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Completed

NCT Number: NCT04675814

Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de Cancérologie de L'Ouest

Angers, 49055, France

About this study

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.

A 12-week Adapted Physical Activity program (APA) is proposed to patients included in the study with an assessment of fatigue, quality of life, level of physical activity and kinesiophobia (fear of movement) at the beginning of the study.

A second assessment of fatigue and quality of life will be done during the 6-week management.

At the end of the program, a final evaluation of fatigue, quality of life and kinesiophobia will be done.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Adapted Physical Activity (APA)

Other

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

Primary outcomes

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

    Time frame: 12 weeks

    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

    • - A little
    • - Moderately
    • - Quite a bit
    • - 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.

Secondary outcomes

  1. Describe Attendance at the APA Program.

    Time frame: 12 weeks

    The number of sessions is planned by the APA coach at the beginning of the APA program. The number of performed sessions is measured.

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

    Time frame: 12 weeks

    Kinesiophobia is measured with the TAMPA Scale for Kinesiophobia (TSK-CF). This scale assesses the kinesiophobia index presented by the patient at the time of the assessment. The higher the score, the greater the level of kinesiophobia. Total score range: 17 to 68. Higher scores indicate greater fear of movement.

    A score ≥ 40 is considered significant kinesiophobia.

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

    Time frame: Week 0

    The level of physical activity (PA) is assessed using the GPAQ questionnaire. The questionnaire consists of 16 items. Physical activity is expressed in MET-minutes per week (Metabolic Equivalent of Task), calculated from reported activity.

    Based on the score, three profiles are defined:

    High

    • ≥3 days vigorous activity (≥1500 MET-min/week) OR
    • ≥7 days walking/moderate/vigorous PA (≥3000 MET-min/week) Moderate
    • ≥20 min vigorous PA / day, ≥3 days/week OR
    • ≥30 min moderate PA/walking / day, ≥5 days/week OR
    • ≥5 days mixed activity (≥600 MET-min/week) Low
    • Does not meet above criteria

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA) at Institut de Cancerologie de l'Ouest (ICO)

Acronym: APA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2020
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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