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NCT Number: 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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fatigue Gastric Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Ovarian Adenocarcinoma Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Antoine Lacassagne

Nice, 06100, France

Location contact

Ludovic EVESQUE, doctor

CONTACT

[email protected]

+33 492 03 16 22

Ludovic EVESQUE, doctor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

APA Program

Other

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

Primary outcomes

  1. 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

    Assessing adherence to the adapted physical activity (APA) program for patients participating in an APA program

  2. 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

    Compare the evolution of fatigue at 3 months in patients who have completed adjuvant systemic chemotherapy for cancer and are participating in an APA program.

    Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). Total score calculated for 5 subscales: general fatigue (items 1, 5, 12, 16), physical fatigue (items 2, 8, 14, 20), reduced activity (items 7, 11, 13, 19), reduced motivation (items 3, 6, 10, 17), and mental fatigue (items 4, 9, 15, 18)." High MFI scores indicate a high degree of fatigue.

Secondary outcomes

  1. evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0;100]

    Time frame: 3 months

    Compare changes in patients' quality of life following the APA program versus standard follow-up.

    QLQ-C30 contains 30 items that assess 15 dimensions of quality of life: 5 functional dimensions (physical functioning, role, cognitive, emotional, and social), one dimension of overall quality of life/health, and 8 symptom dimensions (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea) as well as a dimension corresponding to the level of financial difficulties. A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). These scores are standardized from 0 to 100 so that a high score reflects a high level of overall quality of life/health, a high functional level, and a high symptomatic level.

  2. evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100]

    Time frame: 6 months

    Compare changes in patients' quality of life following the APA program versus standard follow-up. QLQ-C30 contains 30 items that assess 15 dimensions of quality of life: 5 functional dimensions (physical functioning, role, cognitive, emotional, and social), one dimension of overall quality of life/health, and 8 symptom dimensions (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea) as well as a dimension corresponding to the level of financial difficulties. A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). These scores are standardized from 0 to 100 so that a high score reflects a high level of overall quality of life/health, a high functional level, and a high symptomatic level.

  3. evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100]

    Time frame: 12 months

    Compare changes in patients' quality of life following the APA program versus standard follow-up.

    QLQ-C30 contains 30 items that assess 15 dimensions of quality of life: 5 functional dimensions (physical functioning, role, cognitive, emotional, and social), one dimension of overall quality of life/health, and 8 symptom dimensions (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea) as well as a dimension corresponding to the level of financial difficulties. A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). These scores are standardized from 0 to 100 so that a high score reflects a high level of overall quality of life/health, a high functional level, and a high symptomatic level.

  4. Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126]

    Time frame: 3 months

    Compare the motivation for physical activity among patients following the APA program compared to standard follow-up.

    The EMAPS questionnaire comprise six motivational concepts highlighted by self-determination theory (intrinsic, integrated, identified, introjected, and external motivation). A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension).

  5. Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126]

    Time frame: 6 months

    Compare the motivation for physical activity among patients following the APA program compared to standard follow-up.

    The EMAPS questionnaire comprise six motivational concepts highlighted by self-determination theory (intrinsic, integrated, identified, introjected, and external motivation). A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension).

  6. Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126]

    Time frame: 12 months

    Compare the motivation for physical activity among patients following the APA program compared to standard follow-up.

    The EMAPS questionnaire comprise six motivational concepts highlighted by self-determination theory (intrinsic, integrated, identified, introjected, and external motivation). A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension).

  7. 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 difference in MFI-20 fatigue scores between the first visit and the visits at 6 months.

    Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). Total score calculated for 5 subscales: general fatigue (items 1, 5, 12, 16), physical fatigue (items 2, 8, 14, 20), reduced activity (items 7, 11, 13, 19), reduced motivation (items 3, 6, 10, 17), and mental fatigue (items 4, 9, 15, 18)." High MFI scores indicate a high degree of fatigue.

  8. 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

    Compare the difference in MFI-20 fatigue scores between the first visit and the visits at 12 months.

    Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). Total score calculated for 5 subscales: general fatigue (items 1, 5, 12, 16), physical fatigue (items 2, 8, 14, 20), reduced activity (items 7, 11, 13, 19), reduced motivation (items 3, 6, 10, 17), and mental fatigue (items 4, 9, 15, 18)." High MFI scores indicate a high degree of fatigue.

Study contacts

Contact information is provided by the study sponsor or research team.

Ludovic EVESQUE, Doctor

CONTACT

[email protected]

+33 492 03 16 22

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Collaborators

  • Centre Hospitalier Universitaire de Nice

Registry information

Acronym: WATCH AND ACT

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Feb 24, 2026
Registry last updated
Feb 24, 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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