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

September 9, 2016 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University
        • Contact:
          • Shun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • poor functional status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
usual care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-report Questionnaire
Time Frame: Change from baseline physical symptom at 12 months
The questionnaire includes 25 items to assess the physical symptom distresses
Change from baseline physical symptom at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-report Questionnaire
Time Frame: Change from baseline fatigue at 12 months
The questionnaire includes 14 items to assess fatigue intensity and duration
Change from baseline fatigue at 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-report Questionnaire
Time Frame: Change from baseline quality of life at 12 months
The questionnaire includes 32 items to assess quality of life
Change from baseline quality of life at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Science Council, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

September 9, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 9, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201505160RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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