A Geriatric Assessment Intervention for Older Cancer Patients Receiving Chemotherapy
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 70 - Any |
| Updated: | 5/3/2018 |
| Start Date: | July 2013 |
| End Date: | January 2016 |
A Pilot Study of a Geriatric Assessment Intervention for Older Cancer Patients Receiving Chemotherapy
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.
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.
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.
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.
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
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