OPTIMAL

Polypharmacy (5 or more medications used simultaneously) is very common in elderly cancer patients. For example, one in two colorectal cancer patients aged 65 or older is affected by polypharmacy. As the number of prescribed medications increases, the likelihood of drug side effects and interactions increases. Elderly cancer patients are particularly susceptible to unintended consequences of polypharmacy because they often receive chemotherapy, which may carry an additional risk for drug interactions.

Therefore, a comprehensive review of concomitant medications in older cancer patients has great potential to improve quality of life. One tool for comprehensive medication review is the FORTA list, which evaluates medications for their appropriateness for older patients (65 years and older) and suggests alternatives for inappropriate medications. Among patients with polypharmacy, there are often medications that can be discontinued without an exchange for another medication. Sometimes, however, important medications are missing. The FORTA list also provides advice on this so-called overuse and underuse of medications.

The primary objective of the proposed study is to test whether a letter with the result of a comprehensive medication review with the FORTA list to the treating oncologist in rehab improves the quality of life of elderly cancer patients more than usual care, in which no comprehensive medication review takes place.

The study aims to recruit 514 cancer patients in the oncology departments of several German rehabilitation hospitals, who are at least 65 years old, taking at least 5 concurrent medications, and have been diagnosed with one of the 22 most common types of cancer in Germany in the last 12 months. All necessary information about the patients included in the study will be transferred to a pharmacist at the coordinating center (German Cancer Research Center, Heidelberg), who will perform the medication review with the FORTA list for a randomly selected half of all study participants. The results are sent by letter to the responsible oncologist in the rehabilitation clinics, who can discuss the suggested medication changes with the patient at the discharge visit. The oncologist will include medication changes that the patient agrees to in the discharge letter to the primary care physician.

The other half of the study participants not selected at randomization represents the control group. They do not receive medication review with the FORTA list. However, isolated medication changes in the control group are also possible as part of usual care and are not prohibited in the study. Thus, study participants will not be able to know whether proposed medication changes were part of the study or part of usual care. Eight months after the start of the study, study participants in the two groups will be asked about their quality of life by questionnaire and the results will be compared.

Registration number with the German Register of Clinical Trials (DRKS): DRKS00031024