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@ARTICLE{Sauer:169899,
      author       = {C. Sauer and J. Krauß and D. Jäger and S. Zschäbitz and
                      G. M. Haag and T. Walle$^*$ and S. Sauer and S. Kiermeier
                      and H.-C. Friederich and I. Maatouk},
      title        = {e{H}ealth intervention to manage symptoms for patients with
                      cancer on immunotherapy ({SOFIA}): a study protocol for a
                      randomised controlled external pilot trial.},
      journal      = {BMJ open},
      volume       = {11},
      number       = {7},
      issn         = {2044-6055},
      address      = {London},
      publisher    = {BMJ Publishing Group},
      reportid     = {DKFZ-2021-01633},
      pages        = {e047277},
      year         = {2021},
      abstract     = {Immune checkpoint therapy (ICT) is associated with a
                      distinct pattern of immune-related adverse events (irAEs)
                      caused by inadvertently redirecting immune responses to
                      healthy tissues. IrAEs can occur at any time; however, in
                      most cases, they arise during the first 14 weeks of the
                      beginning of immune checkpoint blockade. In many cases,
                      immunotherapy must be discontinued due to irAEs. Early
                      detection of irAEs triggers the temporary withholding of ICT
                      or initiation of short-term immunosuppressive treatment, is
                      crucial in preventing further aggravation of irAEs and
                      enables safe re-exposure to ICT. This prospective study aims
                      to evaluate the feasibility of an eHealth intervention for
                      patients under immunotherapy (managing symptoms of
                      immunotherapy, SOFIA). The SOFIA-App consists of two
                      components: SOFIA-Monitoring, a tool to rate
                      patient-reported outcomes (PROs) including irAEs, and
                      SOFIA-Coaching, which provides important information about
                      cancer-specific and immunotherapy-specific topics and the
                      counselling services of the National Centre for Tumour
                      Diseases (NCT) Heidelberg.We outlined a patient-level
                      two-arm randomised controlled pilot trial of the
                      intervention (SOFIA) versus no-SOFIA for patients with
                      cancer beginning an immunotherapy, aged ≥18 years,
                      recruited from the NCT, Heidelberg. Feasibility outcomes
                      include: recruitment rate; drop-out rate; reasons for
                      refusal and drop-out; willingness to be randomised,
                      utilisation rate of SOFIA-Monitoring and utilisation time of
                      SOFIA-Coaching, physicians utilisation rate of the PROs;
                      feasibility of the proposed outcome measures and optimal
                      sample size estimation. The clinical outcomes are measures
                      of quality of life, psychosocial symptoms, self-efficacy,
                      physician-patient communication and medical process data,
                      which are assessed at the beginning of the intervention,
                      postintervention and at 6-month follow-up.This trial
                      protocol was approved by the Ethical Committee of Heidelberg
                      University, Germany (Reference, S-581/2018).We registered
                      the study in the German Clinical Trial Register (Reference:
                      DRKS00021064). Findings will be disseminated broadly via
                      peer-reviewed empirical journals, articles and conference
                      presentations.},
      keywords     = {adverse events (Other) / mental health (Other) / oncology
                      (Other)},
      cin          = {F230},
      ddc          = {610},
      cid          = {I:(DE-He78)F230-20160331},
      pnm          = {316 - Infektionen, Entzündung und Krebs (POF4-316)},
      pid          = {G:(DE-HGF)POF4-316},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:34281921},
      doi          = {10.1136/bmjopen-2020-047277},
      url          = {https://inrepo02.dkfz.de/record/169899},
}