Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer

PRIMARY OBJECTIVES:

I. To determine if providing information regarding geriatric assessment (GA) and GA-driven
recommendations to oncology physicians reduces clinician-rated grade 3-5 toxicity in patients
aged 70 and over with advanced cancer starting a new treatment regimen.

SECONDARY OBJECTIVES:

I. Proportion of patients who are alive at 6 months after study entry. II. Evaluate whether
providing oncology physicians with information regarding GA summary and GA-driven
recommendations influences clinical care of older patients receiving treatment for advanced
cancer.

IIA. Compare treatment decisions (as measured by relative dose intensity of the agents
administered in the first cycle).

IIB. Compare the number and type of GA-driven recommendations implemented for older patients
starting a new treatment regimen for advanced cancer.

TERTIARY OBJECTIVES:

I. To determine whether providing oncology physicians with GA information and GA-driven
recommendations can slow functional and physical decline in older patients with advanced
cancer.

II. To examine the association between patient-reported symptoms (as measured by
Patient-Reported Outcomes [PRO]-Common Terminology Criteria for Adverse Events [CTCAE]) and
geriatric domains (as measured by geriatric assessment).

III. To compare PRO-CTCAE and physician-rated CTCAE in a sample of older patients receiving
chemotherapy or other agents with similar prevalence of toxicity.

IV. To examine the association between PRO-CTCAE and treatment decisions. V. To examine the
association between PRO-CTCAE and adverse outcomes (early discontinuation of chemotherapy or
other agents with similar prevalence of toxicity, hospitalizations, and mortality).

OUTLINE: Treatment sites are randomized to 1 of 2 arms.

ARM I (GA intervention): Patients complete a geriatric assessment. Patients and physicians
are provided with the geriatric assessment information and recommendations.

ARM II (usual care): Patients complete a geriatric assessment, but information other than
clinically significant cognitive impairment and depression is not provided to the oncology
teams.

After completion of study, patients are followed up at 4-6 weeks, at 3 and 6 months, and at 1
year.

Inclusion Criteria:

- INCLUSION CRITERIA FOR PHYSICIANS

- Oncology physicians must work at a National Cancer Institute (NCI) Community Oncology
Research Program (NCORP) practice site with no plans to leave that NCORP practice site
or retire at the time of enrollment into the study

- INCLUSION CRITERIA FOR PATIENTS

- Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma; in most
situations, this would be a stage IV cancer; patients with a diagnosis of stage III
cancer or lymphoma are eligible if cure is not possible or anticipated; clinical
staging without pathological confirmation of advanced disease is allowed

- Plan to start a new cancer treatment regimen within 4 weeks from time of baseline
registration; the treatment regimen is up to the discretion of the treating oncology
physician; the regimen must include a chemotherapy drug or other agents that have
similar prevalence of toxicity; patients who will receive monoclonal antibody therapy
or other cancer therapies (e.g., tyrosine kinase inhibitors) are eligible if other
agents present a prevalence of toxicity similar to chemotherapy; patients who are
receiving approved cancer treatment in combination with radiation are eligible; a
patient may also be enrolled on a treatment trial and participate in this study, if
all other inclusion and exclusion criteria are met. *Chemotherapy is defined as
cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents)
that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy
(>50%) will be allowed.

- Plan to be on chemotherapy or other allowable treatment for at least 3 months (minimum
70 days) and be willing to come in for study visits

- Have at least one geriatric assessment domain meet the cut-off score for impairment
other than polypharmacy

- Able to provide informed consent, or if the oncology physician determines the patient
to not have decision-making capacity, a patient-designated health care proxy (or
authorized representative per institutional policies) must sign consent by the
baseline visit. If the participant is found to be impaired on the Blessed-Orientation
Memory Concentration Test (BOMC) during screening; they must have a health care proxy
or authorized representative to be eligible to enroll.

- Participant has adequate understanding of the English language

Exclusion Criteria:

- EXCLUSION CRITERIA FOR PATIENTS

- Have surgery planned within 3 months of consent; patients who have previously received
surgery are eligible

- Presence of symptomatic brain metastases at time of study consent process. Patients
with a history of treated brain metastases are eligible if they are not symptomatic at
the time of study enrollment.