Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial

PRIMARY OBJECTIVE:

I. To determine the feasibility of the exercise intervention, as measured by the percentage of participants who attend at least 80% of the exercise sessions and complete the post-intervention functional assessment.

SECONDARY OBJECTIVES:

I. To determine other measures of feasibility of the exercise intervention, including eligibility, recruitment, and achievement of exercise goals.

II. To determine the change in measures of physical function (Short Physical Performance Battery \[SPPB\], grip strength, Two Minute Step Test \[TMST\], Activities of Daily Living \[ADL\], and instrumental ADL) from baseline to end of study.

III. To determine the change in frailty status (Deficit Accumulation Index \[DAI\]) from baseline to end of study.

IV. To determine the change in measures of cognitive function (Montreal Cognitive Assessment \[MOCA\] and Patient Reported Outcomes Measurement Information System \[PROMIS\] Cognitive Function Short Form) from baseline to end of study.

V. To determine the change in anxiety (General Anxiety Disorder-7 \[GAD-7\]) from baseline to end of study.

VI. To determine the change in depression (Patient Health Questionnaire-8 \[PHQ-8\]) from baseline to end of study.

VII. To determine the change in sleep quality (Insomnia Severity Index) from baseline to end of study.

VIII. To determine the change in quality of life (Short Form \[SF\]-36) from baseline to end of study.

IX. To evaluate adverse events (Patient Reported Outcomes version of Common Terminology Criteria for Adverse Events \[PRO-CTCAE\] and Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\]5.0) during the study intervention.

X. To identify patient perspectives on the whether or not the study intervention was worthwhile.

EXPLORATORY OBJECTIVES:

I. To determine the reliability of using remote monitoring devices to measure functional health in real-time during the study intervention.

II. To determine the change in biomarkers of aging from baseline to end of study.

OUTLINE:

Patients receive access to the Moterum application and complete remotely delivered, supervised exercise sessions, over 1 hour, 3 times per week for 8 weeks. Sessions consist of both aerobic and resistance training exercises. Patients also receive written instructions and videos of strengthening exercises. Patients undergo blood sample collection throughout the study.

After completion of study intervention, patients are followed up at 6 months.

• Percentage of patients who are screened that qualify for the intervention [Срок оценки: Up to 16 months]
• Percentage of eligible patients who consent to participate in the intervention [Срок оценки: Up to '6 months]
• Percentage of eligible participants who meet the duration and intensity goals for the aerobic and resistance exercises by the end of the study period [Срок оценки: Up to 8 weeks]
• Change in physical function [Срок оценки: From baseline to 8 weeks]
• Change in grip strength [Срок оценки: From baseline to 8 weeks]
• Change in physical function [Срок оценки: From baseline to 8 weeks]
• Change in activities of daily living [Срок оценки: From baseline to 8 weeks]
• Change in instrumental activities of daily living [Срок оценки: From baseline to 8 weeks]
• Change in frailty status [Срок оценки: From baseline to 6 months]
• Change in cognitive function [Срок оценки: From baseline to 6 months]
• Change in cognitive function [Срок оценки: From baseline to 6 months]
• Change in quality of life [Срок оценки: From baseline to 6 months]