A Geriatric Assessment Intervention for Older Cancer Patients Receiving Chemotherapy

NCT01915056 | Completed DMC

• 1 other identifier: UCCO-13034
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine whether information regarding GA and GA-driven interventions improves outcomes in older cancer patients receiving first-line or second-line chemotherapy by comparing rates of chemotherapy toxicity, hospitalizations, dose delays and early termination of treatment in patients with and without GA-driven interventions. The investigators will identify information that will be useful based on questionnaire responses and blood tests. These results will be used to better understand which recommendations and interventions will benefit older cancer patients. It is our hope that these tools, which are well-established at identifying areas of risk, will provide meaningful opportunities for intervention to promote your safety during cancer management. The investigators will be able to use this information to teach others on how to best care for adults aged 70 and older with cancer.

Conditions

Cancer

Keywords

Comprehensive Geriatric Assessment (CGA); GA-driven interventions; Toxicity; Outcomes; providing information; older cancer patients; first-line chemotherapy; second-line chemotherapy

Outcome Measures

Primary Outcomes (1)

• Chemotherapy Toxicity

  The primary outcome measure for this study is to determine if GA-driven interventions improve outcomes in older cancer patients receiving first-line or second-line chemotherapy by comparing rates of chemotherapy toxicity, hospitalizations, dose delays and early termination of treatment. The primary analysis will be a comparison of the proportion of patients who developed grade \>3 toxicity over 3 months time using the likelihood ratio test.

  Over 3 months

Study Arms (2)

Control Arm

NO INTERVENTION

Control Arm = Standard of Care. Patients who are randomized to the control arm will only have abnormal results on Geriatric Depression Scale (GDS) and cognitive evaluation communicated to their primary oncologist, as is customary. These results will be communicated to the primary team via electronic medical record and/or email communication. No other summary will be provided to oncologist.

Treatment Arm

EXPERIMENTAL

Treatment Arm = Standard care plus GA results and recommendations. For patients assigned to the treatment arm, individuals will be offered the option of completing the GA during a visit with their primary oncologist, or attending an additional visit at the multidisciplinary geriatric oncology clinic (GA-driven intervention). The intervention consists of providing results of geriatric assessment in a summary to oncologists.

Other: GA-driven Intervention

Interventions

GA-driven Intervention OTHER

For patients assigned to the treatment arm, individuals will be offered the option of completing the GA during a visit with their primary oncologist, or attending an additional visit at the multidisciplinary geriatric oncology clinic. The intervention consists of providing results of geriatric assessment in a summary to oncologists.

Treatment Arm

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Have a diagnosis of solid tumor malignancy or lymphoma
• Have advanced cancer
• Have received a recommendation for first or second line treatment with chemotherapy by their primary oncologist. Treatment regimens may include chemotherapy, chemoradiotherapy, targeted agents or monoclonal antibody.
• Planned chemotherapy for at least 3 months
• Be age 70 or older
• Have a live expectancy with treatment of 6 months or greater
• Able to provide informed consent or, if the physician deems the patient to not have decision-making capacity, a patient-designated health care proxy (that was pre-existing; prior to the patient losing decision-making capacity) must sign consent per institutional (University of Rochester and Research Subject Review Board) policies on consent for incapacitated/decisionally impaired subjects164,165
• Able to read and understand English (or possess a designated health care proxy that can do the same that was designated prior to the patient losing decision-making capabilities)

You may not qualify if:

• Have surgery planned within 3 months of consent
• Have a planned referral to the geriatric oncology clinic within one month of treatment initiation
• Patients who do not have decision-making capacity (decisionally or cognitively impaired) AND do NOT have a previously designated health care proxy (established prior to their cognitive impairment) available to sign consent

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (3)

Highland Hospital

Rochester, New York, 14620, United States

Location

Pluta Cancer Center

Rochester, New York, 14623, United States

Location

University of Rochester Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Supriya Mohile, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supriya Gupta Mohile, M.D., M.S. - Associate Professor of Medicine at the James Wilmot Cancer Center at the University of Rochester. Director, Geriatric Oncology Clinic.

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: August 2, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

US (3)