Hematologic MalignancyNCT02359838
Patient-Centered Care for the Older Adult With Hematologic Malignancy
A study testing Baseline Geriatric Screening/Assessment and Geriatrician Co-Management in people with Hematologic Malignancy, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is evaluating if co-management by a geriatrician embedded in the oncology clinic can improve outcomes for frail older adults with blood cancers. A rigorous pre-entry frailty assessment by a trained research assistant will be followed by randomization to geriatrician co-management versus usual care… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Baseline Geriatric Screening/Assessment and Geriatrician Co-Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2015to 1 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All patients aged 75 and older who present for an initial consultation at the Dana-Farber/Brigham and Women's Cancer Center for hematologic malignancy (transplantation consultation excluded).
- Assessed to be pre-frail or frail on formal baseline geriatric assessment.
Who cannot join
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
This research study is evaluating if co-management by a geriatrician embedded in the oncology clinic can improve outcomes for frail older adults with blood cancers. A rigorous pre-entry frailty assessment by a trained research assistant will be followed by randomization to geriatrician co-management versus usual care for patients found to be frail or pre-frail.
Read the detailed description
Older adults have unique health concerns, and in particular, older adults with blood cancers may have different disease and other health related issues than younger adults with similar diagnoses. One aspect of aging which can make older adults more vulnerable is frailty. Frailty is a general term that describes a decline in multiple areas of health, including the loss of energy, physical ability, and mental ability. Frailty can make it difficult for patients with cancer to respond to treatment and more likely to have side effects. On the other hand, many older patients are not frail despite advanced age. This study is being done to determine if co-management by a geriatrician of older adults who are found to be frail through a detailed baseline assessment can improve outcomes.
- Conditions
- Hematologic Malignancy
- Being tested
- Baseline Geriatric Screening/Assessment, Geriatrician Co-Management
- Keywords
- Hematologic Malignancy, Geriatric Assessment, Geriatric Oncology, Frailty
- Medical subject headings
- Hematologic Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline Geriatric Screening/AssessmentOther
All patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status.
Geriatrician Co-ManagementOther
A board-certified geriatrician embedded in the oncology clinic will co-manage patients randomized to this arm.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Other | Frail/pre-frail hematologic oncology patients receive usual care Receives: Other: Baseline Geriatric Screening/Assessment |
| Geriatrician Co-Management | Active comparator | Frail/pre-frail hematologic oncology patients receive co-management by a geriatrician Receives: Other: Baseline Geriatric Screening/Assessment; Other: Geriatrician Co-Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall Survival at one year
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study start1 Feb 2015
- Primary completion1 May 2018
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory A. Abel, MD, Dana-Farber Cancer Institute
- Investigators
- Gregory A. Abel, MD, MPH, Principal investigator, Dana Faber Cancer InstituteJane A Driver, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359838
- Sponsor's protocol ID
- 14-515
- Status last verified
- Mar 2022
- First submitted
- 2 Feb 2015
- Last updated
- 19 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Care for the Older Adult With Hematologic Malignancy
- ClinicalTrials.gov ID
- NCT02359838
- Acronym / sponsor ID
- 14-515
- Conditions
- Hematologic Malignancy
- Keywords
- Hematologic Malignancy, Geriatric Assessment, Geriatric Oncology, Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Posted 19 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating if co-management by a geriatrician embedded in the oncology clinic can improve outcomes for frail older adults with blood cancers. A rigorous pre-entry frailty assessment by a trained research assistant will be followed by randomization to geriatrician co-management versus usual care for patients found to be frail or pre-frail.
Detailed description
Older adults have unique health concerns, and in particular, older adults with blood cancers may have different disease and other health related issues than younger adults with similar diagnoses. One aspect of aging which can make older adults more vulnerable is frailty. Frailty is a general term that describes a decline in multiple areas of health, including the loss of energy, physical ability, and mental ability. Frailty can make it difficult for patients with cancer to respond to treatment and more likely to have side effects. On the other hand, many older patients are not frail despite advanced age. This study is being done to determine if co-management by a geriatrician of older adults who are found to be frail through a detailed baseline assessment can improve outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Other | Other: Baseline Geriatric Screening/AssessmentFrail/pre-frail hematologic oncology patients receive usual care |
| Geriatrician Co-Management | Active comparator | Other: Baseline Geriatric Screening/Assessment, Other: Geriatrician Co-ManagementFrail/pre-frail hematologic oncology patients receive co-management by a geriatrician |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- All patients aged 75 and older who present for an initial consultation at the Dana-Farber/Brigham and Women's Cancer Center for hematologic malignancy (transplantation consultation excluded).
- Assessed to be pre-frail or frail on formal baseline geriatric assessment.
Key exclusion criteria (1 listed)
- Not willing to participate
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 |
|---|---|---|
| Baseline Geriatric Screening/AssessmentAll patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status. | Other | Geriatrician Co-Management, Usual Care |
| Geriatrician Co-ManagementA board-certified geriatrician embedded in the oncology clinic will co-manage patients randomized to this arm. | Other | Geriatrician Co-Management |
Primary outcome
Overall Survival
Time frame: One year
Overall Survival at one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Randomized controlled trial of geriatric consultation versus standard care in older adults with hematologic malignanciesLink provided by the sponsor.
Related trials for Hematologic Malignancy
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
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.
Gregory A. Abel, MD, MPH principal investigator
Dana Faber Cancer Institute
Jane A Driver, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline Geriatric Screening/Assessment and Geriatrician Co-Management in people with Hematologic Malignancy, run by Dana-Farber Cancer Institute at 1 site in United States.
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 2 inclusion and 1 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 19 Jul 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (time frame: One year). 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 19 Jul 2022.