NCT02900677

Brief Summary

The aims of this three-year study are to:

  1. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
168

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

August 24, 2016

Last Update Submit

September 9, 2016

Conditions

Keywords

Pancreatic CancerFatigueNutritionQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Self-report Questionnaire

    The questionnaire includes 25 items to assess the physical symptom distresses

    Change from baseline physical symptom at 12 months

Secondary Outcomes (1)

  • Self-report Questionnaire

    Change from baseline fatigue at 12 months

Other Outcomes (1)

  • Self-report Questionnaire

    Change from baseline quality of life at 12 months

Study Arms (2)

Physical and nutrition program

EXPERIMENTAL

6 education programs with physical enhancement and nutrition related information for 12 weeks.

Behavioral: Physical and nutrition program

Control

NO INTERVENTION

usual care

Interventions

6 education programs with physical enhancement and nutrition related information for 12 weeks

Physical and nutrition program

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • poor functional status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University

Taipei, Taiwan

RECRUITING

Related Publications (1)

  • Yang HY, Shun SC, Lee YH, Liou YT, Chou YJ, Kuo HJ, Tien YW, Lai SR, Hung H. Trajectories of perioperative nutritional status in patients with pancreatic tumor after surgery in six months. Eur J Oncol Nurs. 2024 Oct;72:102687. doi: 10.1016/j.ejon.2024.102687. Epub 2024 Aug 21.

MeSH Terms

Conditions

Pancreatic NeoplasmsFatigue

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Shiow-Ching Shun, PHD

    National Taiwan University

    STUDY CHAIR

Central Study Contacts

Shiow-Ching Shun, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 14, 2016

Study Start

August 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations