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Tele-PancFit: A Multi-site Trial of Video-based Strengthening Exercise Prehabilitation for Patients With Resectable Pancreatic Cancer

RECRUITINGPhase 3Sponsored by M.D. Anderson Cancer Center
Actively Recruiting
PhasePhase 3
SponsorM.D. Anderson Cancer Center
Started2023-07-18
Est. completion2030-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

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:

  1. Behavioral Research and Treatment Center (BRTC) at MDACC
  2. Exercise Physiology laboratory in the Department of Kinesiology and Health Education at UT Austin
  3. 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).

Exclusion criteria:

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.

Conditions2

CancerPancreatic Cancer

Locations1 site

M D Anderson Cancer Center
Houston, Texas, 77030
An Ngo-Huang, DO713-745-2327ango2@mdanderson.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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