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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Ancillary studies
Undergo blood sample collection
Receive written instructions
Receive videos of strengthening exercises
Ancillary studies
Compete exercise sessions
Receive access to Moterum application
Ancillary studies
Ancillary studies
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Percentage of participants who attend at least 80% of the exercise sessions and complete the post-intervention functional assessment
Will use descriptive statistics to summarize the participant population, feasibility metrics, and safety data. The study will be deemed feasible if \> 60% (12 or more) of the 20 enrolled participants are retained.
Time frame: At 8 weeks
Percentage of patients who are screened that qualify for the intervention
Time frame: Up to 16 months
Percentage of eligible patients who consent to participate in the intervention
Time frame: 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
Time frame: Up to 8 weeks
Change in physical function
Assessed via Short Physical Performance Battery. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention.
Time frame: From baseline to 8 weeks
Change in grip strength
Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention.
Time frame: From baseline to 8 weeks
Change in physical function
Assessed via the two minute step test. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The two-minute step test is administered by measuring the midpoint of the participant's patella and the top of their iliac crest and measuring how many times the participant's right knee can reach this point while marching in place for 2 minutes. A higher step count means a better outcome.
Time frame: From baseline to 8 weeks
Change in activities of daily living
Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The activities of daily living assessment is a calculated from the physical component score of the Short Form-36 health survey. This section consists of 10 items that assess different physical activity domains. Each item has a specific response scale which corresponds to a number. These numbers are summed and transformed into a 0-100 scale, where 0 indicates the worst health and 100 indicates the best health.
Time frame: From baseline to 8 weeks
Change in instrumental activities of daily living
Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The instrumental activities of daily living assessment is a 10 items survey that assess different physical activity domains. Each item will be rated and scored based on responses denoting level of limitation (a lot, a little, not at all). The total score ranges from 0 to 100 and higher scores means a better outcome.
Time frame: From baseline to 8 weeks
Change in frailty status
Assessed via Deficit Accumulation Index. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The Deficit Accumulation Index (DAI) is a 50-item frailty index that is derived from the Cancer and Aging Research Group geriatric assessment. The DAI evaluates deficits in multiple geriatric assessment domains. Scores range from 0-1 with a score of 0.0 representing no detected deficits and 1.0 representing the maximum deficit. Based on the score, participants will be categorized into three categories of health status: robust, prefrail, or frail.
Time frame: From baseline to 6 months
Change in cognitive function
Assessed via Montreal Cognitive Assessment. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The Montreal Cognitive Assessment (MoCA) test is a series of questions and assessments to measure eight domains of cognitive function. The MoCA is score from 0-30 with lower scores indicating worse cognitive impairment. A score of \<25 suggests some degree of cognitive impairment.
Time frame: From baseline to 6 months
Change in cognitive function
Assessed via Patient Reported Outcomes Measurement Information System Cognitive Function Short Form. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The PROMIS Short Form v2.0 - Cognitive Function Short Form 8a provides a self-reported measure of cognitive function consisting of 8 items. Each item includes a statement related to cognitive function that the patient would rate with an attribution (very often (several times a day), often (about once a day), sometimes (two or three times), rarely (once), never) that ranges from 0-5. The items will be summed to obtain a composite score from 0-40 and higher scores indicate better cognitive function.
Time frame: From baseline to 6 months
Change in quality of life
Assessed via 36-Item Short Form Survey. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The 36-Item Short Form Health Survey (SF-36) is a composite measure of quality of life that includes 36 items related to physical (10 items) and social functioning (2 items), pain (2 items), role limitations due to physical health (4 items) and emotional problems (3 items), energy/fatigue (4 items), emotional well-being (5 items), and health perceptions (6 items). Each item is scored on a 0 to 100 range, in which a high score represents a more favorable health state.
Time frame: From baseline to 6 months
Change in sleep quality
Assessed via Insomnia Severity Index. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The Insomnia Severity Index is a self-rated questionnaire that assesses sleep problems over a 2-week time interval. Higher scores indicate more acute symptoms of insomnia (no clinically significant insomnia \[0-7\], subthreshold insomnia \[8-14\], moderate clinical insomnia \[15-21\], severe clinical insomnia \[22-28\]).
Time frame: From baseline to 6 months
Change in anxiety
Assessed via General Anxiety Disorder-7. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The General Anxiety Disorder-7 is a 7-item questionnaire that assesses anxiety severity over a 2-week time interval. This is calculated by assigning scores of 0 (not at all), 1 (several days), 2 (more than half the days), and 3 (nearly every day) to each response. GAD-7 total score for the 7 items ranges from 0 to 21 with higher scores indicating more anxiety (minimal anxiety \[0-4\], mild anxiety \[5-9\], moderate anxiety \[10-14\], severe anxiety \[15-21\]).
Time frame: From baseline to 6 months
Change in depression
Assessed via Patient Health Questionnaire-8. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The Patient Health Questionnaire-8 is an 8-item questionnaire that assesses depression over a 2-week time interval. This is calculated by assigning scores of 0 (not at all), 1 (several days), 2 (more than half the days), and 3 (nearly every day) to each response. Higher scores indicate a higher likelihood of clinical depression.
Time frame: From baseline to 6 months
Incidence of adverse events
Assessed via National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Will be determined at each time point per patient as the presence (yes/no) of toxicities of grade ≥ 2. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. Adverse Events (AEs) experienced will be captured as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0). After grading, each AE will be assigned an attribution by the treating clinician (unlikely, possibly, probably, or definitely related to study agent).
Time frame: Up to 8 weeks
Incidence of patient reported adverse events
Assessed via Patient Reported Outcomes version of CTCAE. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. Patient-reported Adverse Events (PRO-CTCAE) is a patient-reported outcome measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. Each item is scored 0-4 with higher scores indicated more severe symptoms. No total score is calculated.
Time frame: Up to 8 weeks
Patient perspectives on whether or not the study intervention was worthwhile
Assessed via Was it Worth It (WIWI) questionnaire. Will use descriptive statistics to summarize the proportion of participants who answer 'yes,' 'uncertain,' and 'no' to the items in the WIWI Questionnaire and compare responses between participants with improvement in physical function and those without, bivariately and multivariately controlling for other factors.
Time frame: At 8 weeks
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