NCT07439484

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

A Pilot Study of an Individually Tailored, Supervised, Remotely Delivered Exercise Intervention to Improve Physical Function in Survivors of Gastroesophageal Cancer (PRECISE Study)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial tests an individually tailored, supervised, remote exercise intervention to improve physical function for stage I-III gastroesophageal cancer survivors. Modern treatments for gastroesophageal cancer are effective at treating the cancer but are often aggressive, can be difficult for patients to tolerate, and can lead to significant debilitation and a loss of independence. Exercise is one promising intervention that could improve physical function in patients with gastroesophageal cancer after finishing systemic treatment. Home based exercise interventions in patients with cancer during and after chemotherapy can improve fatigue and function. An individually tailored, supervised, remote exercise intervention may improve physical function for stage I-III gastroesophageal cancer survivors.

Detailed description

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.

Conditions

• Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8
• Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage I Gastric Cancer AJCC v8
• Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage II Esophageal Adenocarcinoma AJCC v8
• Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage II Gastric Cancer AJCC v8
• Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage III Esophageal Adenocarcinoma AJCC v8
• Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage III Gastric Cancer AJCC v8
• Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8

Interventions

Type	Name	Description
OTHER	Actigraphy	Ancillary studies
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
OTHER	Educational Intervention	Receive written instructions
OTHER	Educational Intervention	Receive videos of strengthening exercises
OTHER	Electronic Health Record Review	Ancillary studies
OTHER	Exercise Intervention	Compete exercise sessions
OTHER	Internet-Based Intervention	Receive access to Moterum application
OTHER	Physical Performance Testing	Ancillary studies
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States