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The purpose of this research is to explore the benefits of an exercise and nutrition program during total neoadjuvant therapy (TNT) in preparation for surgery for participants that have pancreatic ductal adenocarcinoma (PDAC)
This research study involves an exercise and nutrition program that will consist of twice weekly exercise sessions and discussion with a nutritionist with possible nutrition supplementation.
The names of the study interventions involved in this study are:
The research study procedures include: screening for eligibility, study evaluations, and follow up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal Prehabilitation Program | Experimental | Pretreatment exercise program and nutrition program -The prehabilitation intervention will include the following components: (1) a standardized fitness program and (2) nutritional counseling and optimization. Patients are enrolled in the program within 8 weeks of being diagnosed and continued until operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Program | Behavioral | Participants will start the exercise program within 2 weeks of enrollment and will continue until surgery. This program will consist of twice weekly individualized sessions with a trainer. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants to complete prehabilitation program | At least 50% (95% confidence interval +/- 16%) of participants will complete 50% of the components of the prehabilitation program. | 1 year |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naomi Sell, MD, MHS | Contact | 650-868-9440 | nsell@partners.org | |
| Motaz Qadan, MD, PhD | Contact | 617-643-5153 | mqadan@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Motaz Qadan, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | 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
MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D063105 | Food Assistance |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Nutrition Program | Behavioral | Each patient enrolled will undergo nutritional assessment at their initial post-enrollment visit to develop an individualized nutrition plan to be implemented up until when the patient undergoes surgery. |
|
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D011632 | Public Assistance |
| D005380 | Financing, Government |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |