Clinical trial · Interventional
PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program
PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program Including a Regular Physical Training, a Medical and Nutritional Follow-up, on Adjuvant Hormonal Treatment Compliance in Breast Cancer Patients Over 70 Years.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
PROACTIVE randomized study to evaluate the impact of a multidimensional geriatric intervention on treatment compliance, measured regularly by blood dosing of drug metabolites. Patients in the intervention group will be proposed: * A regular geriatric follow up including an attentive screening of joint symptoms and functionality, * An adapted treatment of join pain, * Weekly sessions of adapted physical activity (Taï Chi), * And a systematic correction of vitamin D deficits.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm A: adapted physical activity + enhanced geriatric follow-up | Other | — | UNRESOLVED |
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A: Interventional adapted physical activity + enhanced geriatr
- description
- Geriatric (functionality, gait, nutrition) follow-up, biological tests, anti-aromatase agents blood dosing, clinical assessment. Weekly Taï-Chi exercises.
- interventionNames
- Other: Arm A: adapted physical activity + enhanced geriatric follow-up
- type
- OTHER
- label
- Arm B: control
- description
- Clinical follow-up according to the Guidelines, annual geriatric and nutritional assessment
- interventionNames
- Other: No intervention
Primary outcomes (1)
- measure
- Compliance of an adjuvant hormonal therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 70 years old * Non metastatic breast cancer, with or without node metastases * Hormone Receptor (HR) positive breast cancer patients * Women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery or radiotherapy * Introduce an hormonal therapy during 5 years * Life expectancy \> 6 months (at the discretion of the investigator) * Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research * Patient must be available for follow-up * Having given written informed consent prior to any procedure related to the study Exclusion Criteria: * No other primary malignant tumor \< 5-years old except cured in situ cancer of the cervix, in situ urothelial cancer, or basocellular cancer * Patient with an experimental treatment in the 30 days prior to the enrollment * Evidence of metastatic disease * Not under any administrative or legal supervision
References
Publications (0)
Data not yet available