Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Proportion of patients requiring a hospital admission |
Compare difference in proportion of patients with hospital admissions between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Number of hospital admissions |
Compare difference in number of hospital admissions between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Proportion of patients requiring an emergency department visit |
Compare difference in proportion of patients with emergency department visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Number of emergency department visits |
Compare difference in number of emergency department visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Proportion of patients requiring an urgent care visit |
Compare difference in proportion of patients with urgent care visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Number of urgent care visits |
Compare difference in number of urgent care visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Proportion of patients requiring a hospital admission or emergency department visit |
Compare difference in proportion of patients with a hospital admission or emergency department visit between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Number of hospital admissions or emergency department visits |
Compare difference in number of hospital admissions or emergency department visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Proportion of patients requiring a treatment delay |
Compare difference in proportion of patients with a treatment delay between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Proportion of days in hospital or emergency department |
Compare difference in proportion of days in hospital or emergency department between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Proportion of days in hospital, emergency department, or urgent care |
Compare difference in proportion of days in hospital, emergency department, or urgent care between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Number of cycles of chemotherapy completed |
Compare difference in number of cycles of chemotherapy completed between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Numbers of treatment delays |
Compare difference in number of treatment delays between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Dose intensity |
Compare difference in chemotherapy dose intensity between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Overall survival |
Compare difference in overall survival between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Other |
Progression free survival |
Compare difference in progression free survival between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
2 years |
|
Primary |
Rates of study enrollment |
Proportion of patients who agree to participate in the study and sign informed consent. |
2 years |
|
Primary |
Rates of completion |
Proportion of patients who complete daily patient-reported symptom assessments within the first two weeks of enrollment. |
2 years |
|
Secondary |
Rates of completion of daily symptom monitoring |
Proportion of participants completing daily symptom monitoring throughout the study |
2 years |
|
Secondary |
Rates of completion of daily vital signs |
Proportion of participants completing daily reporting of vital signs throughout the study |
2 years |
|
Secondary |
Rates of completion of weekly body weight |
Proportion of participants completing weekly reporting of body weight throughout the study |
2 years |
|
Secondary |
Number of home visits required |
Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to patients at their home |
2 years |
|
Secondary |
Number of phone calls required |
Number of phone calls required per patient as well as average duration of these calls |
2 years |
|
Secondary |
Number of emails required |
Number of emails from Medically Home to the primary oncology team |
2 years |
|
Secondary |
Patient acceptability |
Qualitative acceptability ratings from patients regarding helpfulness, convenience, and perceptions of the study. |
2 years |
|
Secondary |
Family caregiver acceptability |
Qualitative acceptability ratings from family caregivers regarding helpfulness, convenience, and perceptions of the study. |
2 years |
|
Secondary |
Clinician acceptability |
Qualitative acceptability ratings from clinicians regarding helpfulness, convenience, and perceptions of the study. |
2 years |
|
Secondary |
Number of emergency department visits |
The number of emergency department [ED] visits and the proportion of patients needing an emergency department [ED] visit |
2 Years |
|
Secondary |
Number of urgent visits |
The number of urgent visits to clinic and the proportion of patients needing an urgent visit to clinic |
2 Years |
|
Secondary |
Number of hospital admissions |
The number of hospital admissions and the proportion of patients needing a hospital admission |
2 Years |
|
Secondary |
Change in symptom burden longitudinally throughout the study |
Change in symptom burden (assessed using Edmonton Symptom Assessment System-revised [ESAS-r], range 0-10 for each symptom with higher scores indicating worse symptom burden) throughout the study. |
2 years |
|
Secondary |
Change in psychological distress |
Change in psychological distress (assessed using the Patient Health Questionnaire-4 [PHQ-4], range 0-12 with higher scores indicating greater distress, and subscales for depression/anxiety ranging 0-6 with higher scores indicating greater distress) throughout the study. |
2 years |
|
Secondary |
Change in quality of life longitudinally throughout the study |
Change in quality of life (assessed using the Functional Assessment of Cancer Therapy-General [FACT-G], with range of 0-108 and higher scores indicating better quality of life) throughout the study. |
2 Years |
|
Secondary |
Number of cycles of FOLFIRINOX received |
Describe the number of cycles of FOLFIRINOX chemotherapy received by patients |
2 years |
|
Secondary |
Number of treatment delays |
Describe the number of treatment delays for patients |
2 years |
|
Secondary |
Cumulative dose of FOLFIRINOX received |
Describe the cumulative dose of FOLFIRINOX received |
2 years |
|