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@ARTICLE{Sprave:166564,
      author       = {T. Sprave$^*$ and D. Zöller and R. Stoian$^*$ and A.
                      Rühle$^*$ and T. Kalckreuth$^*$ and E. Haehl$^*$ and H.
                      Fahrner and H. Binder and A.-L. Grosu$^*$ and F.
                      Heinemann$^*$ and N. H. Nicolay$^*$},
      title        = {{A}pp-{C}ontrolled {T}reatment {M}onitoring and {S}upport
                      for {H}ead and {N}eck {C}ancer {P}atients ({APCOT}):
                      {P}rotocol for a {P}rospective {R}andomized {C}ontrolled
                      {T}rial.},
      journal      = {JMIR Research Protocols},
      volume       = {9},
      number       = {12},
      issn         = {1929-0748},
      address      = {Toronto},
      reportid     = {DKFZ-2020-03007},
      pages        = {e21693},
      year         = {2020},
      abstract     = {Head and neck cancers (HNCs) are among the most common
                      malignancies, which often require multimodal treatment that
                      includes radiation therapy and chemotherapy. Patients with
                      HNC have a high burden of symptoms due to both the damaging
                      effects of the tumor and the aggressive multimodal
                      treatment. Close symptom monitoring over the course of the
                      disease may help to identify patients in need of medical
                      interventions.This APCOT (App-Controlled Treatment
                      Monitoring and Support for Head and Neck Cancer Patients)
                      trial is designed to assess the feasibility of monitoring
                      HNC patients during the course of (chemo)radiation therapy
                      daily using a mobile app. Additionally, symptom patterns,
                      patient satisfaction, and quality of life will be measured
                      in app-monitored patients in comparison to a patient cohort
                      receiving standard-of-care physician appointments, and
                      health economy aspects of app monitoring will be
                      analyzed.This prospective randomized single-center trial
                      will evaluate the feasibility of integrating electronic
                      patient-reported outcome measures (ePROMs) into the
                      treatment workflow of HNC patients. Patients undergoing
                      definitive or adjuvant (chemo)radiation therapy as part of
                      their HNC treatment at the Department of Radiation Oncology,
                      University Medical Center Freiburg (Freiburg, Germany) will
                      receive weekly physician appointments and additional
                      appointments as requested to monitor and potentially treat
                      symptoms during the course of treatment. Patients in the
                      experimental arm will additionally be monitored daily using
                      a dedicated app regarding their disease- and
                      treatment-related symptoms, quality of life, and need for
                      personal physician appointments. The feasibility of ePROM
                      monitoring will be tested as the primary endpoint and will
                      be defined if $≥80\%$ of enrolled patients have answered
                      $≥80\%$ of their daily app-based questions. Quality of
                      life will be assessed using the validated European
                      Organisation for Research and Treatment of Cancer
                      questionnaires, and patient satisfaction will be measured by
                      the validated Patient Satisfaction Questionnaire Short Form
                      at the initiation, in the middle, and at completion of
                      radiation therapy, as well as at follow-up examinations.
                      Additionally, the number and duration of physician
                      appointments during the course of radiation therapy will be
                      quantified for both ePROM-monitored and standard-of-care
                      patients.This trial will enroll 100 patients who will be
                      randomized (1:1) between the experimental arm with ePROM
                      monitoring and the control arm with standard patient care.
                      Recruitment will take 18 months, and trial completion is
                      planned at 24 months after enrollment of the last
                      patient.This trial will establish the feasibility of close
                      ePROM monitoring of HNC patients undergoing (chemo)radiation
                      therapy. The results can form the basis for further trials
                      investigating potential clinical benefits of detailed
                      symptom monitoring and patient-centered care in HNC patients
                      regarding oncologic outcomes and quality of life.German
                      Clinical Trials Register DRKS00020491;
                      $https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML\&TRIAL_ID=DRKS00020491.PRR1-10.2196/21693.$},
      keywords     = {HNSCC (Other) / head and neck cancer (Other) / mHealth
                      (Other) / mobile app (Other) / patient-reported outcome
                      measures (Other) / quality of life (Other) / radiotherapy
                      (Other)},
      cin          = {FR01 / E055},
      ddc          = {610},
      cid          = {I:(DE-He78)FR01-20160331 / I:(DE-He78)E055-20160331},
      pnm          = {315 - Imaging and radiooncology (POF3-315)},
      pid          = {G:(DE-HGF)POF3-315},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:33295291},
      doi          = {10.2196/21693},
      url          = {https://inrepo02.dkfz.de/record/166564},
}