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Mindfulness-based cognitive therapy for Fear of Recurrence in Ovarian Cancer Survivors (FROCS): a single-arm, open-label, pilot study

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Abstract

Objective

Fear of recurrence is common following treatment for cancer. Our aim was to assess the feasibility of mindfulness-based cognitive therapy (MBCT) to treat fear of cancer recurrence (FCR) in ovarian cancer survivors.

Methods

Investigator initiated, single-arm, open-label, pilot study. Women were eligible after completing adjuvant treatment. The intervention was an 8-week MBCT course of weekly 2-h group sessions. The primary outcome was FCR measured by the FCR inventory. Secondary outcomes were depression and anxiety measured by the Hospital Anxiety and Depression Scale (HADS). The study is registered with the Australian and New Zealand Clinical Trials Registry ACTRN12615000213549.

Results

Between May 8, 2015, and May 6, 2019, 33 participants were enrolled. Ten women withdrew. Data were evaluable for 19 participants. There was a significant decrease in FCR at 8 weeks (FCR inventory mean 63.00, SD 27.90) compared to pre-intervention (FCR inventory mean 71.03, SD 31.01) but not at 6 months (FCR inventory mean 63.65, SD 30.08). No differences in depression were observed at baseline (HADS mean 3.42, SD 2.41), 8 weeks (HADS mean 3.10, SD 1.79) and 6 months (HADS mean 2.73, SD 1.88). Anxiety decreased from baseline (HADS mean 8.72, SD 3.99) at both 8 weeks (HADS mean 6.89, SD 2.98) and 6 months (HADS mean 7.06, SD 3.87).

Conclusions

MBCT may be effective as a treatment for FCR and anxiety in women following diagnosis and treatment of ovarian cancer. A randomised controlled trial is required to assess the efficacy of MBCT for FCR but may not be feasible due to high rates of withdrawal.

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Data availability

Data analysed during the current study are available in de-identified form from the corresponding author on reasonable request, subject to ethical approval.

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Acknowledgements

The authors would like to thank all the patients who participated in this study. We acknowledge Ms. Sanela Bilic, Project Manager, St John of God Subiaco Hospital, and Ms. Lesley Millar and Ms. Seng Sengsourinho, Cancer Council WA.

Funding

This study is funded by the St John of God Subiaco Hospital and Cancer Council Western Australia.

Author information

Authors and Affiliations

  1. Division of Obstetrics and Gynaecology, University of Western Australia, Crawley, WA, Australia

    Paul A. Cohen

  2. Dept of Gynaecological Oncology, St John of God Hospital, 12 Salvado Road, Subiaco, WA, 6008, Australia

    Paul A. Cohen & Stephanie Jeffares

  3. Division of Surgery, University of Western Australia, Crawley, WA, Australia

    Toni Musiello

  4. Division of Psychiatry, University of Western Australia, Crawley, WA, Australia

    Kellie Bennett

Authors
  1. Paul A. Cohen
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  2. Toni Musiello
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  3. Stephanie Jeffares
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  4. Kellie Bennett
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Contributions

All authors contributed to the study conception and design. Material preparation and data collection were performed by Stephanie Jeffares. Data analysis was performed by Kellie Bennett and Paul A. Cohen. The first draft of the manuscript was written by Paul A. Cohen and all authors revised the manuscript for critically important content. All authors read and approved the final manuscript. The first author (PC), research coordinator (SJ), statistician and senior author (KB) had full access to the data, vouch for the integrity of the data and the adherence to the study protocol and are responsible for the decision to submit the manuscript.

Corresponding author

Correspondence to Paul A. Cohen.

Ethics declarations

Ethics approval

This study was performed in line with the principles of the Declaration of Helsinki and the Australian National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (https://www.nhmrc. gov. au/ about- us/ publications/ national- statement- ethical conduct-human- research- 2007- updated- 2018; accessed 19 October 2020). Approval was granted by the St John of God Healthcare Human Research Ethics Committee (Date 11 February 2015, Reference #769).

Consent to participate

All participants provided written, informed consent.

Consent for publication

Participants provided written informed consent for publication of the study results.

Conflict of interest

Author Paul A. Cohen has received speaker honoraria from Seqirus and Astra Zeneca. All other authors declare no competing interests.

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Cohen, P.A., Musiello, T., Jeffares, S. et al. Mindfulness-based cognitive therapy for Fear of Recurrence in Ovarian Cancer Survivors (FROCS): a single-arm, open-label, pilot study. Support Care Cancer 30, 2317–2325 (2022). https://doi.org/10.1007/s00520-021-06659-y

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