Multidimensional Prehabilitation in Pancreatic Surgery for Pancreatic and Periampullary Neoplasms
NCT ID: NCT05225038
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2022-06-13
2023-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control Arm (Standard of Care)
Participants will receive the current standard preoperative education and counseling. Participants will receive information regarding exercise and nutrition from a member of the surgical team. Participants will meet with a behavioral medicine specialist for additional education regarding factors affecting postoperative stress and relaxation techniques. Participants who are actively smoking will be counseled regarding smoking cessation and offered a referral to smoking cessation resources.
Behavioral Medicine
Participants will have 1 appointment with behavioral medicine - all participants will meet with the same behavioral medicine specialist to ensure consistency. Participants will receive education regarding factors that affect postoperative recovery and relaxation techniques.
Participants will also have the option to request faith support.
Smoking Cessation
Participants who are actively smoking will be counseled regarding smoking cessation during their preoperative appointment with a member of the surgical team. They will also be offered a referral to smoking cessation resources.
Intervention Arm (Prehabilitation)
Participants in the intervention arm will receive all of the standard of care, as listed above, as well as individualized exercise and nutritional prehabilitation regimens.
During the data analysis, participants will be subdivided into treatment groups, upfront surgical resection versus neoadjuvant chemotherapy, in order to determine whether length of prehabilitation affected outcomes and distinguish any possible effect of chemotherapy toxicity.
Exercise
Participants will meet with an exercise physiologist to undergo evaluation and develop individualized regimens for prehabilitation.
Nutritional
Participants will meet with a nutritionist to undergo evaluation and develop individualized regimens for prehabilitation.
Behavioral Medicine
Participants will have 1 appointment with behavioral medicine - all participants will meet with the same behavioral medicine specialist to ensure consistency. Participants will receive education regarding factors that affect postoperative recovery and relaxation techniques.
Participants will also have the option to request faith support.
Smoking Cessation
Participants who are actively smoking will be counseled regarding smoking cessation during their preoperative appointment with a member of the surgical team. They will also be offered a referral to smoking cessation resources.
Interventions
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Exercise
Participants will meet with an exercise physiologist to undergo evaluation and develop individualized regimens for prehabilitation.
Nutritional
Participants will meet with a nutritionist to undergo evaluation and develop individualized regimens for prehabilitation.
Behavioral Medicine
Participants will have 1 appointment with behavioral medicine - all participants will meet with the same behavioral medicine specialist to ensure consistency. Participants will receive education regarding factors that affect postoperative recovery and relaxation techniques.
Participants will also have the option to request faith support.
Smoking Cessation
Participants who are actively smoking will be counseled regarding smoking cessation during their preoperative appointment with a member of the surgical team. They will also be offered a referral to smoking cessation resources.
Eligibility Criteria
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Inclusion Criteria
* Requiring pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms
* Surgery scheduled at least 2 weeks after the initial surgical evaluation
* Fluency in English
* Willingness to answer questionnaires, complete daily exercise \& nutrition log, as well as participate in follow-up telephone calls
* Screening: Physical Activity Readiness - Questionnaire (PAR-Q+)
* PAR-Q+ assesses participants comorbidities and symptoms with current activities. If participants answer "yes" to any of the screening questions, they will need to complete additional questions regarding their chronic medical conditions including, but not limited to, heart disease, stroke, diabetes, depression/anxiety, and COPD/asthma, to determine their ability to participate in physical activity.
Exclusion Criteria
* Participants with concurrent medical conditions that prohibit exercise, such as those who indicate on the questionnaire that they experience chest pain, dizziness, or loss of consciousness with physical activity; those with chest pain at rest; or those with bone/joint/soft tissue conditions that could worsen with physical activity. Participants with specific comorbidities, such as coronary artery disease. congestive heart failure, or uncontrolled asthma/COPD, that may prevent participation will also be excluded.
* Inability to provide own informed consent
* Inability to read or verbally understand questionnaires in English
* Impaired hearing that creates a barrier for telephone follow-up
* Visual deficit that would cause exercise to be hazardous
* Emergent or urgent surgeries
18 Years
ALL
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Locations
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Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE8221
Identifier Type: -
Identifier Source: org_study_id
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