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Examining the preliminary efficacy of an intervention for fear of cancer recurrence in female cancer survivors: a randomized controlled clinical trial pilot study

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Abstract

Purpose

Among cancer survivors, fear of cancer recurrence (FCR) is the most frequently reported unmet need. Despite this, research on psychosocial interventions that target FCR is limited. To address this gap, an individual cognitive-existential psychotherapy intervention for FCR was pilot tested via small-scale RCT.

Methods

Participants were recruited via study posters, healthcare professionals’ referrals, and an electronic hospital database. Twenty-five female cancer survivors were randomized to experimental or wait-list control groups. Sessions included cognitive restructuring techniques, behavioral experiments, discussion of existential concerns, and relaxation exercises. Nineteen women completed the 6-week intervention and completed questionnaire packages at various time points. All participants completed self-administered questionnaires at pre-intervention (T1), post-intervention (T2), and at 3-month follow-up (T3). Participants in the control group also completed the same questionnaires, including at baseline (T0).

Results

Statistically significant results of between-within ANOVAs included time by condition interactions in the primary outcome measure of FCR and, for the experimental group participants, time by condition interactions in the secondary outcome measures of cancer-specific distress and uncertainty in illness. Statistically significant results of repeated measures ANOVAs included reductions in FCR, cancer-specific distress, uncertainty in illness, reassurance seeking, cognitive avoidance, and intolerance of uncertainty, as well as improvements in positive reinterpretation and growth, emotional coping, and quality of life (improved mental health), when compared to the control group. Most changes were maintained at 3-month follow-up.

Conclusions

This intervention responds to a need for evidence-based individual modality interventions targeting quality of life in cancer survivors. Our results demonstrate preliminary promising results in addressing FCR in female cancer survivors. Future research could seek to replicate results with a larger sample. Further research is needed to test this intervention with patients of mixed cancer sites.

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Acknowledgments

We are grateful to our study participants for their strength, courage, and resilience. Thank you all for trusting the therapeutic process.

Funding

This research was supported through a Young Researcher Award from the Faculty of Social Sciences of the University of Ottawa to Dr. Sophie Lebel.

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Correspondence to Christina Tomei.

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The authors declare that they have no conflict of interest.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.

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Informed consent was obtained from all individual participants included in the study.

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Tomei, C., Lebel, S., Maheu, C. et al. Examining the preliminary efficacy of an intervention for fear of cancer recurrence in female cancer survivors: a randomized controlled clinical trial pilot study. Support Care Cancer 26, 2751–2762 (2018). https://doi.org/10.1007/s00520-018-4097-1

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