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@ARTICLE{Schttker:275469,
      author       = {B. Schöttker$^*$ and L.-J. Chen$^*$ and R. Caspari and H.
                      Brenner$^*$},
      title        = {{P}rotocol of the optimal study: {O}ptimization of
                      polypharmacy in geriatric oncology - {A} randomized
                      controlled trial.},
      journal      = {BMC cancer},
      volume       = {23},
      number       = {1},
      issn         = {1471-2407},
      address      = {Heidelberg},
      publisher    = {Springer},
      reportid     = {DKFZ-2023-00779},
      pages        = {357},
      year         = {2023},
      note         = {#EA:C070#LA:C070#LA:C120#},
      abstract     = {Polypharmacy is very common in older cancer patients and
                      these patients are particularly vulnerable to drug-drug
                      interactions and adverse drug reactions because they often
                      receive chemotherapy and symptom-relieving agents.The
                      primary aim of the randomized, controlled Optimization of
                      Polypharmacy in Geriatric Oncology (OPTIMAL) trial is to
                      test whether an advisory letter with the results of a
                      comprehensive medication review conducted with the Fit fOR
                      The Aged (FORTA) list to the caring physician in
                      rehabilitation clinics improves the quality of life (QoL) of
                      older cancer patients exposed to polypharmacy more than
                      usual care. The FORTA list detects medication overuse,
                      underuse, and potentially inappropriate drug use among older
                      adults. In the oncology departments of approximately 10
                      German rehabilitation clinics, we aim to recruit 514 cancer
                      patients (22 common cancers; diagnosis or recurrence
                      requiring treatment in the last 5 years; all stages) who are
                      ≥ 65 years old, regularly take ≥ 5 drugs, and have ≥ 1
                      medication-related problem. All necessary information about
                      the patients will be provided to a pharmacist at the
                      coordinating center (German Cancer Research Center,
                      Heidelberg), who will perform randomization (1:1) and
                      conduct the medication review with the FORTA list. For the
                      intervention group only, the results are sent by letter to
                      the treating physician in the rehabilitation clinics, who
                      shall discuss medication changes with the patient at the
                      discharge visit, as well as implement them afterwards and
                      disclose them in the discharge letter to the general
                      practitioner. The control group gets the usual care provided
                      in German rehabilitation clinics, which usually does not
                      include a comprehensive medication review but can include
                      medication changes. Patients will be blinded, as they cannot
                      know whether proposed medication changes were part of the
                      study or part of usual care. Study physicians cannot be
                      blinded. The primary endpoint will be the EORTC-QLQ-C30
                      global health status/QoL score, assessed via
                      self-administered questionnaires 8 months after baseline.If
                      the planned study shows that a medication review with the
                      FORTA list improves the QoL of older cancer patients in
                      oncological rehabilitation more than usual care, it would
                      provide the necessary evidence to translate the trial's
                      findings into routine care.German Clinical Trials Register
                      (DRKS): DRKS00031024.},
      keywords     = {Cancer (Other) / Polypharmacy (Other) / Potentially
                      inappropriate medication (Other) / Quality of life (Other) /
                      Randomized controlled trial (Other) / Rehabilitation
                      (Other)},
      cin          = {C070 / C120 / HD01},
      ddc          = {610},
      cid          = {I:(DE-He78)C070-20160331 / I:(DE-He78)C120-20160331 /
                      I:(DE-He78)HD01-20160331},
      pnm          = {313 - Krebsrisikofaktoren und Prävention (POF4-313)},
      pid          = {G:(DE-HGF)POF4-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:37072729},
      doi          = {10.1186/s12885-023-10812-7},
      url          = {https://inrepo02.dkfz.de/record/275469},
}