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Not yet recruiting NCT07429487

Assessment of Adherence to Remotely Monitored Physical Activity Tracked on a Smartwatch, and Its Impact on Reducing Fatigue 3 Months After Adjuvant Chemotherapy for Cancer

No phase Interventional Breast Cancer Colorectal Cancer Ovarian Adenocarcinoma Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APA program.
Who it may be relevant to
Registry conditions: Breast Cancer, Colorectal Cancer, Ovarian Adenocarcinoma, Pancreatic Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

A single-center, randomized (1:1) open-label, prospective, stratified study with two parallel arms, designed to evaluate adherence to the adapted physical activity (APA) program for patients participating in an APA program and to compare changes in fatigue at 3 months in patients who have completed adjuvant systemic chemotherapy for cancer and are participating in an APA program.

Interventions

  • Other APA program
    patient will benefit of an activity monitored by a wtach and an APA program during 3 months

Primary outcome measures

  • adherence to the adapted physical activity (APA) program by the percentage of patients who completed 75% of the weekly sessions of the APA program with a heart rate (HR) between 40 and 60% of their reserve HR for 20-40 minutes. [Time frame: 3 months]
  • evolution of fatigue in patients who are participating in an APA program by the difference in Multidimensional Fatigue Inventory (MFI-20) questionnaire scores (20 items) between the first and last visit at 3 months. [Time frame: 3 months]
Secondary outcome measures (8)
  • evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0;100] [Time frame: 3 months]
  • evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100] [Time frame: 6 months]
  • evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100] [Time frame: 12 months]
  • Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126] [Time frame: 3 months]
  • Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126] [Time frame: 6 months]
  • Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126] [Time frame: 12 months]
  • Compare the evolution of fatigue with MFI-20 questionnaire scores (20 items) between the first and last visit at 6 months, in patients who followed the APA program versus standard follow-up [Time frame: 6 months]
  • Compare the evolution of fatigue with MFI-20 questionnaire scores (20 items) between the first and last visit at 12 months, in patients who followed the APA program versus standard follow-up [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Patients aged 18 to 75 years old,
  • Histologically proven non-metastatic adenocarcinoma of breast, colorectal, ovarian, pancreatic, biliary, or gastric origin,
  • Adjuvant chemotherapy completed less than 3 months ago (excluding hormone therapy),
  • PS 0 or 1 according to the World Health Organization (WHO) scale,
  • No recurrence since the end of adjuvant chemotherapy,
  • Patient who has voluntarily agreed to participate in the study and sign the written informed consent form,
  • Patient affiliated with a Social Security scheme.

Exclusion criteria

  • New cancer treatment planned (excluding hormone therapy),
  • Patient who has received adjuvant immunotherapy,
  • Cardiological contraindication to the program
  • Decompensated or unstable chronic conditions
  • Severe malnutrition
  • Rheumatological unfitness as determined by the oncologist,
  • Chronic respiratory failure requiring long-term O2 therapy
  • Diabetes with plantar ulceration
  • Progressive or chronic non-healing bedsore/wound
  • Recent unhealed fracture
  • Patient participating in another interventional clinical study at the time of signing the informed consent form.
  • Vulnerable persons as defined in Articles L1121-5 to -8

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Centre Antoine Lacassagne — Nice

Identifiers

NCT: NCT07429487 · 2024/71 · 2025-A01857-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗