A Geriatric Assessment Intervention for Older Cancer Patients Receiving Chemotherapy

April 29, 2018 updated by: Supriya Mohile, University of Rochester

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14620
        • Highland Hospital
      • Rochester, New York, United States, 14623
        • Pluta Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester Wilmot Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
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.
Experimental: Treatment Arm
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.
Other: GA-driven Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Over 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Supriya Mohile, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 29, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UCCO-13034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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