Geriatric Assessment Intervention for Reducing Chemotherapy Toxicity in Older Patients with Advanced Cancer

Status: Closed to Accrual

Description

This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing chemotherapy toxicity in older patients with cancer that has spread to other places in the body. A geriatric assessment may identify risk factors for chemotherapy toxicity and may improve outcomes for older patients with advanced cancer.

Eligibility Criteria

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 the other agents present a prevalence of toxicity similar to chemotherapy; these therapies can be used in combination with chemotherapy, as a single agent, or in combination with each other * Chemotherapy will be 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; a list of allowable agents (single and in combination) meeting this toxicity criteria will be available on the University of Rochester Cancer Center (URCC) NCORP Research Base website as part of the study materials; given the rapidly changing landscape of new drugs for cancer, the study team led by the principal investigator (PI) will update the list accordingly after reviewing the toxicity profile of new therapies; if the potentially eligible participant is to receive an approved drug or regimen not on the list, contacting the URCC NCORP Research Base study team is required for approval prior to participant enrollment * 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
  • 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 * The plan for treatment should be for at least 3 months at time of study enrollment; the treatment can stop earlier during the study at the discretion of the physician and patient (e.g., due to progression as noted through imaging, toxicity, or patient preference)
  • 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 history of treated brain metastases are eligible if they are not symptomatic at the time of study enrollment

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Arti Hurria
Phone: 800-826-4673
Email: becomingapatient@coh.org

Delaware

Lewes
Beebe Medical Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Newark
Christiana Care Health System-Christiana Hospital
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830

Hawaii

Honolulu
Tripler Army Medical Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-9319
Email: supriya_mohile@urmc.rochester.edu

Illinois

Bloomington
Illinois CancerCare-Bloomington
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Chicago
Illinois Cancer Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Effingham
Crossroads Cancer Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Galesburg
Illinois CancerCare-Galesburg
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Peoria
Illinois CancerCare-Peoria
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Springfield
Springfield Clinic
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Swansea
Cancer Care Specialists of Illinois-Swansea
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830

Indiana

Richmond
Reid Health
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830

Kansas

Lenexa
Kansas Institute of Medicine Cancer and Blood Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Prairie Village
Kansas City NCI Community Oncology Research Program
Status: Active
Contact: Rakesh Gaur
Phone: 816-823-0555
Email: amy.krushelniski@HCAHealthcare.com

Louisiana

New Orleans
Louisiana State University Health Science Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Shreveport
Louisiana State University Health Sciences Center Shreveport
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830

Michigan

Flint
Genesys Hurley Cancer Institute
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-9319
Email: supriya_mohile@urmc.rochester.edu
Grand Rapids
Spectrum Health at Butterworth Campus
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Reed City
Spectrum Health Reed City Hospital
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830

Minnesota

Coon Rapids
Mercy Hospital
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Edina
Fairview-Southdale Hospital
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Fridley
Unity Hospital
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Maplewood
Saint John's Hospital - Healtheast
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Minneapolis
Health Partners Inc
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-9319
Email: supriya_mohile@urmc.rochester.edu
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Saint Paul
Regions Hospital
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Saint Louis
Missouri Baptist Medical Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830

Nevada

Las Vegas
OptumCare Cancer Care at Fort Apache
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-9319
Email: supriya_mohile@urmc.rochester.edu
OptumCare Cancer Care at Oakey
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-9319
Email: supriya_mohile@urmc.rochester.edu

New York

Lake Success
Northwell Health / Center for Advanced Medicine
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
New Hyde Park
Long Island Jewish Medical Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Rochester
University of Rochester
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5513
Email: Supriya_Mohile@URMC.Rochester.edu

North Carolina

Asheville
Mission Hospital Inc-Memorial Campus
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Goldsboro
Wayne Memorial Hospital
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Hendersonville
Hendersonville Hematology and Oncology at Pardee
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Margaret R Pardee Memorial Hospital
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Kernersville
Novant Health Oncology Specialists-Kernersville
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830

Ohio

Chillicothe
Adena Regional Medical Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Portsmouth
Southern Ohio Medical Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830

Oregon

Bend
Saint Charles Health System
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Oregon City
Providence Willamette Falls Medical Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Portland
Providence Portland Medical Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Providence Saint Vincent Medical Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830

South Carolina

Florence
McLeod Regional Medical Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Greenville
Greenville Health System Cancer Institute-Andrews
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Greenville Health System Cancer Institute-Butternut
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Greenville Health System Cancer Institute-Eastside
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Greenville Health System Cancer Institute-Faris
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Seneca
Greenville Health System Cancer Institute-Seneca
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Spartanburg
Greenville Health System Cancer Institute-Spartanburg
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-9319
Email: supriya_mohile@urmc.rochester.edu
Spartanburg Medical Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830

Washington

Centralia
Providence Regional Cancer System-Centralia
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Lacey
Providence Regional Cancer System-Lacey
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830

Wisconsin

Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Madison
Saint Mary's Hospital
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-5830
Manitowoc
Holy Family Memorial Hospital
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-9319
Email: supriya_mohile@urmc.rochester.edu
Marshfield
Marshfield Medical Center-Marshfield
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-9319
Email: supriya_mohile@urmc.rochester.edu
Minocqua
Marshfield Clinic-Minocqua Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-9319
Email: supriya_mohile@urmc.rochester.edu
Weston
Marshfield Clinic - Weston Center
Status: Active
Contact: Supriya Gupta Mohile
Phone: 585-275-9319
Email: supriya_mohile@urmc.rochester.edu

Trial Objectives and Outline

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 participants that 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.

III. Compare treatment decisions (as measured by relative dose intensity of the agents administered in the first cycle).

IV. Compare the number and type of GA-driven recommendations implemented for older participants starting a new treatment regimen for advanced cancer.

TERTIARY OBJECTIVES:

I. To determine whether providing oncology team 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.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Supportive care

Lead Organization

Lead Organization
University of Rochester NCORP Research Base

Principal Investigator
Supriya Gupta Mohile

Trial IDs

Primary ID URCC#13059
Secondary IDs URCC-13059, NCI-2013-01904, 13059, NCT02066168
Clinicaltrials.gov ID NCT02054741