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Longitudinal Assessment of the Quality of Life of Cervical Cancer Survivors from a Tertiary Hospital in Seville, Spain: Does Statistical Significance Equate to Clinical Relevance?

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Indian Journal of Gynecologic Oncology Aims and scope Submit manuscript

Abstract

Purpose

We aimed to perform a longitudinal assessment of the quality of life of cervical cancer survivors comparing statistical significance with minimal clinically important difference.

Methods

We conducted a prospective cohort study on the quality of life of 106 cervical cancer survivors between August 1, 2016 and January 31, 2019. The self-reported measures included the FACT-Cx v.4.0 and the WHOQOL-BREF questionnaires.

Results

We found no statistically significant changes in the quality of life (p > 0.05), except for a significant worsening in the group that underwent primary surgery and adjuvant radiation therapy and chemotherapy (p = 0.041). However, we observed minimal clinically important differences for all questionnaires regarding the total score (7.81 vs. 23.83 vs. 11.5 vs. 15.5 vs. 26.87 SDs), “physical” (7.28 vs. 4.75 vs. 5.13 vs. 3.79 vs. 4.95 SDs), “functional” (7.87 vs. 4.84 vs. 3.21 vs. 6.93 vs. 12.02 SDs), “emotional” (4.12 vs. 2.34 vs. 1 vs. 1 vs. 3.54 SDs; except for the comparison between the questionnaires at 12–24 months and 24–60 months after the end of the therapy), and “additional concerns” (8.59 vs. 11.13 vs. 8.19 vs. 6.93 vs. 5.66 SDs; except for the comparison between the questionnaires at 0–6 months and 12–24 months after the end of the therapy) domains of the FACT-Cx. The quality of life of long-term cervical cancer survivors was moderate-optimal regarding WHOQOL-BREF questionnaire scores (minimum “psychological healtha”: 48 ± 14.04; maximum “environmentd” 67.46 ± 20.40).

Conclusions

The quality of life of long-term cervical cancer survivors was moderate-optimal. No significant changes in the quality of life were found. However, considering minimal clinically important differences, there was an improvement of the quality of life throughout the follow-up.

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Data Availability

The data that support the findings of this study are available from the corresponding author upon reasonable request. The data are not publicly available due to the fact that their containing information could compromise the privacy of research participants.

Code Availability

Not applicable.

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Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Author information

Authors and Affiliations

  1. Clinical Management Unit for Obstetrics and Gynecology, University Hospital Virgen Macarena, 3 Dr Fedriani Ave., 41009, Seville, Spain

    Jorge Cea García, Francisco Márquez Maraver & Inmaculada Rodríguez Jiménez

  2. Institute of Science and Technology, Loyola University, De Las Universidades Ave., 41704, Dos Hermanas, Seville, Spain

    Laura Ríos-Pena

  3. Department of Radiation Oncology in University Hospital Sanchinarro, HM Hospital, 10 De Oña St., 28050, Madrid, Spain

    M. Carmen Rubio Rodríguez

  4. Faculty of Medicine, CEU San Pablo University, Montepríncipe Campus, 1D, 28668, Alcorcón, Madrid, Spain

    M. Carmen Rubio Rodríguez

  5. Department of Radiation Oncology in Puerta del Sur Hospital, HM Hospital, 70 Carlos V Ave., 28938, Móstoles, Madrid, Spain

    M. Carmen Rubio Rodríguez

  6. Advanced Gynecological Surgery Unit for Women in Nisa Aljarafe Hospital, INSEGO, Vithas Hospital, Plácido Fernández Viagas Ave., 41950, Castilleja de la Cuesta, Seville, Spain

    Francisco Márquez Maraver

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Contributions

All authors met the authorship criteria. JCG: investigation, conceptualization, methodology, writing—original draft preparation, visualization, writing-reviewing and editing. LR-P: methodology, software, data curation, formal analysis, validation, writing—reviewing and editing, and supervision. MCRR: supervision. FMM: resources and supervision. IRJ: resources and supervision. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Jorge Cea García.

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Conflict of interest

The authors have no competing interests to report.

Ethical Approval

The research project was approved by the Research Ethics Committee of our institution, according to the requirements of Spanish Law 14/2007 of July 3 on biomedical research and the 1964 Declaration of Helsinki.

Informed Consent

The research assistant obtained a written informed consent from each subject before each interview to participate and publish her data; participants were assured that they could stop the study process at any time and were assured that nonparticipation would have no consequences for their follow-up care or therapy. There was no refund for the participants.

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M. Carmen Rubio Rodríguez: Chief of Department; Francisco Márquez Maraver: Chief of Advanced Gynecological Surgery Unit for Women in INSEGO, Vithas-Nisa Aljarafe Hospital.

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Cea García, J., Ríos-Pena, L., Rubio Rodríguez, M.C. et al. Longitudinal Assessment of the Quality of Life of Cervical Cancer Survivors from a Tertiary Hospital in Seville, Spain: Does Statistical Significance Equate to Clinical Relevance?. Indian J Gynecol Oncolog 22, 24 (2024). https://doi.org/10.1007/s40944-023-00793-7

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