Cancer
Conditions
Keywords
Palliative Care
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPalliative Care Intervention
These patients will receive the palliative care intervention.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Total or partial gastrectomy requiring anastomosis 2. Total or partial pancreatectomy 3. Partial hepatectomy 4. 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 5. Radical cystectomy 6. Pelvic exenteration 7. Abdominal debulking for ovarian or endometrial carcinoma 8. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
Exclusion criteria
1. Non-English speaking patient 2. Residence \>150 miles away from Vanderbilt and do not visit the Nashville area regularly 3. No telephone or otherwise unwilling/unable to complete follow-ups 4. Prisoner 5. 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. 6. Deaf 7. Severe prior cognitive or neurodegenerative disorder that prevents a patient from living independently at baseline 8. Inability to obtain informed consent from patient meeting all inclusion criteria for the following reasons: 1. Attending surgeon refusal 2. Patient refusal 3. Period of time between screening patient and time of operation does not allow preoperative outpatient palliative care visit. 9. Currently participating in palliative care or seeing a palliative care provider.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical and Functional Quality of Life as Measured by the FACT-G TOI | 90 days after operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as Measured by the FACT-G | 90 days after operation | 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). |
| Days Alive at Home Without an Emergency Room Visit | 90 days after operation | 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 |
| Post-Traumatic Stress Disorder (PTSD) Symptoms | 180 days after operation | Score on the PTSD Checklist-Civilian Version--a 17-item scale scored from 17-85 with higher scores indicating more PTSD symptoms |
| Overall Survival | 1 year | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMyrick C Shinall, MD
Assistant Professor
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Palliative Care Intervention Palliative Care Intervention: These patients will receive the palliative care intervention. | 117 |
| Standard of Care These patients received standard perioperative care | 118 |
| Total | 235 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Palliative Care Intervention |
|---|---|---|---|
| Age, Continuous | 66.6 years | 65 years | 62.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants | 233 Participants | 117 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| FACT-G | 87.4 units on a scale | 86.0 units on a scale | 85.0 units on a scale |
| FACT-TOI | 44.0 units on a scale | 43.0 units on a scale | 43.0 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 9 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 | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 113 Participants | 224 Participants | 111 Participants |
| Region of Enrollment United States | 118 participants | 235 participants | 117 participants |
| Sex: Female, Male Female | 48 Participants | 94 Participants | 46 Participants |
| Sex: Female, Male Male | 70 Participants | 141 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 117 | 4 / 118 |
| other Total, other adverse events | 0 / 117 | 0 / 118 |
| serious Total, serious adverse events | 0 / 117 | 0 / 118 |
Outcome results
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.
Time frame: 90 days after operation
Population: Includes all patients who completed the FACT-G instrument at 90 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palliative Care Intervention | Physical and Functional Quality of Life as Measured by the FACT-G TOI | 45.0 units on a scale |
| Standard of Care | Physical and Functional Quality of Life as Measured by the FACT-G TOI | 45.0 units on a scale |
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
Time frame: 90 days after operation
Population: All included patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palliative Care Intervention | Days Alive at Home Without an Emergency Room Visit | 84 days |
| Standard of Care | Days Alive at Home Without an Emergency Room Visit | 83 days |
Secondary
Overall Survival
Time frame: 1 year
Population: All included patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palliative Care Intervention | Overall Survival | 0.83 proportion of patients surviving 1 year |
| Standard of Care | Overall Survival | 0.82 proportion of patients surviving 1 year |
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
Time frame: 180 days after operation
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).
Time frame: 90 days after operation
Population: All patients who completed the FACT-G instrument at 90 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palliative Care Intervention | Quality of Life as Measured by the FACT-G | 88.0 units on a scale |
| Standard of Care | Quality of Life as Measured by the FACT-G | 91.0 units on a scale |
Other Pre-specified
Anxiety
PROMIS Anxiety-6 Score--A six item scale with scores from 5-30 with higher scores indicating more anxiety
Time frame: 90 days, 180 days after operation
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
Time frame: 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
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.)
Time frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Other Pre-specified
Days at Home Without an ER Visit in Last 30 Days of Life
Time frame: last 30 days of life
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
Time frame: 90 days, 180 days after operation
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
Time frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Other Pre-specified
ER Visits
Number of visits to the emergency room
Time frame: 3 years
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
Time frame: 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Other Pre-specified
Hospital Admissions
Number of hospital admissions
Time frame: 3 years
Other Pre-specified
Length of Hospice Enrollment
Time frame: last 30 days of life
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
Time frame: last 30 days of life
Other Pre-specified
Physical and Functional Quality of Life
FACT-G TOI Score
Time frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
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
Time frame: 180 days
Other Pre-specified
Quality of End-of-life Care
FATE-S score
Time frame: last 30 days of life
Other Pre-specified
Quality of Life
FACT-G Score
Time frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Other Pre-specified
Receipt of Chemotherapy in Last 14 Days of Life
Time frame: last 14 days of life
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?
Time frame: 30 days
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
Time frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Other Pre-specified
Survival
Time frame: 3 years
Other Pre-specified
Time to Adjuvant Therapy
Number of days from operation until adjuvant chemotherapy or radiation is initiated
Time frame: 90 days