Breast CancerGIVENCT02785887
Impact of Geriatrician Interventions on Chemotherapy Delivery in Vulnerable Elderly Oncology Patients
A study testing Geriatrician review in people with Breast Cancer and Lung Cancer, run by Azienda USL 4 Prato at 3 sites in Italy.
Trial summary
This is a randomized parallel group trial designed to evaluate the impact of implementing geriatrician-prescribed interventions based on the comprehensive geriatric assessment (CGA), on the ability to deliver adequate chemotherapy treatment, as measured by relative dose intensity (RDI). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Ovarian Cancer
- What is being tested?
- Geriatrician review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Aug 2014to 25 Sep 2018
- 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
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Any solid tumors
- Either early stage disease planned for treatment with neo/adjuvant chemotherapy, or metastatic disease planned for treatment with chemotherapy and ≤ 1 previous chemotherapy treatment in the metastatic setting
- Absence of symptomatic central nervous system (CNS) metastases
- Eastern Cooperative Oncology group (ECOG) performance status 0-2
- Estimated life expectancy of ≥ 12 weeks
- At least 1 deficit identified on CGA at screening/baseline, and/or at least one comorbidity of grade 3 or 4 severity, as defined by CIRS-G
- Written informed consent in according to International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use/Good Clinical Practice (ICH/GCP), and national/local ethics regulations
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up schedule
Who cannot join
- Age ≤ 69 years
- Any patients who did not meet the inclusion criteria
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ospedale Vito Fazi
Lecce, 73100
Ospedale San Paolo
Milan, 20142
Istituto Oncologico Veneto
Padova, 35128
About this study
Official title: Impact of Geriatrician-implemented Interventions on Chemotherapy Delivery in Vulnerable Elderly Patients With Early or Metastatic Solid Malignancies: the GIVE Trial
This is a randomized parallel group trial designed to evaluate the impact of implementing geriatrician-prescribed interventions based on the comprehensive geriatric assessment (CGA), on the ability to deliver adequate chemotherapy treatment, as measured by relative dose intensity (RDI).
Read the detailed description
This randomized parallel group trial is designed to evaluate the impact of implementing geriatrician-prescribed interventions, on the ability to deliver adequate chemotherapy treatment, as measured by RDI of at least 85%, in a cohort of vulnerable [≥1 deficit identified at CGA and/or ≥1 comorbidity Grade 3-4 as defined by Cumulative Illness Rating Scale for Geriatrics (CIRS-G)] elderly cancer patients with early stage or advanced solid organ malignancies.
Patients will be randomized using a 2:1 allocation to Arm A: routine oncological care plus geriatric intervention or Arm B: routine oncological care
- Conditions
- Breast Cancer, Lung Cancer, Ovarian Cancer, Prostate Cancer, Bladder Cancer, Gastrointestinal Cancer
- Being tested
- Geriatrician review
- Keywords
- Breast cancer, lung cancer, Gastrointestinal Cancer, Ovarian cancer, Prostate cancer, bladder cancer
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Urinary Bladder Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatrician reviewOther
In addition to routine oncological care, patients will be reviewed by a geriatrician and may receive intervention if CGA deficits are found
| Study group | Role | What they receive |
|---|---|---|
| Oncological and geriatrician review | Experimental | Routine oncological care plus geriatric intervention Receives: Other: Geriatrician review |
| Oncological care | No intervention | Routine oncological care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative dose intensity
Relative dose intensity (RDI) is defined as the ratio (in percentage) of the total administered dose of chemotherapy to the standard dose of the same chemotherapy regimen, as defined by the treating centre. RDI will be calculated as the total dose delivered from the first day of cycle 1 of chemotherapy until completion of the planned chemotherapy (average of 6 months for early, 3 months for metastatic disease), or until date of relapse or death or discontinuation from any cause, whichever occurs first.
Measured: 6 months
Secondary outcomes (3)
Occurrence of treatment-related toxicity
Severity will be reported based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: every 3-4 weeks up to 6 months
Occurrence of hospitalization
Documentation of hospitalization
Measured: at 6 months for early and at 3 months for metastatic disease
Early mortality
Documentation of death
Measured: death from any cause occurring 12 months of randomization for neo/adjuvant patients, or within 6 months for patients with metastatic disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study start1 Aug 2014
- Primary completion25 Sep 2018
- Study completion25 Sep 2018
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL 4 Prato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Biganzoli, Azienda USL 4 Prato
- Investigators
- Laura Biganzoli, MD, Principal investigator, Azienda USL 4 Prato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785887
- Sponsor's protocol ID
- GIVE
- Acronym
- GIVE
- Status last verified
- Feb 2019
- First submitted
- 26 Mar 2014
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Geriatrician-implemented Interventions on Chemotherapy Delivery in Vulnerable Elderly Patients With Early or Metastatic Solid Malignancies: the GIVE Trial
- ClinicalTrials.gov ID
- NCT02785887
- Acronym / sponsor ID
- GIVE / GIVE
- Conditions
- Breast Cancer, Lung Cancer, Ovarian Cancer, Prostate Cancer, Bladder Cancer, Gastrointestinal Cancer
- Keywords
- Breast cancer, lung cancer, Gastrointestinal Cancer, Ovarian cancer, Prostate cancer, bladder cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Azienda USL 4 PratoUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 30 May 2016 (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.
This is a randomized parallel group trial designed to evaluate the impact of implementing geriatrician-prescribed interventions based on the comprehensive geriatric assessment (CGA), on the ability to deliver adequate chemotherapy treatment, as measured by relative dose intensity (RDI).
Detailed description
This randomized parallel group trial is designed to evaluate the impact of implementing geriatrician-prescribed interventions, on the ability to deliver adequate chemotherapy treatment, as measured by RDI of at least 85%, in a cohort of vulnerable [≥1 deficit identified at CGA and/or ≥1 comorbidity Grade 3-4 as defined by Cumulative Illness Rating Scale for Geriatrics (CIRS-G)] elderly cancer patients with early stage or advanced solid organ malignancies.
Patients will be randomized using a 2:1 allocation to Arm A: routine oncological care plus geriatric intervention or Arm B: routine oncological care
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oncological and geriatrician review | Experimental | Other: Geriatrician reviewRoutine oncological care plus geriatric intervention |
| Oncological care | No intervention | –Routine oncological care only |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Any solid tumors
- Either early stage disease planned for treatment with neo/adjuvant chemotherapy, or metastatic disease planned for treatment with chemotherapy and ≤ 1 previous chemotherapy treatment in the metastatic setting
- Absence of symptomatic central nervous system (CNS) metastases
- Eastern Cooperative Oncology group (ECOG) performance status 0-2
- Estimated life expectancy of ≥ 12 weeks
Key exclusion criteria (2 listed)
- Age ≤ 69 years
- Any patients who did not meet the inclusion criteria
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 |
|---|---|---|
| Geriatrician reviewIn addition to routine oncological care, patients will be reviewed by a geriatrician and may receive intervention if CGA deficits are found | Other | Oncological and geriatrician review |
Primary outcome
Relative dose intensity
Time frame: 6 months
Relative dose intensity (RDI) is defined as the ratio (in percentage) of the total administered dose of chemotherapy to the standard dose of the same chemotherapy regimen, as defined by the treating centre. RDI will be calculated as the total dose delivered from the first day of cycle 1 of chemotherapy until completion of the planned chemotherapy (average of 6 months for early, 3 months for metastatic disease), or until date of relapse or death or discontinuation from any cause, whichever occurs first.
3 secondary outcomes
Occurrence of treatment-related toxicity
Time frame: every 3-4 weeks up to 6 months
Occurrence of hospitalization
Time frame: at 6 months for early and at 3 months for metastatic disease
Early mortality
Time frame: death from any cause occurring 12 months of randomization for neo/adjuvant patients, or within 6 months for patients with metastatic disease
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 15 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Laura Biganzoli, MD principal investigator
Azienda USL 4 Prato
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatrician review in people with Breast Cancer and Lung Cancer, run by Azienda USL 4 Prato at 3 sites in Italy.
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 8 inclusion and 2 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
Relative dose intensity (time frame: 6 months). 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 15 Feb 2019; AzTrials last refreshed its copy on 8 Nov 2026.