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
Conditions
Brief 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.
Interventions
OTHERActigraphy
Ancillary studies
PROCEDUREBiospecimen Collection
Undergo blood sample collection
OTHEREducational Intervention
Receive written instructions
OTHERElectronic Health Record Review
Ancillary studies
OTHERExercise Intervention
Compete exercise sessions
OTHERInternet-Based Intervention
Receive access to Moterum application
OTHERPhysical Performance Testing
Ancillary studies
OTHERSurvey Administration
Ancillary studies
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who attend at least 80% of the exercise sessions and complete the post-intervention functional assessment | At 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who are screened that qualify for the intervention | Up to 16 months | — |
| Percentage of eligible patients who consent to participate in the intervention | 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 | Up to 8 weeks | — |
| Change in physical function | From baseline to 8 weeks | 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. |
| Change in grip strength | From baseline to 8 weeks | 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. |
| Change in activities of daily living | From baseline to 8 weeks | 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. |
| Change in instrumental activities of daily living | From baseline to 8 weeks | 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. |
| Change in frailty status | From baseline to 6 months | 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. |
| Change in cognitive function | From baseline to 6 months | 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. |
| Change in quality of life | From baseline to 6 months | 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. |
| Change in sleep quality | From baseline to 6 months | 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 \[22-28\]). |
| Change in anxiety | From baseline to 6 months | 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 \[15-21\]). |
| Change in depression | From baseline to 6 months | 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. |
| Incidence of adverse events | Up to 8 weeks | 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). |
| Incidence of patient reported adverse events | Up to 8 weeks | 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. |
| Patient perspectives on whether or not the study intervention was worthwhile | At 8 weeks | 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. |
Countries
United States
Contacts
CONTACTJingran Ji, MD
PRINCIPAL_INVESTIGATORJingran Ji, MD
UCLA / Jonsson Comprehensive Cancer Center
Outcome results
None listed