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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation Program | Experimental | 30 participants will be enrolled and will complete study procedures as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Rate (Feasibility) | Number of eligible patients who enroll in study | At screening |
| Completion Rate (Feasibility) | Defined as the number of patients who complete study procedures. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Nutrition Compliance Rate (Feasibility) | 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. | 5 days |
| Physical Function Compliance Rate (Feasibility) |
| Measure | Description | Time Frame |
|---|---|---|
| Sarcopenia | Assessed by baseline Computed Tomography (CT) scan of the thorax. | At baseline |
| Malnutrition | Assessed by the Perioperative Nutrition Screen (PONS) Risk Score, a modified version of the malnutrition universal screening tool, which determines the presence of nutrition risk based on BMI, recent body weight loss, decrement of dietary intake, and preoperative albumin concentration. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Dashti, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02215 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
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. |
| 30 days |
| Sleep Health Compliance Rate (Feasibility) | 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. | 30 days |
| Actigraphy Compliance Rate (Feasibility) | Total daily hours of actiwatch/wearable device wear-time. A cut-off value of 80% will be used to indicate compliance. | 30 days |
| At baseline visit and second measure at post-operative 1 day visit |
| Patient-Reported Sleep Measures | Assessed by the International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity. | At baseline visit and second measure at post-operative 1 day visit |
| Hand Grip Test | Assessed by change in baseline and post-operative Hand Grip tests using a hand-held dynamometer. An average score is calculated using measurements from both hands. | At baseline visit and second measure at post-operative 1 day visit |
| BMI | Assessed by change in baseline and post-operative height and weight. | At baseline visit and second measure at post-operative 1 day visit |
| Energy expenditure | Assessed by change in baseline and post-operative Metabolic Cart, or indirect calorimetry. | At baseline visit and second measure at post-operative 1 day visit |
| 6-Minute Walk Test | Assessed by a baseline and a post-operative 6-Minute Walk Test, a sub-maximal exercise test used to assess aerobic capacity and endurance. | At baseline visit and second measure at post-operative 1 day visit |
| Patient-Reported Measures on Physical Function Score | Assessed by Activity Measure for Post-Acute Care (AM-PAC), a standardized assessment used to measure the physical function and functional status of patients. The AM-PAC consists of 13 tests that divided into lower and upper extremity function, gait and balance and activities of daily living and instrumental activities of daily living. Also assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF), a 45-item self-reported measure to evaluate physical function. | At baseline visit and second measure at post-operative 1 day visit |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |