Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT02054741|
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : April 7, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Adult Solid Neoplasm Toxicity Lymphoma||Other: Comprehensive Geriatric Assessment Other: Quality-of-Life Assessment Other: Survey Administration||Not Applicable|
I. To determine if providing information regarding geriatric assessment (GA) and GA-driven recommendations to oncology physicians reduces clinician-rated grade 3-5 toxicity in patients aged 70 and over with advanced cancer starting a new treatment regimen.
I. Proportion of patients who are alive at 6 months after study entry. II. Evaluate whether providing oncology physicians with information regarding GA summary and GA-driven recommendations influences clinical care of older patients receiving treatment for advanced cancer.
IIA. Compare treatment decisions (as measured by relative dose intensity of the agents administered in the first cycle).
IIB. Describe the number and type of GA-driven recommendations implemented for older patients starting a new treatment regimen for advanced cancer.
OUTLINE: Treatment sites are randomized to 1 of 2 arms.
ARM I (GA intervention): Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
ARM II (usual care): Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
After completion of study, patients are followed up at 4-6 weeks, at 3 and 6 months, and at 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||733 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy or Similar Agents for Advanced Cancer: Reducing Toxicity in Older Adults|
|Actual Study Start Date :||May 15, 2014|
|Actual Primary Completion Date :||October 31, 2021|
|Actual Study Completion Date :||October 31, 2021|
Experimental: Arm I (GA intervention)
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
Other: Comprehensive Geriatric Assessment
Complete geriatric assessment
Other Name: geriatric assessment
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Survey Administration
No Intervention: Arm II (usual care)
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
- Proportion of patients who experience grade 3-5 toxicity within 3 months of initiation, graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0 [ Time Frame: At 3 months ]A generalized linear mixed model (GLMM) methodology will be used. Estimation will be performed using the Residual Pseudo Likelihood procedure, assuming a binomial distribution and logit link. Using the fitted model, estimates and 95% confidence intervals will be provided for proportion of patients who experience toxicity for each arm, as well as risk ratios between the arms.
- Proportion of patients who are alive at 6 months after study entry [ Time Frame: At 6 months ]Logrank tests and survival plots will be used.
- Describe geriatric assessment interventions (percentage of recommended interventions carried out) [ Time Frame: At 4-6 weeks ]Prevalence
- Compare prevalence of Reduced Dose Intensity in Cycle 1 by arm [ Time Frame: At 4-6 weeks ]A generalized linear mixed model (GLMM) methodology will be used. Estimation will be performed using the Residual Pseudo Likelihood procedure, assuming a binomial distribution and logit link. Using the fitted model, estimates and 95% confidence intervals will be provided for proportion of patients who experience toxicity for each arm, as well as risk ratios between the arms.
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|Ages Eligible for Study:||70 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- INCLUSION CRITERIA FOR PHYSICIANS
- Oncology physicians must work at a National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practice site with no plans to leave that NCORP practice site or retire at the time of enrollment into the study
- INCLUSION CRITERIA FOR PATIENTS
- Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma; in most situations, this would be a stage IV cancer; patients with a diagnosis of stage III cancer or lymphoma are eligible if cure is not possible or anticipated; clinical staging without pathological confirmation of advanced disease is allowed
- Plan to start a new cancer treatment regimen within 4 weeks from time of baseline registration; the treatment regimen is up to the discretion of the treating oncology physician; the regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity; patients who will receive monoclonal antibody therapy or other cancer therapies (e.g., tyrosine kinase inhibitors) are eligible if other agents present a prevalence of toxicity similar to chemotherapy; patients who are receiving approved cancer treatment in combination with radiation are eligible; a patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met. *Chemotherapy is defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy (>50%) will be allowed.
- Plan to be on chemotherapy or other allowable treatment for at least 3 months (minimum 70 days) and be willing to come in for study visits
- Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy
- Able to provide informed consent, or if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (or authorized representative per institutional policies) must sign consent by the baseline visit. If the participant is found to be impaired on the Blessed-Orientation Memory Concentration Test (BOMC) during screening; they must have a health care proxy or authorized representative to be eligible to enroll.
- Participant has adequate understanding of the English language
- EXCLUSION CRITERIA FOR PATIENTS
- Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible
- Presence of symptomatic brain metastases at time of study consent process. Patients with a history of treated brain metastases are eligible if they are not symptomatic at the time of study enrollment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054741
|Principal Investigator:||Supriya Mohile||University of Rochester NCORP Research Base|
|Responsible Party:||Supriya Mohile, Professor, University of Rochester NCORP Research Base|
|Other Study ID Numbers:||
NCI-2013-01904 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
URCC13059 ( Other Identifier: University of Rochester )
URCC-13059 ( Other Identifier: DCP )
URCC-13059 ( Other Identifier: CTEP )
UG1CA189961 ( U.S. NIH Grant/Contract )
U10CA037420 ( U.S. NIH Grant/Contract )
R01CA177592 ( U.S. NIH Grant/Contract )
|First Posted:||February 4, 2014 Key Record Dates|
|Last Update Posted:||April 7, 2022|
|Last Verified:||March 2022|