Back to resultsDeveloping Prehabilitation Program in Patients With Operable Pancreatic Cancer Perioperatively and Following Surgery
Primary Purpose
Pancreatic Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Physical and nutrition program
Sponsored by
About this trial
This is an interventional supportive care trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Fatigue, Nutrition, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- patients with pancreatic cancer and are going to receive surgery.
Exclusion Criteria:
- poor functional status
Sites / Locations
- National Taiwan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physical and nutrition program
Control
Arm Description
6 education programs with physical enhancement and nutrition related information for 12 weeks.
usual care
Outcomes
Primary Outcome Measures
Self-report Questionnaire
The questionnaire includes 25 items to assess the physical symptom distresses
Secondary Outcome Measures
Self-report Questionnaire
The questionnaire includes 14 items to assess fatigue intensity and duration
Full Information
NCT ID
NCT02900677
First Posted
August 24, 2016
Last Updated
September 9, 2016
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02900677
Brief Title
Developing Prehabilitation Program in Patients With Operable Pancreatic Cancer Perioperatively and Following Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aims of this three-year study are to:
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic Cancer, Fatigue, Nutrition, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physical and nutrition program
Arm Type
Experimental
Arm Description
6 education programs with physical enhancement and nutrition related information for 12 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
Physical and nutrition program
Intervention Description
6 education programs with physical enhancement and nutrition related information for 12 weeks
Primary Outcome Measure Information:
Title
Self-report Questionnaire
Description
The questionnaire includes 25 items to assess the physical symptom distresses
Time Frame
Change from baseline physical symptom at 12 months
Secondary Outcome Measure Information:
Title
Self-report Questionnaire
Description
The questionnaire includes 14 items to assess fatigue intensity and duration
Time Frame
Change from baseline fatigue at 12 months
Other Pre-specified Outcome Measures:
Title
Self-report Questionnaire
Description
The questionnaire includes 32 items to assess quality of life
Time Frame
Change from baseline quality of life at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with pancreatic cancer and are going to receive surgery.
Exclusion Criteria:
poor functional status
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiow-Ching Shun, PHD
Phone
886-2-23123456
Ext
88439
Email
scshun@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiow-Ching Shun, PHD
Organizational Affiliation
National Taiwan University
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiow-Ching Shun, PHD
Phone
886-2-2312-3456
Ext
88439
Email
scshun@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Shun
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Developing Prehabilitation Program in Patients With Operable Pancreatic Cancer Perioperatively and Following Surgery
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