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URCC 13059: Solid Tumors or Lymphoma; GAP

A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Advanced Cancer: Reducing Chemotherapy Toxicity in Older Adults

Objective

Overview

This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing cancer treatment toxicity in older patients with cancer that has spread to other places in the body. A geriatric assessment may identify risk factors for cancer treatment toxicity and may improve outcomes for older patients with advanced cancer.

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
  • 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
  • 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

Key Exclusion Criteria

A patient will not be eligible for participation in this study if any of the following criteria apply.
  • 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.

Phase: N/A

Learn More

ClinicalTrials.Gov

IRB Protocol Number
URCC 13059
Principal Investigator(s)
James D. Bearden III, M.D.

Clinical Trial Categories

  • Symptom Management & Cancer Control
Sponsor(s)
Gary Morrow
How to Participate

LaToya Davis

864-560-0297

ldavis@gibbscc.org

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