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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02900677
• Other study ID #: 201505160RINB
• Status: Recruiting
• Phase: N/A
• First received: August 24, 2016
• Last updated: September 9, 2016
• Start date: August 2015
• Est. completion date: July 2018

Study information

• Verified date: September 2016
• Source: National Taiwan University Hospital
• Contact: Shiow-Ching Shun, PHD
• Phone: 886-2-23123456
• Email: scshun[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• poor functional status

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Behavioral:
• Physical and nutrition program
6 education programs with physical enhancement and nutrition related information for 12 weeks

Locations

Country	Name	City	State
Taiwan	National Taiwan University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-report Questionnaire	The questionnaire includes 32 items to assess quality of life	Change from baseline quality of life at 12 months	No
Primary	Self-report Questionnaire	The questionnaire includes 25 items to assess the physical symptom distresses	Change from baseline physical symptom at 12 months	No
Secondary	Self-report Questionnaire	The questionnaire includes 14 items to assess fatigue intensity and duration	Change from baseline fatigue at 12 months	No