Skip to main content
OpenTrials
Completed

NCT Number: NCT01915056

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Highland Hospital, Rochester, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Chemotherapy Toxicity

    Time frame: Over 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

A Pilot Study of a Geriatric Assessment Intervention for Older Cancer Patients Receiving Chemotherapy

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 2, 2013
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.