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2023-07-18
2030-12-31
2032-12-31
120
NCT05836870
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
INTERVENTIONAL
Tele-PancFit: A Multi-site Trial of Video-based Strengthening Exercise Prehabilitation for Patients With Resectable Pancreatic Cancer
To learn if a supervised exercise program during chemotherapy treatments can help to improve outcomes in patients who have been diagnosed with pancreatic cancer
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 press,1-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 (T2a/b). 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 (yes/no) 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 ⊬tive" 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, race/ethnicity, 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-04-20 | N/A | 2025-08-12 |
2023-04-20 | N/A | 2025-08-15 |
2023-05-01 | N/A | 2025-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Group A-Enhanced Usual Care Participants will be given general recommendations to increase physical activity and improve nutrition before surgery. | OTHER: Enhanced Usual Care
|
| EXPERIMENTAL: Group B-Tele-supervised resistance exercises Participants will take part in a monitored exercise program. The study team will provide more instructions and information about the program | BEHAVIORAL: Tele-supervised resistance exercises
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Safety and adverse events (AEs) | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | thorugh study completion; an average of 1 year. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: An Ngo-Huang, DO Phone Number: (713) 745-2327 Email: ango2@mdanderson.org |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
