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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02517034
Recruitment Status : Active, not recruiting
First Posted : August 6, 2015
Last Update Posted : December 12, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Neoplasm Other: Comprehensive Geriatric Assessment Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Survey Administration Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Advancing Screening and Treatment for Older Patients With Cancer
Actual Study Start Date : August 4, 2015
Estimated Primary Completion Date : November 20, 2023
Estimated Study Completion Date : November 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (geriatric assessment-driven treatment)
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
Follow geriatric assessment-driven treatment plan

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies
Active Comparator: Arm II (standard of care)
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
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517034


Locations
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United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
City of Hope Antelope Valley
Lancaster, California, United States, 93534
City of Hope Rancho Cucamonga
Rancho Cucamonga, California, United States, 91730
City of Hope South Pasadena
South Pasadena, California, United States, 91030
City of Hope West Covina
West Covina, California, United States, 91790
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Daneng Li City of Hope Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT02517034    
Other Study ID Numbers: 15161
NCI-2015-01202 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
15161 ( Other Identifier: City of Hope Medical Center )
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: December 12, 2022
Last Verified: December 2022