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@ARTICLE{Sauer:289215,
      author       = {C. Sauer and S. Zschäbitz and J. Krauss and T. Walle$^*$
                      and G. M. Haag$^*$ and D. Jäger$^*$ and K. Hiller and T. J.
                      Bugaj and H.-C. Friederich and I. Maatouk},
      title        = {{E}lectronic health intervention to manage symptoms of
                      immunotherapy in patients with cancer ({SOFIA}): {R}esults
                      from a randomized controlled pilot trial.},
      journal      = {Cancer},
      volume       = {130},
      number       = {14},
      issn         = {0008-543X},
      address      = {New York, NY},
      publisher    = {Wiley-Liss},
      reportid     = {DKFZ-2024-00649},
      pages        = {2503-2514},
      year         = {2024},
      note         = {2024 Jul 15;130(14):2503-2514},
      abstract     = {For patients receiving immune checkpoint inhibitors, early
                      detection of immune-related adverse events (irAEs) is
                      critical for one's safety. To this end, a smartphone app
                      (SOFIA) was developed that featured the assessment of
                      electronic patient-reported outcomes (ePROs) focusing on
                      irAEs as well as a set of comprehensive supportive
                      information. Its feasibility and preliminary efficacy were
                      evaluated in a randomized controlled trial (RCT).Patients
                      who received immune checkpoint inhibition therapy were
                      randomly assigned to an intervention group (IG) or a control
                      group (CG; care as usual). During the 12-week intervention
                      period, IG patients used SOFIA to report twice weekly ePROs
                      and receive cancer- and immunotherapy-relevant contents.
                      Before a patient's next clinical visit, the physician in
                      charge was given the ePRO reports. The primary objective was
                      to test the feasibility of SOFIA. Furthermore, the
                      preliminary efficacy of SOFIA for health-related quality of
                      life (HRQOL), psychosocial outcomes, and medical data was
                      examined. Clinical outcomes were assessed at baseline (T0),
                      post-intervention (T1), and a 3-month follow-up
                      (T2).Seventy-one patients were randomized to the IG (n = 34)
                      or the CG (n = 37). SOFIA showed high feasibility and
                      acceptance. At T1, patients in the IG reported significantly
                      better HRQOL and role functioning and less depression,
                      distress, and appetite loss. No significant differences were
                      revealed regarding medical data, the utilization of
                      supportive care services, or survival.SOFIA showed high
                      feasibility and acceptance and improved HRQOL and
                      psychosocial outcomes. These results suggest further
                      evaluation of efficacy in a large-scale confirmatory
                      multicenter RCT.},
      keywords     = {cancer (Other) / electronic health (eHealth) (Other) /
                      electronic patient‐reported outcomes (ePROs) (Other) /
                      immunotherapy (Other) / mobile health (mHealth) (Other) /
                      psycho‐oncology (Other)},
      cin          = {F230 / D490 / D120 / HD01},
      ddc          = {610},
      cid          = {I:(DE-He78)F230-20160331 / I:(DE-He78)D490-20160331 /
                      I:(DE-He78)D120-20160331 / I:(DE-He78)HD01-20160331},
      pnm          = {314 - Immunologie und Krebs (POF4-314)},
      pid          = {G:(DE-HGF)POF4-314},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:38564338},
      doi          = {10.1002/cncr.35300},
      url          = {https://inrepo02.dkfz.de/record/289215},
}