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Trial Outcomes & Findings for Surgery for Cancer With Option of Palliative Care Expert (NCT NCT03436290)

NCT ID: NCT03436290

Last Updated: 2026-01-28

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

236 participants

Primary outcome timeframe

90 days after operation

Results posted on

2026-01-28

Participant Flow

Participant milestones

Participant milestones
Measure
Palliative Care Intervention
Palliative Care Intervention: These patients will receive the palliative care intervention.
Standard of Care
Patients received standard perioperative care
Overall Study
STARTED
118
118
Overall Study
COMPLETED
77
118
Overall Study
NOT COMPLETED
41
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Palliative Care Intervention
Palliative Care Intervention: These patients will receive the palliative care intervention.
Standard of Care
Patients received standard perioperative care
Overall Study
Post-randomization Exclusion
1
0
Overall Study
Death
6
0
Overall Study
Withdrawal by Subject
4
0
Overall Study
Protocol Violation
30
0

Baseline Characteristics

Surgery for Cancer With Option of Palliative Care Expert

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Palliative Care Intervention
n=117 Participants
Palliative Care Intervention: These patients will receive the palliative care intervention.
Standard of Care
n=118 Participants
These patients received standard perioperative care
Total
n=235 Participants
Total of all reporting groups
Age, Continuous
62.3 years
n=158 Participants
66.6 years
n=157 Participants
65 years
n=315 Participants
Sex: Female, Male
Female
46 Participants
n=158 Participants
48 Participants
n=157 Participants
94 Participants
n=315 Participants
Sex: Female, Male
Male
71 Participants
n=158 Participants
70 Participants
n=157 Participants
141 Participants
n=315 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=158 Participants
2 Participants
n=157 Participants
2 Participants
n=315 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
117 Participants
n=158 Participants
116 Participants
n=157 Participants
233 Participants
n=315 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=158 Participants
0 Participants
n=157 Participants
0 Participants
n=315 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=158 Participants
0 Participants
n=157 Participants
0 Participants
n=315 Participants
Race (NIH/OMB)
Asian
1 Participants
n=158 Participants
0 Participants
n=157 Participants
1 Participants
n=315 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=158 Participants
0 Participants
n=157 Participants
0 Participants
n=315 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=158 Participants
4 Participants
n=157 Participants
9 Participants
n=315 Participants
Race (NIH/OMB)
White
111 Participants
n=158 Participants
113 Participants
n=157 Participants
224 Participants
n=315 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=158 Participants
0 Participants
n=157 Participants
0 Participants
n=315 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=158 Participants
1 Participants
n=157 Participants
1 Participants
n=315 Participants
Region of Enrollment
United States
117 participants
n=158 Participants
118 participants
n=157 Participants
235 participants
n=315 Participants
FACT-TOI
43.0 units on a scale
n=158 Participants
44.0 units on a scale
n=157 Participants
43.0 units on a scale
n=315 Participants
FACT-G
85.0 units on a scale
n=158 Participants
87.4 units on a scale
n=157 Participants
86.0 units on a scale
n=315 Participants

PRIMARY outcome

Timeframe: 90 days after operation

Population: Includes all patients who completed the FACT-G instrument at 90 days

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.

Outcome measures

Outcome measures
Measure
Palliative Care Intervention
n=104 Participants
Palliative Care Intervention: These patients will receive the palliative care intervention.
Standard of Care
n=113 Participants
These patients received standard perioperative care
Physical and Functional Quality of Life as Measured by the FACT-G TOI
45.0 units on a scale
Interval 36.2 to 50.0
45.0 units on a scale
Interval 39.0 to 50.0

SECONDARY outcome

Timeframe: 90 days after operation

Population: All patients who completed the FACT-G instrument at 90 days

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).

Outcome measures

Outcome measures
Measure
Palliative Care Intervention
n=104 Participants
Palliative Care Intervention: These patients will receive the palliative care intervention.
Standard of Care
n=113 Participants
These patients received standard perioperative care
Quality of Life as Measured by the FACT-G
88.0 units on a scale
Interval 72.8 to 99.0
91.0 units on a scale
Interval 79.5 to 98.3

SECONDARY outcome

Timeframe: 90 days after operation

Population: All included patients

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

Outcome measures

Outcome measures
Measure
Palliative Care Intervention
n=117 Participants
Palliative Care Intervention: These patients will receive the palliative care intervention.
Standard of Care
n=118 Participants
These patients received standard perioperative care
Days Alive at Home Without an Emergency Room Visit
84 days
Interval 76.0 to 86.0
83 days
Interval 79.0 to 85.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: All included patients

Outcome measures

Outcome measures
Measure
Palliative Care Intervention
n=117 Participants
Palliative Care Intervention: These patients will receive the palliative care intervention.
Standard of Care
n=118 Participants
These patients received standard perioperative care
Overall Survival
0.83 proportion of patients surviving 1 year
Interval 0.76 to 0.9
0.82 proportion of patients surviving 1 year
Interval 0.75 to 0.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation

FACT-G TOI Score

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation

Karnofsky Performance Status--a score that ranges from 0 to 100, with 100 indicating full functional status and 0 indicating death

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation

FACT-G Score

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days, 180 days after operation

PROMIS Depression-6 Score--A six item scale with scores from 5-30 with higher scores indicating more symptoms of depression

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days, 180 days after operation

PROMIS Anxiety-6 Score--A six item scale with scores from 5-30 with higher scores indicating more anxiety

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Number of days from operation until adjuvant chemotherapy or radiation is initiated

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

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?

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 180 days

Post-Traumatic Growth Inventory score--a 21-item scale scored from 0-105 with higher scores indicating more growth after trauma

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation

Zarit Burden Interview score--a 12 item scale with score 0-48 with higher scores indicating more care-giver burden

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Number of hospital admissions

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Number of visits to the emergency room

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation

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.)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: last 30 days of life

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: last 14 days of life

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: last 30 days of life

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: last 30 days of life

FATE-S score

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: last 30 days of life

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Outcome measures

Outcome data not reported

Adverse Events

Palliative Care Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths

Standard of Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Myrick Shinall, principal investigator

Vanderbilt University Medical Center

Phone: 615-343-5613

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place