Geriatric Assessment in Predicting Chemotherapy Toxicity and Vulnerabilities in Older Patients With Cancer

NCT02517034 | Active Not Recruiting DMC

• 2 other identifiers: 15161NCI-2015-01202
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 5

Brief Summary

This randomized clinical trial studies a geriatric assessment intervention in predicting chemotherapy toxicity and vulnerabilities (or weakness) in older patients with cancer. Assessing patients' functional status, comorbidities, psychological state, social support, nutritional status, and cognitive function before treatment may help identify vulnerabilities, improve care, and decrease chemotherapy side effects in older patients with cancer.

Conditions

Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Rate of grade 3-5 toxicity during chemotherapy

  Compared pre versus (vs) post-chemotherapy. Tested using general linear models with an alpha of 0.05.

  Up to 6 months

Secondary Outcomes (3)

• Rate of hospitalizations during chemotherapy

  Up to 6 months

• Change in functional status as measured by the Older American Resources and Services Instrumental Activities of Daily Living

  Baseline to up to 6 months

• Change in quality of life as measured by Functional Assessment of Cancer Therapy - General

  Baseline to up to 6 months

Study Arms (2)

Arm I (geriatric assessment-driven treatment)

EXPERIMENTAL

Patients follow an intervention plan created by the NP using the results of the geriatric assessment. The NP discusses the results of the assessment and treatment recommendations with the patient. They also share the treatment plan, proposed referrals, and specific vulnerabilities with the primary care physician and community oncologist. Some patients complete the intervention plan via Telehealth, which uses telecommunication technology to provide health services over a distance.

Other: Comprehensive Geriatric Assessment; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration

Arm II (standard of care)

ACTIVE COMPARATOR

Patients follow a standard of care treatment plan at the discretion of the primary oncologist. Beginning 6 months from the start of chemotherapy, patients undergo the geriatric assessment as in Arm I. Some patients complete the standard of care treatment plan via Telehealth.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration

Interventions

Comprehensive Geriatric Assessment OTHER

Follow geriatric assessment-driven treatment plan

Arm I (geriatric assessment-driven treatment)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (geriatric assessment-driven treatment); Arm II (standard of care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (geriatric assessment-driven treatment); Arm II (standard of care)

Survey Administration OTHER

Ancillary studies

Arm I (geriatric assessment-driven treatment); Arm II (standard of care)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Diagnosis of a solid tumor malignancy (any stage)
• Scheduled to start a new chemotherapy regimen (any line, combination cytotoxic chemotherapy with targeted agents are allowed)
• English, Spanish, and/or Chinese speaking
• Able to provide written informed consent

You may not qualify if:

• Not fluent in English, Spanish and/or Chinese (because not all questionnaires have been validated in other languages)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope Antelope Valley

Lancaster, California, 93534, United States

Location

City of Hope Rancho Cucamonga

Rancho Cucamonga, California, 91730, United States

Location

City of Hope South Pasadena

South Pasadena, California, 91030, United States

Location

City of Hope West Covina

West Covina, California, 91790, United States

Location

Related Publications (1)

• Li D, Sun CL, Kim H, Soto-Perez-de-Celis E, Chung V, Koczywas M, Fakih M, Chao J, Cabrera Chien L, Charles K, Hughes SFDS, Katheria V, Trent M, Roberts E, Jayani R, Moreno J, Kelly C, Sedrak MS, Dale W. Geriatric Assessment-Driven Intervention (GAIN) on Chemotherapy-Related Toxic Effects in Older Adults With Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Nov 1;7(11):e214158. doi: 10.1001/jamaoncol.2021.4158. Epub 2021 Nov 18.

  PMID: 34591080 DERIVED

MeSH Terms

Interventions

Geriatric Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Daneng Li

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 6, 2015
• Study Start: August 4, 2015
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (5)