Clinical trial NCT02054741: Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Solid Neoplasm
Toxicity
Lymphoma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Chicago
name: City of Hope National Medical Center
First posted: 2014-02-04
Enrollment: 733
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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.

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 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.

Primary outcomes:
measure: Patient Experienced Any Grade 3-5 Toxicity
timeFrame: 3 months
Secondary outcomes:
measure: Patient Survival at 6 Months
timeFrame: 6 months
measure: Reduced Dose Intensity
timeFrame: 4-6 weeks
measure: GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
timeFrame: Baseline
measure: GA-driven Recommendations Made Among Patients With Impaired Functional Status.
timeFrame: Baseline
measure: GA-driven Recommendations Made Among Patients With Impaired Comorbidities.
timeFrame: Baseline
measure: GA-driven Recommendations Made Among Patients With Impaired Cognition.
timeFrame: Baseline
measure: GA-driven Recommendations Made Among Patients With Impaired Nutrition.
timeFrame: Baseline
measure: GA-driven Recommendations Made Among Patients With Impaired Social Support.
timeFrame: Baseline
measure: GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.
timeFrame: Baseline
measure: GA-driven Recommendations Made Among Patients With Impaired Psychological Status.
timeFrame: Baseline
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Newark
country: United States
facility: Delaware/Christiana Care NCORP
state: Delaware
city: Honolulu
country: United States
facility: Hawaii MU-NCORP
state: Hawaii
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Decatur
country: United States
facility: Heartland NCORP
state: Illinois
city: Prairie Village
country: United States
facility: Kansas City NCORP
state: Kansas
city: Wichita
country: United States
facility: Wichita NCORP
state: Kansas
city: New Orleans
country: United States
facility: Gulf South MU-NCORP
state: Louisiana
city: Grand Rapids
country: United States
facility: Cancer Research Consortium of West Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Metro Minnesota NCORP
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City NCORP
state: Missouri
city: Las Vegas
country: United States
facility: Nevada NCORP
state: Nevada
city: Lake Success
country: United States
facility: North Shore LIJ Health System NCORP
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Winston-Salem
country: United States
facility: Southeast Clinical Oncology Research Program
state: North Carolina
city: Columbus
country: United States
facility: Columbus NCORP
state: Ohio
city: Dayton
country: United States
facility: Dayton NCORP
state: Ohio
city: Portland
country: United States
facility: Pacific Cancer Research Consortium Ncorp
state: Oregon
city: Danville
country: United States
facility: Geisinger Cancer Institute NCORP
state: Pennsylvania
city: Greenville
country: United States
facility: NCORP of the Carolinas
state: South Carolina
city: Tacoma
country: United States
facility: Northwest NCORP
state: Washington
city: Marshfield
country: United States
facility: Wisconsin NCORP
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora NCORP
state: Wisconsin
Study officials:
affiliation: University of Rochester NCORP Research Base
name: Supriya Mohile
role: PRINCIPAL_INVESTIGATOR
References:
citation: Culakova E, Mohile SG, Peppone L, Ramsdale E, Mohamed M, Xu H, Wells M, Tylock R, Java J, Loh KP, Magnuson A, Jamieson L, Vogel V, Duberstein PR, Chapman BP, Dale W, Flannery MA. Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer. J Clin Oncol. 2023 Feb 1;41(4):835-846. doi: 10.1200/JCO.22.00738. Epub 2022 Nov 10.
citation: Presley CJ, Mohamed MR, Culakova E, Flannery M, Vibhakar PH, Hoyd R, Amini A, VanderWalde N, Wong ML, Tsubata Y, Spakowicz DJ, Mohile SG. A Geriatric Assessment Intervention to Reduce Treatment Toxicity Among Older Adults With Advanced Lung Cancer: A Subgroup Analysis From a Cluster Randomized Controlled Trial. Front Oncol. 2022 Mar 31;12:835582. doi: 10.3389/fonc.2022.835582. eCollection 2022.
citation: Mohile SG, Mohamed MR, Xu H, Culakova E, Loh KP, Magnuson A, Flannery MA, Obrecht S, Gilmore N, Ramsdale E, Dunne RF, Wildes T, Plumb S, Patil A, Wells M, Lowenstein L, Janelsins M, Mustian K, Hopkins JO, Berenberg J, Anthony N, Dale W. Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): a cluster-randomised study. Lancet. 2021 Nov 20;398(10314):1894-1904. doi: 10.1016/S0140-6736(21)01789-X. Epub 2021 Nov 3.
citation: Mohamed MR, Kyi K, Mohile SG, Xu H, Culakova E, Loh KP, Flannery M, Obrecht S, Ramsdale E, Patil A, Dunne RF, DiGiovanni G, Hezel A, Burnette B, Desai N, Giguere J, Magnuson A. Prevalence of and factors associated with treatment modification at first cycle in older adults with advanced cancer receiving palliative treatment. J Geriatr Oncol. 2021 Nov;12(8):1208-1213. doi: 10.1016/j.jgo.2021.06.007. Epub 2021 Jul 14.