RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To learn if a supervised exercise program during chemotherapy treatments can help to improve outcomes in patients who have been diagnosed with pancreatic cancer

Official Title

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

Quick Facts

Study Start:2023-07-18

Study Completion:2032-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05836870

Participation Criteria

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Contact

An Ngo-Huang, DO

CONTACT

(713) 745-2327

ango2@mdanderson.org

Principal Investigator

An Ngo-Huang, DO

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

An Ngo-Huang, DO, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

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

Study Start Date2023-07-18

Study Completion Date2032-12-31

Study Record Updates

Study Start Date2023-07-18

Study Completion Date2032-12-31

Terms related to this study

Additional Relevant MeSH Terms

Pancreatic Cancer