Totally Implantable Venous Access Devices: A Randomized Controlled Trial on the Effect of Psychological Support on Quality of Life and Body Image (BI-PORT)

Eleonora Pinto, Elisa Granziera, Matteo Cagol, Sandra Cappellato, Rita Alfieri, Valentina Mari, Muzio Meroni, Vittorina Zagonel, Pierfranco Conte, Pierluigi Pilati, Carlo Castoro, Francesco Cavallin, Marco Scarpa, Eleonora Pinto, Elisa Granziera, Matteo Cagol, Sandra Cappellato, Rita Alfieri, Valentina Mari, Muzio Meroni, Vittorina Zagonel, Pierfranco Conte, Pierluigi Pilati, Carlo Castoro, Francesco Cavallin, Marco Scarpa

Abstract

Background: The presence of totally implantable venous access devices (TIVADs), as any permanent or semipermanent medical devices, has an impact on the quality of life (QoL) of patients. Therefore, the purpose of this trial was to evaluate the efficacy of psychological support for patients undergoing this procedure. Methods: This randomized controlled trial (RCT) aimed to compare the efficacy of a psychological intervention vs. standard care on QoL in patients receiving TIVAD for chemotherapy treatment (ClinicalTrials.gov NCT02075580). The trial was conducted at the Veneto Institute of Oncology IOV-IRCCS (Padua, Italy) between October 2013 and September 2018. Participants were neoplastic adults receiving TIVAD for chemotherapy treatment for any cancer, not undergoing visible demolitive interventions, without psychopathological diagnosis and language understanding. The exclusion criteria were patients without a diagnosis of cancer, with psychopathological diagnosis, or with language misunderstanding. Results: The variation of C30-QL2 and BR32-BI was not statistically different between intervention and control arms in men and women. However, the variation of C30-SF was statistically better in the intervention than control arm in men [mean difference (MD) 22.3, 95% CI 3.5 to 41.0] but not in women (MD -2.7, 95% CI -24.0 to 18.7). The variations of the other secondary outcome measures were not statistically different between intervention and control arms. Conclusion: Psychological support did not show any clear advantages on global QoL and body image perception in patients at 15 days after TIVAD insertion for chemotherapy. In contrast, male patients might benefit from even a very short psychological counseling before or during chemotherapy even if they do not seem to ask for it.

Keywords: body image; chemotherapy; psychological support; quality of life; totally implantable venous access devices.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Pinto, Granziera, Cagol, Cappellato, Alfieri, Mari, Meroni, Zagonel, Conte, Pilati, Castoro, Cavallin and Scarpa.

Figures

FIGURE 1
FIGURE 1
Study design.
FIGURE 2
FIGURE 2
Flowchart of patient inclusion.
FIGURE 3
FIGURE 3
Primary and secondary outcome measures stratified by sex: variation from baseline (hospital admission) to postoperative (15 days after surgery).

References

    1. Aaronson N. K., Ahmedzai S., Bergman B., Bullinger M., Cull A., Duez N. J., et al. (1993). The European Organisation for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J. Natl. Cancer Inst. 85 365–376.
    1. Ahadzadeh A. S., Rafik-Galea S., Alavi M., Amini M. (2018). Relationship between body mass index, body image, and fear of negative evaluation: moderating role of self-esteem. Health Psychol. Open 5:205510291877 4251.
    1. Apolone G., Filiberti A., Cifani S., Ruggiata R., Mosconi P. (1998). Evaluation of the EORTC QLQ-C30 questionnaire: a comparison with SF-36 health survey in a cohort of Italian long-survival cancer patients. Ann. Oncol. 9 549–557.
    1. Araújo C., Silva J. P., Antunes P., Fernandes J. M., Dias C., Pereira H., et al. (2008). A comparative study between two central veins for the introduction of totally implantable venous access devices in 1201 cancer patients. Eur. J. Surg. Oncol. 34 222–226. 10.1016/j.ejso.2007.04.003
    1. Aricò D., Raggi A., Ferri R. (2016). Cognitive behavioral therapy for insomnia in breast cancer survivors: a review of the literature. Front. Psychol. 7:1162. 10.3389/fpsyg.2016.01162
    1. Biffi R., De Braud F., Orsi F., Pozzi S., Arnaldi P., Goldhirsch A., et al. (2001). A randomized, prospective trial of central venous ports connected to standard open-ended or Groshong catheters in adult oncology patients. Cancer 92 1204–1212. 10.1002/1097-0142(20010901)92:5<1204::AID-CNCR1439>;2-9
    1. Bowie J., Brunckhorst O., Stewart R., Dasgupta P., Ahmed K. (2020). A systematic review of tools used to assess body image, masculinity and self-esteem in men with prostate cancer. Psychooncology 29 1761–1771. 10.1002/pon.5518
    1. Brédart A., Bottomley A., Blazeby J. M., Conroy T., Coens C., D’Haese S., et al. (2005). An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32). Eur. J. Cancer 41 2120–2131. 10.1016/j.ejca.2005.04.041
    1. Burbridge B., Chan I. Y., Bryce R., Lim H. J., Stoneham G., Haggag H., et al. (2016). Satisfaction and quality of life related to chemotherapy with an Arm Port: a pilot study. Can. Assoc. Radiol. J. 67 290–297. 10.1016/j.carj.2015.11.007
    1. Burbridge B., Goyal K. (2016). Quality-of-life assessment: arm TIVAD versus chest TIVAD. J. Vasc. Access. 17 527–534. 10.5301/jva.5000609
    1. Conessa C., Talfer S., Herve S., Chollet O., Poncet J. L. (2002). Cephalic vein access for implantable venous access devices. tech long-term follow-up. Rev. Laryngol. Otol. Rhinol. (Bord) 123 143–148.
    1. Friston K. (2012). Prediction, perception and agency. Int. J. Psychophysiol. 83 248–252. 10.1016/j.ijpsycho.2011.11.014
    1. Galloway S., Bodenham A. (2004). Long-term central venous access. Br. J. Anaesth. 92 722–734. 10.1093/bja/aeh109
    1. Gamsakhurdia V. L. (2019). Constructive urge for self-presentation-mediating between the past and the future. Integr. Psychol. Behav. Sci. 53 238–257. 10.1007/s12124-018-9466-2
    1. Gjerset G. M., Tendille M., Skaali T., Kiserud C. E., Dahl A. A., Gudbergsson S. B., et al. (2019). Gender differences in health status and benefits of a one-week educational programme for caregivers of cancer patients. Eur. J. Cancer Care (Engl.) 28:e12992. 10.1111/ecc.12992
    1. Granziera E., Scarpa M., Ciccarese A., Filip B., Cagol M., Manfredi V., et al. (2014). Totally implantable venous access devices: retrospective analysis of different insertion techniques and predictors of complications in 796 devices implanted in a single institution. BMC Surg. 14:27. 10.1186/1471-2482-14-27
    1. Harris K., Spiegelhalder K., Espie C. A., MacMahon K. M., Woods H. C., Kyle S. D. (2015). Sleep-related attentional bias in insomnia: a state-of-the-science review. Clin. Psychol. Rev. 42 16–27. 10.1016/j.cpr.2015.08.001
    1. Jordan K., Behlendorf T., Surov A., Kegel T., Maher G., Wolf H. H. (2008). Venous access ports: frequency and management of complications in oncology patients. Onkologie 31 404–410. 10.1159/000140451
    1. Kelly M. P. (2015). Diagnostic categories in autobiographical accounts of illness. Perspect. Biol. Med. 58 89–104. 10.1353/pbm.2015.0002
    1. Lewis-Smith H., Diedrichs P. C., Rumsey N., Harcourt D. (2018). Efficacy of psychosocial and physical activity-based interventions to improve body image among women treated for breast cancer: a systematic review. Psychooncology 27 2687–2699. 10.1002/pon.4870
    1. Marcy P. Y., Schiappa R., Ferrero J. M., Dahlet C., Brenet O., Yazbec G., et al. (2017). Patient satisfaction and acceptance of their totally implanted central venous catheter: a French prospective multicenter study. J. Vasc. Access. 18 390–395. 10.5301/jva.5000744
    1. Minichsdorfer C., Füreder T., Mähr B., Berghoff A. S., Heynar H., Dressler A., et al. (2016). A cross-sectional study of patients’ satisfaction with totally implanted access ports. Clin. J. Oncol. Nurs. 20 175–180. 10.1188/16.CJON.175-180
    1. Morales-Sánchez L., Luque-Ribelles V., Gil-Olarte P., Ruiz-González P., Guil R. (2021). Enhancing self-esteem and body image of breast cancer women through interventions: a systematic review. Int. J. Environ. Res. Public Health 18:1640. 10.3390/ijerph18041640
    1. R Core Team (2020). R: A Language and Environment for Statistical Computing. Vienna: R Foundation for Statistical Computing.
    1. Rhoten B. A. (2016). Body image disturbance in adults treated for cancer–a concept analysis. J. Adv. Nurs. 72 1001–1011. 10.1111/jan.12892
    1. Ruesch S., Walder B., Tramer M. R. (2002). Complications of central venous catheters: internal jugular versus subclavian accesse a systematic review. Crit. Care Med. 30 454–460. 10.1097/00003246-200202000-00031
    1. Ryan C., Hesselgreaves H., Wu O., Moss J., Paul J., Dixon-Hughes J., et al. (2019). Patient acceptability of three different central venous access devices for the delivery of systemic anticancer therapy: a qualitative study. BMJ Open 9:e026077.
    1. Satinsky S., Reece M., Dennis B., Sanders S., Bardzell S. (2012). An assessment of body appreciation and its relationship to sexual function in women. Body Image 9 137–144. 10.1016/j.bodyim.2011.09.007
    1. Scarpa M., Pinto E., Saraceni E., Cavallin F., Parotto M., Alfieri R., et al. (2017). Randomized clinical trial of psychological support and sleep adjuvant measures for postoperative sleep disturbance in patients undergoing oesophagectomy. Br. J. Surg. 104 1307–1314. 10.1002/bjs.10609
    1. Schulmeister L. (2010). Management of non-infectious central venous access device complications. Semin. Oncol. Nurs. 26 132–141. 10.1016/j.soncn.2010.02.003
    1. Schulz K. F., Altman D. G., Moher D. CONSORT Group (2010). CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 340:c332. 10.1136/bmj.c332
    1. Scott N. W., Fayers P. M., Aaronson N. K., Bottomley A., de Graeff A., Groenvold M., et al. (2008). EORTC QLQ-C30 Reference Values. Brussels: EORTC Quality of Life Group Publications.
    1. Sebri V., Durosini I., Triberti S., Pravettoni G. (2021). The efficacy of psychological intervention on body image in breast cancer patients and survivors: a systematic-review and meta-analysis. Front. Psychol. 12:611954. 10.3389/fpsyg.2021.611954
    1. Sherman K. A., Przezdziecki A., Alcorso J., Kilby C. J., Elder E., Boyages J., et al. (2018). Reducing body image-related distress in women with breast cancer using a structured online writing exercise: results from the my changed body randomized controlled trial. J. Clin. Oncol. 36 1930–1940. 10.1200/JCO.2017.76.3318
    1. Sidika K., Pinar S., Tulay A. (2002). Totally implantable venous-access ports: local problems and extravasation injury. Lancet Oncol. 3 684–693. 10.1016/S1470-2045(02)00905-1
    1. Sitlinger A., Zafar S. Y. (2018). Health-related quality of life: the impact on morbidity and mortality. Surg. Oncol. Clin. N. Am. 27 675–684. 10.1016/j.soc.2018.05.008
    1. Sommer K., Cottone F., Aaronson N. K., Fayers P., Fazi P., Rosti G., et al. (2020). Consistency matters: measurement invariance of the EORTC QLQ-C30 questionnaire in patients with hematologic malignancies. Qual. Life Res. 29 815–823. 10.1007/s11136-019-02369-5
    1. Spatuzzi R., Vespa A., Lorenzi P., Miccinesi G., Ricciuti M., Cifarelli W., et al. (2016). Evaluation of social support, quality of life, and body image in women with breast cancer. Breast Care (Basel) 11 28–32. 10.1159/000443493
    1. Sprangers M. A., Groenvold M., Arraras J. I., Franklin J., te Velde A., Muller M., et al. (1996). The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J. Clin. Oncol. 14 2756–2768. 10.1200/JCO.1996.14.10.2756
    1. Trerotola S. O., Kuhn-Fulton J., Johnson M. S., Shah H., Ambrosius W. T., Kneebone P. H. (2000). Tunneled infusion catheters: increased incidence of symptomatic venous thrombosis after subclavian versus internal jugular venous access. Radiology 217 89–93. 10.1148/radiology.217.1.r00oc2789
    1. Triberti S., Savioni L., Sebri V., Pravettoni G. (2019). eHealth for improving quality of life in breast cancer patients: a systematic review. Cancer Treat. Rev 74 1–14. 10.1016/j.ctrv.2019.01.003
    1. Tylka T. L., Wood-Barcalow N. L. (2015). What is and what is not positive body image? Conceptual foundations and construct definition. Body Image 14 118–129. 10.1016/j.bodyim.2015.04.001
    1. Vanaken L., Bijttebier P., Hermans D. (2021). An investigation of the coherence of oral narratives: associations with mental health, social support and the coherence of written narratives. Front. Psychol. 11:602725. 10.3389/fpsyg.2020.602725
    1. Vilela L. D., Nicolau B., Mahmud S., Edgar L., Hier M., Black M., et al. (2006). Comparison of psychosocial outcomes in head and neck cancer patients receiving a coping strategies intervention and control subjects receiving no intervention. J. Otolaryngol. 35 88–96. 10.2310/7070.2005.5002
    1. WHOQOL Group (1995). The World Health Organization Quality of Life assessment (WHOQOL): position paper from the World Health Organization. Soc. Sci. Med. 41 1403–1409. 10.1016/0277-9536(95)00112-K
    1. Xiong Z. Y., Zhou H. M., Li S. Y. (2021). Prolonged flushing and locking interval for totally implantable vascular access device: a systematic review and meta-analysis. J. Vasc. Access. 22, 1–10. 10.1177/11297298211003003
    1. Yoon S. Y., Jeon G. S., Jung S. (2021). Image-guided placement of totally implanted vascular access device: retrospective analysis of the clinical outcomes and associated risk factors. BMJ Support. Palliat. Care 29, 1–9. 10.1136/bmjspcare-2021-002917
    1. Zaghal A., Khalife M., Mukherji D., El Majzoub N., Shamseddine A., Hoballah J., et al. (2012). Update on totally implantable venous access devices. Surg. Oncol. 21 207–215. 10.1016/j.suronc.2012.02.003

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