Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial
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About
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.
Full 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.
Enrollment
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Inclusion criteria
- Adults ≥ 18 years old at the start of study treatment
- Diagnosis of early-stage (Stage I, II, III) esophageal, gastroesophageal junction, or gastric cancer. Histology can be adenocarcinoma, squamous cell carcinoma, or poorly differentiated carcinoma
- Treated with at least one systemic therapy (chemotherapy or immunotherapy) and within 12 months of completing curative intent gastroesophageal cancer (GEC) treatment
- Have evidence of physical function impairment, defined as a SPPB score of < 12) at baseline
- Ability to understand English and the willingness to sign a written informed consent document
Exclusion criteria
- Patients with stage I disease who underwent endoscopic resection or surgery alone without perioperative systemic therapy
- Patients with stage IV disease or unresectable locally advanced disease taking a palliative treatment approach without a clearly defined end of treatment
- Patients currently receiving ongoing systemic therapy for GEC or another malignancy
- Patients who are unable to provide informed consent
- Any other condition or pre-existing co-morbidity that would, in the Investigator's judgment, contraindicate the participation in the study due to safety concerns with study procedures
- Currently participating in another exercise intervention research study seeking to improve functional status, alleviate frailty, muscle strength, exhaustion/fatigue, or cognitive function
Trial design
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Interventional model
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20 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Jingran Ji, MD
Data sourced from clinicaltrials.gov
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