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出境医 / 临床实验 / Physical Activity and Its Impact on Colon Cancer Surgery (PACOS)

Physical Activity and Its Impact on Colon Cancer Surgery (PACOS)

Study Description
Brief Summary:

This is a prospective clinical study that studies how the physical activity level before operation of colon cancer affects the outcome of complication and histology.

The hypothesis is that patients who are more physical active have less postoperative complications and different histological immunological response around the tumor.

The investigators are testing the patients before the surgery with physical tests for fitness, strength and physical activity level. Questionnaires are also filled by the patients for pain, anxiety, depression and motivation for life style changes. Their body mass is analyzed with a DEXA (Dual-energy X-ray absorptiometry scan).

For one years the investigators are monitoring their activity and follow up for physical tests, DEXA and questionnaires is at 6 and 12 months.

The histology is analyzed after surgery to se if there is a different immunological response around the tumor.


Condition or disease Intervention/treatment
Colon Cancer Physical Activity Behavioral: Physical activity

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Physical Activity and Its Impact on Colon Cancer Surgery: Clinical and Histological Effects
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : January 30, 2022
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Number of postoperative complications [ Time Frame: 1 year ]
    To study if there are differences in postoperative complications in different active patients.

  2. Rate of immunological response [ Time Frame: 1 year ]
    To study if there is a difference in immunological reaction among physical active patients.


Secondary Outcome Measures :
  1. Rate of recovery in physical activity [ Time Frame: 1 year ]
    To study if physical active patients have a faster postoperative recovery


Biospecimen Retention:   Samples Without DNA
Histological samples from the tumor

Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 9, 2019
First Posted Date May 13, 2019
Last Update Posted Date December 1, 2020
Actual Study Start Date January 30, 2019
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 25, 2019)
  • Number of postoperative complications [ Time Frame: 1 year ]
    To study if there are differences in postoperative complications in different active patients.
  • Rate of immunological response [ Time Frame: 1 year ]
    To study if there is a difference in immunological reaction among physical active patients.
Original Primary Outcome Measures
 (submitted: May 9, 2019)
  • Postoperative complications [ Time Frame: 1 year ]
    To study if there are differences in postoperative complications in different active patients.
  • Immunological response [ Time Frame: 1 year ]
    To study if there is a difference in immunological reaction among physical active patients.
Change History
Current Secondary Outcome Measures
 (submitted: September 25, 2019) 		Rate of recovery in physical activity [ Time Frame: 1 year ]
To study if physical active patients have a faster postoperative recovery
Original Secondary Outcome Measures
 (submitted: May 9, 2019) 		Faster recovery [ Time Frame: 1 year ]
To study if physical active patients have a faster postoperative recovery
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Physical Activity and Its Impact on Colon Cancer Surgery
Official Title Physical Activity and Its Impact on Colon Cancer Surgery: Clinical and Histological Effects
Brief Summary

This is a prospective clinical study that studies how the physical activity level before operation of colon cancer affects the outcome of complication and histology.

The hypothesis is that patients who are more physical active have less postoperative complications and different histological immunological response around the tumor.

The investigators are testing the patients before the surgery with physical tests for fitness, strength and physical activity level. Questionnaires are also filled by the patients for pain, anxiety, depression and motivation for life style changes. Their body mass is analyzed with a DEXA (Dual-energy X-ray absorptiometry scan).

For one years the investigators are monitoring their activity and follow up for physical tests, DEXA and questionnaires is at 6 and 12 months.

The histology is analyzed after surgery to se if there is a different immunological response around the tumor.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples Without DNA
Description:
Histological samples from the tumor
Sampling Method Probability Sample
Study Population Patients who are going to surgery due to colon cancer.
Condition
  • Colon Cancer
  • Physical Activity
Intervention Behavioral: Physical activity
Se their physical activity level
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 9, 2019) 		80
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 30, 2022
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 18 years.
  • Colon cancer which is going to surgery

Exclusion Criteria:

  • Not able to do physical tests
  • Severe disease that makes a risk to do tests.
  • Not able to make informed consent due to psychic disease or dementia
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Karin Strigård 0046907853583 ext 0046907853583 karin.strigard@umu.se
Contact: Niillas Blind 0046703210971 ext 0046907853583 niillas.blind@umu.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT03947840
Other Study ID Numbers PACOS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Umeå University
Study Sponsor Umeå University
Collaborators Västerbotten County Council, Sweden
Investigators
Principal Investigator: Karin Strigård Umeå Universitet
PRS Account Umeå University
Verification Date November 2020