CancerNCT01915056
A Geriatric Assessment Intervention for Older Cancer Patients Receiving Chemotherapy
A study testing GA-driven Intervention in people with Cancer, run by University of Rochester at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether information regarding GA and GA-driven interventions improves outcomes in older cancer patients receiving first-line or second-line chemotherapy by comparing rates of chemotherapy toxicity, hospitalizations, dose delays and early termination of treatment in patients… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- GA-driven Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2013to Jan 2016
- 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
- Have a diagnosis of solid tumor malignancy or lymphoma
- Have advanced cancer
- Have received a recommendation for first or second line treatment with chemotherapy by their primary oncologist. Treatment regimens may include chemotherapy, chemoradiotherapy, targeted agents or monoclonal antibody.
- Planned chemotherapy for at least 3 months
- Be age 70 or older
- Have a live expectancy with treatment of 6 months or greater
- Able to provide informed consent or, if the physician deems the patient to not have decision-making capacity, a patient-designated health care proxy (that was pre-existing; prior to the patient losing decision-making capacity) must sign consent per institutional (University of Rochester and Research Subject Review Board) policies on consent for incapacitated/decisionally impaired subjects164,165
- Able to read and understand English (or possess a designated health care proxy that can do the same that was designated prior to the patient losing decision-making capabilities)
Who cannot join
- Have surgery planned within 3 months of consent
- Have a planned referral to the geriatric oncology clinic within one month of treatment initiation
- Patients who do not have decision-making capacity (decisionally or cognitively impaired) AND do NOT have a previously designated health care proxy (established prior to their cognitive impairment) available to sign consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Highland Hospital
Rochester, New York, 14620
Pluta Cancer Center
Rochester, New York, 14623
University of Rochester Wilmot Cancer Center
Rochester, New York, 14642
About this study
Official title: A Pilot Study of a Geriatric Assessment Intervention for Older Cancer Patients Receiving Chemotherapy
The purpose of this study is to determine whether information regarding GA and GA-driven interventions improves outcomes in older cancer patients receiving first-line or second-line chemotherapy by comparing rates of chemotherapy toxicity, hospitalizations, dose delays and early termination of treatment in patients with and without GA-driven interventions. The investigators will identify information that will be useful based on questionnaire responses and blood tests. These results will be used to better understand which recommendations and interventions will benefit older cancer patients. It is our hope that these tools, which are well-established at identifying areas of risk, will provide meaningful opportunities for intervention to promote your safety during cancer management. The investigators will be able to use this information to teach others on how to best care for adults aged 70 and older with cancer.
Read the detailed description
Although cancer is very common in older patients, the optimal treatment for cancer for this subset of patients is not well established. As a result of lack of knowledge on the safety and efficacy of chemotherapy in older adults, a significant proportion of older patients receiving chemotherapy have toxicity. There is also little information regarding how to best make decisions for and implement interventions to improve outcomes of older patients with cancer who are to receive treatment. Additionally, there is marked heterogeneity in the geriatric population, and patients of similar chronologic age may have wide disparity in their overall health status. Geriatricians utilize a tool called the Geriatric Assessment (GA) to gauge an older patient's overall health status and identify potential areas of deficits. The GA is a comprehensive tool, incorporating the assessment of physical function, co-morbid conditions, social support, nutritional, psychological, and cognitive status and medication review. A small number of studies in the oncology literature have demonstrated the value of GA in guiding cancer-directed treatment plans for older patients. GA can identify potential areas of deficits in an older patient's overall health status that have been shown to predict chemotherapy toxicity and guide interventions to improve outcomes for older patients. Studies of interventions in community-dwelling older adults have demonstrated efficacy at improving deficits identified on GA. However, in older patients with cancer, there is currently limited data regarding how GA can affect decision-making for treatment and impact overall clinical care.
In a two-arm, randomized pilot study, we will evaluate the effect of GA and GA-driven interventions on the outcomes of older cancer patients receiving first-line or second-line chemotherapy.
- Conditions
- Cancer
- Being tested
- GA-driven Intervention
- Keywords
- Comprehensive Geriatric Assessment (CGA), GA-driven interventions, Toxicity, Outcomes, providing information, older cancer patients, first-line chemotherapy, second-line chemotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GA-driven InterventionOther
For patients assigned to the treatment arm, individuals will be offered the option of completing the GA during a visit with their primary oncologist, or attending an additional visit at the multidisciplinary geriatric oncology clinic. The intervention consists of providing results of geriatric assessment in a summary to oncologists.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Control Arm = Standard of Care. Patients who are randomized to the control arm will only have abnormal results on Geriatric Depression Scale (GDS) and cognitive evaluation communicated to their primary oncologist, as is customary. These results will be communicated to the primary team via electronic medical record and/or email communication. No other summary will be provided to oncologist. |
| Treatment Arm | Experimental | Treatment Arm = Standard care plus GA results and recommendations. For patients assigned to the treatment arm, individuals will be offered the option of completing the GA during a visit with their primary oncologist, or attending an additional visit at the multidisciplinary geriatric oncology clinic (GA-driven intervention). The intervention consists of providing results of geriatric assessment in a summary to oncologists. Receives: Other: GA-driven Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy Toxicity
The primary outcome measure for this study is to determine if GA-driven interventions improve outcomes in older cancer patients receiving first-line or second-line chemotherapy by comparing rates of chemotherapy toxicity, hospitalizations, dose delays and early termination of treatment. The primary analysis will be a comparison of the proportion of patients who developed grade >3 toxicity over 3 months time using the likelihood ratio test.
Measured: Over 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supriya Mohile, University of Rochester
- Investigators
- Supriya Mohile, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915056
- Sponsor's protocol ID
- UCCO-13034
- Status last verified
- Apr 2018
- First submitted
- 23 Jul 2013
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Geriatric Assessment Intervention for Older Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT01915056
- Acronym / sponsor ID
- UCCO-13034
- Conditions
- Cancer
- Keywords
- Comprehensive Geriatric Assessment (CGA), GA-driven interventions, Toxicity, Outcomes, providing information, older cancer patients, first-line chemotherapy, second-line chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Aug 2013 (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.
The purpose of this study is to determine whether information regarding GA and GA-driven interventions improves outcomes in older cancer patients receiving first-line or second-line chemotherapy by comparing rates of chemotherapy toxicity, hospitalizations, dose delays and early termination of treatment in patients with and without GA-driven interventions. The investigators will identify information that will be useful based on questionnaire responses and blood tests. These results will be used to better understand which recommendations and interventions will benefit older cancer patients. It is our hope that these tools, which are well-established at identifying areas of risk, will provide meaningful opportunities for intervention to promote your safety during cancer management. The investigators will be able to use this information to teach others on how to best care for adults aged 70 and older with cancer.
Detailed description
Although cancer is very common in older patients, the optimal treatment for cancer for this subset of patients is not well established. As a result of lack of knowledge on the safety and efficacy of chemotherapy in older adults, a significant proportion of older patients receiving chemotherapy have toxicity. There is also little information regarding how to best make decisions for and implement interventions to improve outcomes of older patients with cancer who are to receive treatment. Additionally, there is marked heterogeneity in the geriatric population, and patients of similar chronologic age may have wide disparity in their overall health status. Geriatricians utilize a tool called the Geriatric Assessment (GA) to gauge an older patient's overall health status and identify potential areas of deficits. The GA is a comprehensive tool, incorporating the assessment of physical function, co-morbid conditions, social support, nutritional, psychological, and cognitive status and medication review. A small number of studies in the oncology literature have demonstrated the value of GA in guiding cancer-directed treatment plans for older patients. GA can identify potential areas of deficits in an older patient's overall health status that have been shown to predict chemotherapy toxicity and guide interventions to improve outcomes for older patients. Studies of interventions in community-dwelling older adults have demonstrated efficacy at improving deficits identified on GA. However, in older patients with cancer, there is currently limited data regarding how GA can affect decision-making for treatment and impact overall clinical care.
In a two-arm, randomized pilot study, we will evaluate the effect of GA and GA-driven interventions on the outcomes of older cancer patients receiving first-line or second-line chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Control Arm = Standard of Care. Patients who are randomized to the control arm will only have abnormal results on Geriatric Depression Scale (GDS) and cognitive evaluation communicated to their primary oncologist, as is customary. These results will be communicated to the primary team via electronic medical record and/or email communication. No other summary will be provided to oncologist. |
| Treatment Arm | Experimental | Other: GA-driven InterventionTreatment Arm = Standard care plus GA results and recommendations. For patients assigned to the treatment arm, individuals will be offered the option of completing the GA during a visit with their primary oncologist, or attending an additional visit at the multidisciplinary geriatric oncology clinic (GA-driven intervention). The intervention consists of providing results of geriatric assessment in a summary to oncologists. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Have a diagnosis of solid tumor malignancy or lymphoma
- Have advanced cancer
- Have received a recommendation for first or second line treatment with chemotherapy by their primary oncologist. Treatment regimens may include chemotherapy, chemoradiotherapy, targeted agents or monoclonal antibody.
- Planned chemotherapy for at least 3 months
- Be age 70 or older
Key exclusion criteria (3 listed)
- Have surgery planned within 3 months of consent
- Have a planned referral to the geriatric oncology clinic within one month of treatment initiation
- Patients who do not have decision-making capacity (decisionally or cognitively impaired) AND do NOT have a previously designated health care proxy (established prior to their cognitive impairment) available to sign consent
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 |
|---|---|---|
| GA-driven InterventionFor patients assigned to the treatment arm, individuals will be offered the option of completing the GA during a visit with their primary oncologist, or attending an additional visit at the multidisciplinary geriatric oncology clinic. The intervention consists of providing results of geriatric assessment in a summary to oncologists. | Other | Treatment Arm |
Primary outcome
Chemotherapy Toxicity
Time frame: Over 3 months
The primary outcome measure for this study is to determine if GA-driven interventions improve outcomes in older cancer patients receiving first-line or second-line chemotherapy by comparing rates of chemotherapy toxicity, hospitalizations, dose delays and early termination of treatment. The primary analysis will be a comparison of the proportion of patients who developed grade >3 toxicity over 3 months time using the likelihood ratio test.
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 1 May 2018.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
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
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Supriya Mohile, MD principal investigator
University of Rochester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GA-driven Intervention in people with Cancer, run by University of Rochester at 3 sites 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 8 inclusion and 3 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 1 May 2018. 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 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?
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?
Chemotherapy Toxicity (time frame: Over 3 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 1 May 2018.