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Vaginal morbidity, sexual functioning, and health-related quality of life in cervical cancer survivors: a cross-sectional multicenter study (VAMOS)

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Abstract

Purpose

To compare sexual/vaginal functioning between early cervical cancer (ECC) and locally advanced cervical cancer (LACC) survivors.

Methods

VAMOS was a multicenter, cross-sectional, questionnaire, noninferiority study including ECC patients treated with surgery and, if clinically indicated, adjuvant (chemo)radiotherapy and LACC patients treated with neoadjuvant (chemo)radiotherapy followed by surgery. Patient-reported outcomes (PROs) were assessed using the EORTC QLQ-C30, EORTC QLQ-CX24, and Female Sexual Functioning Index (FSFI) questionnaires. Clinical reported outcomes (ClinROs) consisted of vaginal morbidity scored according to the CTCAE v4.0 scoring system.

Results

One hundred forty-three patients were included. Compared to ECC patients (n = 97), LACC patients (n = 46) were significantly less sexually active in the 4 weeks prior to completion of the questionnaires (65% vs. 41%; p = .005). The primary endpoint was not met: LACC patients reported a higher mean score (more problems) for sexual/vaginal functioning than ECC patients, with a non-clinically relevant mean difference of 6.38 ([95% CI: − 6.41, 19.17]; p = .570 for noninferiority). Regarding the secondary endpoints, the prevalence of sexual dysfunction between the two groups did not differ significantly (p = 0.124). Compared to ECC patients, LACC patients did not have significantly more vaginal morbidity (adjusted odds ratio [OR] 1.51 [95% CI: 0.22, 10.29]; p = .674). Moreover, there was poor agreement between any vaginal morbidity and sexual dysfunction (Cohen’s kappa of 0.17).

Conclusion

Compared to ECC survivors, LACC survivors were significantly less sexually active and reported equivalent or worse sexual/vaginal functioning, although the proportion of patients with sexual dysfunction was similar. Clinical assessment of vaginal morbidity was poorly correlated with sexual dysfunction.

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Data availability

The data that support the findings of this study are available on request from the corresponding author, E.N. The data are not publicly available due to information that could compromise the privacy of research participants.

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Acknowledgements

We thank all the women, their families, and their caregivers for participating in this study. E.N. is a clinical PhD Fellow of the Research Foundation-Flanders (FWO) (Grant Number: 1703020N). E.N. is supported by a grant from the Fund of Innovation and Research of Ghent University Hospital. E.A.D. is an “aspirant” (PhD Fellow) of the FWO (Grant Number: 1195919N) (https://www.fwo.be/en/). This work was supported by a grant from Fundamental Scientific Research/Fight Against Cancer Belgium (G0F9319N) in the name of K.V.

Funding

This work was supported by a grant from the Fundamental Scientific Research/Fight Against Cancer Belgium (G0F9319N) in the name of K.V.

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Authors and Affiliations

Authors

Contributions

Conceptualization: E.N., H.V., P.T., H.D., and K.V.; Methodology: E.N., H.V., P.T., H.D., and K.V.; Investigation: E.N., R.S., P.T., H.D., and K.V.; Data Curation: E.N., A.D., R.B., and K.V.; Formal analysis: A.D.; Writing – Original Draft: E.N.; Writing – Review & Editing: all authors; Funding: K.V.; Resources: all authors; Supervision: H.V., P.T., H.D., and K.V.

Corresponding author

Correspondence to Eline Naert.

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Ethics approval

Approval was obtained from the ethics committee of Ghent University Hospital, Belgium (B.U.N.: B670201939288). The procedures used in this study adhere to the tenets of the Declaration of Helsinki.

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Written informed consent was obtained from all participants included in the study.

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The authors declare no competing interests.

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Naert, E., Decruyenaere, A., Bultijnck, R. et al. Vaginal morbidity, sexual functioning, and health-related quality of life in cervical cancer survivors: a cross-sectional multicenter study (VAMOS). Support Care Cancer 31, 703 (2023). https://doi.org/10.1007/s00520-023-08155-x

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