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Developing Prehabilitation Program in Patients With Operable Pancreatic Cancer Perioperatively and Following Surgery

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ClinicalTrials.gov Identifier: NCT02900677
Recruitment Status : Unknown
Verified September 2016 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 14, 2016
Last Update Posted : September 14, 2016
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

The aims of this three-year study are to:

  1. explore the change of fatigue, nutritional status, quality of life and care needs in patients with operable pancreatic cancer perioperatively and following surgery within 3 months.
  2. develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Behavioral: Physical and nutrition program Not Applicable

Detailed Description:
Develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Developing and Testing the Effects of Patient-centered Prehabilitation Program on Improving Fatigue, Nutritional Status, and Quality of Life in Patients With Operable Pancreatic Cancer Perioperatively and Following Surgery
Study Start Date : August 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical and nutrition program
6 education programs with physical enhancement and nutrition related information for 12 weeks.
Behavioral: Physical and nutrition program
6 education programs with physical enhancement and nutrition related information for 12 weeks

No Intervention: Control
usual care



Primary Outcome Measures :
  1. Self-report Questionnaire [ Time Frame: Change from baseline physical symptom at 12 months ]
    The questionnaire includes 25 items to assess the physical symptom distresses


Secondary Outcome Measures :
  1. Self-report Questionnaire [ Time Frame: Change from baseline fatigue at 12 months ]
    The questionnaire includes 14 items to assess fatigue intensity and duration


Other Outcome Measures:
  1. Self-report Questionnaire [ Time Frame: Change from baseline quality of life at 12 months ]
    The questionnaire includes 32 items to assess quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with pancreatic cancer and are going to receive surgery.

Exclusion Criteria:

  • poor functional status

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900677


Contacts
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Contact: Shiow-Ching Shun, PHD 886-2-23123456 ext 88439 scshun@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Recruiting
Taipei, Taiwan
Contact: Shiow-Ching Shun, PHD    886-2-2312-3456 ext 88439    scshun@ntu.edu.tw   
Contact: Shun         
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
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Study Chair: Shiow-Ching Shun, PHD National Taiwan University

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02900677     History of Changes
Other Study ID Numbers: 201505160RINB
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by National Taiwan University Hospital:
Pancreatic Cancer
Fatigue
Nutrition
Quality of Life
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases