NCT04675814

Brief Summary

The objective of this study is to evaluate the effects of regular physical practice on fatigue, quality of life and kinesiophobia in patients treated at the ICO in Angers, regardless of the type of cancer and the type of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 14, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2021

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

January 27, 2026

Completed
Last Updated

January 27, 2026

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

December 1, 2020

Results QC Date

November 24, 2025

Last Update Submit

January 8, 2026

Conditions

Keywords

Adapted Physical Activity program (APA)kinesiophobiaFatigueQuality of life

Outcome Measures

Primary Outcomes (1)

  • Quality of Life of Patients Participating in the 12-week Adapted Physical Activity Program.

    Describe the evolution of the quality of life of patients being treated for their cancer pathology at the ICO site in Angers, and participating in the 12-week adapted physical activity program at ICO. Quality of life is measured with the FACIT-F Fatigue and Quality of Life Questionnaire. The questionnaire is structured into five sections, each containing between 6 and 13 items. In total, it includes 40 items, each scored from 0 to 4: 0 - Not at all 1. \- A little 2. \- Moderately 3. \- Quite a bit 4. \- Very much By adding up the answers, the score range obtained is: 0 to 160. The higher the score, the less tired the patient is.

    12 weeks

Secondary Outcomes (3)

  • Describe Attendance at the APA Program.

    12 weeks

  • Measure the Evolution of Kinesiophobia (Fear of Movement).

    12 weeks

  • Measure Physical Activity at the Initiation of the APA Program.

    Week 0

Interventions

Adults participating in the APA program at ICO during the first semester of 2020, regardless of cancer type and ongoing treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy). The APA program duration is : 12 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects participating in the ICO's APA program during the enrolment period regardless of the type of cancer and the type of treatment in progress (chemotherapy, radiotherapy, hormone therapy, immunotherapy) who accept to participate to the study.

You may qualify if:

  • Oncological care at the ICO
  • All types of cancer
  • Regardless of the type of treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy)
  • Age \> 18 years old
  • Follow the APA program at the ICO
  • Subject informed of the study

You may not qualify if:

  • Contraindication to the practice of sport
  • APA Program outside the ICO
  • Subject opposing the use of his data
  • Minor or adult patient under guardianship or curatorship
  • Pregnant woman
  • Altered general condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancérologie de L'Ouest

Angers, 49055, France

Location

MeSH Terms

Conditions

KinesiophobiaFatigue

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr ABADIE-LACOURTOISIE Sophie
Organization
Institut de Cancérologie de l'Ouest

Study Officials

  • Sophie ABADIE-LACOURTOISIE, MD

    Institut de Cancérologie de l'Ouest

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 19, 2020

Study Start

September 14, 2020

Primary Completion

March 14, 2021

Study Completion

March 14, 2021

Last Updated

January 27, 2026

Results First Posted

January 27, 2026

Record last verified: 2021-05

Locations