Breast CancerPROACTIVENCT02216162
PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program
A study testing Arm A: adapted physical activity + enhanced geriatric follow-up in people with Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Arm A: adapted physical activity + enhanced geriatric follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2014to 4 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Breast Cancer
- Being tested
- Arm A: adapted physical activity + enhanced geriatric follow-up, No intervention
- Keywords
- oncogeriatrics, adjuvant endocrine therapy, compliance, elderly, Taï Chi, Physical training
- Medical subject headings
- Breast Neoplasms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm A: adapted physical activity + enhanced geriatric follow-upOther
Patients have 3-monthly geriatric follow-up with biological tests, anti-aromatase agents blood dosing and a clinical assessment (M3 to M9, M15 to M22 and M27 to M33). Musculoskeletal adverse events and quality of life level will be reported and analgesic treatment adapted. Patients will be proposed weekly Taï-Chi exercises to improve joint flexibility, muscular tonus and balance and reduce fall risk.
A broader geriatric assessment including functionality, gait analysis and nutrition will be performed each year (M12, M24 and M36).
No interventionOther
Usual clinical follow-up
| Study group | Role | What they receive |
|---|---|---|
| A: Interventional adapted physical activity + enhanced geriatr | Experimental | Geriatric (functionality, gait, nutrition) follow-up, biological tests, anti-aromatase agents blood dosing, clinical assessment. Weekly Taï-Chi exercises. Receives: Other: Arm A: adapted physical activity + enhanced geriatric follow-up |
| Arm B: control | Other | Clinical follow-up according to the Guidelines, annual geriatric and nutritional assessment Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance of an adjuvant hormonal therapy
Compliance rate is defined as the rate of blood samplings of anti-hormone metabolites in the therapeutic range, within the 7 blood samplings distributed in the 3 years of follow-up
Measured: 3 years of follow up
Secondary outcomes (5)
Intensity and duration of musculoskeletal adverse events
Musculoskeletal adverse events will be graded using NCI CTC version 4.0
Measured: 3 years of follow up
Activities of daily living, functional walking capacity and changes in balance
Measured: 3 years of follow up
Quality of life
Using the Functional Assessment of Cancer Therapy General (FACT-G7) questionnaire
Measured: 3 years of follow up
Nutritional status
Using Mini Nutritional Assessment, weight, weight loss, albuminemia
Measured: 3 years of follow up
Analgesics consumption
issued from the exhaustive list of documented concomitant medications
Measured: 3 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study start11 Apr 2014
- Primary completionFeb 2019
- Study completion4 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Falandry, MD-PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216162
- Sponsor's protocol ID
- 2012-777
- Acronym
- PROACTIVE
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2014
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02216162
- Acronym / sponsor ID
- PROACTIVE / 2012-777
- Conditions
- Breast Cancer
- Keywords
- oncogeriatrics, adjuvant endocrine therapy, compliance, elderly, Taï Chi, Physical training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Apr 2014 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Interventional adapted physical activity + enhanced geriatr | Experimental | Other: Arm A: adapted physical activity + enhanced geriatric follow-upGeriatric (functionality, gait, nutrition) follow-up, biological tests, anti-aromatase agents blood dosing, clinical assessment. Weekly Taï-Chi exercises. |
| Arm B: control | Other | Other: No interventionClinical follow-up according to the Guidelines, annual geriatric and nutritional assessment |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm A: adapted physical activity + enhanced geriatric follow-upPatients have 3-monthly geriatric follow-up with biological tests, anti-aromatase agents blood dosing and a clinical assessment (M3 to M9, M15 to M22 and M27 to M33). Musculoskeletal adverse events and quality of life level will be reported and analgesic treatment adapted. Patients will be proposed weekly Taï-Chi exercises to improve joint flexibility, muscular tonus and balance and reduce fall risk. A broader geriatric assessment including functionality, gait analysis and nutrition will be performed each year (M12, M24 and M36). | Other | A: Interventional adapted physical activity + enhanced geriatr |
| No interventionUsual clinical follow-up | Other | Arm B: control |
Primary outcome
Compliance of an adjuvant hormonal therapy
Time frame: 3 years of follow up
Compliance rate is defined as the rate of blood samplings of anti-hormone metabolites in the therapeutic range, within the 7 blood samplings distributed in the 3 years of follow-up
5 secondary outcomes
Intensity and duration of musculoskeletal adverse events
Time frame: 3 years of follow up
Activities of daily living, functional walking capacity and changes in balance
Time frame: 3 years of follow up
Quality of life
Time frame: 3 years of follow up
Nutritional status
Time frame: 3 years of follow up
Analgesics consumption
Time frame: 3 years of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Falandry, MD-PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm A: adapted physical activity + enhanced geriatric follow-up in people with Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance of an adjuvant hormonal therapy (time frame: 3 years of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.