Trial record 5 of 19 for:    hurria

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT02517034
First received: July 28, 2015
Last updated: August 26, 2015
Last verified: August 2015
  Purpose

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 Intervention
Solid Neoplasm
Other: Comprehensive Geriatric Assessment
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Advancing Screening and Treatment for Older Patients With Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Rate of grade 3-5 toxicity during chemotherapy [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Compared pre versus (vs) post-chemotherapy. Tested using general linear models with an alpha of 0.05.


Secondary Outcome Measures:
  • Rate of hospitalizations during chemotherapy [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Compared pre vs post-chemotherapy. We will consider general linear models for testing, but no alpha adjustments will be applied for multiple comparisons.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Change in quality of life as measured by the FACT-G (Functional Assessment of Cancer Therapy-General) [ Time Frame: Baseline to up to 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
Study Start Date: August 2015
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies

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.

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. 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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 and/or Spanish speaking
  • Able to provide written informed consent

Exclusion Criteria:

  • Not fluent in English and/or Spanish
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02517034

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Arti Hurria    800-826-4673      
Principal Investigator: Arti Hurria         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Arti Hurria City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT02517034     History of Changes
Other Study ID Numbers: 15161, NCI-2015-01202, 15161
Study First Received: July 28, 2015
Last Updated: August 26, 2015
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on August 27, 2015