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

ConditionsClinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage I Gastric Cancer AJCC v8Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage II Gastric Cancer AJCC v8Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage III Gastric Cancer AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Actigraphy

    Other intervention

    Ancillary studies

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Educational Intervention

    Other intervention

    Receive written instructions

  • Educational Intervention

    Other intervention

    Receive videos of strengthening exercises

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Exercise Intervention

    Other intervention

    Compete exercise sessions

  • Internet-Based Intervention

    Other intervention

    Receive access to Moterum application

  • Physical Performance Testing

    Other intervention

    Ancillary studies

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Supportive care (Remote exercise intervention)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

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.

Time frame
At 8 weeks

Secondary outcomes

1

Percentage of patients who are screened that qualify for the intervention

Time frame
Up to 16 months
2

Percentage of eligible patients who consent to participate in the intervention

Time frame
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

Time frame
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.

Time frame
From baseline to 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonsson Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: