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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 : March 11, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of Chicago
City of Hope National Medical Center
Information provided by (Responsible Party):
Supriya Mohile, University of Rochester NCORP Research Base

Tracking Information
First Submitted Date  ICMJE January 31, 2014
First Posted Date  ICMJE February 4, 2014
Last Update Posted Date March 11, 2020
Actual Study Start Date  ICMJE May 15, 2014
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2014)
Proportion of patients who experience grade 3-5 chemotherapy toxicity within 3 months of chemotherapy 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 chemotherapy toxicity for each arm, as well as risk ratios between the arms.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2014)
  • 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.
  • Decisional regret [ 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 CCOP 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.
  • Relative dose intensity (RDI) of chemotherapy given in the first line setting [ Time Frame: Up to 6 months ]
    The effect of the intervention on RDI of chemotherapy will be compared using four linear mixed models. For each model, Arm will be the fixed effect and CCOP will be a random effect. REML estimation will be used, and inference will be performed using the Kenward-Roger degrees of freedom adjustment procedure. A linear mixed model will be used to investigate whether the intervention changes chemotherapy dosing. In this model, RDI will be the response. The fixed effect will be Armand, the random effect will be CCOP. Overall change in dosing will be assessed with an F Test.
  • Likelihood of developing chemotherapy toxicity [ Time Frame: Up to 6 months ]
    Variables to be evaluated will be derived from patient assessments (Perceived Efficacy in Patient-Physician Interactions [PEPPI], Peace, Equanimity, and Acceptance in the Cancer Experience [PEACE], control preferences [CP]) and physician comfort (PC) with shared decision-making. A GLMM will be fit with chemotherapy toxicity as the response, Arm, PEPPI, PEACE, CP and PC as fixed factors, and CCOP site as a random effect independent of residual error.
  • 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 chemotherapy toxicity as the outcome, percent of recommended interventions as the fixed effect, and CCOP site as a random effect independent of residual error.
Current Other Pre-specified Outcome Measures
 (submitted: February 20, 2016)
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: January 31, 2014)
  • Change in functional abilities, measured with Instrumental Activities of Daily Living (IADL) score [ Time Frame: Baseline up to 6 months ]
    A GLMM will be used.
  • 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 used.
  • 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 chemotherapy decisions.
 
Descriptive Information
Brief Title  ICMJE Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer
Official Title  ICMJE A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy or Similar Agents for Advanced Cancer: Reducing Toxicity in Older Adults
Brief Summary This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing cancer treatment toxicity in older patients with cancer that has spread to other places in the body. A geriatric assessment may identify risk factors for cancer treatment toxicity and may improve outcomes for older patients with advanced cancer.
Detailed Description

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

TERTIARY OBJECTIVES:

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Adult Solid Neoplasm
  • Toxicity
  • Lymphoma
Intervention  ICMJE
  • Other: Comprehensive Geriatric Assessment
    Complete geriatric assessment
    Other Name: geriatric assessment
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Survey Administration
    Ancillary studies
Study Arms  ICMJE
  • Experimental: Arm I (GA intervention)
    Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
    Interventions:
    • Other: Comprehensive Geriatric Assessment
    • Other: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 12, 2019)
733
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2014)
750
Estimated Study Completion Date  ICMJE July 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02054741
Other Study ID Numbers  ICMJE URCC13059
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Supriya Mohile, University of Rochester NCORP Research Base
Study Sponsor  ICMJE Supriya Mohile
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • University of Chicago
  • City of Hope National Medical Center
Investigators  ICMJE
Principal Investigator: Supriya Mohile University of Rochester NCORP Research Base
PRS Account University of Rochester
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP