Clinical trial NCT01915056: A Geriatric Assessment Intervention for Older Cancer Patients Receiving Chemotherapy
Official title: A Pilot Study of a Geriatric Assessment Intervention for Older Cancer Patients Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Comprehensive Geriatric Assessment (CGA)
GA-driven interventions
Toxicity
Outcomes
providing information
older cancer patients
first-line chemotherapy
second-line chemotherapy
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 80
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Although cancer is very common in older patients, the optimal treatment for cancer for this subset of patients is not well established. As a result of lack of knowledge on the safety and efficacy of chemotherapy in older adults, a significant proportion of older patients receiving chemotherapy have toxicity. There is also little information regarding how to best make decisions for and implement interventions to improve outcomes of older patients with cancer who are to receive treatment. Additionally, there is marked heterogeneity in the geriatric population, and patients of similar chronologic age may have wide disparity in their overall health status. Geriatricians utilize a tool called the Geriatric Assessment (GA) to gauge an older patient's overall health status and identify potential areas of deficits. The GA is a comprehensive tool, incorporating the assessment of physical function, co-morbid conditions, social support, nutritional, psychological, and cognitive status and medication review. A small number of studies in the oncology literature have demonstrated the value of GA in guiding cancer-directed treatment plans for older patients. GA can identify potential areas of deficits in an older patient's overall health status that have been shown to predict chemotherapy toxicity and guide interventions to improve outcomes for older patients. Studies of interventions in community-dwelling older adults have demonstrated efficacy at improving deficits identified on GA. However, in older patients with cancer, there is currently limited data regarding how GA can affect decision-making for treatment and impact overall clinical care.

In a two-arm, randomized pilot study, we will evaluate the effect of GA and GA-driven interventions on the outcomes of older cancer patients receiving first-line or second-line chemotherapy.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Chemotherapy Toxicity
timeFrame: Over 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Highland Hospital
state: New York
city: Rochester
country: United States
facility: Pluta Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Wilmot Cancer Center
state: New York
Study officials:
affiliation: University of Rochester
name: Supriya Mohile, MD
role: PRINCIPAL_INVESTIGATOR
References: