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Original research
Digital therapeutic to improve cancer-related well-being: a pilot randomized controlled trial
  1. Josefine Wolff1,
  2. Jens Stupin1,
  3. Jessica Olschewski1,
  4. Adak Pirmorady Sehouli2,
  5. Ayline Maier3,
  6. Mariama Fofana3,
  7. Jan Simon Raue3,
  8. Gandolf Finke3 and
  9. Jalid Sehouli1
  1. 1 Department of Gynecology with Center for Oncological Surgery, Charité Campus Virchow Clinic, Berlin University of Medicine, Berlin, Germany
  2. 2 Department of Psychosomatic Medicine and Psychotherapy, Charité – Berlin University of Medicine, Berlin, Germany
  3. 3 Fosanis GmbH, Berlin, Germany
  1. Correspondence to Professor Jalid Sehouli, Department of Gynecology with Center of Oncological Surgery, Charité – Berlin University of Medicine, Berlin, Germany; jalid.sehouli{at}charite.de

Abstract

Objective This randomized waitlist controlled pilot study aimed to evaluate the feasibility and preliminary efficacy of Mika, an app-based digital therapeutic intervention hypothesized to improve management and the support of cancer patients.

Methods Patients with gynecological malignancies undergoing post-operative or routine outpatient chemotherapy were randomized (5:2) into intervention (Mika plus treatment-as-usual) and control (treatment-as-usual alone). Feasibility outcomes including dropout rate, reasons for dropout, and intervention adherence, as well as efficacy outcomes including depression, fatigue, and health literacy were assessed at baseline, 4, 8, and 12 weeks. Changes in efficacy outcomes from baseline to week 12 were evaluated in the intervention group only by means of Wilcoxon signed-rank tests.

Results Seventy participants (intervention group, n=50; control group, n=20) with gynecological cancer (ovarian, cervical, and endometrial) were randomized. The dropout rate increased from 15.7% (11/70) between baseline and week 4 to 37.1% (26/70) between weeks 8 and 12. Primary reasons for dropout were death (n=10) and health status deterioration (n=11). The initial high intervention adherence observed between baseline and week 4 (86% usage rate, average usage time: 120 min, average number of logins: 16.7) declined in weeks 8 to 12 (46% usage rate, average usage time: 41 min, average number of logins: 9). Participants in the intervention group showed significant intra-individual reductions in depressive symptoms by 42% (d=0.85) and fatigue symptoms by 23.1% (d=0.5) from baseline to 12 weeks.

Conclusions This pilot study provides initial evidence of the feasibility and efficacy of Mika in improving the well-being of cancer patients. The high initial intervention adherence and significant reductions in depressive and fatigue symptoms suggest that Mika has the potential to improve the management and support of cancer patients.

Trial Registration German Clinical Trials Register (DRKS) ID: DRKS00023791; retrospectively registered on February 24, 2022.

  • Ovarian Cancer
  • Cervical Cancer
  • Endometrium

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/ijgc-2023-004304

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Contributors JW, J Stupin (first author), and J Sehouli contributed to the conception and design of the study, and data acquisition. Data analyses and interpretation were performed by JW, J Stupin, AM, and J Sehouli. The first draft of the manuscript was written by JW and J Stupin and revised by AM and MF. All authors commented on previous versions of the manuscript and contributed to the writing of the final manuscript. All authors read the final manuscript and approved the version to be published. J Sehouli is the contributing author and guarantor.

    • Funding This work was funded by Fosanis GmbH, the digital health company in Berlin, Germany that developed the Mika app.

    • Competing interests Co-authors JSR and GF are the two co-founders and managing directors of Fosanis GmbH, the company that developed the Mika app and funded the present research. Co-authors AM and MF are employees of Fosanis GmbH. All the other authors declare that they have no conflicts of interest.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.