Tele-PancFit: A Multi-site Trial of Video-based Strengthening Exercise Prehabilitation for Patients With Resectable Pancreatic Cancer
2 other identifiers
interventional
58
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pancreatic-cancer
Started Jul 2023
Longer than P75 for phase_3 pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedStudy Start
First participant enrolled
July 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2032
March 2, 2026
February 1, 2026
7.5 years
April 20, 2023
February 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
Group A-Enhanced Usual Care
EXPERIMENTALParticipants will be given general recommendations to increase physical activity and improve nutrition before surgery.
Group B-Tele-supervised resistance exercises
EXPERIMENTALParticipants will take part in a monitored exercise program. The study team will provide more instructions and information about the program
Interventions
Participants will receive general recommendations to maintain physical activity.
Participants will take part in a monitored exercise program.
Eligibility Criteria
You may qualify if:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Biopsy-proven pancreatic adenocarcinoma, resectable/borderline resectable (T1-3, N0-2, M0)
- Recommended to receive 2-6 months of neoadjuvant chemotherapy followed by surgical resection including participants who have not yet received chemotherapy and participants who have already received their first cycle of chemotherapy.
- Willingness to adhere to the Tele-PancFit study intervention
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Able to schedule baseline (T0) appointment for fitness testing and program teaching at the fitness testing location at each study site or able to schedule remote fitness testing and program teaching:
- Behavioral Research and Treatment Center (BRTC) at MDACC
- Exercise Physiology laboratory in the Department of Kinesiology and Health Education at UT Austin
- Outpatient Rehabilitation gymnasium at Banner MDA
- Able to understand the description of the study, exercise program, and willing to participate
- Home or community access to wireless internet (Wi-Fi) and agreement to engage with study personnel for real-time tele-RT sessions
- Age ≥ 18
- Meet all screening requirements (described below).
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Non-English speaking
- Has participated in regular RT (RT for all major muscle groups at least twice per week) throughout the month prior to recruitment
- Unable to complete the baseline assessment questionnaires or functional assessments
- Screen failure for exercise safety based on PAR-Q and/or PROMIS questions as described in section 4.4 (Screening Procedure).
- Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV).
- Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention.
- Numeric pain rating scale of ≥7 out of 10
- Myopathic or rheumatologic disease that impacts physical function.
- (Females only) Known pregnancy, as communicated to study personnel by clinicians in GI Medical Oncology; females of childbearing potential receive advice to use methods of contraception per usual care.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
An Ngo-Huang, DO
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2023
First Posted
May 1, 2023
Study Start
July 18, 2023
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2032
Last Updated
March 2, 2026
Record last verified: 2026-02