Exercise Regimens and Neoadjuvant Chemotherapy
Assessing the Non-inferiority of Virtual vs. In-person Concurrent Exercise Regimens in Patients Receiving Neoadjuvant Therapy Prior to Surgical Resection of a Primary GI Tumor
The purpose of this study is to assess the effectiveness of exercise therapy for patients undergoing neoadjuvant chemotherapy for primary gastrointestinal (GI) tract cancer, providing a reproducible exercise regimen designed to improve or preserve aerobic fitness, strength, and quality of life. In addition, this study will address shifts in healthcare delivery needed as a result of the coronavirus disease 2019 (COVID-19) pandemic, evaluating the effectiveness of telehealth instruction as a method for exercise therapy.
The study hypotheses are:
- To evaluate the effectiveness of exercise therapy for cancer patients undergoing neoadjuvant treatment when delivered via telehealth, as compared to an in-person setting.
- To assess stair test instrumentation, previously validated in a healthy population, as a measure to gauge health status in cancer patients undergoing neoadjuvant treatment.
- To assess patient satisfaction with exercise therapy when delivered via telehealth, as compared to an in-person setting.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Texas
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Fort Worth, Texas, États-Unis, 76104
- UT Southwestern Medical Center, Moncrief Cancer Institute
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Fort Worth, Texas, États-Unis, 76104
- UT Southwestern Simmons Comprehensive Cancer Center - Fort Worth
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 18 to 75 years of age
- Primary language is either English or Spanish
- Primary cancer diagnosis of GI cancer
- Undergoing neoadjuvant chemotherapy prior to surgical resection.
- Patients are being treated by medical oncologist at Simmons Cancer Center at Moncrief Cancer Institute in Fort Worth
Exclusion Criteria:
- Patient has had systemic cancer treatment in the past year
- Patient initiated neoadjuvant chemotherapy treatment prior to study enrollment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: In-Person Exercise Protocol (IPEP)
This group will receive exercise instruction and monitoring in-person from the certified Cancer Exercise Trainer (CET) in the gym facility at Moncrief Cancer Institute (MCI).
Study participants will be scheduled for exercise sessions twice a week with the oncology exercise trainer.
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Supervised aerobic, resistance, flexibility, balance, and agility exercises, which could include yoga for a total of approximately 75 minutes per in-person session.
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Expérimental: Virtual Exercise Protocol (VEP)
This group will receive exercise instruction and monitoring from the CET via telehealth sessions at home.
Study participants will be scheduled for exercise sessions twice a week with the oncology exercise trainer.
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Supervised aerobic, resistance, flexibility, balance, and agility exercises, which could include yoga for a total of approximately 75 minutes each virtual session.
A TheraBand (resistance band) will be provided to patients in this group to be used for resistance and flexibility training.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportion of patients with a primary GI tumor who complete neoadjuvant treatment and are cleared for surgical resection
Délai: Up to Week 12
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The primary efficacy endpoint is the proportion of patients who complete neoadjuvant treatment and surgical resection for a primary GI tumor.
All individuals failing to achieve the success definition described above will be considered treatment failures.
All individuals who drop out of the study or discontinue in the exercise program prior to completion of neoadjuvant chemotherapy (NAC) and surgical resection will be considered treatment failures.
Patients will be evaluated for surgical resection at completion of NAC (Week 8-12).
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Up to Week 12
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline in aerobic ability, resistance, agility, balance, and posture as measured by the Timed Up and Go Test
Délai: Baseline prior to initial exercise therapy session, midpoint (Week 4, Up to Week 6), neoadjuvant chemotherapy completion prior to surgery (Week 8, Up to Week 16), and 30 days post-operative surgery for tumor removal.
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Analyses of change from baseline will be measured by the Timed Up and Go Test (TUG). Change from baseline measurement at 30 days post-op will be fit with terms for treatment group and the measurement at baseline. Values for subjects who do not undergo the final assessment will be imputed using the last recorded value. The TUG test is a validated measurement of patient agility and balance, in addition to assessing if patient is a fall risk. Patients will be timed in seconds on standing up from a seated position, walking to a 3 meter line, and returning to the chair in a seated position at their regular pace without assistance from another person. Reference values for ages 60-99 years range from 7.1-12.7 seconds, with additional cut-off values predictive of falls. Results correlate with gait speed, balance, functional level, the ability to go out, and can follow change over time. |
Baseline prior to initial exercise therapy session, midpoint (Week 4, Up to Week 6), neoadjuvant chemotherapy completion prior to surgery (Week 8, Up to Week 16), and 30 days post-operative surgery for tumor removal.
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Change from baseline in aerobic ability, resistance, agility, balance, and posture as measured by the Stair Test
Délai: Baseline prior to initial exercise therapy session, midpoint (Week 4, Up to Week 6), neoadjuvant chemotherapy completion prior to surgery (Week 8, Up to Week 16), and 30 days post-operative surgery for tumor removal.
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Analyses of change from baseline will be measured by the Stair Test. Change from baseline measurement at 30 days post-op will be fit with terms for treatment group and the measurement at baseline. Values for subjects who do not undergo the final assessment will be imputed using the last recorded value. The Stair test is a validated measurement of aerobic ability, resistance, agility, balance, and posture. Patients will be timed in seconds to climb 2 flights of stairs in a constant rhythm, one step at a time. Patients will not be allowed to stop at any point during the climb or use side railings for support. The cancer exercise trainer will accompany each subject to ensure protocol compliance and safety. Maximal oxygen intake (VO2max) will be calculated for each patient and compared against predicted VO2 calculations based on gender, age, BMI, and heart rate at end of the stair climb. |
Baseline prior to initial exercise therapy session, midpoint (Week 4, Up to Week 6), neoadjuvant chemotherapy completion prior to surgery (Week 8, Up to Week 16), and 30 days post-operative surgery for tumor removal.
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Change in patient function as measured by Karnosfky Performance Status Scale
Délai: Baseline prior to initial exercise therapy session, midpoint (Week 4, Up to Week 6), neoadjuvant chemotherapy completion prior to surgery (Week 8, Up to Week 16), and 30 days post-operative surgery for tumor removal.
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The Karnosfky Performance Status Scale measures the ability of cancer patients to perform ordinary tasks. Possible scores range from 0 to 100 by increments of 10, with higher scores indicating that patients are better able to carry out daily activities. Patient function will be assessed using the Timed Up and Go (TUG) test, Stairs Test, which evaluate patient's aerobic ability, resistance, agility, balance, and posture, as well as the Karnosfky Performance Status Scale. Patient quality of life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) survey. All assessments will be completed at baseline, prior to the initial exercise therapy session, at midpoint, and at the final session prior to surgery, as well as 30 days post-surgery. Exercise therapy will be deemed effective by preventing a reduction to patient function and quality of life over the course of enrollment in the study. |
Baseline prior to initial exercise therapy session, midpoint (Week 4, Up to Week 6), neoadjuvant chemotherapy completion prior to surgery (Week 8, Up to Week 16), and 30 days post-operative surgery for tumor removal.
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Change in quality of life assessment
Délai: Baseline prior to initial exercise therapy session (Week 1), midpoint (Week 4, Up to Week 6), neoadjuvant chemotherapy completion prior to surgery (Week 8, Up to Week 16), and 30 days post-operative surgery for tumor removal (Week 13, Up to Week 17).
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Analyses of change from baseline for quality of life will be measured by the Functional Assessment of Cancer Therapy - General (FACT-G) survey. Change from baseline measurement at 30 days post-op will be fit with terms for treatment group and the measurement at baseline. Values for subjects who do not undergo the final assessment will be imputed using the last recorded value. The FACT-G survey measures patient quality of life. This validated survey contains 27 items measured by a 5 point Likert-type scale in 4 domains relevant to cancer patients: Physical, Social, Emotional, and Functional well-being. Possible scores range from 0 to 108, with higher scores indicating a better quality of life. |
Baseline prior to initial exercise therapy session (Week 1), midpoint (Week 4, Up to Week 6), neoadjuvant chemotherapy completion prior to surgery (Week 8, Up to Week 16), and 30 days post-operative surgery for tumor removal (Week 13, Up to Week 17).
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean total Patient Satisfaction score of Telehealth Exercise Therapy
Délai: Immediately after administration of each exercise session
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The Virtual Exercise Protocol Satisfaction Survey Scale (VEPSS1) measures patient satisfaction with the service delivery method of the exercise intervention. This is a researcher-designed survey for use in this study. Possible scores range from 0 to 20, with higher scores indicating a better outcome. The VEPSS1 will be used for telehealth cohort only. Satisfaction will be summarize as a continuous score for the participant populations. Median and interquartile ranges of the score will be recorded. Differences in comprehension will be measured between the In-Person Exercise Protocol Satisfaction Survey Scale and the VEPSS1. |
Immediately after administration of each exercise session
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Mean total Patient Satisfaction score of In-Person Exercise Therapy
Délai: Immediately after administration of each exercise session
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The In-Person Exercise Protocol Satisfaction Survey Scale (IPEPSS1) measures patient satisfaction with the in-person service delivery method of the exercise intervention. This is a researcher-designed survey for use in this study. Possible scores range from 0 to 20, with higher scores indicating a better outcome. The IPEPSS1 will be used for in-person exercise cohort only. Satisfaction will be summarize as a continuous score for the participant populations. Median and interquartile ranges of the score will be recorded. Differences in comprehension will be measured between the IPEPSS1 and the VEPSS1. |
Immediately after administration of each exercise session
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Jay Lohrey, Jay.Lohrey@UTSouthwestern.edu
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STU-2020-0948
Informations sur les médicaments et les dispositifs, documents d'étude
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