Trials
Search / Trial NCT05658341

Program of Physical Activity, Nutrition and Supportive to Improve the Quality of Life of Breast Cancer Survivors

Launched by SIEL BLEU · Dec 16, 2022

Trial Information

Current as of January 21, 2025

Recruiting

Keywords

Adapted Physical Activity Breast Cancer Survivors

ClinConnect Summary

This clinical trial is studying a program called ADA (Activité physique adaptée Doublée d'un Accompagnement spécifique post-cancer), which combines physical activity, nutrition, and supportive care to help improve the quality of life for women who have survived breast cancer. The trial aims to find out if this program can make a positive difference in the physical and mental health of participants over the course of a year. Researchers will compare the results of women participating in the ADA program with those receiving standard care to see how effective the program is in the real world.

To participate in the trial, women must be between 18 and 72 years old, have been diagnosed with localized breast cancer, and completed their treatment within the last 15 months. They should be French-speaking and covered by a health insurance system. Participants can expect to join a group setting where they will engage in physical activities and receive support to adopt healthier lifestyles. It’s important to note that women with other types of cancer, those experiencing a cancer relapse, or those with certain medical conditions that prevent them from exercising are not eligible to join. This trial is not only about improving health but also aims to provide valuable insights into how to help many breast cancer survivors lead healthier lives.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • adult women who are between 18 and 72 years of age
  • had a diagnosis of localized breast cancer of any type, and who have completed their treatment (surgery, chemotherapy, radiotherapy) within the last 15 months, or still undergoing hormone therapy or nearing the end of their Herceptin treatment.
  • French-speaking
  • covered by the French Social Security system or benefiting from a similar health insurance system
  • Exclusion Criteria:
  • A cancer diagnosis other than breast cancer, or a relapse/metastasis of breast cancer, or generalized cancer,
  • A medical contraindication to exercise (a medical certificate of absence of contraindication to the practice of physical activity will be required, as for all physical activity in community settings).
  • Significant visual or auditory problems or behavioral problems that make it difficult to participate in group physical activity sessions.
  • a plan of moving away from the study site.
  • participating in another clinical trial
  • Male sex

Trial Officials

Gwenn Menvielle, PhD

Principal Investigator

Institut National de la Santé Et de la Recherche Médicale, France

Patricia Dargent, PhD

Principal Investigator

Institut National de la Santé Et de la Recherche Médicale, France

Fabienne El Khoury, PhD

Study Chair

Institut National de la Santé Et de la Recherche Médicale, France

About Siel Bleu

Siel Bleu is a leading organization dedicated to enhancing the quality of life for individuals through innovative therapeutic interventions and tailored physical activity programs. As a clinical trial sponsor, Siel Bleu focuses on promoting health and well-being among diverse populations, including seniors and individuals with chronic conditions. With a commitment to evidence-based practices, Siel Bleu collaborates with healthcare professionals and researchers to develop and implement clinical trials that explore the efficacy of physical activity in improving health outcomes. Their mission emphasizes inclusivity and accessibility, ensuring that effective solutions reach those in need, ultimately contributing to healthier communities.

Locations

Marseille, Bouches Du Rhon, France

La Rochelle, Charentes Maritimes, France

Dijon, Cote D'or, France

Brest, Finistere, France

Laval, Mayenne, France

Lille, Nord, France

Creil, Oise, France

Lyon, Rhone, France

La Roche Sur Yon, Vendée, France

Sens, Yonne, France

Saint Brieuc, Cotes D'armor, France

Laval, Mayenne, France

Lorient, Morbihan, France

Nevers, Nièvre, France

Saint Quentin, Aisne, France

Arras, Pas De Calais, France

Amiens, Somme, France

Arpajon, Essonne, France

Blagnac, Haute Garonne, France

Saint Pée Sur Nivelle, Pyrénées Atlantiques, France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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