Esophageal Cancer, Esophageal Neoplasms
Conditions
Keywords
Esophageal Cancer, Esophageal Neoplasms
Brief summary
The goal of this research study is to investigate the feasibility of implementing a prehabilitation program that aims to improve a patient's physical, nutritional, and sleep health before surgery in an older, at-risk group with esophageal cancer.
Detailed description
This research study is to test whether a novel, 4-week surgical multimodal prehabilitation protocol is feasible in at-risk older adult patients who have previously undergone neoadjuvant chemotherapy or radiotherapy and are scheduled for surgical removal of esophageal cancer. Research study procedures include screening for eligibility, clinic visits, questionnaires, blood tests, and Computed Tomography (CT) scans. Participation in this research study is expected to last 7 months. It is expected about 30 patients will participate in this study.
Interventions
BEHAVIORALPrehabilitation Program
Multimodal prehabilitation program consisting of pre-surgical optimization of nutrition, physical function, and sleep health via individualized plans. Participants will also be supplied with Nestle Impact Advances Recovery Immunonutrition Drink.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 65 years of age and over * Adult male or non-pregnant female volunteers * Completed neoadjuvant chemotherapy or radiotherapy for esophageal cancer * At least four weeks to esophageal cancer surgery * Without skin conditions that preclude wearing sensors * Able to speak English and consent
Exclusion criteria
* Participants in any other interventional study that may bias results or limit study adherence during our study * Dietary restrictions that prevent consumption of nutritional supplements * Women who are pregnant, nursing, or at risk of becoming pregnant * Profound physical disability (for example, quadriplegia) that precludes participation in any aerobic or strength training.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate (Feasibility) | At screening | Number of eligible patients who enroll in study |
| Completion Rate (Feasibility) | 30 days | Defined as the number of patients who complete study procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutrition Compliance Rate (Feasibility) | 5 days | Comparison of number of nutritional supplements consumed compared to number of nutritional supplements prescribed as determined from daily check-ins. A cut-off value of 80% will be used to indicate compliance. |
| Physical Function Compliance Rate (Feasibility) | 30 days | Comparison of the total minutes of physical function completed compared to the total minutes of physical function prescribed as determined from daily check-ins and wearable device. A cut-off value of 80% will be used to indicate compliance. |
| Sleep Health Compliance Rate (Feasibility) | 30 days | Comparison of the average daily hours of sleep duration, minutes of wake after sleep onset, and variability in sleep timing, achieved compared to prescribed as determined from actigraphy. A cut-off value of 80% will be used to indicate compliance. |
| Actigraphy Compliance Rate (Feasibility) | 30 days | Total daily hours of actiwatch/wearable device wear-time. A cut-off value of 80% will be used to indicate compliance. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHassan Dashti, PhD
Massachusetts General Hospital
Outcome results
None listed