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

• ClinicalTrials.gov Identifier: NCT02517034
• Recruitment Status: Active, not recruiting
• First Posted: August 6, 2015
• Last Update Posted: December 12, 2022
• Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): City of Hope Medical Center

Tracking Information

• First Submitted Date: July 28, 2015
• First Posted Date: August 6, 2015
• Last Update Posted Date: December 12, 2022
• Actual Study Start Date: August 4, 2015
• Estimated Primary Completion Date: November 20, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 4, 2015)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 7, 2019)

• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: August 4, 2015)

• Rate of hospitalizations during chemotherapy [ Time Frame: Up to 6 months ]
  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 ]
  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 ]
  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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Geriatric Assessment in Predicting Chemotherapy Toxicity and Vulnerabilities in Older Patients With Cancer
• Official Title: Advancing Screening and Treatment for Older Patients With Cancer
• 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Solid Neoplasm

Intervention

• 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

Study Arms

• 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.
  Interventions:

  • Other: Comprehensive Geriatric Assessment
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Other: Survey Administration
• 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.
  Interventions:

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

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 4, 2015): 600
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 20, 2023
• Estimated Primary Completion Date: November 20, 2023 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02517034
• Other Study ID Numbers: 15161; NCI-2015-01202 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 15161 ( Other Identifier: City of Hope Medical Center )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: City of Hope Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: City of Hope Medical Center
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Daneng Li; City of Hope Medical Center

• PRS Account: City of Hope Medical Center
• Verification Date: December 2022