Improving Communication in Older Cancer Patients and Their Caregivers

OBJECTIVES:

I. Primary Aim - Direct Communication about Age-related Concerns: To determine if providing
GA summary plus GA-driven recommendations to patients, their caregivers, and oncology
physicians increases discussions about age-related issues during clinic consultation.
[Patient-Centered Outcomes Research Institute (PCORI) specified]

II. Primary Aim - Patient Satisfaction with Communication about Age-related Concerns: To
determine if providing geriatric assessment (GA) summary plus GA-driven recommendations to
patients, their caregivers and oncology physicians improves patient satisfaction with
communication with the oncology physician regarding age-related concerns. [National Cancer
Institute (NCI) specified]

III. Secondary Aim - To determine whether initially providing patients, their caregivers, and
oncology physicians with GA summary plus GA-driven recommendations prior to their treatment
influences quality of life of older patients receiving treatment and their caregivers.

IV. Secondary Aim - To determine whether providing patients, their caregivers, and oncology
physicians with GA summary plus GA-driven recommendations influences caregiver satisfaction
with communication about age-related issues.

OUTLINE: Patients are randomized to 1 of 2 arms.

Arm I: At the first study visit with their oncologist, patients and their caregivers (if
participating) complete the GA and receive the GA summary plus GA targeted recommendations
which is provided to the oncology team to discuss and implement if they so choose.

Arm II: At the first study visit with their oncologist, patients and their caregivers (if
participating) complete the GA (no GA summary or recommendations are provided).

Patients are followed at 4-6 weeks, 3 months, and 6 months. Survival data will be collected
at 1 year after enrollment.

Inclusion Criteria for Patients

- Male or female 70 years of age or older

- Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma. In most
situations, this would be a stage IV cancer. A patient with a diagnosis of stage III
cancer or lymphoma is eligible if cure is not possible or anticipated. Clinical
staging without pathological confirmation of advanced disease is allowed.

- Must be considering or currently receiving any kind of cancer treatment (any line),
including but not limited to hormonal treatment, chemotherapy, monoclonal antibody
therapy, or targeted therapy. Patients who are considering therapy are eligible even
if they ultimately choose not to be on therapy. Patients with a history of any
previous cancer treatment, including radiation and/or surgery 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.

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

- Have visits planned with the oncology physician for at least 3 months and be willing
to come in for study visits.

- 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 (per
institutional policies) must sign consent by the baseline visit.

- Subject has adequate understanding of the English language because not all GA measures
have been validated in other languages.

Exclusion Criteria for Patients

- Have surgery planned within 3 months of consent. Patients who have previously received
surgery are eligible.

- Have already made a decision to not undergo any cancer treatment (e.g., being followed
in best supportive care or hospice).

Inclusion Criteria for Caregivers

- Selected by the patient when asked if there is a "family member, partner, friend or
caregiver [age 21 or older] with whom you discuss or who can be helpful in
health-related matters;" patients who cannot identify such a person ("caregiver") can
be eligible for the study. A caregiver need not be someone who lives with the patient
or provides direct hands-on care. A caregiver can be any person who provides support
(in any way) to the patient.

- If a health care proxy signs consent for or with a patient, and wants to participate
in the caregiver portion of the study, this same person will always be the caregiver
selected. If a health care proxy does not want to enroll as a caregiver in the study
or, if enrolled, chooses to stop their own participation in the caregiver portion of
the study, but is able to assist the patient in completing the study, the patient can
still participate. In other words, the health care proxy can choose NOT to participate
in the caregiver portion of the study. This does not preclude the patient from
participating in the patient portion of the study with the health care proxy's
assistance.

Exclusion Criteria for Caregivers

-Caregivers unable to understand the consent form due to cognitive, health, or sensory
impairment will be excluded.