Program to enhance quality of life for breast cancer survivors through physical activity and nutrition
Evaluating Effectiveness of an Integrative Intervention Based on Physical Activity, Nutrition and Supportive Care to Improve Quality of Life of Breast Cancer Survivors: Protocol for a Pragmatic Cluster Randomized Trial and Embedded Qualitative Study
NA · Siel Bleu · NCT05658341
This study is testing a program that helps women who have survived breast cancer improve their quality of life through personalized exercise and nutrition support.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 72 Years |
| Sex | Female |
| Sponsor | Siel Bleu (other) |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (La Rochelle, Charentes-maritimes and 7 other locations) |
| Trial ID | NCT05658341 on ClinicalTrials.gov |
What this trial studies
This program focuses on improving the quality of life for women who have survived breast cancer by integrating adapted physical activity and nutritional support. It aims to address the long-term effects of cancer treatment that often diminish the well-being of survivors. The intervention is designed to be pragmatic, evaluating its effectiveness in real-life conditions to encourage adherence to healthy lifestyle behaviors. Participants will receive tailored support to help them engage in regular exercise and maintain a healthy diet.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18 to 72 who have completed treatment for localized breast cancer within the last 15 months and are French-speaking.
Not a fit: Patients with other cancer diagnoses, significant medical contraindications to exercise, or those experiencing a relapse of breast cancer may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly enhance the quality of life for breast cancer survivors by promoting healthier lifestyles.
How similar studies have performed: Previous studies have shown positive outcomes with similar interventions focusing on physical activity and nutrition for cancer survivors, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
La Rochelle, Charentes-maritimes and 7 other locations
- La Rochelle — La Rochelle, Charentes-maritimes, France (RECRUITING)
- Saint Brieuc — Saint-Brieuc, Cotes d'Armor, France (RECRUITING)
- Arpajon — Arpajon, Essonne, France (RECRUITING)
- Brest — Brest, Finistere, France (RECRUITING)
- Blagnac — Blagnac, Haute Garonne, France (RECRUITING)
- Angers — Angers, Maine Et Loire, France (ACTIVE_NOT_RECRUITING)
- Pyrénées Atlantiques — Saint-Pée-sur-Nivelle, Pyrénées Atlantiques, France (SUSPENDED)
- La Roche sur Yon — La Roche-sur-Yon, Vendée, France (RECRUITING)
Study contacts
- Principal investigator: Gwenn Menvielle, PhD — Institut National de la Santé Et de la Recherche Médicale, France
- Study coordinator: Nicolas Deschamps
- Email: nicolas.deschamps@sielbleu.org
- Phone: 0033607129986
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Quality of Life, Breast Cancer, Adapted physical activity, Breast cancer survivors