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NCT Number: NCT02517034

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Solid Neoplasm

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center, Duarte, California, United States

Loading trial locations.

About this study

PRIMARY OBJECTIVES:

I. To identify areas of vulnerability in older adults with cancer through the use of a geriatric assessment, and to identify the potential referrals to an interdisciplinary team based on geriatric assessment results.

II. To determine whether the geriatric assessment driven interventions will lead to decrease in grade 3-5 toxicity.

SECONDARY OBJECTIVES:

I. To determine whether the geriatric assessment driven interventions will lead to improvement in the following outcomes: unplanned hospitalization, average length of stay (ALOS), emergency visits, unplanned readmission rates, and advance directive completion.

II. To determine whether there is significantly better quality of life (QOL) and function in the geriatric assessment intervention group compared to the standard of care group from start of treatment to the follow-up timepoint.

III. To determine the feasibility of delivering geriatric assessment driven interventions in a community setting using telemedicine.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients follow an intervention plan created by the nurse practitioner (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.

ARM II: 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Comprehensive Geriatric Assessment

Other

Follow geriatric assessment-driven treatment plan

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Rate of grade 3-5 toxicity during chemotherapy

    Time frame: Up to 6 months

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

Secondary outcomes

  1. Rate of hospitalizations during chemotherapy

    Time frame: Up to 6 months

    Compared pre vs post-chemotherapy. General linear models will be considered for testing, but no alpha adjustments will be applied for multiple comparisons.

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

    Time frame: Baseline to up to 6 months

    Compared pre vs post-chemotherapy. Explored using multivariate analyses. Results will be stratified by covariates such as patient age, poly- versus mono-chemotherapy, dose reduced or full dose therapy upfront, adjuvant versus metastatic disease, and number of prior chemotherapy regimens.

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

    Time frame: Baseline to up to 6 months

    Compared pre vs post-chemotherapy. Explored using multivariate analyses. Results will be stratified by covariates such as patient age, poly- versus mono-chemotherapy, dose reduced or full dose therapy upfront, adjuvant versus metastatic disease, and number of prior chemotherapy regimens.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Advancing Screening and Treatment for Older Patients With Cancer

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2015
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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