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Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8PRECISENCT07439484

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

A study testing Actigraphy, Biospecimen Collection and Educational Intervention in people with Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8 and Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Actigraphy, Biospecimen Collection and Educational Intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Sep 2026to 1 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

    Jingran Ji, MD, 310-829-5471, jingranji@mednet.ucla.edu

    Jingran Ji, MD

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

  1. 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.

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

EXPLORATORY OBJECTIVES:

  1. 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.

Being tested
Actigraphy, Biospecimen Collection, Educational Intervention, Electronic Health Record Review, Exercise Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ActigraphyOther

    Ancillary studies

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Educational InterventionOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Receive written instructions

  • Educational InterventionOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Receive videos of strengthening exercises

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Exercise InterventionOther

    Compete exercise sessions

  • Internet-Based InterventionOther

    Receive access to Moterum application

  • Physical Performance TestingOther

    Also called Physical Fitness Testing, Physical Function Testing

    Ancillary studies

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT07439484
Study groupRoleWhat they receive
Supportive care (Remote exercise intervention)ExperimentalPatients 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.
Receives: Other: Actigraphy; Procedure: Biospecimen Collection; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Exercise Intervention; Other: Internet-Based Intervention; Other: Physical Performance Testing; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 8 weeks

Secondary outcomes (18)
  1. Percentage of patients who are screened that qualify for the intervention

    Measured: Up to 16 months

  2. Percentage of eligible patients who consent to participate in the intervention

    Measured: Up to '6 months

  3. Percentage of eligible participants who meet the duration and intensity goals for the aerobic and resistance exercises by the end of the study period

    Measured: Up to 8 weeks

  4. 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.

    Measured: From baseline to 8 weeks

  5. 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.

    Measured: From baseline to 8 weeks

  6. 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.

    Measured: From baseline to 8 weeks

  7. 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.

    Measured: From baseline to 8 weeks

  8. 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.

    Measured: From baseline to 8 weeks

  9. 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.

    Measured: From baseline to 6 months

  10. 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.

    Measured: From baseline to 6 months

  11. 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.

    Measured: From baseline to 6 months

  12. 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.

    Measured: From baseline to 6 months

  13. 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]).

    Measured: From baseline to 6 months

  14. 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]).

    Measured: From baseline to 6 months

  15. 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.

    Measured: From baseline to 6 months

  16. 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).

    Measured: Up to 8 weeks

  17. 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.

    Measured: Up to 8 weeks

  18. 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.

    Measured: At 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07439484
Sponsor's protocol ID
25-0954
Other IDs
NCI-2026-00630
Acronym
PRECISE
Status last verified
Feb 2026
First submitted
10 Feb 2026
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Actigraphy, Biospecimen Collection and Educational Intervention in people with Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8 and Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jingran Ji, MD (310-829-5471, jingranji@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants who attend at least 80% of the exercise sessions and complete the post-intervention functional assessment (time frame: At 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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