| Other Pre-specified | Size of Life Space | Life Space Assessment Questionnaire score--a five item scale with scores from 0-120 with higher scores indicating larger life space i.e. larger area traversed during daily activities | Not Posted | 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation | Participants |
| Other Pre-specified | Length of Hospice Enrollment | Not Posted | last 30 days of life | Participants |
| Other Pre-specified | Receipt of Chemotherapy in Last 14 Days of Life | Not Posted | last 14 days of life | Participants |
| Other Pre-specified | Days at Home Without an ER Visit in Last 30 Days of Life | Not Posted | last 30 days of life | Participants |
| Other Pre-specified | Quality of End-of-life Care | FATE-S score | Not Posted | last 30 days of life | Participants |
| Other Pre-specified | Location of Death | Care-giver report of whether patient died in a private residence or in a healthcare facility such as a nursing home, hospital, or inpatient hospice facility | Not Posted | last 30 days of life | Participants |
| Other Pre-specified | Survival | Not Posted | 3 years | Participants |
| 6 |
| 117 |
| 0 |
| 117 |
| 0 |
| 117 |
| EG001 | Standard of Care | These patients received standard perioperative care | 4 | 118 | 0 | 118 | 0 | 118 |
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