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@ARTICLE{Boyer:298172,
      author       = {L. Boyer and C. Bernardi and M. Leitzmann and M. Koller and
                      T. Pukrop and S. Einhell and D. Heudobler and K.
                      Steindorf$^*$ and W. Herr and A. Herrmann},
      title        = {{P}reliminary effectiveness of social prescription and
                      virtual patient information in increasing tertiary
                      prevention among cancer patients ({ESPRIT}): protocol for a
                      single-centre, randomised controlled pilot trial.},
      journal      = {BMJ open},
      volume       = {15},
      number       = {1},
      issn         = {2044-6055},
      address      = {London},
      publisher    = {BMJ Publishing Group},
      reportid     = {DKFZ-2025-00191},
      pages        = {e087177},
      year         = {2025},
      abstract     = {Tertiary prevention through physical activity and
                      psychosocial support can positively impact patient outcomes,
                      such as physical function and quality of life (QoL).
                      However, more research is required on the effectiveness of
                      strategies designed to increase the uptake of tertiary
                      prevention programmes among cancer patients. Here, we
                      present the protocol for a single-centre, randomised
                      controlled pilot trial testing the preliminary effectiveness
                      of social prescription and virtual patient information in
                      increasing tertiary prevention among cancer patients and
                      support persons (SPs) (ESPRIT 'Effectiveness of a social
                      prescription and virtual patient information in increasing
                      tertiary prevention' pilot trial).Cancer patients attending
                      medical oncology units at a university hospital in southern
                      Germany and their SPs will be randomly allocated as a dyad
                      to group A (social prescription (n=36)), group B (virtual
                      patient information (n=36)) or group C (usual care (n=36)).
                      The hospital is part of a Comprehensive Cancer Centre mainly
                      treating patients living in rural areas. Primary outcomes
                      are the uptake of physical activity, participation in social
                      activities and psychosocial support. Secondary outcomes are
                      overall QoL, knowledge of the health benefits of physical
                      activity and psychosocial support and self-efficacy of
                      patients. The outcomes will be assessed at baseline and
                      after 3, 6 and 12 months of follow-up. Physical activity
                      will be assessed using accelerometers and measured by
                      average steps per day within the last 2 weeks after
                      recruitment and at follow-up visits (3, 6 and 12 months).
                      Cost-effectiveness and the time spent in the consultation,
                      as well as potential implementation barriers and
                      facilitators, will also be explored as part of a
                      mixed-methods hybrid design. All data will be summarised
                      descriptively. Regarding the analysis of primary endpoints,
                      the average number of steps per day, as well as the summary
                      score of the social activity log and self-report on the use
                      of psychosocial support, will be compared between the groups
                      (A, B and C) using analysis of variance, followed by
                      Dunnett's test for pairwise comparisons of the intervention
                      groups against the control group. Mean differences and
                      $95\%$ CIs will be presented as effect estimates. The
                      analysis of secondary endpoints will include appropriate
                      statistical methods such as the χ2 test of independence or
                      linear regression models, which will be used to analyse
                      secondary endpoints and to investigate factors influencing
                      preliminary effectiveness.This trial has been approved by
                      the ethics committee of the University of Regensburg
                      (reference: 23-3317-101). Signed written informed consent is
                      required from all study participants. The results of the
                      study will be used to inform the power calculation for
                      future confirmatory trials and will be submitted for
                      publication.DRKS00033771.},
      keywords     = {Humans / Pilot Projects / Quality of Life / Neoplasms:
                      psychology / Neoplasms: prevention $\&$ control / Exercise /
                      Tertiary Prevention: methods / Social Support / Germany /
                      Male / Randomized Controlled Trials as Topic / Female / Self
                      Efficacy / ONCOLOGY (Other) / Patient-Centered Care (Other)
                      / Psychosocial Intervention (Other) / Quality of Life
                      (Other) / Social Support (Other)},
      cin          = {C110},
      ddc          = {610},
      cid          = {I:(DE-He78)C110-20160331},
      pnm          = {313 - Krebsrisikofaktoren und Prävention (POF4-313)},
      pid          = {G:(DE-HGF)POF4-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:39832968},
      pmc          = {pmc:PMC11752006},
      doi          = {10.1136/bmjopen-2024-087177},
      url          = {https://inrepo02.dkfz.de/record/298172},
}