A Pilot Study of an Individually Tailored, Supervised, Remotely Delivered Exercise Intervention to Improve Physical Function in Survivors of Gastroesophageal Cancer (PRECISE Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 20
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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