Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05836870
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2023-04-20
Brief Title:
Tele-PancFit A Multi-site Trial of Video-based Strengthening Exercise Prehabilitation for Patients With Resectable Pancreatic Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Tele-PancFit A Multi-site Trial of Video-based Strengthening Exercise Prehabilitation for Patients With Resectable Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if a supervised exercise program during chemotherapy treatments can help to improve outcomes in patients who have been diagnosed with pancreatic cancer
Detailed Description:
Primary Objectives
Compare the rate of adjuvant chemotherapy initiation in patients who receive Tele-PancFit telesupervised strengthening and remotely-monitored moderate intensity aerobic exercise versus an enhanced usual care group who receive general recommendations for physical activity and receive an activity tracker
Hypothesis Tele-PancFit participation Arm B will improve the rate of adjuvant therapy compared to enhanced usual care Arm A
Secondary Objectives
1 Determine the effects of Tele-PancFit intervention on HRQOL among patients with localized PDAC including the change of the HRQOL over time and the between study groups
2 Compare skeletal muscle maintenance indicated by SMI using CT between patients in the exercise and UC groups of the Tele-PancFit intervention
3 Define the effects of Tele-PancFit participation on tumor vascular density and maturity among patients undergoing neoadjuvant chemotherapy for PDAC
Other exploratory objectives include
4 Determine the effects of the Tele-PancFit intervention on secondary physical function symptom and body composition study measures Compare changes between baseline preoperative and postoperative timepoints within each study arm and between study arms of the following measures Also compare outcome values between study arms at each data collection timepoint
1 Skeletal muscle maintenance skeletal muscle index SMI using routinely-obtained CT scans
2 Skeletal muscle quality skeletal muscle density SMD using routinely-obtained CT scans
3 Visceral fat and subcutaneous fat using routinely-obtained CT scans
4 Muscle strength 1-RM chest press1-RM leg press 30 second chair stand test and 30 second arm curl test
5 Muscle endurance
6 Submaximal exercise capacity 6MWT
7 Self-reported exercise Modified Godin
8 Self-reported physical functioning PROMIS Cancer Function
9 Fatigue FACIT-F
10 HRQOL FACT-Hep
5 To compare levels of circulating tumor-associated and angiogenic factors such as CA 19-9 thrombospondin CXCL12 IL-1b VEGF S1P between groups upon enrollment T0 following administration of preoperative therapy T1 and at postoperative visits T2ab
6 To compare cancer associated fibroblasts CAFs and tumor infiltrating immune cells between groups among patients who have undergone surgical resection
7 Determine the effects of the Tele-PancFit intervention on oncology treatment outcomes by comparing these measures in the Arms A and B
1 Completion of intended NT dose
2 Dose reduction or change in NT treatment plan
3 Time of initiation of AT after surgery
4 Dose reduction or change in AT treatment plan
5 Completion of AT 6 months total perioperative chemotherapy
6 incidence of perioperative adverse events that occur within 90 days between groups Accordion score
7 Hospital length of stay
8 Acute cancer care center or emergency center visits within 30 days of surgery
8 Evaluate the effects of adherence to nutritional recommendations to body composition and physical function Evaluate the effects of weight loss and sarcopenia status yesno on body composition
9 To assess the change in nutrition status PGSGAsf along all study time points in all enrolled participants Also to correlate the PGSGAsf score with the corresponding anthropometric measures at each time point for all participants
10 To examine differences among Fitbit-measured physical activity and sleep between groups and associations among Fitbit variables and secondary endpoints between and within groups
11 To compare the 6MWT distance and secondary endpoints of participants within subgroups of patients who are stratified as active versus insufficiently active based on the Godin-Shephard Leisure Time Physical Activity Questionnaire
12 To compare the 6MWT distance and secondary endpoints of participants within subgroups of patients with different levels of physical activity light moderate high intensity activity
13 To explore the effect of sociodemographic variables sex age raceethnicity zip code for urban vs rural classification distance form the hospital marital status insurance need to borrow devices and Wi-Fi connection on patient clinical outcomes and adherence to the activity prescription
Compare the rate of adjuvant chemotherapy initiation in patients who receive Tele-PancFit telesupervised strengthening and remotely-monitored moderate intensity aerobic exercise versus an enhanced usual care group who receive general recommendations for physical activity and receive an activity tracker
Hypothesis Tele-PancFit participation Arm B will improve the rate of adjuvant therapy compared to enhanced usual care Arm A
Secondary Objectives
1 Determine the effects of Tele-PancFit intervention on HRQOL among patients with localized PDAC including the change of the HRQOL over time and the between study groups
2 Compare skeletal muscle maintenance indicated by SMI using CT between patients in the exercise and UC groups of the Tele-PancFit intervention
3 Define the effects of Tele-PancFit participation on tumor vascular density and maturity among patients undergoing neoadjuvant chemotherapy for PDAC
Other exploratory objectives include
4 Determine the effects of the Tele-PancFit intervention on secondary physical function symptom and body composition study measures Compare changes between baseline preoperative and postoperative timepoints within each study arm and between study arms of the following measures Also compare outcome values between study arms at each data collection timepoint
1 Skeletal muscle maintenance skeletal muscle index SMI using routinely-obtained CT scans
2 Skeletal muscle quality skeletal muscle density SMD using routinely-obtained CT scans
3 Visceral fat and subcutaneous fat using routinely-obtained CT scans
4 Muscle strength 1-RM chest press1-RM leg press 30 second chair stand test and 30 second arm curl test
5 Muscle endurance
6 Submaximal exercise capacity 6MWT
7 Self-reported exercise Modified Godin
8 Self-reported physical functioning PROMIS Cancer Function
9 Fatigue FACIT-F
10 HRQOL FACT-Hep
5 To compare levels of circulating tumor-associated and angiogenic factors such as CA 19-9 thrombospondin CXCL12 IL-1b VEGF S1P between groups upon enrollment T0 following administration of preoperative therapy T1 and at postoperative visits T2ab
6 To compare cancer associated fibroblasts CAFs and tumor infiltrating immune cells between groups among patients who have undergone surgical resection
7 Determine the effects of the Tele-PancFit intervention on oncology treatment outcomes by comparing these measures in the Arms A and B
1 Completion of intended NT dose
2 Dose reduction or change in NT treatment plan
3 Time of initiation of AT after surgery
4 Dose reduction or change in AT treatment plan
5 Completion of AT 6 months total perioperative chemotherapy
6 incidence of perioperative adverse events that occur within 90 days between groups Accordion score
7 Hospital length of stay
8 Acute cancer care center or emergency center visits within 30 days of surgery
8 Evaluate the effects of adherence to nutritional recommendations to body composition and physical function Evaluate the effects of weight loss and sarcopenia status yesno on body composition
9 To assess the change in nutrition status PGSGAsf along all study time points in all enrolled participants Also to correlate the PGSGAsf score with the corresponding anthropometric measures at each time point for all participants
10 To examine differences among Fitbit-measured physical activity and sleep between groups and associations among Fitbit variables and secondary endpoints between and within groups
11 To compare the 6MWT distance and secondary endpoints of participants within subgroups of patients who are stratified as active versus insufficiently active based on the Godin-Shephard Leisure Time Physical Activity Questionnaire
12 To compare the 6MWT distance and secondary endpoints of participants within subgroups of patients with different levels of physical activity light moderate high intensity activity
13 To explore the effect of sociodemographic variables sex age raceethnicity zip code for urban vs rural classification distance form the hospital marital status insurance need to borrow devices and Wi-Fi connection on patient clinical outcomes and adherence to the activity prescription
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-03448 | OTHER | NCI-CTRP Clinical Trials Registry | None |