NCT02512263

Brief Summary

The purpose is to assess the adherence and the efficiency of a home-based training program on muscular strength, endurance and the quality of life, fatigue, physical activity, anxiety and depression for colon cancer patient treated by chemotherapy.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

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

July 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

July 27, 2015

Last Update Submit

July 28, 2015

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Muscular strength measured by Microfet

    15 minutes

Secondary Outcomes (6)

  • Quality of life measured by questionnaire

    3 minutes

  • Fatigue measured by questionnaire

    3 minutes

  • Physical activity measured by questionnaire

    3 minutes

  • Anxiety measured by questionnaire

    3 minutes

  • Exercise tolerance measured by Six minute walking test

    6 minutes

  • +1 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

They will have to do all the tests and to follow the home-based training program during 9 weeks.

Procedure: Home-based training program

control group

NO INTERVENTION

They will have to do all the tests but not to follow the home-based training program.

Interventions

Home-based training programPROCEDURE

A home-based training program of 8 exercises to do 5 times a week during 9 weeks

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colon cancer patients treated by chemotherapy adjuvant

You may not qualify if:

  • Patients who have metastasis
  • Patients hospitalized during the experimentation
  • Patients who have major orthopedic or neurologic problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2015

First Posted

July 30, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2015

Study Completion

July 1, 2017

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations

BE(1)