Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT02054741|
Recruitment Status : Active, not recruiting
First Posted : February 4, 2014
Last Update Posted : April 16, 2019
|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. Compare the number and type of GA-driven recommendations implemented for older patients starting a new treatment regimen for advanced cancer.
I. To determine whether providing oncology physicians with GA information and GA-driven recommendations can slow functional and physical decline in older patients with advanced cancer.
II. To examine the association between patient-reported symptoms (as measured by Patient-Reported Outcomes [PRO]-Common Terminology Criteria for Adverse Events [CTCAE]) and geriatric domains (as measured by geriatric assessment).
III. To compare PRO-CTCAE and physician-rated CTCAE in a sample of older patients receiving chemotherapy or other agents with similar prevalence of toxicity.
IV. To examine the association between PRO-CTCAE and treatment decisions. V. To examine the association between PRO-CTCAE and adverse outcomes (early discontinuation of chemotherapy or other agents with similar prevalence of toxicity, hospitalizations, and mortality).
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|
|Estimated Primary Completion Date :||October 25, 2019|
|Estimated Study Completion Date :||February 21, 2020|
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.
- Decision making [ Time Frame: Up to 6 months ]The effect of the intervention on decisional regret for both patient and physician will be compared using four linear mixed models (regret). For each model, Arm will be the fixed effect and NCORP will be a random effect (independent of residual error). Restricted Maximum Likelihood (REML) estimation will be used, and inference will be performed using the Kenward-Roger degrees of freedom adjustment procedure. The effect of the intervention on relative dose intensity (RDI) of treatment will be analyzed in the same manner. In this model, RDI will be the response.
- Uptake of geriatric assessment interventions (percentage of recommended interventions carried out) [ Time Frame: Up to 6 months ]The data from the intervention arm will be fit to a GLMM with toxicity as the outcome, percent of recommended interventions as the fixed effect, and NCORP site as a random effect independent of residual error. Otherwise, the modeling methodology is the same as for the Primary Aim.
- Change in functional abilities, measured with Instrumental Activities of Daily Living (IADL) score [ Time Frame: Baseline up to 6 months ]A GLMM will be fit with toxicity as the response, Arm, IADL as fixed factors, and NCORP site as a random effect independent of a residual error.
- Change in physical performance, measured with the Older Americans Resources and Services (OARS) Physical Health Subscale and the Short Physical Performance Battery [ Time Frame: Baseline up to 6 months ]A GLMM will be fit with toxicity as the response, Arm, OARS Physical health and/or SPPB as fixed factors, and NCORP site as a random effect independent of a residual error.
- PRO-CTCAE [ Time Frame: Up to 6 months ]PRO-CTCAE analyses will be performed using descriptive statistics, correlations, and regressions to evaluate changes in symptoms over time, relationship between PRO results and clinician-related to toxicity, and relationship of symptoms with treatment decisions.
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
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|Principal Investigator:||Supriya Mohile||University of Rochester NCORP Research Base|